§ 01 Overview
Overview
Synthetic octapeptide zonulin antagonist that blocks tight-junction disassembly. Phase 3 CedLara trial for celiac was terminated for futility in June 2022.
Phase 3 CedLara terminated June 2022 for futility.
§ 02 Mechanism
Mechanism of action
Larazotide is an octapeptide that binds and neutralizes zonulin, the regulator of intestinal tight junctions. By preserving barrier integrity it reduces the paracellular passage of immunogenic peptides in celiac disease.
- 01Rationale for barrier-preserving therapy in celiac
- 02Positive signals in Phase 2
§ 03 Dosing
Dosing protocol
Standard Protocol
- Dose Range
- 0.5 – 8 mg (trial doses)
- Route
- Oral
- Timing
- Before meals
- Frequency
- Up to 3x daily
§ 04 Evidence
Evidence & research
Phase 3 CedLara terminated June 2022 for futility.
FDA Status
Not FDA-approved. Phase 3 program terminated.
§ 06 News
In the news
8 articles from the last 12 months · updates hourly
1001 Nottingham St, Orlando, FL 32803 - Realtor.com
1001 Nottingham St, Orlando, FL 32803 Realtor.com
1001 Durango Dr, Mission, TX 78574 - Realtor.com
1001 Durango Dr, Mission, TX 78574 Realtor.com
1001 W Cedar St, Florence, SC 29501 - Realtor.com
1001 W Cedar St, Florence, SC 29501 Realtor.com
Kelowna Rockets, City ready for the Memorial Cup - Kelowna Capital News
Kelowna Rockets, City ready for the Memorial Cup Kelowna Capital News
Around 1:03 p.m. on April 14, 2026, firefighters received several 911 calls reporting a large fire at 1001 Bellevue Ave. - Syracuse.com
Around 1:03 p.m. on April 14, 2026, firefighters received several 911 calls reporting a large fire at 1001 Bellevue Ave. Syracuse.com
Aleur Event Collective opens near downtown Sarasota: see photos - Sarasota Herald-Tribune
Aleur Event Collective opens near downtown Sarasota: see photos Sarasota Herald-Tribune
Northrop Grumman requests environmental permit for Waynesboro facility - Virginia Business
Northrop Grumman requests environmental permit for Waynesboro facility Virginia Business
New Park at 1001-1037 The Queensway - City of Toronto
New Park at 1001-1037 The Queensway City of Toronto
§ 07 Sourcing
Sourcing & supply
Regulatory status
Investigational, no compounding path
Currently in active clinical trials. No compounding pathway. No brand product. The only US channels are RUO vendors that the FDA has targeted with warning letters. Assume any sourcing carries significant regulatory and quality risk.
No suppliers in our directory currently stock this compound. For investigational or research-only compounds, legitimate channels may not exist outside clinical trials.
Browse full supplier directory§ 09 Safety
Safety & side effects
Side effects
- 01Headache
- 02Urinary tract symptoms
Contraindications
None specified.
§ 10 Questions
Larazotide FAQ
- What is Larazotide?
- Synthetic octapeptide zonulin antagonist that blocks tight-junction disassembly. Phase 3 CedLara trial for celiac was terminated for futility in June 2022. Larazotide is an octapeptide that binds and neutralizes zonulin, the regulator of intestinal tight junctions. By preserving barrier integrity it reduces the paracellular passage of immunogenic peptides in celiac disease.
- What is Larazotide used for?
- Reported uses include rationale for barrier-preserving therapy in celiac and positive signals in phase 2. Evidence strength is rated Clinical — see the evidence section for detail.
- How is Larazotide dosed?
- Commonly referenced dosing is 0.5 – 8 mg (trial doses), typically up to 3x daily, administered Oral. This is educational reference only; consult a licensed clinician before use.
- What are the side effects of Larazotide?
- Commonly reported side effects include headache and urinary tract symptoms. This list is not exhaustive.
- Is Larazotide legal?
- Currently in active clinical trials. No compounding pathway. No brand product. The only US channels are RUO vendors that the FDA has targeted with warning letters. Assume any sourcing carries significant regulatory and quality risk. FDA status: Not FDA-approved. Phase 3 program terminated..
§ 11 References
Selected references
- 01
Leffler Gastroenterology 2015
PMID: 25753138
- 02
CedLara Phase 3 (terminated)
NCT03569007