Larazotide Research Evidence
The Larazotide evidence base: trials, journals, and what the data does not yet show.
A Positive Phase 2 That Didn't Carry Through
In a 2015 Phase 2 trial (Leffler et al., Gastroenterology, n=342), larazotide at 0.5mg three times daily reduced persistent celiac symptoms compared to placebo in patients already on a gluten-free diet — notably, higher doses performed no better. This positive signal supported advancement to Phase 3.
Phase 3 Termination and Regulatory and Legal Status
The pivotal Phase 3 trial, CeDLara, was terminated in 2022 at a pre-planned futility interim analysis — it could not reach statistical significance, and the development program was discontinued. Larazotide is not FDA-approved and has no path to market as things stand. It is sold today only as a research-grade compound (RUO); researchers and users should verify the legal status of larazotide in their jurisdiction prior to purchase or use.
Trials and reviews
- Leffler celiac Phase 2Gastroenterology2015
0.5mg TID reduced persistent celiac symptoms vs. placebo (n=342)
- CeDLara Phase 3 (terminated)9 Meters Biopharma2022
Terminated at a pre-planned futility interim; program discontinued
References
- Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet · Leffler DA, et al. · 2015