Synthetic analog · 8 amino acids · 725.8 Da

Larazotide studies and research data

PepBank has 26 larazotide studies with results. 24 of them gave larazotide, with 91 results, grouped by what the studies measured. In each group, results from studies in people come first. Data as of 2026-10-30.

Searches 91 results and 53 papers. Newer studies from Europe PMC

Results in people

34% of 91 results

Results in animals

31% of 91 results

Results in lab cells

34% of 91 results

From computer models

1% of 91 results

The molecule

Larazotide identity

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

Larazotide is an octapeptide with the sequence GGVLVQPG. Larazotide acetate is its acetate salt. The clinical registry describes a phase 3 celiac trial that the sponsor terminated. The query requires larazotide or the AT1001 code with barrier context. It does not use AT-1001 alone.

Kind: Synthetic analog · 8 residues
Identifiers: PubChem CID9810532 (opens in a new tab)UNIIZN3R5560ZV (opens in a new tab)DrugBankDB05645 (opens in a new tab)CAS258818-34-7
Parent: Synthetic analog Zonula occludens toxin (Zot) of Vibrio choleraeIUPHAR and DrugBank describe the sequence as derived from Zot. This describes design ancestry. It does not establish an exact contiguous parent sequence or residue range.
Development: Phase 39 Meters Biopharma, Inc.NCT03569007 is phase 3 and terminated by its sponsor. Termination does not establish approval or a treatment benefit. Source (opens in a new tab)

Targets

No molecular target is recorded for this peptide.

Sequence and structure

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

Sequence

8 amino acids

H-

GGVLVQPG

-OH

Parent: Zonula occludens toxin (Zot) of Vibrio cholerae

No sequence is listed for the parent, so no alignment is shown.IUPHAR and DrugBank describe the sequence as derived from Zot. This describes design ancestry. It does not establish an exact contiguous parent sequence or residue range.

Properties

From identity sources

Formula: C₃₂H₅₅N₉O₁₀
Molecular weight: 725.8 g/mol
Monoisotopic mass: 725.4072 Da

GSRS UNII ZN3R5560ZV(opens in a new tab)retrieved 2026-10-21
PubChem CID 9810532(opens in a new tab)retrieved 2026-10-21
iuphar gtopdb 13724(opens in a new tab)retrieved 2026-10-21

Calculated from the sequence

pKa set

Average mass: 725.84 Da; Sum of ExPASy residue masses + water · ExPASy Compute pI/Mw; FindMod
Monoisotopic mass: 725.4072 Da; Sum of ExPASy residue masses + water · ExPASy FindMod
Isoelectric point (pI): 6.10; pH of zero net charge, EMBOSS pKa set · EMBOSS iep, Epk.dat
Net charge at pH 7.4: −0.06; Henderson-Hasselbalch, EMBOSS pKa set · EMBOSS iep, Epk.dat
GRAVY (hydropathy): 0.738; Mean Kyte-Doolittle hydropathy · Kyte and Doolittle 1982; Positive: hydrophobic on average.
Extinction coefficient, 280 nm (Cys reduced): 0 M⁻¹ cm⁻¹; 5500 x Trp + 1490 x Tyr · Pace et al. 1995 (ExPASy ProtParam); No Trp or Tyr: absorbance at 280 nm cannot measure this peptide.
Instability index: 48.25; Dipeptide instability weights (DIWV) · Guruprasad et al. 1990; Above 40: classed as possibly unstable (ExPASy).
Aliphatic index: 121.3; Mole % A + 2.9 V + 3.9 (I + L) · Ikai 1980
Boman index: −1.29 kcal/mol; Mean solubility value (negated) · Boman 2003; 2.48 or below: lower protein-binding potential (Boman).
Hydrophobic moment (μH): Not calculated; The sequence is too short for this method.
pI with each pKa set: EMBOSS 6.10Bjellqvist (ExPASy) 5.53IPC peptide 5.97IPC protein 5.98

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

pI 6.10 · Net charge at pH 7.4: −0.06

Point or use arrow keys

Henderson-Hasselbalch, EMBOSS pKa set. Calculated, not measured.

Show as table

pH	Net charge
0	1.00
1	1.00
2	0.98
3	0.80
4	0.28
5	0.04
6	0.00
7	−0.02
8	−0.20
9	−0.72
10	−0.96
11	−1.00
12	−1.00
13	−1.00
14	−1.00

Composition

Hydrophobic38% (3)L V
Polar13% (1)Q
Special50% (4)G P

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

A Ala0 · 0%

I Ile0 · 0%

L Leu1 · 13%

M Met0 · 0%

V Val2 · 25%

F Phe0 · 0%

W Trp0 · 0%

Y Tyr0 · 0%

H His0 · 0%

K Lys0 · 0%

R Arg0 · 0%

D Asp0 · 0%

E Glu0 · 0%

N Asn0 · 0%

Q Gln1 · 13%

S Ser0 · 0%

T Thr0 · 0%

C Cys0 · 0%

G Gly3 · 38%

P Pro1 · 13%

3D structure

No 3D structure

No experimental structure (PDB) and no UniProt entry for an AlphaFold model are listed for this peptide. Synthetic peptides often have neither. The sequence view above is the reference.

