Conjugate · 191 amino acids · 23,305.1 Da

Somapacitan studies and research data

PepBank has 46 somapacitan studies with results. All of them gave somapacitan, with 320 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.

Searches 320 results and 64 papers. Newer studies from Europe PMC

Results in people

289

90% of 320 results

Results in animals

7% of 320 results

Results in lab cells

3% of 320 results

From computer models

0% of 320 results

The molecule

Somapacitan identity

Identifiers, parent molecule, targets and development stage, from curated data.

Somapacitan is a 191-residue growth hormone analog with an albumin-binding side chain at Cys101. It replaces endogenous growth hormone in labeled populations.

Kind: Conjugate · 191 residues
Identifiers: ChEMBLCHEMBL3707290 (opens in a new tab)UNII8FOJ430U94 (opens in a new tab)DrugBankDB15093 (opens in a new tab)CAS1338578-34-9
Parent: Analog of Human growth hormoneSomapacitan uses the 191-residue mature human growth hormone backbone with L101C and a side chain conjugated at Cys101. Alignment to UniProt P01241 residues 27-217 shows only L101C. The existing somatotropin record remains the parent. No fragment positions are asserted.
Development: Approved in the US and EU (Sogroya, 2020)Novo NordiskSogroya is approved. The US label and EMA EPAR establish the approved populations. Novo Nordisk holds the product authorisation. A trial indication alone does not establish approval. Source (opens in a new tab)

Targets

Molecular targets with action and evidence source
Target	Action	Evidence
Growth hormone receptorGHRP10912 (opens in a new tab)	Agonist	Official prescribing information, mechanism of actionSource (opens in a new tab)

Sequence and structure

Residues, differences from the parent, calculated properties and 3D structure. Source values and calculated values are shown separately.

Sequence

191 amino acids · 1 modification · 2 disulfide bonds

H-

FPTIPLSRLF

DNAMLRAHRL

HQLAFDTYQE

FEEAYIPKEQ

KYSFLQNPQT

SLCFSESIPT

PSNREETQQK

SNLELLRISL

LLIQSWLEPV

QFLRSVFANS

VYGASDSNV

YDLLKDLEEG

IQTLMGRLED

GSPRTGQIFK

QTYSKFDTNS

HNDDALLKNY

GLLYCFRKDM

DKVETFLRIV

QCRSVEGSCG

-OH

Alignment to Human growth hormone

Calculated from the two sequences. Curated notes are shown as given.

190 of 191 aligned residues identical (99%) · 1 substitution · Human growth hormone 1–191

Top row: Human growth hormone (parent)
Bottom row: Somapacitan

FPTIPLSRLF

DNAMLRAHRL

HQLAFDTYQE

FEEAYIPKEQ

KYSFLQNPQT

SLCFSESIPT

PSNREETQQK

SNLELLRISL

LLIQSWLEPV

QFLRSVFANS

VYGASDSNV

YDLLKDLEEG

IQTLMGRLED

GSPRTGQIFK

QTYSKFDTNS

HNDDALLKNY

GLLYCFRKDM

DKVETFLRIV

QCRSVEGSCG

Same as parent
Substituted
Non-canonical or D-form
Added
Gap
Modified side chain or end

Differences from the parent

1Parent 101 · analog 101Leu → Cys · SubstitutionThe L101C substitution introduces L-cysteine. Its sulfur carries the albumin-binding side chain and hydrophilic spacer.

Basis: Somapacitan uses the 191-residue mature human growth hormone backbone with L101C and a side chain conjugated at Cys101. Alignment to UniProt P01241 residues 27-217 shows only L101C. The existing somatotropin record remains the parent. No fragment positions are asserted.

Calculated from the two sequences with @pepdb/chem alignToParent (ungapped unless a gap scores higher). The record’s curated notes are shown as given.

Properties

From identity sources

Formula: C₁₀₃₈H₁₆₀₉N₂₇₃O₃₁₉S₉
Molecular weight: 23,305.1 g/mol

GSRS UNII 8FOJ430U94(opens in a new tab)retrieved 2026-10-27
Curated Sogroya US label(opens in a new tab)retrieved 2026-10-27
Curated EMA initial assessment, structure and receptor activation(opens in a new tab)retrieved 2026-10-27
Curated FDA pharmacology review, stereochemical name(opens in a new tab)retrieved 2026-10-27
Curated GSRS modified Cys101 fragment(opens in a new tab)retrieved 2026-10-27

Calculated from the sequence

pKa set

Some values cannot be calculated. A modification changes this value and is not modeled here (for example a lipid, metal or linker).

Average mass: Not calculated
Monoisotopic mass: Not calculated
Isoelectric point (pI): Not calculated
Net charge at pH 7.4: Not calculated
GRAVY (hydropathy): −0.418; Mean Kyte-Doolittle hydropathy · Kyte and Doolittle 1982; Negative: hydrophilic on average.
Extinction coefficient, 280 nm (Cys reduced): 17,420 M⁻¹ cm⁻¹; 5500 x Trp + 1490 x Tyr · Pace et al. 1995 (ExPASy ProtParam)
Extinction coefficient, 280 nm (all Cys as cystines): 17,670 M⁻¹ cm⁻¹; 5500 x Trp + 1490 x Tyr + 125 x cystine · Pace et al. 1995 (ExPASy ProtParam)
Instability index: 42.08; Dipeptide instability weights (DIWV) · Guruprasad et al. 1990; Above 40: classed as possibly unstable (ExPASy).
Aliphatic index: 81.7; Mole % A + 2.9 V + 3.9 (I + L) · Ikai 1980
Boman index: 1.96 kcal/mol; Mean solubility value (negated) · Boman 2003; 2.48 or below: lower protein-binding potential (Boman).
Hydrophobic moment (μH): 0.678; Eisenberg scale, 100° per residue, best 11-residue window · Eisenberg et al. 1982, 1984

Not included: other modification. Mass, charge and pI are not calculated; use the identity-source values.
Defined and validated for proteins; use with care for short peptides.
Assumes an ideal alpha helix. Many short peptides are not helical.

@pepdb/chem 0.2.0 · EMBOSS pKa set · ExPASy residue masses

Net charge by pH

No charge curve

A modification changes this value and is not modeled here (for example a lipid, metal or linker).

Composition

Hydrophobic26% (50)A I L M V
Aromatic12% (22)F W Y
Positive12% (23)H K R
Negative13% (25)D E
Polar26% (50)N Q S T
Special11% (21)C G P

191 residues. Each residue counts in one class; F and W count as aromatic.

A Ala7 · 4%

I Ile8 · 4%

L Leu25 · 13%

M Met3 · 2%

V Val7 · 4%

F Phe13 · 7%

W Trp1 · 1%

Y Tyr8 · 4%

H His3 · 2%

K Lys9 · 5%

R Arg11 · 6%

D Asp11 · 6%

E Glu14 · 7%

N Asn9 · 5%

Q Gln13 · 7%

S Ser18 · 9%

T Thr10 · 5%

C Cys5 · 3%

G Gly8 · 4%

P Pro8 · 4%

3D structure

PredictedAlphaFold DB · P01241

Loads the 3D viewer (3Dmol.js, about 150 KB) and the model file from AlphaFold DB (EMBL-EBI).

Helical wheel

An ideal alpha-helix projection. It shows where the hydrophobic residues fall if the peptide folds as a helix. It does not show that it does.

μH, residues shown: 0.175
μH, best 11-residue window: 0.678
Arrow direction: 156°
Residues: 1–54 of 191 · 3 rings of 18

HydrophilicHydrophobic

Eisenberg consensus (normalized) scale · + K, R · − D, E

Assumes an ideal α-helix: 100° per residue, 3.6 residues per turn. The arrow is the mean hydrophobic moment (Eisenberg et al. 1984) and points at the hydrophobic face.

Show as table

Position	Residue	Angle	Eisenberg consensus (normalized)
1	F	0°	1.19
2	P	100°	0.12
3	T	200°	-0.05
4	I	300°	1.38
5	P	40°	0.12
6	L	140°	1.06
7	S	240°	-0.18
8	R	340°	-2.53
9	L	80°	1.06
10	F	180°	1.19
11	D	280°	-0.90
12	N	20°	-0.78
13	A	120°	0.62
14	M	220°	0.64
15	L	320°	1.06
16	R	60°	-2.53
17	A	160°	0.62
18	H	260°	-0.40
19	R	0°	-2.53
20	L	100°	1.06
21	H	200°	-0.40
22	Q	300°	-0.85
23	L	40°	1.06
24	A	140°	0.62
25	F	240°	1.19
26	D	340°	-0.90
27	T	80°	-0.05
28	Y	180°	0.26
29	Q	280°	-0.85
30	E	20°	-0.74
31	F	120°	1.19
32	E	220°	-0.74
33	E	320°	-0.74
34	A	60°	0.62
35	Y	160°	0.26
36	I	260°	1.38
37	P	0°	0.12
38	K	100°	-1.50
39	E	200°	-0.74
40	Q	300°	-0.85
41	K	40°	-1.50
42	Y	140°	0.26
43	S	240°	-0.18
44	F	340°	1.19
45	L	80°	1.06
46	Q	180°	-0.85
47	N	280°	-0.78
48	P	20°	0.12
49	Q	120°	-0.85
50	T	220°	-0.05
51	S	320°	-0.18
52	L	60°	1.06
53	C	160°	0.29
54	F	260°	1.19

Results by area

Somapacitan results by year and outcome

Counts are exact and come from studies that gave the peptide.

Studies by year

46 of 64 studies have results (72%), published 2017 to 2026. Top row: every study. Bottom row: studies with results about Somapacitan, by class. The rows use different scales.

Studies
Human
Animal
Lab
Computer model
Natural levels, tool or combination only

Studies64 in all, 2017 to 2026

Studies with results46 in all, 2017 to 2026

Retracted studies are left out. A study with results in two classes counts in both.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

What the studies measured

People first in each area, then animals, then lab cells. Counts are exact and come from studies that gave the peptide.

Somapacitan studies on growth hormone and growth

98 results · people 94 · animals 4 · lab 0

Top 5 of 98 results

In children with GHD, growth speed was numerically lower with somapacitan than daily GH, within the trial's noninferiority limit.The Journal of clinical endocrinology and metabolism, 2022
In girls with Turner syndrome, growth velocity was lower with somapacitan than daily GH, but met non-inferiority criteria.The Journal of clinical endocrinology and metabolism, 2026
In children with GHD, height scores were similar with somapacitan and daily GH.Journal of the Endocrine Society, 2020
In children with GHD, somapacitan growth speed was numerically lower than daily GH and met the noninferiority threshold.Journal of the Endocrine Society, 2022
In children with Noonan syndrome, somapacitan produced faster growth than daily GH.European journal of endocrinology, 2026

Somapacitan studies on side effects

75 results · people 75 · animals 0 · lab 0

Top 5 of 75 results

In Japanese adults with GH deficiency, adverse event rates were similar with somapacitan and daily GH.Clinical endocrinology, 2020
In children with GHD, injection-site reactions occurred in 5.3% with somapacitan and 5.9% with daily GH.The Journal of clinical endocrinology and metabolism, 2022
In Japanese adults with GHD, no antibodies against somapacitan were detected.Journal of the Endocrine Society, 2020
In adults with GH deficiency, no new diabetes cases occurred with somapacitan.Pituitary, 2023
During year 4 in children continuing somapacitan, four patients had nasopharyngitis.Journal of the Endocrine Society, 2022

Somapacitan studies on blood sugar

25 results · people 25 · animals 0 · lab 0

Top 3 of 25 results

In GH-naïve adults, blood sugar changed less with somapacitan than daily GH at 34 weeks.Pituitary, 2023
In children with GHD, somapacitan showed no clinically relevant changes in glucose metabolism.Journal of the Endocrine Society, 2022
In adults with GHD, HbA1c, fasting glucose, and insulin resistance did not differ significantly after switching from somatropin to somapacitan.Journal of the Endocrine Society, 2026

Somapacitan studies on blood levels and clearance

38 results · people 22 · animals 16 · lab 0

Top 3 of 38 results

In healthy participants, total somapacitan exposure met bioequivalence limits for the lower versus higher strength.Clinical pharmacokinetics, 2024
In children with GHD, blood somapacitan concentrations increased nonlinearly as the dose increased.Clinical endocrinology, 2017
In healthy men, 94.0% of a somapacitan dose was recovered as related material after 28 days.European journal of pharmaceutical sciences, 2021

Somapacitan studies on weight and appetite

19 results · people 17 · animals 2 · lab 0

Top 5 of 19 results

In adults with GH deficiency, somapacitan reduced trunk fat more than placebo.The Journal of clinical endocrinology and metabolism, 2020
In Japanese adults with GH deficiency, visceral fat decreased from baseline with somapacitan and daily GH.Frontiers in endocrinology, 2025
In rats without a pituitary gland, somapacitan increased growth as the dose increased.Growth hormone & IGF research, 2017
In Japanese adults with GH deficiency, visceral fat was numerically lower with somapacitan than daily GH, without statistical significance.Clinical endocrinology, 2020
In adults with GH deficiency, lean mass change did not differ between somapacitan and daily GH.The Journal of clinical endocrinology and metabolism, 2026

Somapacitan studies on daily life and fitness

12 results · people 12 · animals 0 · lab 0

Top 5 of 12 results

In Japanese adults with GHD, effectiveness scores numerically favored somapacitan over daily GH, without statistical significance.Journal of the Endocrine Society, 2020
In adults with GH deficiency, switching to somapacitan was linked to improved handgrip strength.The Journal of clinical endocrinology and metabolism, 2026
In children with GHD, emotional scores numerically favored somapacitan over daily GH and exceeded the important-difference threshold, without statistical significance.Journal of the Endocrine Society, 2020
In children with GHD, physical functioning scores numerically favored somapacitan over daily GH, without statistical significance.Journal of the Endocrine Society, 2020
In children with GHD, total scores numerically favored somapacitan over daily GH and exceeded the important-difference threshold, without statistical significance.Journal of the Endocrine Society, 2020

Somapacitan studies on use, access and costs

11 results · people 11 · animals 0 · lab 0

Top 5 of 11 results

In Chinese children with GHD, somapacitan reduced treatment burden compared with daily GH.Hormone research in paediatrics, 2026
Children with GHD and their parents seemed to experience less treatment burden after switching from daily GH to somapacitan.The Journal of clinical endocrinology and metabolism, 2023
In children with GHD, somapacitan reduced treatment burden more than daily GH.The Journal of clinical endocrinology and metabolism, 2022
In Japanese adults with GH deficiency, the mean somapacitan dose after titration was 1.780 mg/week.Clinical endocrinology, 2020
In children with GHD, mean and median adherence were higher with somapacitan than daily GH.Journal of the Endocrine Society, 2022

Somapacitan studies on immune system and inflammation

7 results · people 7 · animals 0 · lab 0

Top 5 of 7 results

In adults receiving somapacitan, hs-CRP changes were positively linked to AST changes.Journal of endocrinological investigation, 2025
In children with GHD receiving somapacitan, no neutralizing antibodies against somapacitan were detected.Journal of the Endocrine Society, 2022
In adults with GHD, hs-CRP decreased from baseline after somapacitan therapy.Journal of endocrinological investigation, 2025
In adults receiving somapacitan, hs-CRP changes were positively linked to ALT changes.Journal of endocrinological investigation, 2025
In children with GHD receiving somapacitan, no neutralizing antibodies against GH were detected.Journal of the Endocrine Society, 2022

Somapacitan studies on liver

6 results · people 6 · animals 0 · lab 0

Top 3 of 6 results

In adults with GHD, AST decreased slightly after somapacitan, but the change was not statistically significant.Journal of endocrinological investigation, 2025
In adults with GHD, switching to somapacitan was linked to improved liver function after 6 months compared with baseline.Medicine, 2023
In adults with GH deficiency, AST improved after switching to somapacitan compared with the switch assessment.Drug discoveries & therapeutics, 2026

Somapacitan studies on pain

5 results · people 5 · animals 0 · lab 0

Top 3 of 5 results

In children with GHD, injection-site pain occurred in 1.5% with somapacitan and daily GH.Journal of the Endocrine Society, 2022
In children with prior injection pain, questionnaire responses favored somapacitan over somatrogon for pain at needle insertion.Frontiers in endocrinology, 2026
In children with prior injection pain, questionnaire responses favored somapacitan over somatrogon for pain during injection.Frontiers in endocrinology, 2026

Somapacitan studies on cholesterol and blood fats

4 results · people 4 · animals 0 · lab 0

Top 3 of 4 results

In adults with GH deficiency, switching to somapacitan was linked to improved HDL cholesterol.The Journal of clinical endocrinology and metabolism, 2026
In adults with GH deficiency, triglycerides improved after switching to somapacitan compared with the switch assessment.Drug discoveries & therapeutics, 2026
In a man with T1DM receiving somapacitan, blood fatty acids followed a trend parallel to weekly glucose fluctuations.JCEM case reports, 2025

Somapacitan studies on hormones

4 results · people 4 · animals 0 · lab 0

Top 3 of 4 results

In adults with GH deficiency, TSH did not change after switching from somatropin to somapacitan.Growth hormone & IGF research, 2026
In adults with GH deficiency, FT3 decreased after switching to somapacitan, particularly among those receiving levothyroxine.Growth hormone & IGF research, 2026
In adults with GH deficiency, FT4 decreased after switching to somapacitan, particularly among those receiving levothyroxine.Growth hormone & IGF research, 2026

Somapacitan studies on heart and blood vessels

3 results · people 3 · animals 0 · lab 0

3 results

In adults with GH deficiency, systolic blood pressure improved after switching to somapacitan compared with the switch assessment.Drug discoveries & therapeutics, 2026
In adults with GHD, somapacitan and daily GH showed similar changes in IGF-1, glucose, lipids, visceral fat, fat percentage, lean mass, and vascular measures.Endocrine practice, 2025
In adults with GH deficiency, diastolic blood pressure improved after switching to somapacitan compared with the switch assessment.Drug discoveries & therapeutics, 2026

Somapacitan studies on bones and joints

2 results · people 2 · animals 0 · lab 0

2 results

In children with GHD, bone age changes were similar with somapacitan and daily GH.The Journal of clinical endocrinology and metabolism, 2022
In adults with GHD, lumbar spine bone density change was lower with somapacitan than daily GH.Endocrine practice, 2025

Somapacitan studies on overall treatment results

2 results · people 2 · animals 0 · lab 0

2 results

In children born SGA, disease burden decreased with somapacitan, as with daily GH 0.067 mg/kg/day.European journal of endocrinology, 2026
In children with GHD, disease burden fell from baseline with both somapacitan and daily GH, to a similar degree.The Journal of clinical endocrinology and metabolism, 2022

Somapacitan studies on receptors and cell signals

9 results · people 0 · animals 1 · lab 8

Top 4 of 9 results

In rats, somapacitan activated growth hormone receptor signaling in growth-plate tissues.International journal of molecular sciences, 2020
In cells, somapacitan signaling was slightly slower than GH signaling.International journal of molecular sciences, 2020
In lab tests, one somapacitan molecule bound strongly to human serum albumin.Biochemistry, 2020
In cells, somapacitan signaling was slightly less intense than GH signaling.International journal of molecular sciences, 2020

Trials and papers

Somapacitan trials

Registered trials that test the peptide, with phase, status and dates. A dot marks trials with posted results.

StatusPhase

21 trials match. Highest phase first. Data from ClinicalTrials.gov.

Trials on this page (21 of 21)

21 trials · 8 ongoing · 13 completed · 8 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20152020202520302035

Ph 1
First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects
NCT01514500
16 Jan 2012 to 18 Mar 2013
Ph 1
A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency
NCT01706783
12 Oct 2012 to 18 Nov 2013
Ph 1
A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency
NCT01973244
16 Dec 2013 to 4 Nov 2014
Ph 3
REAL 1
NCT02229851
31 Oct 2014 to 7 May 2018
Ph 3
REAL 2
NCT02382939
12 Feb 2015 to 4 Jan 2016
Ph 2
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency
NCT02616562
31 Mar 2016 to 26 Sept 2024
Ph 1
A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects
NCT02962440
Nov 2016 to Jan 2017
Ph 3
A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency
NCT03075644
3 Mar 2017 to 4 Oct 2018
Ph 1
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function
NCT03186495
20 Jun 2017 to 17 May 2018
Ph 1
Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.
NCT03212131
16 Aug 2017 to 8 Mar 2018

21 trials · 8 ongoing · 13 completed · 8 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03811535

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Novo Nordisk A/Sn = 20020 May 2019 to 30 Sept 2025

Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 22 Oct 2026

Active, not recruitingPhase 3Results postedNCT05723835

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

Novo Nordisk A/Sn = 471 Feb 2023 to est. 29 Oct 2027

SGA · Turner Syndrome · Noonan Syndrome · ISS

Trial page ClinicalTrials.govUpdated 13 Aug 2026

Active, not recruitingPhase 3NCT05330325

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

Novo Nordisk A/Sn = 41210 Aug 2022 to est. 29 Oct 2027

SGA, Turner Syndrome, Noonan Syndrome, ISS

Trial page ClinicalTrials.govUpdated 12 Jun 2026

CompletedPhase 3Results postedNCT04970654

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

Novo Nordisk A/Sn = 11022 Jul 2021 to 18 Dec 2023

Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 6 Jan 2026

CompletedPhase 3Results postedNCT02229851

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Novo Nordisk A/Sn = 30131 Oct 2014 to 7 May 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 23 Nov 2020

CompletedPhase 3Results postedNCT03075644

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 623 Mar 2017 to 4 Oct 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 23 Nov 2020

CompletedPhase 3Results postedNCT02382939

A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 9212 Feb 2015 to 4 Jan 2016

Adult Growth Hormone Deficiency · Growth Hormone Disorder

Trial page ClinicalTrials.govUpdated 9 Jul 2020

Active, not recruitingPhase 2Results postedNCT03878446

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Novo Nordisk A/Sn = 624 Jul 2019 to est. 23 Dec 2026

Short Stature Children Born Small for Gestational Age (SGA)

Trial page ClinicalTrials.govUpdated 6 Oct 2026

CompletedPhase 2Results postedNCT02616562

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Novo Nordisk A/Sn = 7631 Mar 2016 to 26 Sept 2024

Growth Hormone Disorder · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 16 Jan 2026

CompletedPhase 1NCT01514500

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

Novo Nordisk A/Sn = 10516 Jan 2012 to 18 Mar 2013

Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children · Healthy

Trial page ClinicalTrials.govUpdated 24 Dec 2020

CompletedPhase 1NCT01706783

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 3512 Oct 2012 to 18 Nov 2013

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 24 Dec 2020

CompletedPhase 1NCT01973244

A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Novo Nordisk A/Sn = 3216 Dec 2013 to 4 Nov 2014

Growth Hormone Disorder · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 24 Dec 2020

CompletedPhase 1NCT03186495

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Novo Nordisk A/Sn = 4420 Jun 2017 to 17 May 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 17 Apr 2020

CompletedPhase 1NCT03905850

A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

Novo Nordisk A/Sn = 3329 Mar 2019 to 15 Jul 2019

Healthy Volunteers · Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 6 Aug 2019

CompletedPhase 1NCT03212131

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

Novo Nordisk A/Sn = 3416 Aug 2017 to 8 Mar 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency · Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 24 May 2019

CompletedPhase 1NCT02962440

A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Novo Nordisk A/Sn = 7Nov 2016 to Jan 2017

Healthy

Trial page ClinicalTrials.govUpdated 7 Jun 2017

RecruitingEarly phase 1NCT06803589

Growth Hormone for the Treatment of Gastroparesis

Mayo Clinicn = 1022 Oct 2024 to est. Dec 2027

Gastroparesis

Trial page ClinicalTrials.govUpdated 16 Apr 2026

Enrolling by invitationPhase not statedNCT05718570

A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Novo Nordisk A/Sn = 4003 Feb 2023 to est. 15 Dec 2032

Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 12 Jun 2026

Enrolling by invitationPhase not statedNCT06109935

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

Novo Nordisk A/Sn = 2004 Oct 2023 to est. 31 Dec 2026

Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 29 Apr 2026

Active, not recruitingPhase not statedNCT05230550

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

Novo Nordisk A/Sn = 2003 Feb 2022 to est. 31 Dec 2026

Adult Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 13 Apr 2026

Enrolling by invitationPhase not statedNCT06709040

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

Novo Nordisk A/Sn = 50013 Dec 2024 to est. 14 Apr 2034

Growth Hormone Deficiency · Neoplasms · Diabetes Mellitus Type 2

Trial page ClinicalTrials.govUpdated 6 Apr 2026

Papers

Studies on this peptide. Some have results. The others have none yet.

Sort

Design

64 studies match. Retracted studies are left out.

Showing 23 of 64 studiesquery qry_82d46fbe91466aeacb7efddb

Studies with results

46 studies in all, 17 on this page

Randomized controlled trial · 2020

5 results

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

Johannsson et al. 2020The Journal of clinical endocrinology and metabolismcited by 65

PMID 32022863PMC7076631DOI 10.1210/clinem/dgaa049PUB-32022863

CC BY5 results where Somapacitan was given

Download PDF See results (5)

Randomized controlled trial · 2022

10 results

Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

Miller et al. 2022The Journal of clinical endocrinology and metabolismn = 200cited by 65

PMID 36062966PMC9693810DOI 10.1210/clinem/dgac513PUB-36062966

Free to read · publisher termsCC BY-NC-ND10 results where Somapacitan was given

Read at source See results (10)

Randomized controlled trial · 2018

6 results

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

Johannsson et al. 2018European journal of endocrinologyn = 92cited by 56

PMID 29500310PMC5920019DOI 10.1530/eje-17-1073PUB-29500310

CC BY6 results where Somapacitan was given

Download PDF See results (6)

Randomized controlled trial · 2017

14 results

Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial.

Battelino et al. 2017Clinical endocrinologyn = 32cited by 48

PMID 28656605DOI 10.1111/cen.13409PUB-28656605

Full text at the publisher14 results where Somapacitan was given

Publisher page See results (14)

Randomized controlled trial · 2022

5 results

Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.

Sävendahl et al. 2022The Journal of clinical endocrinology and metabolismcited by 47

PMID 34964458PMC9016428DOI 10.1210/clinem/dgab928PUB-34964458

Free to read · publisher termsCC BY-NC-ND5 results where Somapacitan was given

Read at source See results (5)

Randomized controlled trial · 2020

7 results

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

Otsuka et al. 2020Clinical endocrinologyn = 62cited by 34

PMID 32603494PMC7689735DOI 10.1111/cen.14273PUB-32603494

Free to read · publisher termsCC BY-NC7 results where Somapacitan was given

Read at source See results (7)

Non-randomized trial · 2023

4 results

Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.

Sävendahl et al. 2023The Journal of clinical endocrinology and metabolismn = 50cited by 32

PMID 36995872PMC10505532DOI 10.1210/clinem/dgad183PUB-36995872

Free to read · publisher termsCC BY-NC-ND4 results where Somapacitan was given

Read at source See results (4)

Animal study (in vivo) · cynomolgus monkey, minipig and rat · 2017

11 results

Nonclinical pharmacokinetic and pharmacodynamic characterisation of somapacitan: A reversible non-covalent albumin-binding growth hormone.

Thygesen et al. 2017Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Societycited by 30

PMID 28595133DOI 10.1016/j.ghir.2017.05.006PUB-28595133

Full text at the publisher11 results where Somapacitan was given

Publisher page See results (11)

In vitro (cell-free) · 2020

7 results

Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative.

Johansson et al. 2020Biochemistrycited by 28

PMID 32208682DOI 10.1021/acs.biochem.0c00019PUB-32208682

Rights unknown5 results where Somapacitan was given (plus 2 on tools or combinations, listed separately)

Source link See results (7)

Randomized controlled trial · 2024

7 results

Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial.

Mori et al. 2024Clinical endocrinologyn = 30cited by 16

PMID 38368603DOI 10.1111/cen.15025PUB-38368603

Full text at the publisher7 results where Somapacitan was given

Publisher page See results (7)

Observational study · 2023

1 result

Model-Based Analysis of IGF-I Response, Dosing, and Monitoring for Once-Weekly Somapacitan in Children With GH Deficiency.

Kildemoes et al. 2023Journal of the Endocrine Societycited by 15

PMID 37818403PMC10561011DOI 10.1210/jendso/bvad115PUB-37818403

Free to read · publisher termsCC BY-NC-ND1 result where Somapacitan was given

Read at source See results (1)

Non-randomized trial · 2021

14 results

Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects.

Helleberg et al. 2021European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciencesn = 7cited by 12

PMID 34601071DOI 10.1016/j.ejps.2021.106030PUB-34601071

Full text at the publisher14 results where Somapacitan was given

Publisher page See results (14)

Randomized controlled trial · 2023

10 results

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Takahashi et al. 2023Pituitaryn = 239cited by 12

PMID 36380045PMC9908671DOI 10.1007/s11102-022-01283-3PUB-36380045

CC BY10 results where Somapacitan was given

Download PDF See results (10)

Observational study · 2022

1 result

Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency.

Kildemoes et al. 2022European journal of endocrinologycited by 11

PMID 35521713PMC9175552DOI 10.1530/eje-21-1167PUB-35521713

CC BY1 result where Somapacitan was given

Download PDF See results (1)

Randomized controlled trial · 2026

7 results

Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.

Fu et al. 2026Hormone research in paediatricsn = 110cited by 9

PMID 40324364PMC12129415DOI 10.1159/000545786PUB-40324364

Free to read · publisher termsCC BY-NC7 results where Somapacitan was given

Read at source See results (7)

Randomized controlled trial · 2025

11 results

Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.

Juul et al. 2025The Journal of clinical endocrinology and metabolismn = 62cited by 8

PMID 39271158PMC11913088DOI 10.1210/clinem/dgae616PUB-39271158

Free to read · publisher termsCC BY-NC-ND11 results where Somapacitan was given

Read at source See results (11)

Animal study (in vivo) · rat · 2020

4 results

Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative.

Petersen et al. 2020International journal of molecular sciencescited by 7

PMID 32053994PMC7072805DOI 10.3390/ijms21041181PUB-32053994

CC BY4 results where Somapacitan was given

Download PDF See results (4)

More studies

14 studies in all, 6 on this page

PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase II · 2020

Corrected

Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial.

Sävendahl et al. 2020The Journal of clinical endocrinology and metabolismcited by 54

PMID 31917835PMC7069655DOI 10.1210/clinem/dgz310PUB-31917835

CC BY

Download PDF Read the notice

PubMed tag: none · 2021

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.

Juul Kildemoes et al. 2021The Journal of clinical endocrinology and metabolismcited by 30

PMID 33313798PMC7823237DOI 10.1210/clinem/dgaa775PUB-33313798

CC BY

Download PDF

PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase III · 2023

Corrected

Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH.

Miller et al. 2023The Journal of clinical endocrinology and metabolismcited by 26

PMID 37406251PMC10655534DOI 10.1210/clinem/dgad394PUB-37406251

Free to read · publisher termsCC BY-NC-ND

Read at source Read the notice

PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase II · 2023

Corrected

Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study.

Juul et al. 2023European journal of endocrinologycited by 15

PMID 36651161DOI 10.1093/ejendo/lvac008PUB-36651161

Full text at the publisher

Publisher page Read the notice

PubMed tag: none · 2025

Long-acting growth hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency.

Rodaro et al. 2025Annals of pediatric endocrinology & metabolismcited by 9

PMID 39810511PMC12061763DOI 10.6065/apem.2448202.101PUB-39810511

Free to read · publisher termsCC BY-NC

Read at source

PubMed tag: Meta-Analysis · 2021

Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin^® in Children and Adults.

Papathanasiou et al. 2021Clinical pharmacokineticscited by 8

PMID 33864240PMC8416863DOI 10.1007/s40262-021-01011-3PUB-33864240

Free to read · publisher termsCC BY-NC

Read at source

No result for Somapacitan (2 studies on this page, 4 in all)

These studies name Somapacitan but give no result for it (for example, the results concern another peptide in the study).

PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase I · 2019

Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials.

Juul et al. 2019Clinical pharmacokineticscited by 29

PMID 29671202PMC6325982DOI 10.1007/s40262-018-0662-5PUB-29671202

Free to read · publisher termsCC BY-NC

Read at source

PubMed tag: Randomized Controlled Trial, Clinical Trial, Phase III · 2024

Gene Expression Signatures Predict First-Year Response to Somapacitan Treatment in Children With Growth Hormone Deficiency.

Garner et al. 2024The Journal of clinical endocrinology and metabolismcited by 8

PMID 38066644PMC11031233DOI 10.1210/clinem/dgad717PUB-38066644

CC BY

Download PDF

Newer studies

PepBank reads each paper before it shows the results. This search looks in Europe PMC for newer papers that PepBank has not read yet.

