Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Larazotide · 1 trial · 1 indication
The primary efficacy endpoint was average on-treatment (Baseline to Week 12) score of theCeliac Disease Gastrointestinal Symptom Rating Scale (CeD GSRS).
| Arm | Type | Description |
|---|---|---|
| Larazotide Acetate 0.5 mg | EXPERIMENTAL | larazotide acetate 0.5 mg capsules TID |
| Larazotide Acetate 1 mg | EXPERIMENTAL | larazotide acetate 1 mg capsules TID |
| Larazotide Acetate 2 mg | EXPERIMENTAL | larazotide acetate 2 mg capsules TID |
| