larazotide

larazotide acetate (AT-1001) is an eight-amino-acid oral tight-junction regulator. a celiac phase 2b found a symptom benefit at 0.5 mg three times daily, but the pivotal phase 3 was terminated after an interim sample-size review and posted no results.

tier D · healing · 342 adults in the published celiac phase 2b

verdict

the phase 2b symptom signal did not become pivotal confirmation: the celiac phase 3 was terminated without posted results. the molecule remains in a separate Long COVID study, also without posted results, and has no US approval.

what it is

Larazotide acetate, code AT-1001, is a synthetic single-chain peptide of eight amino acids: Gly-Gly-Val-Leu-Val-Gln-Pro-Gly. It was studied in an enteric-coated oral capsule designed to release the acetate form in the small intestine. Company clinical reports describe it as gut restricted, with larazotide and its peptide metabolites not detected in human serum by the assays used.

what it does

Larazotide was designed to antagonize zonulin-linked signaling and preserve the organization of tight-junction proteins at the intestinal lining. In celiac disease it was studied as an adjunct for persistent symptoms despite a gluten-free diet, not as a replacement for the diet and not as a general gut-health treatment.

origin

The program moved from Alba Therapeutics through Innovate Biopharmaceuticals to 9 Meters Biopharma. The company discontinued the CeDLara celiac phase 3 in June 2022. A separate investigator-led Long COVID phase 2 remains active, not recruiting, with no posted results.

does it work

The best published human result is narrow: in 342 adults with persistent celiac symptoms, 0.5 mg three times daily reduced symptoms over 12 weeks, while 1 mg and 2 mg did not improve on placebo. The 307-participant CeDLara phase 3 was terminated after an interim sample-size review and has no posted results. A separate 107-participant Long COVID phase 2 is active, not recruiting, and also has no posted results. Human efficacy outside that phase 2b celiac signal remains unestablished.

key facts

• amino acids: 8
• half-life: systemic half-life not established; company assays did not detect larazotide or peptide metabolites in human serum
• type: synthetic oral tight-junction regulator
• 8 aa larazotide acetate is an octapeptide
• 342 adults in the published celiac phase 2b
• 307 actual CeDLara enrollment before termination
• 107 actual Long COVID phase 2 enrollment, no posted results

frequently asked questions

Is larazotide still being studied?

The celiac phase 3 was discontinued in 2022. A separate 107-participant oral phase 2 in Long COVID is active, not recruiting, with no posted results and an estimated completion in September 2026. That study does not establish efficacy, availability, or an approved use.

related peptides

• bpc-157: a different gut-market peptide with a distinct evidence record; it is not a larazotide substitute
• kpv: a different anti-inflammatory tripeptide with preclinical gut research; its evidence does not transfer here

reptides grades the research record and cites the literature behind every call. research reference only; not medical advice.