Somapacitan studies: 46 papers with results

Page 1 of 1

Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.
Miller BS · The Journal of clinical endocrinology and metabolism · 2022
Randomized controlled trial · 10 results
RF14 | LBMON195 Once-weekly Somapacitan Is Effective And Well Tolerated In Children With GH Deficiency: A Randomized Phase 3 Trial
Journal of the Endocrine Society · 2022
Randomized controlled trial · 11 results
Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.
Fu J · Hormone research in paediatrics · 2026
Randomized controlled trial · 7 results
Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study.
Mauras N · The Journal of clinical endocrinology and metabolism · 2026
Randomized controlled trial · 5 results
Once-weekly somapacitan in children with Noonan syndrome: randomized controlled phase 3 trial.
Jorge AAL · European journal of endocrinology · 2026
Randomized controlled trial · 3 results
Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.
Otsuka F · Clinical endocrinology · 2020
Randomized controlled trial · 7 results
MON-265 Once-Weekly Somapacitan in Japanese Adults with GH Deficiency Was Well Tolerated, with Similar Efficacy to Daily GH: A Randomized Trial
Otsuka F · Journal of the Endocrine Society · 2020
Randomized controlled trial · 12 results
Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial.
Mori J · Clinical endocrinology · 2024
Randomized controlled trial · 7 results
Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.
Johannsson G · The Journal of clinical endocrinology and metabolism · 2020
Randomized controlled trial · 5 results
Somapacitan in children born small for gestational age: a randomized controlled phase 3 trial.
Linglart A · European journal of endocrinology · 2026
Randomized controlled trial · 6 results
Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.
Takahashi Y · Pituitary · 2023
Randomized controlled trial · 10 results
Efficacy, safety, and insulin-like growth factor I of weekly somapacitan in children with growth hormone deficiency: 3-year results from REAL4.
Miller BS · European journal of endocrinology · 2025
Randomized controlled trial · 8 results
Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.
Johannsson G · European journal of endocrinology · 2018
Randomized controlled trial · 6 results
Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.
Juul A · The Journal of clinical endocrinology and metabolism · 2025
Randomized controlled trial · 11 results
Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial.
Otsuka F · Frontiers in endocrinology · 2025
Randomized controlled trial · 4 results
Investigating the Bioavailability and Insulin-like Growth Factor-I Release of Two Different Strengths of Somapacitan: A Randomised, Double-Blind Crossover Trial.
Dombernowsky SL · Clinical pharmacokinetics · 2024
Randomized controlled trial · 5 results
Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial.
Battelino T · Clinical endocrinology · 2017
Randomized controlled trial · 14 results
Efficacy of Somapacitan in Treatment-Fatigue Adult Patients With Growth Hormone Deficiency Previously Treated With Once-Daily Growth Hormone Injections: A 24-Week Randomized Active-Controlled Trial.
Jensterle M · Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2025
Randomized controlled trial · 3 results
SAT-091 First Report of Disease-Specific Patient-Reported Outcomes from a Randomized Phase 2 Trial of Once-Weekly Somapacitan vs Daily GH in Children with GHD
Brod M · Journal of the Endocrine Society · 2020
Randomized controlled trial · 8 results
Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.
Sävendahl L · The Journal of clinical endocrinology and metabolism · 2022
Randomized controlled trial · 5 results
Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study.
Abuzzahab J · European journal of endocrinology · 2026
Randomized controlled trial · 2 results
SAT-LB12 Once-Weekly Somapacitan vs Daily Growth Hormone in Growth Hormone Deficiency: 2-Year Safety Results From Real 3, a Randomized Phase 2 Trial
Savendahl L · Journal of the Endocrine Society · 2020
Randomized controlled trial · 16 results
Effect of Kidney or Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Somapacitan: Two Open-Label, Parallel-Group Trials.
Bentz Damholt B · Clinical pharmacokinetics · 2021
Non-randomized trial · 9 results
Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.
Sävendahl L · The Journal of clinical endocrinology and metabolism · 2023
Non-randomized trial · 4 results
RF26 | PMON334 Once-Weekly Somapacitan in Growth Hormone Deficiency: 4-Year Efficacy and Safety Results from REAL 3, a Randomised Controlled Phase 2 Trial
Journal of the Endocrine Society · 2022
Non-randomized trial · 17 results
Distinct Glucose Profiles with Daily and Weekly Growth Hormone Therapy Revealed by Continuous Glucose Monitoring.
Taguchi T · Journal of the Endocrine Society · 2026
Non-randomized trial · 5 results
Injection-site pain after switching from somatrogon to somapacitan in children reporting pain or discomfort during once-weekly growth hormone therapy: a prospective single-arm switch study.
Iwayama H · Frontiers in endocrinology · 2026
Non-randomized trial · 5 results
Reduced high-sensitivity C-reactive protein levels following weekly somapacitan in adults with growth hormone deficiency: a prospective pilot study.
Seki Y · Journal of endocrinological investigation · 2025
Non-randomized trial · 9 results
Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects.
Helleberg H · European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2021
Non-randomized trial · 14 results
Seven-year Safety and Efficacy of Somapacitan in Children With GH Deficiency: Final Results From REAL 3.
Sävendahl L · Journal of the Endocrine Society · 2026
Non-randomized trial · 6 results
Somapacitan in children born small for gestational age: 4-year results from phase 2.
Juul A · European journal of endocrinology · 2026
Non-randomized trial · 4 results
Efficacy and Safety of Somapacitan versus Daily Growth Hormone in Children with Growth Hormone Deficiency: A Pooled Analysis of Randomised Trial Data.
Sävendahl L · Hormone research in paediatrics · 2026
Non-randomized trial · 5 results
Metabolic and muscular effects of switching from somatropin to somapacitan in adults with growth hormone deficiency.
Oi-Yo Y · The Journal of clinical endocrinology and metabolism · 2026
Observational study · 8 results
Safety and efficacy of weekly somapacitan for growth hormone deficiency in children: A 72-week observational study.
Al-Agha AE · Saudi medical journal · 2025
Observational study · 4 results
Effects of switching from somatropin to somapacitan on thyroid hormone levels in adult growth hormone deficiency: A pilot study.
Tsujimoto Y · Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2026
Observational study · 5 results
Investigation of the metabolic and endocrinological differences between daily and weekly growth hormone replacement therapy, somapacitan, in patients with adult growth hormone deficiency: A real-world pilot study.
Abe I · Medicine · 2023
Observational study · 7 results
Model-Based Analysis of IGF-I Response, Dosing, and Monitoring for Once-Weekly Somapacitan in Children With GH Deficiency.
Kildemoes RJ · Journal of the Endocrine Society · 2023
Observational study · 1 result
Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency.
Kildemoes RJ · European journal of endocrinology · 2022
Observational study · 1 result
Metabolic and endocrinological effects of weekly growth hormone replacement therapy with somapacitan in patients with adult growth hormone deficiency after switching from daily growth hormone replacement therapy: A real-world exploratory cohort study.
Abe I · Drug discoveries & therapeutics · 2026
Observational study · 14 results
Somapacitan-induced reversible lipoatrophy in an adult woman with hypopituitarism.
Rakusa M · Pituitary · 2024
Case report or series · 2 results
Long-acting GH Use in Patients With Adult GH Deficiency Coexisting With Type 1 Diabetes Mellitus.
Higuchi Y · JCEM case reports · 2025
Case report or series · 4 results
Administration study of somapacitan, a long-acting growth hormone derivative, in horse for doping control purpose.
Shimizu Y · Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2025
Animal study (in vivo) · horse · 3 results
Nonclinical pharmacokinetic and pharmacodynamic characterisation of somapacitan: A reversible non-covalent albumin-binding growth hormone.
Thygesen P · Growth hormone & IGF research : official journal of the Growth Hormone Research Society and the International IGF Research Society · 2017
Animal study (in vivo) · cynomolgus monkey, minipig and rat · 11 results
Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative.
Petersen M · International journal of molecular sciences · 2020
Animal study (in vivo) · rat · 4 results
Structure identification of circulating metabolites from somapacitan, a long-acting growth hormone derivative, and pharmacokinetics after single and multiple subcutaneous dosing in rats.
Helleberg H · European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences · 2022
Animal study (in vivo) · rat · 8 results
Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative.
Johansson E · Biochemistry · 2020
In vitro (cell-free) · 7 results

Status and safety

Regulatory and safety

Approval and sport status, and the safety outcomes reported in study results. Laws and labels change, so check the regulator for the current status.

