B
Tier
Tight-junction-regulating peptide for leaky gut and celiac support.
Gut Health Support
Peptide
WADA Status:
Not listed
Human Trial Scoreboard
Completed human RCTs
Including one Phase 3
Largest Human Study
Phase 3 CeDLara, planned
Longest exposure
24 weeks
Most Recent Trial
Phase 3 discontinued
Description
Larazotide is the closest anyone has come to a drug for celiac disease. In celiac disease, gluten triggers an immune reaction that loosens the junctions between the cells lining the gut, letting fragments through that provoke further inflammation. Larazotide was designed to tighten those junctions and hold the barrier closed. It stays in the gut rather than being absorbed, which is unusual and helpful. It performed well enough in mid-stage testing, in a trial of three hundred and forty two adults, to become the first celiac drug ever to reach a late-stage trial. That trial, CeDLara, was stopped in June 2022 after an interim analysis showed the effect was too small to prove within any realistic number of patients. It failed on effectiveness rather than safety, and a strict gluten-free diet remains the only established treatment.
What Are The Claims
Claims made for this compound: May reduce symptoms of intestinal permeability as a celiac adjunct (positive Phase 2b at one dose); Acts locally with minimal systemic absorption; Proposed to tighten intestinal tight junctions
Evidence
The nuance here matters and I want to state it precisely rather than simplify it into something punchier. The trial was stopped for futility at an interim analysis, not for a formal endpoint miss and not for safety. The interim look indicated the enrollment required to reach statistical significance was impractically large. In plain terms: it was not working well enough to be worth finishing. This compound had the most rigorous development path of almost anything in this database. Positive Phase 2b results did not survive the confirmatory trial. That is a useful and slightly deflating lesson about how often promising peptide data fails to hold up when tested properly, and it is worth carrying into how you read every other entry here.
Evidence Strength
Preliminary (positive Phase 2b; Phase 3 failed)
Caveats
Phase 3 CeDLara stopped for futility (2022, company-reported); not approved; Phase 2b was positive only at the 0.5 mg dose.
Safety
Alternative Measures
Legal Status
US
Not approved; development discontinued
UK
Not approved
EU
Not approved
AU
Not approved
WADA
Not listed
Not approved. The Phase 3 CeDLara trial in celiac disease, registry number NCT03569007, was discontinued in June 2022. 9 Meters Biopharma subsequently moved away from the programme.
Citations
CeDLara Phase 3 trial, NCT03569007, discontinued for futility June 2022 following interim analysis. Not stopped for safety.