Home›Larazotide›Legal status
Educational — Not Legal AdviceReviewed
Is Larazotide legal? FDA status and US regulatory standing
Current status
Investigational. Larazotide is an investigational compound in active clinical trials, not yet FDA-approved.
Primary source: clinicaltrials.gov
Federal legal status
FDA approval status
Larazotide is an investigational compound in active clinical trials, not yet FDA-approved. Tight junction regulator (AT-1001) for celiac disease. Phase 3 ILIT-1 (NCT02633956) failed primary endpoint 2019. No NDA filed. Additional Phase 3 planned by ImmunoGenX. Investigational.
Also known as
AT1001 · Larazotide acetate
Frequently asked questions
- Is Larazotide FDA approved?
- Larazotide is an investigational compound in active clinical trials, not yet FDA-approved. Primary source linked on this page.
- Is Larazotide legal to buy?
- Larazotide is available in the U.S. as a research-use-only compound. It is an investigational compound in active clinical trials, not yet FDA-approved. Sale for human consumption is not permitted.
PeptideBase provides educational research tools and provider discovery. It does not provide medical advice, diagnosis, treatment, prescribing guidance, or dosing instructions. Consult a qualified healthcare professional before making health decisions.
Content review: Regulatory status is sourced from the linked primary records and reviewed by the PeptideBase editorial team. This page is educational — not legal or medical advice. Last reviewed: .