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Larazotide Acetate
Research Use
Also known as AT-1001, INN-202
Function
Primary
Celiac disease (adjunct) · Leaky-gut / barrier dysfunction (research)
Mechanism
8-aa peptide that antagonizes zonulin signaling — preserves intestinal tight junctions, reducing paracellular permeability and antigen translocation.
Evidence
Clinical RCT (Limited)
Research
Phase 2b positive; Phase 3 missed primary endpoint (2022)
Dosing
Range
0.5 mg TID before meals (trial)
Frequency
3× daily
Route
Oral
Cycling
Continuous with meals.
Benefits
- ·Reduced GI symptoms in gluten-exposed celiac patients
- ·Decreased intestinal permeability markers
Risks
- ·Headache
- ·Mild GI upset
- ·Mixed efficacy data
Contraindications
- ·Hypersensitivity
- ·Pregnancy (insufficient data)
Regulatory
Investigational (9 Meters Biopharma) — Phase 3 CeDLara
Functional Groups
Cited Works
- Leffler DA et al. Larazotide acetate for celiac disease — Phase 2b RCT. Gastroenterology. 2015;148:1311.source