Larazotide Side Effects: Safety Signals and Warnings
Larazotide safety concerns are compound-specific. The main listed side effects are Generally well-tolerated in clinical trials, Headache, and Urinary tract infection. The main warning signals are Not yet FDA-approved; Phase 3 trials ongoing, Not a substitute for a gluten-free diet in celiac disease, and Intended as adjunctive therapy for inadvertent gluten exposure.
Direct Answer
Larazotide has Phase 3 data in celiac disease as a tight junction regulator, showing statistically significant reduction in GI symptoms even on a gluten-free diet. While its primary Phase 3 trial missed its primary endpoint, secondary endpoints were positive and a new trial is ongoing. For tight junction biology and celiac disease research, it is the most advanced clinical candidate in its mechanistic class.
- Evidence grade
- Level B
- Research status
- Phase 3
- Category
- Healing & Recovery
- Best for
- Celiac disease symptom management, tight junction permeability research, intestinal barrier restoration
Reported Side Effects
- Generally well-tolerated in clinical trials
- Headache
- Urinary tract infection
- Nausea
- Upper respiratory tract infection
- Adverse event profile similar to placebo in most studies
Warnings
- Not yet FDA-approved; Phase 3 trials ongoing
- Not a substitute for a gluten-free diet in celiac disease
- Intended as adjunctive therapy for inadvertent gluten exposure
- Long-term safety data is limited
- Efficacy in refractory celiac disease has not been established
Known or Plausible Interactions
- Minimal systemic drug interactions expected due to local gut action
- Gluten-free diet (intended to be used concomitantly)
- Immunosuppressants used in refractory celiac disease (no interaction data)
Regulatory Context
Larazotide acetate is an investigational drug in Phase 3 clinical trials. Not yet approved by the FDA or other regulatory agencies. Fast Track designation granted by the FDA for celiac disease. Developed by 9 Meters Biopharma (formerly Innovate Biopharmaceuticals).
Evidence Snapshot
| Evidence grade | Level B |
|---|---|
| Research status | Phase 3 |
| Best supported outcomes | Celiac Disease Symptom Reduction (Level B), Intestinal Permeability Improvement (Level B), and Gluten-Induced Immune Activation Reduction (Level C) |
| Primary citation count | 3 |
| Last reviewed | 2026-04-04 |
Related Guides
How to Cite This Page
ExaminePeptides. "Larazotide Side Effects: Safety Signals and Warnings." Last reviewed 2026-04-04. https://examinepeptides.com/answers/larazotide-side-effects-safety/
This static answer page is built for fast indexing and direct citation. It summarizes the matching full evidence review and links back to primary sources where the source database includes them.