Larazotide

Main evidence: Human clinical trials. Updated 2026-10-28.

What research and users report, not a recommendation or medical advice. Many of these products are not approved for human use. Ask your doctor. Packs report what sources say, each with its evidence label. A claim labelled community, educator, manufacturer or animal has not been validated in humans.

Summary

This pack organizes cited evidence, protocol context, safety cautions, and Australian legal status for the compound.

What the sources say

Larazotide acetate (AT-1001) is an oral peptide studied mainly as an adjunct to a gluten-free diet for celiac disease; one phase 2b trial found a symptom signal at the lowest tested dose, while higher doses did not separate from placebo. (Human clinical trials; Leffler et al., "Larazotide Acetate for Persistent Symptoms of Celiac Disease Despite a Gluten-Free Diet: A Randomized Controlled Trial", 2015-02-13)
A four-child open-label MIS-C case series used larazotide alongside standard immune-directed treatments and reported reductions in antigenemia and faster symptom resolution than historical comparators; the uncontrolled sample and concomitant therapies prevent attributing outcomes to larazotide alone. (Small human studies; "Zonulin Antagonist, Larazotide (AT1001), As an Adjuvant Treatment for Multisystem Inflammatory Syndrome in Children: A Case Series", 2022-02-18)
A completed phase 2a Long COVID study enrolled 107 participants and used oral larazotide for 21 days, but the ClinicalTrials.gov record reviewed had no results posted; no efficacy conclusion can be drawn from the protocol. (Educator material (not peer reviewed); ClinicalTrials.gov, "AT1001 for the Treatment of Long COVID" (NCT05747534), 2026-08-18)
In the phase 2b celiac trial, treatment-emergent adverse events were comparable with placebo across groups and no drug-related serious adverse event was reported; the study was limited to 12 weeks. (Human clinical trials; Leffler et al., "Larazotide Acetate for Persistent Symptoms of Celiac Disease Despite a Gluten-Free Diet: A Randomized Controlled Trial", 2015-02-13)
The celiac evidence is symptom-based and short-term; the phase 2b study did not establish long-term mucosal, complication-prevention or histological benefit, and the inverse dose pattern remains unexplained. (Human clinical trials; Leffler et al., "Larazotide Acetate for Persistent Symptoms of Celiac Disease Despite a Gluten-Free Diet: A Randomized Controlled Trial", 2015-02-13)
The Long COVID study record had no posted results at its 2026-08-18 update, so its completed status must not be described as proof of benefit or safety. (Educator material (not peer reviewed); ClinicalTrials.gov, "AT1001 for the Treatment of Long COVID" (NCT05747534), 2026-08-18)
No larazotide/AT-1001 ARTG entry or TGA approval record was identified in the public register search checked on 2026-10-28; this is a search finding, not a published TGA ruling about every possible product or pathway. (Educator material (not peer reviewed); TGA, "Searching the Australian Register of Therapeutic Goods (ARTG)" (public search checked 2026-10-28; page last updated 2021-06-22), 2026-10-28)
The TGA states that therapeutic peptide products generally need ARTG inclusion before supply in Australia unless a specific approval, authority or exemption applies; restricted access mechanisms do not make an unapproved medicine generally market-authorised. (Educator material (not peer reviewed); TGA, "How we regulate therapeutic peptide products" (undated page; accessed 2026-10-28), 2026-10-28)

Sources

Dosing, stacking and protocol details are not published here.