Larazotide Acetate
Also referenced as: Larazotide
An oral octapeptide investigated for epithelial tight-junction regulation in celiac disease.
- Evidence grade
- CEarly Human Research
Early Human Research
- Regulatory status
- Not FDA Approved
Investigational; not FDA-approved for the uses discussed.
- Human data
- Yes
Registered clinical trials exist
- Last reviewed
- October 27, 2026
Overview
An oral octapeptide investigated for epithelial tight-junction regulation in celiac disease.
Investigational; not FDA-approved for the uses discussed.
Historical phase 3 enrollment should not be described as a successful or necessarily active current program.
Why It's Being Studied
- Celiac disease
- Intestinal permeability
Mechanism of Action
It is intended to influence intestinal permeability rather than remove gluten or replace dietary management.
It is intended to influence intestinal permeability rather than remove gluten or replace dietary management. Historical phase 3 enrollment should not be described as a successful or necessarily active current program.
From molecular target to clinical evidence
Tap each stage to see what happens.
Background: Clinical Peptide Medicines
Clinical peptide medicines include endocrine treatments, antimicrobial drugs, receptor blockers and targeted diagnostic or cancer agents. They do not share one mechanism or one set of indications.
An approval belongs to a specific medicine and indication. A diagnostic tracer, an antibiotic and a hormone are not interchangeable wellness products; read each profile's own mechanism and prescribing source.
Research Areas & Routes Studied
- Celiac disease
- Intestinal permeability
- Oral clinical research
Evidence Summary
Earlier human studies suggested symptom signals, but the phase 3 CedLara trial was terminated in 2022.
Higher tiers carry more weight. Filled tiers have evidence for Larazotide Acetate; tap to read it.
- Earlier human studies suggested symptom signals, but the phase 3 CedLara trial was terminated in 2022.
1 cited sources.
- Regulatory document1
Human clinical evidence
- Earlier human studies suggested symptom signals, but the phase 3 CedLara trial was terminated in 2022.
Reported Adverse Events in Research
- Long-term treatment safety and efficacy are not established; an experimental product cannot be assumed to protect against gluten injury.
Limitations of Current Evidence
- Historical phase 3 enrollment should not be described as a successful or necessarily active current program.
- Findings apply to the product, route and population studied; they do not establish benefits or safety for unrelated wellness uses or research-vial products.
How to Read This Research
- Is this a single molecule or a family of medicines?
- Is the use diagnostic, therapeutic or investigational?
- Does the quoted outcome match the exact product, formulation and population?
- Use the compound-specific mechanism above; this diagram describes drug development, not a shared biological pathway.
- Historical approval, present availability and off-label use are distinct questions.
- For radiopharmaceuticals and hospital medicines, specialist handling is part of the treatment context.
- Indication
- The condition and population for which a medicine is approved.
- Antagonist
- A compound that blocks activity at a receptor.
- Radiopharmaceutical
- A medicine containing a radioactive isotope for imaging or treatment.
Compare With Other Compounds
| Larazotide Acetate | Trofinetide | |
|---|---|---|
| Evidence grade | C — Early Human Research | B — Moderate Human Evidence |
| Regulatory status | Not FDA Approved | FDA Approved for Specific Indication |
| Human data | Yes | Yes |
| Clinical trials | Registered trials exist | Registered trials exist |
| Research routes | Oral clinical research | Oral approved medicine |
| Cited sources | 1 | 2 |
Frequently Asked Questions
Research References
- Regulatory document
Larazotide Acetate — regulatory document