Larazotide results: what to expect and when

An oral gut-barrier peptide with mixed celiac results and a stopped phase 3 trial.

Also called: Larazotide acetate, AT-1001, AT1001, INN-202, NM-001.

Gut peptides · Oral tight-junction regulator; proposed zonulin-pathway antagonist.

13 primary human study records: 10 registries, one additional sponsor-listed phase 1 study and two compassionate-use reports. Several lack results; the celiac phase 3 trial stopped.

Key studies

  • First healthy-volunteer study (2005): A sponsor filing documents 24 participants; detailed dose cohorts and results were not recovered. (source)
  • First celiac proof-of-concept trial (2007): A small inpatient study found less acute gut leak and fewer symptoms after gluten exposure. (source)
  • Healthy volunteers: 10-day dosing: The completed registry describes fixed cohorts; no tabulated results were posted. (source)
  • Two-week gluten challenge (2012): The permeability endpoint failed; some lower-dose symptom results favored larazotide. (source)
  • Six-week gluten challenge (2013): The 1 mg arm reduced symptoms; none of the three doses improved the primary permeability test. (source)
  • Active celiac disease: 8 weeks: This completed 105-person study has no posted results or recovered peer-reviewed report. (source)

Related to Larazotide

Sources

Sources checked: 2026-10-18.

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