Gut barrier researchHuman RCTInvestigational (US)

Larazotide

AT-1001 · Larazotide acetate

Larazotide acts on tight-junction regulation, a mechanism relevant to intestinal barrier function and celiac-associated symptoms.

Not medical advice. Educational reference only.

Typical dose
100 mcg subcutaneously once daily; 250 mcg subcutaneously once daily
Route
Subcutaneous injection
Storage
Keep at 2–8°C after mixing and use within 28 days.

What is Larazotide?

Larazotide regulates tight junctions. Research examines its effects on the intestinal barrier and symptoms associated with celiac disease. It remains investigational and has no FDA approval.

Research settings generally indicate good tolerability. Adverse effects depend on the amount administered, route and individual response. Consult a clinician before considering use.

Mechanism of action

Larazotide acts on tight-junction regulation, a mechanism relevant to intestinal barrier function and celiac-associated symptoms.

Targets: Intestinal tight junctions

Research indications

  • Tissue Repair

    Most effective

    Research investigates faster wound closure and repair of damaged soft tissue.

  • Gut Health

    Effective

    Investigations indicate potential benefits for the intestinal lining and gastrointestinal function.

    Human, randomised1 reference

  • Joint Support

    Effective

    Potential joint benefits include less inflammation and better movement.

  • Muscle Recovery

    Moderate

    Possible benefits include more rapid recovery from strained muscles and exertion.

Research protocols

These are commonly discussed research protocols — not medical advice. Consult a healthcare provider before use.

GoalAmountFrequencyRoute
Starting100 mcgOnce dailySubcutaneous injection
Standard250 mcgOnce dailySubcutaneous injection

Interactions

  • TB-500 / BPC-157

    Compatible
  • NSAIDs (Ibuprofen, Naproxen)

    Caution
  • Corticosteroids

    Caution
  • Anticoagulants

    Monitor
  • GH Secretagogues

    Compatible
  • NAD+

    Compatible

How to reconstitute and inject

Diluent: Use bacteriostatic water; avoid saline because precipitation may occur.

  1. Let the refrigerated vial stand at room temperature for 15–20 minutes before preparation.
  2. Disinfect the stopper using an alcohol swab, then wait until it has dried fully in the air.
  3. Measure the calculated quantity of bacteriostatic water with a sterile syringe. Use only this diluent; avoid saline because precipitation may occur.
  4. Add the water gradually against the inner vial wall. Keep the stream away from the powder itself.
  5. Rotate the vial with a gentle swirling motion. Do not shake forcefully, because this can degrade the contents.
  6. Wait 2–3 minutes for the powder to dissolve completely, and check that the liquid is transparent and has no color.
  7. Use an insulin syringe to withdraw the calculated amount for injection beneath the skin.
  8. Inject in the thigh, abdomen or upper arm. Change the injection location each time to help prevent lipodystrophy.
  9. Refrigerate the mixed solution at 2–8°C. Use it within a maximum of 28 days after preparation.

What to expect

Week 1–2
Early anti-inflammatory activity may reduce pain and swelling in the affected tissue during weeks 1–2.
Week 2–4
During weeks 2–4, movement may improve as discomfort decreases and healing begins to accelerate.
Week 4–8
Weeks 4–8 may bring meaningful recovery milestones, more tissue repair and improved function.
Week 8–12
By weeks 8–12, healing may approach completion in many cases, with better strength and tissue integrity. These are research expectations rather than established outcomes for people.

Side effects and safety

  • Nausea that is mild and more likely with larger doses
  • Local redness or discomfort after injection
  • Lightheadedness or dizziness · Rare
  • Possible changes in blood pressure; monitor if you have hypertension

Larazotide: investigational in the US.

Regulatory status

  • US

    Investigational

    FDA: investigational; no approval for treatment. No 503A ban is identified; compounding authorization remains unknown. Telehealth is not applicable.

    Rx required
    No
    Telehealth
    N/A

Frequently asked questions

What is Larazotide?

Larazotide regulates tight junctions. Research examines its effects on the intestinal barrier and symptoms associated with celiac disease. It remains investigational and has no FDA approval.

Which benefits are being investigated?

Investigations address gut function, tissue repair, joint support and recovery after muscle strain.

Which dosing schedules are discussed?

Subcutaneous research schedules use 100 mcg or 250 mcg once daily. Neither schedule establishes an approved regimen.

What safety issues matter?

Animal research generally indicates good tolerability. Mild nausea, injection reactions and rare dizziness can occur. Monitor blood pressure if hypertensive.

References

  1. Larazotide acetate for persistent symptoms of celiac disease despite a gluten-free diet: a randomized controlled trial. (2015)

  2. Coeliac disease and the intestinal barrier: mechanisms of disruption and strategies for restoration. (2026)

  3. The potential utility of tight junction regulation in celiac disease: focus on larazotide acetate. (2016)