Regulatory status by jurisdiction, with date and source
Jurisdiction	Body	Status	As of	Source
US	FDA	Sogroya · 28 Aug 2020	27 Oct 2026	dailymed.nlm.nih.gov (opens in a new tab)
EU	EMA	Sogroya	27 Oct 2026	ema.europa.eu (opens in a new tab)
Sport	WADA	Banned in sport (WADA S2.2.3) Growth hormone and its analogs are prohibited at all times.	2026 List	wada-ama.org (opens in a new tab)

Safety outcomes

83 safety results for Somapacitan.

Human evidence· 83

In children with GHD, injection-site reactions occurred in 5.3% with somapacitan versus 5.9% with daily GH.
Randomized controlled trialn = 200
Injection-site reactions
5.3%
Somapacitan
Injection-site reactions
5.9%
Daily GH
In children with GHD, injection-site reactions occurred in 5.3% with somapacitan versus 5.9% with daily GH, described as similar.
Randomized controlled trialn = 200
Injection-site reactions
5.3 % of patients
Somapacitan
Injection-site reactions
5.9 % of patients
Daily GH
In girls with Turner syndrome, somapacitan and daily GH had similar safety profiles.
Randomized controlled trialn = 105
In children with Noonan syndrome, somapacitan was well tolerated and had a safety profile similar to daily GH.
Randomized controlled trialn = 77
In Japanese adults with GH deficiency, AE rates were similar with somapacitan and daily GH: 312.7 versus 309.8 per 100 patient-years.
Randomized controlled trialn = 62
Adverse event rate
312.7 per 100 patient-years
somapacitan arm
Adverse event rate
309.8 per 100 patient-years
daily GH arm
In children born SGA, safety and tolerability were reported as similar across all groups, including the somapacitan and daily GH groups.
Randomized controlled trialn = 62
In Japanese adults with GHD, AE rates were similar with somapacitan and daily GH: 312.7 versus 309.8 per 100 patient-years.
Randomized controlled trialn = 62
Adverse event rate
312.7 per 100 patient-years
once-weekly somapacitan arm
Adverse event rate
309.8 per 100 patient-years
daily GH arm
In Japanese adults with GH deficiency, somapacitan had a safety profile similar to daily GH.
Randomized controlled trialn = 36

The top 24 of 83 results.

Doses studied · 37

The doses that these studies used. They are not recommendations.

0.16 mg/kg/wkHuman
Species
human
Route
subcutaneous
Duration
52 weeks
Design
Randomized controlled trial · n = 200
0.16 mg/kg/weekHuman
Species
human
Route
subcutaneous
Duration
52 weeks
Design
Randomized controlled trial · n = 200
0.16 mg/kg/weekHuman
Species
human
Route
Not reported
Duration
52 weeks
Design
Randomized controlled trial · n = 110
0.24 mg/kg/weekHuman
Species
human
Route
subcutaneous
Duration
52 weeks
Design
Randomized controlled trial · n = 105
0.24 mg/kg/weekHuman
Species
human
Route
subcutaneous
Duration
52 weeks
Design
Randomized controlled trial · n = 77
0.16 mg/kg/weekHuman
Species
human
Route
Not reported
Duration
52 weeks
Design
Randomized controlled trial · n = 30

Doses studied in the study results, as given in the studies.
Dose as reported	Class	Species	Route	Duration	Design
0.16 mg/kg/wk	Human	human	subcutaneous	52 weeks	Randomized controlled trial · n = 200
0.16 mg/kg/week	Human	human	subcutaneous	52 weeks	Randomized controlled trial · n = 200
0.16 mg/kg/week	Human	human	Not reported	52 weeks	Randomized controlled trial · n = 110
0.24 mg/kg/week	Human	human	subcutaneous	52 weeks	Randomized controlled trial · n = 105
0.24 mg/kg/week	Human	human	subcutaneous	52 weeks	Randomized controlled trial · n = 77
0.16 mg/kg/week	Human	human	Not reported	52 weeks	Randomized controlled trial · n = 30

6 of 37 shown

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Data

Data and API

Data version, change history and code for this peptide.

Data version 30856030 Oct 2026

Peptide

Peptide id: PEP-000169
Peptide version: 2
Peptide hash: fd86f8de7821d851…
Data version: 308560

Latest changes

28 Oct 2026UpdatedData version 304201
27 Oct 2026CreatedData version 256777

For developers

curl -s https://pepbank.io/v1/briefs/somapacitan

Evidence summary for Somapacitan: counts by class, key results with sources, notices, data version.

Peptide as JSON Evidence summary as JSON

Outcome group	Human	Animal	Lab	Computer model	Total
Adverse eventsWhole body	Human: 75 results from 29 studies: 4 increase, 4 decrease, 11 no significant change, 56 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	75
Growth hormone and IGF-1Endocrine and hormones	Human: 74 results from 25 studies: 24 increase, 9 decrease, 12 no significant change, 1 mixed, 28 not reported. Strongest design: Randomized controlled trial	Animal: 4 results from 2 studies: 4 increase. Strongest design: Animal study (in vivo)	No results	No results	78
Glycemic controlMetabolic and weight	Human: 25 results from 6 studies: 2 increase, 4 decrease, 8 no significant change, 1 mixed, 10 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	25
PharmacokineticsPharmacology	Human: 22 results from 5 studies: 4 increase, 2 decrease, 16 not reported. Strongest design: Randomized controlled trial	Animal: 16 results from 3 studies: 1 increase, 15 not reported. Strongest design: Animal study (in vivo)	No results	No results	38
Linear growthMusculoskeletal	Human: 20 results from 8 studies: 8 increase, 8 decrease, 4 no significant change. Strongest design: Randomized controlled trial	No results	No results	No results	20
Body weightMusculoskeletal	Human: 12 results from 5 studies: 4 decrease, 3 no significant change, 5 not reported. Strongest design: Randomized controlled trial	Animal: 2 results from 1 study: 2 increase. Strongest design: Animal study (in vivo)	No results	No results	14
Liver fat and liver functionLiver	Human: 6 results from 3 studies: 2 decrease, 4 not reported. Strongest design: Non-randomized trial	No results	No results	No results	6
Patient-reported outcomesWhole body	Human: 6 results from 4 studies: 6 increase. Strongest design: Randomized controlled trial	No results	No results	No results	6
Patterns of useWhole body	Human: 6 results from 5 studies: 3 decrease, 3 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	6
Body compositionMetabolic and weight	Human: 5 results from 2 studies: 2 increase, 2 decrease, 1 no significant change. Strongest design: Non-randomized trial	No results	No results	No results	5
Inflammation markersLiver	Human: 5 results from 1 study: 3 increase, 2 decrease. Strongest design: Non-randomized trial	No results	No results	No results	5
PainSkin and wound	Human: 5 results from 2 studies: 4 decrease, 1 no significant change. Strongest design: Randomized controlled trial	No results	No results	No results	5

