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Larazotide (Larazotide Acetate (AT-1001))

Category: Gut Health. Status: Investigational (Phase 3).

A first-in-class tight junction regulator designed to reduce intestinal permeability ("leaky gut"). Originally developed for celiac disease, now researched for broader applications in autoimmune and inflammatory gut conditions.

How it works

Acts as a zonulin peptide antagonist, preventing zonulin-mediated disassembly of tight junction proteins (ZO-1, occludin, claudins). Maintains paracellular barrier integrity without systemic absorption.

Key facts

  • Molecular weight: 1026 Da
  • Half-life: Not systemically absorbed (local GI action)
  • Bioavailability: Minimal systemic absorption (acts locally in GI lumen)
  • Storage: Room temperature. Protect from moisture.

Dosing overview

  • Typical dose: 0.5-1 mg
  • Frequency: 3x daily before meals
  • Duration: 12-16 weeks
  • Route: Oral capsule

Reported benefits

  • Reduced intestinal permeability
  • Decreased GI symptoms
  • Tight junction restoration
  • Reduced systemic inflammation from gut
  • Improved gluten tolerance

Possible side effects

  • Headache (mild)
  • Nausea (rare)
  • Abdominal discomfort
  • Generally well-tolerated

Research

  • Larazotide acetate Phase 2b for celiac disease (2022): Reduced intestinal permeability by 70% and GI symptoms by 50% vs placebo over 12-week trial in celiac patients on gluten-free diet.
  • Tight junction modulation and autoimmunity (2021): Zonulin antagonism reduced systemic inflammatory markers (IL-6, TNF-α) by 30-40% in leaky gut models.

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