Is larazotide FDA-approved?

No. Larazotide isn't FDA-approved, and Drugs@FDA lists no application with it as an active ingredient.

Checked 1 Nov 2026. The sources are below.

Larazotide

Also: larazotide acetate, AT-1001, INN-202, Gly-Gly-Val-Leu-Val-Gln-Pro-Gly

Status label in the Peptimes Library
Not FDA-Approved
Routes in Peptimes
Oral
Updated
1 Nov 2026

US regulatory status

  • FDA status

    Not FDA-Approved. Drugs@FDA lists no application with larazotide or larazotide acetate as an active ingredient.

    Source: Drugs@FDA, checked 1 Nov 2026

What studies have looked at

Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.

  • Review of studies

    A 2022 meta-analysis of 4 randomized trials in 626 people with celiac disease: larazotide improved gastrointestinal symptom scores compared with placebo in people given a gluten challenge, but not in people on a gluten-free diet alone. It didn't change a gut permeability test.

    Source: PMID 34339872, checked 1 Nov 2026

How to track it in Peptimes

Add larazotide in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “Not FDA-Approved”.

  • Logging: the amount you took and how you feel. It’s logged as oral, so there’s no injection site to record.
  • Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.

Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell larazotide or any other compound.

More sources

  • FDA, Global Substance Registration System, Larazotide and Larazotide acetate, checked 1 Nov 2026: its sequence of 8 amino acids, and the code name AT-1001.
  • FDA, Drugs@FDA, checked 1 Nov 2026 through FDA’s openFDA Drugs@FDA data: no application lists larazotide as an active ingredient.
  • ClinicalTrials.gov, search “larazotide”, checked 1 Nov 2026: its registered trials are completed or terminated.

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