2D structure

Draws the structure in your browser with RDKit (about 2.3 MB, loaded once).

SMILES fromPubChem CID 9810532(opens in a new tab)

CC(C)C[C@@H](C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCC(=O)N)C(=O)N1CCC[C@H]1C(=O)NCC(=O)O)NC(=O)[C@H](C(C)C)NC(=O)CNC(=O)CN

Results by area

Larazotide results by year and outcome

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

Studies by year

26 of 53 studies have results (49%), published 2012 to 2026. Top row: every study. Bottom row: studies with results about Larazotide, by class. The rows use different scales.

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

Studies53 in all, 2012 to 2026

Studies with results26 in all, 2012 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.

Larazotide studies on stomach and gut

45 results · people 12 · animals 14 · lab 18 · computer models 1

Top 4 of 45 results

In adults with celiac disease, larazotide 0.5 mg reduced symptoms more than placebo during a gluten-free diet.Gastroenterology, 2015
In mice, AT1001 alleviated abnormally low saliva production.International journal of oral science, 2025
In patients with celiac disease during gluten challenge, larazotide and placebo did not significantly differ in the intestinal permeability measure.The American journal of gastroenterology, 2012
In patients with coeliac disease during gluten challenge, larazotide did not significantly change the intestinal permeability measure compared with placebo.Alimentary pharmacology & therapeutics, 2013

Larazotide studies on side effects

7 results · people 7 · animals 0 · lab 0

Top 3 of 7 results

In adults with celiac disease, larazotide and placebo had comparable safety.Gastroenterology, 2015
In patients with coeliac disease during gluten challenge, larazotide and placebo had similar adverse event rates.Alimentary pharmacology & therapeutics, 2013
In patients with celiac disease, larazotide was generally well tolerated.The American journal of gastroenterology, 2012

Larazotide studies on immune system and inflammation

6 results · people 4 · animals 2 · lab 0

Top 5 of 6 results

In patients with coeliac disease, larazotide 1 mg produced a lower antibody ratio than placebo during gluten challenge.Alimentary pharmacology & therapeutics, 2013
In a patient with MIS-C, larazotide treatment coincided with lower inflammatory markers.The Journal of clinical investigation, 2021
In mice with stressed, P-CAB-treated enteritis, larazotide reduced ileal inflammation.Digestion, 2026
In patients with coeliac disease, larazotide 4 mg produced a lower antibody ratio than placebo during gluten challenge.Alimentary pharmacology & therapeutics, 2013
In patients with coeliac disease, larazotide 8 mg produced a lower antibody ratio than placebo during gluten challenge.Alimentary pharmacology & therapeutics, 2013

Larazotide studies on infections

6 results · people 3 · animals 0 · lab 3

Top 3 of 6 results

In children with MISC, larazotide cleared spike antigen faster than placebo.Science translational medicine, 2025
Children with MIS-C receiving adjunctive larazotide cleared Spike antigen faster than those receiving steroids and/or IVIG alone.Critical care explorations, 2022
In a patient with MIS-C, larazotide treatment coincided with lower plasma spike antigen levels.The Journal of clinical investigation, 2021

Larazotide studies on daily life and fitness

2 results · people 2 · animals 0 · lab 0

2 results

In adults with celiac disease, larazotide 0.5 mg reduced tiredness compared with placebo.Gastroenterology, 2015
In children with MISC, larazotide enabled a faster return to usual activities than placebo.Science translational medicine, 2025

Larazotide studies on survival and serious illness

3 results · people 1 · animals 2 · lab 0

3 results

Children with MIS-C receiving adjunctive larazotide showed a trend toward shorter stays than those receiving steroids and/or IVIG alone.Critical care explorations, 2022
In mice, AT1001 completely reversed DSS-associated mortality compared with DSS without AT1001.Annals of the New York Academy of Sciences, 2017
In mice, AT1001 reduced epithelial barrier dysfunction.International journal of oral science, 2025

Larazotide studies on overall treatment results

1 result · people 1 · animals 0 · lab 0

1 result

A patient with MIS-C treated with larazotide improved beyond the response achieved with currently available treatments.The Journal of clinical investigation, 2021

Larazotide studies on pain

1 result · people 1 · animals 0 · lab 0

1 result

In adults with celiac disease, larazotide 0.5 mg reduced headache symptoms compared with placebo.Gastroenterology, 2015

Larazotide studies on receptors and cell signals

12 results · people 0 · animals 4 · lab 8

Top 5 of 12 results

In mice with ligated salivary gland ducts, AT1001 reduced endothelial barrier disruption.Journal of dental research, 2023
In mice with DSS colitis, AT1001 did not change zonulin gene expression compared with DSS without AT1001.Annals of the New York Academy of Sciences, 2017
In mice, AT1001 promoted ZO-1-dependent stabilization of blood vessels.Advanced science, 2025
In mice, AT1001 restored tricellulin expression.International journal of oral science, 2025
In cells, larazotide promoted tight junction assembly in a calcium switch assay.Peptides, 2012

Larazotide studies on liver

3 results · people 0 · animals 3 · lab 0

3 results

In rats with liver failure, drinking-water larazotide lowered ALT compared with TAA alone.Human & experimental toxicology, 2021
In rats with liver failure, drinking-water larazotide did not significantly change liver damage scores compared with TAA alone.Human & experimental toxicology, 2021
In rats with liver failure, gavage larazotide did not significantly change liver damage scores compared with TAA alone.Human & experimental toxicology, 2021

Larazotide studies on bones and joints

2 results · people 0 · animals 2 · lab 0

2 results

In mice, AT1001 improved bone defect repair.Advanced science, 2025
In autoimmune models, larazotide acetate reduced arthritis onset.Nature communications, 2020

Larazotide studies on lungs and breathing

1 result · people 0 · animals 1 · lab 0

1 result

In mice with ligated salivary gland ducts, AT1001 reduced gland fibrosis.Journal of dental research, 2023

Larazotide studies on skin, hair and wounds

2 results · people 0 · animals 0 · lab 2

2 results

In cells, larazotide increased electrical resistance after histamine challenge.JID innovations, 2025
In cells, larazotide reduced epithelial permeability after histamine challenge.JID innovations, 2025

Trials and papers

Larazotide trials

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

StatusPhase

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

Trials on this page (10 of 10)

10 trials · 8 completed · 2 stopped early

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

20052010201520202025

Ph 1
Safety Study of Larazotide Acetate to Treat Celiac Disease.
NCT00386165
29 Nov 2005 to 26 Jan 2006
Ph 1
Safety of Larazotide Acetate in Healthy Volunteers
NCT00386490
10 Jan 2006 to 27 Feb 2006
Ph 2
Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects
NCT00362856
13 Sept 2006 to 6 Mar 2007
Ph 2
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
NCT00492960
Aug 2007 to Mar 2009
Ph 2
Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease
NCT00620451
Feb 2008 to Dec 2009
Ph 2
Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease
NCT00889473
Apr 2009 to Apr 2010
Ph 2
A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease
NCT01396213
7 Nov 2011 to 20 Aug 2013
Ph 3
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms
NCT03569007
29 May 2019 to 21 Jul 2022
Terminated
Terminated
Ph 2
AT1001 for the Treatment of COVID-19 Related MIS-C
NCT05022303
1 Oct 2021 to 15 May 2024
Terminated
Terminated
Ph 2
AT1001 for the Treatment of Long COVID
NCT05747534
31 May 2023 to 18 Jun 2026

10 trials · 8 completed · 2 stopped early · source ClinicalTrials.gov (opens in a new tab)

TerminatedPhase 3NCT03569007

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

9 Meters Biopharma, Inc.n = 30729 May 2019 to 21 Jul 2022

Celiac Disease

Trial page ClinicalTrials.govUpdated 26 Jul 2022

CompletedPhase 2NCT05747534

AT1001 for the Treatment of Long COVID

Massachusetts General Hospitaln = 10731 May 2023 to 18 Jun 2026

Long COVID · Long COVID-19 · Post Acute COVID-19 Syndrome · Post Acute Sequelae of COVID-19

Trial page ClinicalTrials.govUpdated 18 Aug 2026

TerminatedPhase 2NCT05022303

AT1001 for the Treatment of COVID-19 Related MIS-C

Massachusetts General Hospitaln = 121 Oct 2021 to 15 May 2024

Covid19 · Multisystem Inflammatory Syndrome in Children

Trial page ClinicalTrials.govUpdated 13 Jun 2024

CompletedPhase 2NCT00492960

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

9 Meters Biopharma, Inc.n = 171Aug 2007 to Mar 2009

Celiac Disease

Trial page ClinicalTrials.govUpdated 20 Sept 2017

CompletedPhase 2NCT00620451

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

9 Meters Biopharma, Inc.n = 105Feb 2008 to Dec 2009

Celiac Disease

Trial page ClinicalTrials.govUpdated 20 Sept 2017

CompletedPhase 2NCT00889473

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

9 Meters Biopharma, Inc.n = 42Apr 2009 to Apr 2010

Celiac Disease

Trial page ClinicalTrials.govUpdated 20 Sept 2017

CompletedPhase 2NCT01396213

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

9 Meters Biopharma, Inc.n = 3427 Nov 2011 to 20 Aug 2013

Celiac Disease

Trial page ClinicalTrials.govUpdated 20 Sept 2017

CompletedPhase 2NCT00362856

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

9 Meters Biopharma, Inc.n = 8013 Sept 2006 to 6 Mar 2007

Celiac Disease

Trial page ClinicalTrials.govUpdated 12 Sept 2017

CompletedPhase 1NCT00386490

Safety of Larazotide Acetate in Healthy Volunteers

9 Meters Biopharma, Inc.n = 2410 Jan 2006 to 27 Feb 2006

Healthy

Trial page ClinicalTrials.govUpdated 12 Sept 2017

CompletedPhase 1NCT00386165

Safety Study of Larazotide Acetate to Treat Celiac Disease.

9 Meters Biopharma, Inc.n = 2129 Nov 2005 to 26 Jan 2006

Celiac Disease

Trial page ClinicalTrials.govUpdated 11 Sept 2017

Papers

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

Sort

Design

53 studies match. Retracted studies are left out.

Showing 24 of 53 studiesquery qry_1770cde4e4020b2e6ac0f1e1

Studies with results

26 studies in all, 14 on this page

Other design · 2020

2 results

Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.

Tajik et al. 2020Nature communicationscited by 401

PMID 32332732PMC7181728DOI 10.1038/s41467-020-15831-7PUB-32332732

CC BY2 results where Larazotide was given

Download PDF See results (2)

Case report or series · 2021

3 results

Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier.

Yonker et al. 2021The Journal of clinical investigationn = 1cited by 218

PMID 34032635PMC8279585DOI 10.1172/jci149633PUB-34032635

Rights unknown3 results where Larazotide was given

Source link See results (3)

Randomized controlled trial · 2015

9 results

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

Leffler et al. 2015Gastroenterologyn = 342cited by 178

PMID 25683116PMC4446229DOI 10.1053/j.gastro.2015.02.008PUB-25683116

Rights unknown9 results where Larazotide was given

Source link See results (9)

Randomized controlled trial · 2013

6 results

Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.

Kelly et al. 2013Alimentary pharmacology & therapeuticsn = 184cited by 147

PMID 23163616DOI 10.1111/apt.12147PUB-23163616

Full text at the publisher6 results where Larazotide was given

Publisher page See results (6)

Randomized controlled trial · 2012

5 results

A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.

Leffler et al. 2012The American journal of gastroenterologyn = 86cited by 138

PMID 22825365PMC3463856DOI 10.1038/ajg.2012.211PUB-22825365

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

Read at source See results (5)

In vitro (cells) · mouse · 2018

1 result

Marked differences in tight junction composition and macromolecular permeability among different intestinal cell types.

Pearce et al. 2018BMC biologycited by 109

PMID 29391007PMC5793346DOI 10.1186/s12915-018-0481-zPUB-29391007

CC BY1 result where Larazotide was given

Download PDF See results (1)

Animal study (in vivo) · mouse · 2012

8 results

Larazotide acetate regulates epithelial tight junctions in vitro and in vivo.

Gopalakrishnan et al. 2012Peptidescited by 95

PMID 22401908DOI 10.1016/j.peptides.2012.02.015PUB-22401908

Full text at the publisher8 results where Larazotide was given

Publisher page See results (8)

Animal study (in vivo) · mouse · 2017

5 results

Zonulin transgenic mice show altered gut permeability and increased morbidity/mortality in the DSS colitis model.

Sturgeon et al. 2017Annals of the New York Academy of Sciencescited by 65

PMID 28423466PMC5479715DOI 10.1111/nyas.13343PUB-28423466

Rights unknown5 results where Larazotide was given

Source link See results (5)

In vitro (cells) · 2012

8 results

Larazotide acetate promotes tight junction assembly in epithelial cells.

Gopalakrishnan et al. 2012Peptidescited by 59

PMID 22401910DOI 10.1016/j.peptides.2012.02.016PUB-22401910

Full text at the publisher8 results where Larazotide was given

Publisher page See results (8)

Animal study (in vivo) · mouse · 2022

1 result

Sex-dependent Lupus Blautia (Ruminococcus) gnavus strain induction of zonulin-mediated intestinal permeability and autoimmunity.

Silverman et al. 2022Frontiers in immunologycited by 58

PMID 36032126PMC9405438DOI 10.3389/fimmu.2022.897971PUB-36032126

CC BY1 result where Larazotide was given

Download PDF See results (1)

In vitro (cell-free) · 2020

5 results

In silico Analysis Revealed Potential Anti-SARS-CoV-2 Main Protease Activity by the Zonulin Inhibitor Larazotide Acetate.

Di Micco et al. 2020Frontiers in chemistrycited by 21

PMID 33520943PMC7843458DOI 10.3389/fchem.2020.628609PUB-33520943

CC BY2 results where Larazotide was given (plus 3 on tools or combinations, listed separately)

Download PDF See results (5)

Case report or series · 2022

5 results

Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series.

Yonker et al. 2022Critical care explorationsn = 26cited by 17

PMID 35211683PMC8860335DOI 10.1097/cce.0000000000000641PUB-35211683

Free to read · publisher termsCC BY-NC-ND4 results where Larazotide was given (plus 1 on tools or combinations, listed separately)

Read at source See results (5)

In vitro (cells) · 2022

1 result

Rational design of the zonulin inhibitor AT1001 derivatives as potential anti SARS-CoV-2.

Di Micco et al. 2022European journal of medicinal chemistrycited by 16

PMID 36332548PMC9579148DOI 10.1016/j.ejmech.2022.114857PUB-36332548

Rights unknown1 result where Larazotide was given

Source link See results (1)

Ex vivo tissue · pig · 2021

9 results

Larazotide acetate induces recovery of ischemia-injured porcine jejunum via repair of tight junctions.

Slifer et al. 2021PloS onecited by 11

PMID 33886649PMC8061941DOI 10.1371/journal.pone.0250165PUB-33886649

CC BY6 results where Larazotide was given (plus 3 on tools or combinations, listed separately)

Download PDF See results (9)

More studies

25 studies in all, 10 on this page

PubMed tag: review-article, Review · 2016

The potential utility of tight junction regulation in celiac disease: focus on larazotide acetate.

Khaleghi et al. 2016Therapeutic advances in gastroenterologycited by 69

PMID 26770266PMC4699279DOI 10.1177/1756283x15616576PUB-26770266

Rights unknown

Source link

PubMed tag: review-article, Review · 2023

Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions.

Veres-Székely et al. 2023International journal of molecular sciencescited by 68

PMID 37108711PMC10139156DOI 10.3390/ijms24087548PUB-37108711

CC BY

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PubMed tag: Review · 2019

Breaking Down Barriers: How Understanding Celiac Disease Pathogenesis Informed the Development of Novel Treatments.

Valitutti et al. 2019Digestive diseases and sciencescited by 54

PMID 31076989PMC6586517DOI 10.1007/s10620-019-05646-yPUB-31076989

Rights unknown

Source link

PubMed tag: Meta-Analysis, Systematic Review · 2022

Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials.

Hoilat et al. 2022Clinics and research in hepatology and gastroenterologycited by 43

PMID 34339872DOI 10.1016/j.clinre.2021.101782PUB-34339872

Full text at the publisher

Publisher page

PubMed tag: review-article, Review · 2021

Larazotide acetate: a pharmacological peptide approach to tight junction regulation.

Slifer et al. 2021American journal of physiology. Gastrointestinal and liver physiologycited by 35

PMID 33881350PMC11735010DOI 10.1152/ajpgi.00386.2020PUB-33881350

Rights unknown

Source link

PubMed tag: Review · 2012

Non-dietary therapeutic clinical trials in coeliac disease.

Crespo Pérez et al. 2012European journal of internal medicinecited by 28

PMID 22153524DOI 10.1016/j.ejim.2011.08.030PUB-22153524

Full text at the publisher

Publisher page

PubMed tag: Review · 2021

The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases.

Troisi et al. 2021Current medicinal chemistrycited by 28

PMID 33397225DOI 10.2174/0929867328666210104110053PUB-33397225

Full text at the publisher

Publisher page

PubMed tag: Review · 2015

Pharmacological approaches in celiac disease.

McCarville et al. 2015Current opinion in pharmacologycited by 21

PMID 26414923DOI 10.1016/j.coph.2015.09.002PUB-26414923

Full text at the publisher

Publisher page

PubMed tag: Letter · 2021

Lack of relationship of AT1001 to zonulin and prehaptoglobin-2: clinical implications.

Sollid et al. 2021Gutcited by 14

PMID 33443022DOI 10.1136/gutjnl-2020-323829PUB-33443022

Full text at the publisher

Publisher page

PubMed tag: Review · 2021

Current pharmacological approaches and potential future therapies for Celiac disease.

Kulkarni et al. 2021European journal of pharmacologycited by 12

PMID 34418405DOI 10.1016/j.ejphar.2021.174434PUB-34418405

Full text at the publisher

Publisher page

No result for Larazotide (1 study on this page, 2 in all)

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

PubMed tag: none · 2021

Peptide Derivatives of the Zonulin Inhibitor Larazotide (AT1001) as Potential Anti SARS-CoV-2: Molecular Modelling, Synthesis and Bioactivity Evaluation.

Di Micco et al. 2021International journal of molecular sciencescited by 18

PMID 34502335PMC8431481DOI 10.3390/ijms22179427PUB-34502335

CC BY

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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.

Larazotide studies: 26 papers with results

Page 1 of 1

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.
Leffler DA · Gastroenterology · 2015
Randomized controlled trial · 9 results
A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.
Leffler DA · The American journal of gastroenterology · 2012
Randomized controlled trial · 5 results
Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.
Kelly CP · Alimentary pharmacology & therapeutics · 2013
Randomized controlled trial · 6 results
Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide.
Yonker LM · Science translational medicine · 2025
Randomized controlled trial · 4 results
Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series.
Yonker LM · Critical care explorations · 2022
Case report or series · 5 results
Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier.
Yonker LM · The Journal of clinical investigation · 2021
Case report or series · 3 results
Larazotide acetate regulates epithelial tight junctions in vitro and in vivo.
Gopalakrishnan S · Peptides · 2012
Animal study (in vivo) · mouse · 8 results
Zonulin transgenic mice show altered gut permeability and increased morbidity/mortality in the DSS colitis model.
Sturgeon C · Annals of the New York Academy of Sciences · 2017
Animal study (in vivo) · mouse · 5 results
Sex-dependent Lupus Blautia (Ruminococcus) gnavus strain induction of zonulin-mediated intestinal permeability and autoimmunity.
Silverman GJ · Frontiers in immunology · 2022
Animal study (in vivo) · mouse · 1 result
The Role of Endothelial Barrier Function in the Fibrosis of Salivary Gland.
Mao XD · Journal of dental research · 2023
Animal study (in vivo) · mouse · 2 results
Delayed Administration of IGFBP7 Improved Bone Defect Healing via ZO-1 Dependent Vessel Stabilization.
Sun S · Advanced science (Weinheim, Baden-Wurttemberg, Germany) · 2025
Animal study (in vivo) · mouse · 2 results
Loss of tricellular tight junction tricellulin leads to hyposalivation in Sjögren's syndrome.
Mao X · International journal of oral science · 2025
Animal study (in vivo) · mouse · 3 results
Effects of larazotide acetate, a tight junction regulator, on the liver and intestinal damage in acute liver failure in rats.
Caliskan AR · Human & experimental toxicology · 2021
Animal study (in vivo) · rat · 7 results
Ameliorative Effects of Larazotide Acetate on Intestinal Permeability and Bacterial Translocation in Acute Pancreatitis Model in Rats.
Karahan D · Digestive diseases and sciences · 2024
Animal study (in vivo) · rat · 4 results
Characterizing zonulin and par2 Expression in Zonulin Transgenic and Zonulin Inhibition Mouse Models of Motility and Inflammation.
Martinez EE · International journal of molecular sciences · 2025
Animal study (in vivo) · mouse · 3 results
Potassium-Competitive Acid Blocker Increases Ileal Permeability and Exacerbates Ileal Inflammation under Stress Conditions in a Mouse Model of Eosinophilic Enteritis.
Yamamoto K · Digestion · 2026
Animal study (in vivo) · mouse · 2 results
Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.
Tajik N · Nature communications · 2020
Other design · 2 results
Larazotide acetate induces recovery of ischemia-injured porcine jejunum via repair of tight junctions.
Slifer ZM · PloS one · 2021
Ex vivo tissue · pig · 9 results
Marked differences in tight junction composition and macromolecular permeability among different intestinal cell types.
Pearce SC · BMC biology · 2018
In vitro (cells) · mouse · 1 result
Larazotide acetate promotes tight junction assembly in epithelial cells.
Gopalakrishnan S · Peptides · 2012
In vitro (cells) · 8 results
Rational design of the zonulin inhibitor AT1001 derivatives as potential anti SARS-CoV-2.
Di Micco S · European journal of medicinal chemistry · 2022
In vitro (cells) · 1 result
Larazotide Acetate Protects the Intestinal Mucosal Barrier from Anoxia/Reoxygenation Injury via Various Cellular Mechanisms.
Kim J · Biomedicines · 2025
In vitro (cells) · 5 results
The PAR2 Antagonist Larazotide Can Mitigate Acute Histamine-Stimulated Epithelial Barrier Disruption in Keratinocytes: A Potential Adjunct Treatment for Atopic Dermatitis.
Glinka DM · JID innovations : skin science from molecules to population health · 2025
In vitro (cells) · 2 results
In silico Analysis Revealed Potential Anti-SARS-CoV-2 Main Protease Activity by the Zonulin Inhibitor Larazotide Acetate.
Di Micco S · Frontiers in chemistry · 2020
In vitro (cell-free) · 5 results
Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment.
Yu F · Journal of controlled release : official journal of the Controlled Release Society · 2025
Not a test of Larazotide alone · 12 results
The influence of AT1002 on the nasal absorption of molecular weight markers and therapeutic agents when co-administered with bioadhesive polymers and an AT1002 antagonist, AT1001.
Song KH · The Journal of pharmacy and pharmacology · 2012
Not a test of Larazotide alone · 2 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	No US medicinal approval was established from the reviewed sources.	21 Oct 2026	Not recorded
EU	EMA	No central or national medicinal approval was established from the reviewed sources.	21 Oct 2026	Not recorded
Sport	WADA	Status unknown Not specifically named.	2026 List	wada-ama.org (opens in a new tab)

Safety outcomes

8 safety results for Larazotide.

Human evidence· 7

In adults with celiac disease, larazotide safety was comparable with placebo.
Randomized controlled trialn = 342
In patients with coeliac disease during gluten challenge, adverse event rates were similar with larazotide and placebo.
Randomized controlled trialn = 184
In patients with celiac disease, larazotide was generally well tolerated.
Randomized controlled trialn = 86
In the celiac disease trial, no serious adverse events were observed.
Randomized controlled trialn = 86
In the celiac disease trial, headache and urinary tract infection were the most common adverse events; arm-specific rates were not reported.
Randomized controlled trialn = 86
In children with MISC, no larazotide-related adverse events were reported.
Randomized controlled trialn = 12
Four children with MIS-C given larazotide as an adjuvant to steroid and/or intravenous immunoglobulin therapy tolerated it without adverse effects.
Case report or seriesn = 4

Animal evidence· 1

In zonulin transgenic mice, AT1001 completely reversed DSS-associated mortality.
Animal study (in vivo)mouse

Doses studied · 15

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

0.5 mg 3 times dailyHuman
Species
human
Route
Not reported
Duration
12 weeks
Design
Randomized controlled trial · n = 340
0.25, 1, 4, or 8 mg three times per dayHuman
Species
human
Route
Not reported
Duration
14 days
Design
Randomized controlled trial
1, 4, or 8 mg three times dailyHuman
Species
human
Route
oral
Duration
6 weeks
Design
Randomized controlled trial · n = 184
1 mg 3 times dailyHuman
Species
human
Route
Not reported
Duration
12 weeks
Design
Randomized controlled trial
2 mg 3 times dailyHuman
Species
human
Route
Not reported
Duration
12 weeks
Design
Randomized controlled trial
1 mg three times dailyHuman
Species
human
Route
oral
Duration
6 weeks
Design
Randomized controlled trial

Doses studied in the study results, as given in the studies.
Dose as reported	Class	Species	Route	Duration	Design
0.5 mg 3 times daily	Human	human	Not reported	12 weeks	Randomized controlled trial · n = 340
0.25, 1, 4, or 8 mg three times per day	Human	human	Not reported	14 days	Randomized controlled trial
1, 4, or 8 mg three times daily	Human	human	oral	6 weeks	Randomized controlled trial · n = 184
1 mg 3 times daily	Human	human	Not reported	12 weeks	Randomized controlled trial
2 mg 3 times daily	Human	human	Not reported	12 weeks	Randomized controlled trial
1 mg three times daily	Human	human	oral	6 weeks	Randomized controlled trial

6 of 15 shown

PepBank is a research reference. Talk to a doctor before you use any peptide.

Data

Data and API

Data version, change history and code for this peptide.

Data version 30856030 Oct 2026

Peptide

Peptide id: PEP-000109
Peptide version: 3
Peptide hash: c7920d8050672b6a…
Data version: 308560

Latest changes

27 Oct 2026UpdatedData version 256715
22 Oct 2026UpdatedData version 254540
21 Oct 2026CreatedData version 228099

For developers

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

Evidence summary for Larazotide: 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
Gastrointestinal protectionGastrointestinal	Human: 12 results from 5 studies: 3 increase, 4 decrease, 4 no significant change, 1 mixed. Strongest design: Randomized controlled trial	Animal: 13 results from 7 studies: 1 increase, 9 decrease, 1 no significant change, 2 not reported. Strongest design: Animal study (in vivo)	Lab: 18 results from 5 studies: 4 increase, 10 decrease, 2 no significant change, 2 not reported. Strongest design: Ex vivo tissue	Computer model: 1 result from 1 study: 1 not reported. Strongest design: In silico	44
Adverse eventsWhole body	Human: 7 results from 5 studies: 2 no significant change, 5 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	7
Antiviral activityInfection	Human: 3 results from 3 studies: 1 increase, 2 decrease. Strongest design: Randomized controlled trial	No results	Lab: 3 results from 2 studies: 2 decrease, 1 not reported. Strongest design: In vitro (cells)	No results	6
Immune responseImmune and inflammation	Human: 3 results from 1 study: 3 decrease. Strongest design: Randomized controlled trial	Animal: 1 result from 1 study: 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	4
Exercise and physical functionWhole body	Human: 2 results from 2 studies: 1 increase, 1 decrease. Strongest design: Randomized controlled trial	No results	No results	No results	2
Inflammation markersImmune and inflammation	Human: 1 result from 1 study: 1 decrease. Strongest design: Case report or series	Animal: 1 result from 1 study: 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	2
Intensive care and hospital outcomesWhole body	Human: 1 result from 1 study: 1 decrease. Strongest design: Case report or series	No results	No results	No results	1
Overall treatment effectWhole body	Human: 1 result from 1 study: 1 increase. Strongest design: Case report or series	No results	No results	No results	1
PainNervous system and cognition	Human: 1 result from 1 study: 1 decrease. Strongest design: Randomized controlled trial	No results	No results	No results	1
Receptor activity and mechanismWhole body	No results	Animal: 4 results from 4 studies: 2 increase, 1 decrease, 1 no significant change. Strongest design: Animal study (in vivo)	Lab: 8 results from 1 study: 7 increase, 1 decrease. Strongest design: In vitro (cells)	No results	12
Liver fat and liver functionLiver	No results	Animal: 3 results from 1 study: 1 decrease, 2 no significant change. Strongest design: Animal study (in vivo)	No results	No results	3
Bone and jointMusculoskeletal	No results	Animal: 2 results from 2 studies: 1 increase, 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	2

Outcome group	Human	Animal	Lab	Computer model	Total
Gastrointestinal protectionGastrointestinal	Human: 12 results from 5 studies: 3 increase, 4 decrease, 4 no significant change, 1 mixed. Strongest design: Randomized controlled trial	Animal: 13 results from 7 studies: 1 increase, 9 decrease, 1 no significant change, 2 not reported. Strongest design: Animal study (in vivo)	Lab: 18 results from 5 studies: 4 increase, 10 decrease, 2 no significant change, 2 not reported. Strongest design: Ex vivo tissue	Computer model: 1 result from 1 study: 1 not reported. Strongest design: In silico	44
Adverse eventsWhole body	Human: 7 results from 5 studies: 2 no significant change, 5 not reported. Strongest design: Randomized controlled trial	No results	No results	No results	7
Antiviral activityInfection	Human: 3 results from 3 studies: 1 increase, 2 decrease. Strongest design: Randomized controlled trial	No results	Lab: 3 results from 2 studies: 2 decrease, 1 not reported. Strongest design: In vitro (cells)	No results	6
Immune responseImmune and inflammation	Human: 3 results from 1 study: 3 decrease. Strongest design: Randomized controlled trial	Animal: 1 result from 1 study: 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	4
Exercise and physical functionWhole body	Human: 2 results from 2 studies: 1 increase, 1 decrease. Strongest design: Randomized controlled trial	No results	No results	No results	2
Inflammation markersImmune and inflammation	Human: 1 result from 1 study: 1 decrease. Strongest design: Case report or series	Animal: 1 result from 1 study: 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	2
Intensive care and hospital outcomesWhole body	Human: 1 result from 1 study: 1 decrease. Strongest design: Case report or series	No results	No results	No results	1
Overall treatment effectWhole body	Human: 1 result from 1 study: 1 increase. Strongest design: Case report or series	No results	No results	No results	1
PainNervous system and cognition	Human: 1 result from 1 study: 1 decrease. Strongest design: Randomized controlled trial	No results	No results	No results	1
Receptor activity and mechanismWhole body	No results	Animal: 4 results from 4 studies: 2 increase, 1 decrease, 1 no significant change. Strongest design: Animal study (in vivo)	Lab: 8 results from 1 study: 7 increase, 1 decrease. Strongest design: In vitro (cells)	No results	12
Liver fat and liver functionLiver	No results	Animal: 3 results from 1 study: 1 decrease, 2 no significant change. Strongest design: Animal study (in vivo)	No results	No results	3
Bone and jointMusculoskeletal	No results	Animal: 2 results from 2 studies: 1 increase, 1 decrease. Strongest design: Animal study (in vivo)	No results	No results	2

Larazotide studies and research data

Larazotide identity

Targets

Sequence and structure

Sequence

Parent: Zonula occludens toxin (Zot) of Vibrio cholerae

Properties

Net charge by pH

Composition

3D structure

2D structure

Larazotide results by year and outcome

What the studies measured

Larazotide studies on stomach and gut

Larazotide studies on side effects

Larazotide studies on immune system and inflammation

Larazotide studies on infections

Larazotide studies on daily life and fitness

Larazotide studies on survival and serious illness

Larazotide studies on overall treatment results

Larazotide studies on pain

Larazotide studies on receptors and cell signals

Larazotide studies on liver

Larazotide studies on bones and joints

Larazotide studies on lungs and breathing

Larazotide studies on skin, hair and wounds

Larazotide trials

Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

AT1001 for the Treatment of Long COVID

AT1001 for the Treatment of COVID-19 Related MIS-C

Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease

Randomized, Double-Blind, Placebo-Controlled Study of Larazotide Acetate in Subjects With Active Celiac Disease

Study of the Efficacy of Larazotide Acetate to Treat Celiac Disease

A Double-blind Placebo-controlled Study to Evaluate Larazotide Acetate for the Treatment of Celiac Disease

Safety and Tolerability Study of Larazotide Acetate in Celiac Disease Subjects

Safety of Larazotide Acetate in Healthy Volunteers

Safety Study of Larazotide Acetate to Treat Celiac Disease.

Papers

Studies with results

Targeting zonulin and intestinal epithelial barrier function to prevent onset of arthritis.

Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier.

Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial.

Larazotide acetate in patients with coeliac disease undergoing a gluten challenge: a randomised placebo-controlled study.

A randomized, double-blind study of larazotide acetate to prevent the activation of celiac disease during gluten challenge.

Marked differences in tight junction composition and macromolecular permeability among different intestinal cell types.

Larazotide acetate regulates epithelial tight junctions in vitro and in vivo.

Zonulin transgenic mice show altered gut permeability and increased morbidity/mortality in the DSS colitis model.

Larazotide acetate promotes tight junction assembly in epithelial cells.

Sex-dependent Lupus Blautia (Ruminococcus) gnavus strain induction of zonulin-mediated intestinal permeability and autoimmunity.

In silico Analysis Revealed Potential Anti-SARS-CoV-2 Main Protease Activity by the Zonulin Inhibitor Larazotide Acetate.

Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series.

Rational design of the zonulin inhibitor AT1001 derivatives as potential anti SARS-CoV-2.

Larazotide acetate induces recovery of ischemia-injured porcine jejunum via repair of tight junctions.

More studies

The potential utility of tight junction regulation in celiac disease: focus on larazotide acetate.

Zonulin as a Potential Therapeutic Target in Microbiota-Gut-Brain Axis Disorders: Encouraging Results and Emerging Questions.

Breaking Down Barriers: How Understanding Celiac Disease Pathogenesis Informed the Development of Novel Treatments.

Larazotide acetate for treatment of celiac disease: A systematic review and meta-analysis of randomized controlled trials.

Larazotide acetate: a pharmacological peptide approach to tight junction regulation.

Non-dietary therapeutic clinical trials in coeliac disease.

The Therapeutic use of the Zonulin Inhibitor AT-1001 (Larazotide) for a Variety of Acute and Chronic Inflammatory Diseases.

Pharmacological approaches in celiac disease.

Lack of relationship of AT1001 to zonulin and prehaptoglobin-2: clinical implications.

Current pharmacological approaches and potential future therapies for Celiac disease.

Peptide Derivatives of the Zonulin Inhibitor Larazotide (AT1001) as Potential Anti SARS-CoV-2: Molecular Modelling, Synthesis and Bioactivity Evaluation.

Newer studies

Larazotide studies: 26 papers with results

Regulatory and safety

Human evidence· 7

Animal evidence· 1

Doses studied · 15

Data and API

Peptide

Latest changes

For developers

Related peptides

Larazotide results by year and outcome

Larazotide studies on stomach and gut

Larazotide studies on side effects

Larazotide studies on immune system and inflammation