For research and educational purposes only. Not medical advice.
Larazotide Reference
Educational, not medical advice reference for Larazotide: Immune, Recovery; regulatory status, evidence posture, source review, and schedule not…
Reference summary
Peer-reviewed Phase 2b data (Leffler 2015) showed symptom improvement in celiac patients with persistent symptoms on a gluten-free diet, but the subsequent Phase 3 CeDLara trial was stopped early for futility in 2022. pepSmart presents larazotide only as trial-context educational content.
Regulatory and posture
- Categories
- Immune, Recovery
- Aliases
- Larazotide acetate, AT-1001, INN-202
- Evidence posture
- human - Human Phase 2 data exist, but the Phase 3 CeDLara celiac trial was discontinued in 2022 for futility; larazotide remains investigational with no approved product.
- Regulatory status
- Investigational. Larazotide acetate is a tight-junction regulator studied as an oral add-on to gluten-free diet in celiac disease. The Phase 3 CeDLara trial was discontinued in 2022 after an interim futility analysis; no FDA-approved drug label currently exists.
- Content review status
- investigational verified
Selected public sources
- PubMed: Leffler 2015 larazotide acetate for persistent celiac symptoms RCT (Gastroenterology)
- ClinicalTrials.gov larazotide acetate Phase 3 (CeDLara) celiac-disease search
Related tools
- Protocol builder overview - Public overview of the Pro protocol builder.