Larazotide acetate
Pronunciation: pronunciation varies by local usage.
- Generic name
- larazotide acetate
- Drug class
- Investigational locally acting synthetic peptide; tight-junction regulator / zonulin inhibitor
- Form
- No marketed dosage form or regulatory prescribing information was identified
- Route
- Oral administration in clinical studies
- Legal status
- Investigational drug; not an FDA-approved or marketed medicine based on the research reviewed
Availability and supply rules vary by country
Trade names by country:
Australia: · Full directory
What larazotide acetate is and how it works
Larazotide acetate is an investigational, orally administered, locally acting synthetic peptide studied as a potential adjunct treatment for celiac disease. It is described as a tight-junction regulator and zonulin inhibitor intended to reduce intestinal permeability and exposure to gliadin, a gluten protein. (1)
Larazotide acetate is not an FDA-approved medicine and no marketed product, approved indication, approved dose, or regulatory prescribing label was identified. Its pivotal Phase 3 CedLara trial was discontinued after an interim analysis found that the treatment-group size required to show a statistically significant clinical outcome versus placebo was too large to make continuation feasible.
Mechanism of action: how larazotide acetate works
Larazotide acetate is described as an orally administered, locally acting synthetic peptide that functions as a tight-junction regulator and zonulin inhibitor. It is intended to close leaky intestinal tight junctions, reduce gliadin exposure, and decrease intestinal permeability in people with celiac disease. (1)
What larazotide acetate is used for
No approved use
No approved indication was identified. Larazotide acetate has been studied as an investigational potential adjunct treatment for celiac disease, but the pivotal Phase 3 CedLara trial was discontinued and this was not reported as a completed positive or negative efficacy result. (1)
Before taking larazotide acetate
Do not take / not appropriate for
- No regulatory contraindications can be stated because no FDA-approved prescribing label or marketed product was identified. () (1)
Tell your clinician about
- Larazotide acetate is investigational and no approved patient-use instructions or regulatory safety label were identified.
- If considering participation in any research study involving this compound, discuss the study-specific eligibility, safety procedures, potential risks, and alternatives with the study team and an appropriate clinician.
How to take larazotide acetate
- There is no approved dose, schedule, or marketed product for larazotide acetate.
- Trial doses and trial-phase findings must not be treated as prescribing information or as a self-directed treatment plan.
- Any administration in a research setting must follow the authorised study protocol and direction of the research team.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1)
Missed dose
No approved missed-dose guidance exists because larazotide acetate is not a marketed medicine. Participants in a clinical study should contact the study team for protocol-specific direction.
Overdose
No approved overdose guidance or regulatory label was identified. If an investigational product administration error or unexpected symptoms occur in a research setting, contact the study team or seek urgent medical assessment as appropriate. (1)
Side effects
There is no approved-drug safety label for larazotide acetate. Reported findings below are from Phase 1 and Phase 2 development and do not establish the safety profile of an approved medicine.
Mild gastrointestinal adverse events
What to notice: Across clinical development, most reported adverse events were described as mild and gastrointestinal in nature.
What to do: In a clinical study, report symptoms to the study team so they can assess them under the study protocol. (1)
Unexpected or concerning symptoms during research participation
What to notice: A specific serious-adverse-effect profile, warning list, and regulatory safety guidance were not established in the research reviewed.
What to do: Contact the research team or an appropriate clinician promptly for assessment. (1)
Serious warnings
Regulatory safety information unavailable —
Symptoms: No approved prescribing label or confirmed regulatory serious-warning list was identified.
Action: Urgent symptoms require appropriate urgent or emergency medical assessment. Research participants should also notify the study team according to the study protocol. (1)
Interactions
| Medicine or test | Effect | Action |
|---|---|---|
| Medicines, supplements, and other treatments | Interaction information from an approved regulatory label was not available because larazotide acetate is investigational and no marketed prescribing label was identified. | Research participants should provide the study team with a complete list of medicines, supplements, and treatments for protocol-specific review. (1) |
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy and breastfeeding
No approved-label guidance or population-specific information was established in the research reviewed. Any research-study eligibility decision requires protocol-specific assessment by the study team. (1)
Children and adolescents
No approved paediatric use, dose, or regulatory guidance was identified. Adult research findings cannot establish use in children or adolescents. (1)
Renal or hepatic impairment
Renal and hepatic impairment guidance was not established in the research reviewed. (1)
Monitoring
Before starting
- No approved treatment-starting assessment exists because larazotide acetate is not a marketed medicine.
- For any clinical trial, eligibility and baseline assessment must follow the specific research protocol and study team's procedures.
During treatment
- No approved monitoring schedule or regulatory safety-monitoring requirements were identified.
- Clinical-trial monitoring must follow the specific research protocol and study team's procedures.
Storage
No marketed product storage instructions were identified. Storage of any investigational supply must follow the applicable clinical-study protocol and study-site instructions.
Investigational-compound information
Clinician-facing context only. Larazotide acetate is investigational, with no identified FDA-approved prescribing label, marketed product, approved indication, or approved dose. This page is not a substitute for a clinical-trial protocol or study-investigator guidance.
All regions
Indication: No approved indication identified
Dose summary: No approved dose or dosing schedule exists. Phase 1 studies reportedly included single and multiple doses from 0.25 mg to 36 mg in healthy volunteers; these research doses are not prescribing guidance.
Renal context: Renal and hepatic impairment dosing information was not established in the research reviewed. (1)
Hepatic guidance
Hepatic impairment information was not established in the research reviewed.
Overdose note
No approved overdose-management guidance was identified. Investigational-product errors require assessment under the relevant study protocol and by the study team or appropriate medical service. (1)
Frequently asked questions
Is larazotide acetate an approved treatment for celiac disease?
No. The research reviewed found no FDA approval, marketed product, approved indication, approved dose, or regulatory prescribing label for larazotide acetate. (1)
What happened to the Phase 3 larazotide acetate trial?
The pivotal Phase 3 CedLara trial was discontinued by its developer after an interim analysis found that the treatment-group size needed to demonstrate a statistically significant clinical outcome versus placebo was too large to make continuing feasible. This was reported as a discontinuation, not as a completed positive or negative efficacy result. (1)
Do trial doses provide a dose I can use?
No. Reported Phase 1 trial doses from 0.25 mg to 36 mg were research doses in healthy volunteers, not an approved dose or a patient treatment instruction. (1)
What is the mechanism of action of larazotide acetate?
Larazotide acetate is described as an orally administered, locally acting synthetic peptide that functions as a tight-junction regulator and zonulin inhibitor. It is intended to close leaky intestinal tight junctions, reduce gliadin exposure, and decrease intestinal permeability in people with celiac disease. (1)
What is the generic name of Larazotide acetate?
The generic name is larazotide acetate. (1)
What class of drug is larazotide acetate?
Larazotide acetate is classed as: Investigational locally acting synthetic peptide; tight-junction regulator / zonulin inhibitor. (1)
References
- Larazotide acetate clinical-development status and mechanism reviewSearch-aggregated review including Beyond Celiac and ClinicalTrials.gov · United States · accessed 2026-08-05 · source 1
Brand names by country
Single-ingredient larazotide acetate names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.