How to Use Larazotide acetate
Complete guide to Larazotide acetate dosing, administration, timing, and protocol recommendations.
Quick Overview
Larazotide is an 8-amino-acid oral peptide (GGVLVQPG) designed to tighten the junctions between gut lining cells, aimed at celiac disease. For years it was the furthest-along celiac drug in development and it gets talked about online as a 'leaky gut' or zonulin blocker. The honest story is short: one phase 2b trial found a modest symptom benefit at the lowest dose only, the phase 3 trial was stopped in 2022 when it could not show a clear effect, and the sponsor 9 Meters Biopharma filed for Chapter 7 liquidation in July 2023. It is not approved anywhere.
Dosing Guidelines
Common Dose
0.5 mg three times daily before meals (trial dose)
Frequency
Three times daily, before meals
Dose Range
0.5-2 mg three times daily tested; only 0.5 mg showed any effect
Note: These are clinical trial doses, not a recommendation. Larazotide was always tested as an add-on to a strict gluten-free diet, never as a way to eat gluten. The higher doses did not work in phase 2b, and the phase 3 at 0.5 mg was halted.
Administration Method
Oral capsule taken before meals, alongside a gluten-free diet (not instead of it)
Best Time to Take
About 15 minutes before each main meal (trial protocol)
It acts locally in the gut, so the trials timed it to be in place before food (and any stray gluten) arrived.
Protocol Duration
12 weeks of treatment in the phase 2b trial
Possible Side Effects
Not everyone experiences these. Individual responses vary.
- •GI complaints at rates similar to placebo in phase 2b
- •Headache
- •No drug-related serious adverse events reported in phase 2b
- •Long-term safety unknown (no trial ran past a few months)
- •Quality and identity of non-trial material are unknown
Frequently Asked Questions
What is the recommended dose for Larazotide acetate?
0.5 mg three times daily before meals (trial dose)
How do you administer Larazotide acetate?
Oral capsule taken before meals, alongside a gluten-free diet (not instead of it)
When is the best time to take Larazotide acetate?
About 15 minutes before each main meal (trial protocol)
How long should you use Larazotide acetate?
12 weeks of treatment in the phase 2b trial
This information is for educational purposes only. Always consult with a healthcare professional before using any peptide. Dosing information is based on research literature and community reports, not medical advice.