Outcome group	Human	Animal	Lab	Computer model	Total
Adverse eventsWhole body	Human: 75 results from 29 studies: 4 increase, 4 decrease, 11 no significant change, 56 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	75
Growth hormone and IGF-1Endocrine and hormones	Human: 74 results from 25 studies: 24 increase, 9 decrease, 12 no significant change, 1 mixed, 28 not reported. Strongest design: Randomized controlled trial	Animal: 4 results from 2 studies: 4 increase. Strongest design: Animal study (in vivo)	No results	No results	78
Glycemic controlMetabolic and weight	Human: 25 results from 6 studies: 2 increase, 4 decrease, 8 no significant change, 1 mixed, 10 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	25
PharmacokineticsPharmacology	Human: 22 results from 5 studies: 4 increase, 2 decrease, 16 not reported. Strongest design: Randomized controlled trial	Animal: 16 results from 3 studies: 1 increase, 15 not reported. Strongest design: Animal study (in vivo)	No results	No results	38
Linear growthMusculoskeletal	Human: 20 results from 8 studies: 8 increase, 8 decrease, 4 no significant change. Strongest design: Randomized controlled trial	No results	No results	No results	20
Body weightMusculoskeletal	Human: 12 results from 5 studies: 4 decrease, 3 no significant change, 5 not reported. Strongest design: Randomized controlled trial	Animal: 2 results from 1 study: 2 increase. Strongest design: Animal study (in vivo)	No results	No results	14
Liver fat and liver functionLiver	Human: 6 results from 3 studies: 2 decrease, 4 not reported. Strongest design: Non-randomized trial	No results	No results	No results	6
Patient-reported outcomesWhole body	Human: 6 results from 4 studies: 6 increase. Strongest design: Randomized controlled trial	No results	No results	No results	6
Patterns of useWhole body	Human: 6 results from 5 studies: 3 decrease, 3 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	6
Body compositionMetabolic and weight	Human: 5 results from 2 studies: 2 increase, 2 decrease, 1 no significant change. Strongest design: Non-randomized trial	No results	No results	No results	5
Inflammation markersLiver	Human: 5 results from 1 study: 3 increase, 2 decrease. Strongest design: Non-randomized trial	No results	No results	No results	5
PainSkin and wound	Human: 5 results from 2 studies: 4 decrease, 1 no significant change. Strongest design: Randomized controlled trial	No results	No results	No results	5

Somapacitan studies and research data

Somapacitan identity

Targets

Sequence and structure

Sequence

Alignment to Human growth hormone

Properties

Net charge by pH

Composition

3D structure

Helical wheel

Somapacitan results by year and outcome

What the studies measured

Somapacitan studies on growth hormone and growth

Somapacitan studies on side effects

Somapacitan studies on blood sugar

Somapacitan studies on blood levels and clearance

Somapacitan studies on weight and appetite

Somapacitan studies on daily life and fitness

Somapacitan studies on use, access and costs

Somapacitan studies on immune system and inflammation

Somapacitan studies on liver

Somapacitan studies on pain

Somapacitan studies on cholesterol and blood fats

Somapacitan studies on hormones

Somapacitan studies on heart and blood vessels

Somapacitan studies on bones and joints

Somapacitan studies on overall treatment results

Somapacitan studies on receptors and cell signals

Somapacitan trials

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9

A Research Study to Compare Somapacitan Once a Week With Norditropin® Once a Day in Children Who Need Help to Grow

A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

A Trial to Compare the Safety of Once Weekly Dosing of Somapacitan With Daily Norditropin® FlexPro® for 26 Weeks in Previously Human Growth Hormone Treated Adults With Growth Hormone Deficiency

A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

First Human Dose Trial of NNC0195-0092 (Somapacitan) in Healthy Subjects

A Trial Investigating the Safety, Tolerability, Availability and Distribution in the Body of Once-weekly Long-acting Growth Hormone (Somapacitan) Compared to Once Daily Norditropin NordiFlex® in Adults With Growth Hormone Deficiency

A Trial Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of Long-acting Growth Hormone (Somapacitan) Compared to Daily Dosing of Norditropin® SimpleXx® in Children With Growth Hormone Deficiency

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

A Study to Compare the Uptake Into the Blood of Two Strengths of Somapacitan After Injection Under the Skin in Healthy Subjects

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Mild and Moderate Degrees of Hepatic Impairment Compared to Subjects With Normal Hepatic Function.

A Trial Investigating the Absorption, Metabolism and Excretion of Somapacitan After Single Dosing in Healthy Male Subjects

Growth Hormone for the Treatment of Gastroparesis

A Study to Follow Patients With Adult Growth Hormone Deficiency (AGHD) Treated With Sogroya® for Long Term Safety Information

Special Use-results Surveillance on Long Term Use of Sogroya® in Children With Short Stature Due to Growth Hormone Deficiency Where Epiphysial Discs Are Not Closed

Post-Marketing Surveillance (Special Use-results Surveillance on Long-term Use) With Sogroya®

A Study to Follow Paediatric Participants With Growth Hormone Deficiency Treated With Somapacitan for Long Term Safety Information and Clinical Parameters

Papers

Studies with results

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency: A randomized dose-escalation trial.

Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.

Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

Weekly Somapacitan in GH Deficiency: 4-Year Efficacy, Safety, and Treatment/Disease Burden Results From REAL 3.

Nonclinical pharmacokinetic and pharmacodynamic characterisation of somapacitan: A reversible non-covalent albumin-binding growth hormone.

Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative.

Effective growth hormone replacement with once-weekly somapacitan in Japanese children with growth hormone deficiency: Results from REAL4, a phase 3 clinical trial.

Model-Based Analysis of IGF-I Response, Dosing, and Monitoring for Once-Weekly Somapacitan in Children With GH Deficiency.

Absorption, metabolism and excretion of once-weekly somapacitan, a long-acting growth hormone derivative, after single subcutaneous dosing in human subjects.

Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency.

Dose-exposure-IGF-I response of once-weekly somapacitan in adults with GH deficiency.

Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.

Somapacitan in Children Born SGA: 52-Week Efficacy, Safety, and IGF-I Response Results From the Phase 2 REAL5 Study.

Tissue Distribution and Receptor Activation by Somapacitan, a Long Acting Growth Hormone Derivative.

More studies

Once-Weekly Somapacitan vs Daily GH in Children With GH Deficiency: Results From a Randomized Phase 2 Trial.

Optimal Monitoring of Weekly IGF-I Levels During Growth Hormone Therapy With Once-Weekly Somapacitan.

Effective GH Replacement With Somapacitan in Children With GHD: REAL4 2-year Results and After Switch From Daily GH.

Somapacitan in children born small for gestational age: a multi-centre, open-label, controlled phase 2 study.

Long-acting growth hormones: innovations in treatment and guidance on patient selection in pediatric growth hormone deficiency.

Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin® in Children and Adults.

Pharmacokinetics and Pharmacodynamics of Once-Weekly Somapacitan in Children and Adults: Supporting Dosing Rationales with a Model-Based Analysis of Three Phase I Trials.

Gene Expression Signatures Predict First-Year Response to Somapacitan Treatment in Children With Growth Hormone Deficiency.

Newer studies

Population Pharmacokinetics and Pharmacodynamics of Once-Daily Growth Hormone Norditropin^® in Children and Adults.