§ 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
Firefighter Activity - Citizen app
Firefighter Activity Citizen app
Former banking executive lists historic Russian Hill mansion for $25 million - The Business Journals
Former banking executive lists historic Russian Hill mansion for $25 million The Business Journals
What's that going to be off Santa Maria Avenue in front of Stripes? - Laredo Morning Times
What's that going to be off Santa Maria Avenue in front of Stripes? Laredo Morning Times
Power Outage Reported - Citizen app
Power Outage Reported Citizen app
Chord Energy expands headquarters lease at 1001 Fannin in downtown Houston by 20% - The Business Journals
Chord Energy expands headquarters lease at 1001 Fannin in downtown Houston by 20% The Business Journals
Fire Alarm Activation - Citizen app
Fire Alarm Activation Citizen app
Main Street warehouse near Waterfront Park heads to auction - The Business Journals
Main Street warehouse near Waterfront Park heads to auction The Business Journals
1001 NE 77th St Lot 3, Ocala, FL 34479 - Realtor.com
1001 NE 77th St Lot 3, Ocala, FL 34479 Realtor.com
§ 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