At a glance
- Larazotide is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 58 publications mentioning it, including 5 randomized controlled trials and 8 animal-only studies.
- ClinicalTrials.gov lists 31 registered studies testing it (3 active).
- FDA's adverse event system (FAERS) holds 2 reports mentioning it; 1 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Potassium-Competitive Acid Blocker Increases Ileal Permeability and Exacerbates Ileal Inflammation under Stress Conditions in a Mouse Model of Eosinophilic Enteritis.
- Integrated Role of Microbial, Fungal, and Plant-Derived Interventions in the Management of Celiac Disease: A Narrative Review.
- Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration.
- Preventive effects of Larazotide acetate (AT-1001) on non-alcoholic fatty liver diseases (NAFLD) in a mouse model.
- Larazotide Acetate Protects the Intestinal Mucosal Barrier from Anoxia/Reoxygenation Injury via Various Cellular Mechanisms.
- Is There a Future Without Gluten Restrictions for Celiac Patients? Update on Current Treatments.
- Antibacterial hyaluronic acid hydrogel with sustained release of larazotide as effective colitis treatment.
- Viral spike antigen clearance and augmented recovery in children with post-COVID multisystem inflammatory syndrome treated with larazotide.
- The PAR2 Antagonist Larazotide Can Mitigate Acute Histamine-Stimulated Epithelial Barrier Disruption in Keratinocytes: A Potential Adjunct Treatment for Atopic Dermatitis.
- New Therapeutic Challenges in Pediatric Gastroenterology: A Narrative Review.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 31
- Active
- 3
- With posted results
- 12
Conditions studied
Show 21 more studies
All 31 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2
- Serious
- 1
- With death outcome
- 1
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
Change history
No changes since monitoring began on October 30, 2026.