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, Lindecrona RH, Thygesen P, Bjelke M

European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences2 Oct 2021Cited by 6 (Europe PMC)

PMID34610450DOI10.1016/j.ejps.2021.106032PepBankPUB-34610450

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. No result from this study comes from people.

01AnimalAnimal study (in vivo)Pharmacokinetics
In male rats, seven somapacitan-related plasma metabolites were detected after a single radiolabelled dose.
In plain wordsIn male rats, seven somapacitan-related substances were detected in plasma after a single dose.
Peptide
Somapacitan
Outcome
Not applicablePlasma metabolite detection in males
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Measurements
Metabolites
7 count
Male rat plasma
Source sentences
Summary
After a single dose of radiolabelled somapacitan and analysis by high-performance liquid chromatography with radiochemical detection, seven somapacitan-related metabolites were detected in plasma from male rats, of which six were seen in plasma from female rats.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045001
02AnimalAnimal study (in vivo)Pharmacokinetics
In female rats, six of the seven somapacitan-related plasma metabolites detected in males were seen after a single dose.
In plain wordsIn female rats, six of the seven somapacitan-related substances detected in males were seen after a single dose.
Peptide
Somapacitan
Outcome
Not applicablePlasma metabolite detection in females
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Measurements
Metabolites
6 count
Female rat plasma
Source sentences
Summary
After a single dose of radiolabelled somapacitan and analysis by high-performance liquid chromatography with radiochemical detection, seven somapacitan-related metabolites were detected in plasma from male rats, of which six were seen in plasma from female rats.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045002
03AnimalAnimal study (in vivo)Pharmacokinetics
In rats dosed with somapacitan, M1, M2 and M3 structures were identified, and P1 was characterized by its retention time.
In plain wordsIn rats, tests identified somapacitan breakdown products M1, M2 and M3 and characterized P1.
Peptide
Somapacitan
Outcome
Not applicableMetabolite structures
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Source sentences
Summary
The three most abundant metabolites (M1, M2 and M3) were structurally identified from liquid chromatography and mass spectrometry data, and a fourth metabolite (P1) was characterised from its specific retention time (lacking retention to the stationary phase) in plasma analysis with reversed-phase l…
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045003
04AnimalAnimal study (in vivo)Pharmacokinetics
In rats, somapacitan metabolites resulted from proteolysis of its peptide backbone.
In plain wordsIn rats, somapacitan broke into smaller peptide products.
Peptide
Somapacitan
Outcome
Not applicableProteolytic metabolism
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Source sentences
Summary
The metabolites were products from proteolysis of the peptide backbone in somapacitan.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045004
05AnimalAnimal study (in vivo)Pharmacokinetics
In rats dosed with somapacitan, a deamidated M1 metabolite called M1B was identified.
In plain wordsIn rats, tests identified M1B, a changed form of a somapacitan breakdown product.
Peptide
Somapacitan
Outcome
Not applicableM1B identification
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Source sentences
Summary
A deamidation product of the M1 metabolite (M1B) was also identified.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045005
06AnimalAnimal study (in vivo)Pharmacokinetics
In rats after twice-weekly dosing for 4 weeks, somapacitan remained the principal plasma component through 36 h.
In plain wordsIn rats after repeated dosing, somapacitan remained the main plasma component through 36 hours.
Peptide
Somapacitan
Outcome
Not applicablePrincipal plasma component through 36 hours
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Twice-weekly dosing · subcutaneous · 4 weeksAs given in this study (rat).
Source sentences
Summary
Following multiple, twice-weekly dosing for 4 weeks, somapacitan was the principal plasma component up to 36 h after dosing.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045006
07AnimalAnimal study (in vivo)Pharmacokinetics
In rats after repeated somapacitan dosing, M1+M1B were the most abundant plasma components after 36 h.
In plain wordsIn rats, somapacitan breakdown products M1 and M1B became the main plasma components after 36 hours.
Peptide
Somapacitan
Outcome
Not applicablePrincipal plasma components after 36 hours
Study
ratn: not reported in source
Rats
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Twice-weekly dosing · subcutaneous · 4 weeksAs given in this study (rat).
Source sentences
Summary
After 36 h, metabolites M1+M1B were the most abundant plasma components.
2 context sentences(design, population, supporting numbers)
Summary · context
Following multiple, twice-weekly dosing for 4 weeks, somapacitan was the principal plasma component up to 36 h after dosing.
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045007
08AnimalAnimal study (in vivo)Pharmacokinetics
In rats, the most abundant somapacitan metabolites occurred at higher levels than in the parallel human study.
In plain wordsIn rats, the main somapacitan breakdown products reached higher levels than in humans in a parallel study.
Peptide
Somapacitan
Outcome
IncreaseMetabolite levels versus humans
Study
ratn: not reported in source
Rats
Comparator
Humans in parallel study
Outcome group
Pharmacokinetics · Pharmacology
Studied dose
Dose not stated · subcutaneousAs given in this study (rat).
Source sentences
Summary
Comparison of our data generated from rats with data from the parallel human study demonstrated that the most abundant metabolites were present in rats at higher levels than in humans.
1 context sentence(design, population, supporting numbers)
Summary · context
The purpose of this study was to obtain non-clinical data from rats to support the safety evaluation of the most abundant metabolites of somapacitan in humans.
Report a problemFND-3461045008

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

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

Journal Article

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