Gut and barrier
Conceptual educational illustration of Larazotide / Larazotida in a glass vial, labelled MOLECULE PROFILE.

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MOLECULE PROFILE

Larazotide / Larazotida

Peptide or peptide-related

Investigational intestinal tight-junction modulation.

Sources checked · October 16, 2026

Published for review · Scientific, medical, translation and citation review pending. Reported uses are not authorized indications. Frequency reflects mentions in supplied sources, not sales or global clinical prevalence.

Identity and synonyms

AT1001 also retrieves migalastat studies: exclude those from larazotide evidence.

Synonyms: Larazotide acetate · AT-1001 (ambiguous code)

Peptide or peptide-related · Peptide or peptide derivative

Detailed molecular class: Peptide

Supplied sequence or chemical reference

See identity note; no supplier sequence accepted as verification.

Mechanism

Investigational intestinal tight-junction modulation.

Evidence and critical reading

Reported scientific and empirical uses

Gut and barrier · Immune modulation and inflammation

Reported for intestinal permeability and GI symptoms; the specific trial addressed persistent celiac symptoms.

Human evidence

A 342-adult celiac trial found a symptom signal in one study arm; this does not establish efficacy in IBS or all permeability complaints.

Preclinical evidence

Barrier models do not establish a universal gut-repair effect.

Critical reading and limitations

A randomized 342-adult trial found a signal in one arm; it does not validate every “leaky gut” claim or replace a gluten-free diet.

Evidence applies to the exact molecule, formulation, route, population and endpoint studied. Supplier identity, purity and clinical equivalence are unverified.

Source-specific regimens

Descriptive source observations, not individual recommendations.

Regulatory product labeling

Listed regimens preserve source/context. An empty layer means no regimen attributable to this identity was verified in this review; it does not prove universal absence of data.

Human-study exposure

NOT A RECOMMENDATION.Each amount is attributed to the source identified for that entry: regulatory product labeling, human research, or community and practice sources. These source categories have different evidentiary roles. They are not medical advice, not a protocol, not a recommended or safe dose, and not evidence that it works. Do not use them to start, change or stop any treatment. Talk to a qualified healthcare professional.

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

0.5 / 1 / 2 mg · Per administration in separate arms

Frequency
Three times/day
Duration
12 treatment weeks
Route
Oral
Context
342 adults with symptomatic celiac disease despite diet; favorable signal only in 0.5-mg arm.
Presentation
A dosage-form presentation is not specified in the reviewed record.
Interpretation
Research exposure: not a prescription or starting regimen. It does not reconstruct protocol titration, exclusions or monitoring.

PMID25683116 · October 16, 2026

NOT A RECOMMENDATION.Each amount is attributed to the source identified for that entry: regulatory product labeling, human research, or community and practice sources. These source categories have different evidentiary roles. They are not medical advice, not a protocol, not a recommended or safe dose, and not evidence that it works. Do not use them to start, change or stop any treatment. Talk to a qualified healthcare professional.

Empirical handbook

Listed regimens preserve source/context. An empty layer means no regimen attributable to this identity was verified in this review; it does not prove universal absence of data.

Regulation and safety

Jurisdiction-specific regulatory context

Jurisdiction-specific approval not verified in this card; do not infer global nonapproval.

Adverse effects and unknowns

Trial tolerability and exclusions do not characterize long-term combination safety.

Trial tolerability is population/formulation-specific; BPC/KPV blends do not inherit those data.

Contraindications

See supported safety statements and exact product label; a complete contraindication set has not been established for this catalog material.

A complete list must match the exact authorized product. For experimental materials without verified human labeling, a complete contraindication set is not established here. No list does not mean safety.

Interactions

Only explicitly cited interactions may be asserted; unstudied combinations remain unknown, not interaction-free.

Separate documented interaction, pharmacologic plausibility and unknown interaction. Absence of a blend trial does not establish compatibility.

Studies and trials

Selected studies

PMID25683116 · Randomized controlled trial

Symptomatic celiac disease despite gluten-free diet.

Oral three times/day, 12 weeks.

0.5-mg arm met symptom endpoint; 1/2 mg did not differ from placebo.

Trial product/population; does not authenticate supplier material or permit simple indirect comparisons.

n = 342

Trials attributed in the package

NCT03569007 · Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD SymptomsRegistry status: TerminatedLast update posted: July 26, 2022Query verification: October 16, 2026

Trial registration does not establish efficacy or validate commercial material.

Query candidates; attribution pending

Larazotide · 29 unfiltered query results, not authenticated trials

Query verification: October 16, 2026

Exact phrase intervention query; first three most recently updated records, not exhaustive. Aliases may be missed and heterogeneous products may appear. The total is the unfiltered registry query count, not authenticated trials. Source-integrity holds are excluded from ordinary listings.

View trial registry query

NCT06904261 · A Study of Migalastat in Pediatric Subjects (2 to <12 Yrs) With Fabry Disease and Amenable GLA VariantsRegistry status: RecruitingLast update posted: September 1, 2026Query verification: October 16, 2026

NCT05747534 · AT1001 for the Treatment of Long COVIDRegistry status: CompletedLast update posted: August 18, 2026Query verification: October 16, 2026

NCT04020055 · A Study to Evaluate Migalastat in Fabry Subjects With Amenable GLA Variant and Renal DiseaseRegistry status: Active, not recruitingLast update posted: July 6, 2026Query verification: October 16, 2026

Source issues and references

References include queries and bibliographic handbook attributions; not all are clinical studies. Human review remains pending.

  1. PMID25683116

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

    Leffler DA, Kelly CP, Green PH, Fedorak RN, DiMarino A, Perrow W, Rasmussen H, Wang C, Bercik P, Bachir NM, Murray JA.

    October 16, 2026

  2. R17

    Larazotide celiac disease randomized trial, 2015

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