Is Larazotide acetate legal in the US?
No. It is not approved; its last big trial was stopped.
BSome human evidenceIn clinical trialsas of 2026-10-26
Not approved by the FDA for any use. Larazotide acetate reached a phase 3 trial for celiac disease, which 9 Meters Biopharma stopped in June 2022 after an interim analysis found it unlikely to show a difference from placebo. 2
No. It never reached an approval application. The phase 3 celiac trial was stopped in 2022 after an interim look. 9 Meters moved its resources to other programs. 2
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Citations
- Slifer 2021, Am J Physiol GI: larazotide acetate, a pharmacological peptide approach to tight junction regulation doi.org
- Beyond Celiac 2022: Phase 3 study of larazotide acetate discontinued beyondceliac.org
- Hoilat 2022, Clin Res Hepatol Gastroenterol: larazotide acetate for celiac disease, systematic review and meta-analysis of four RCTs doi.org
Reference information only, not medical advice. Drawn from the Larazotide acetate article, fact-checked against the cited sources. No dosing anywhere on this site.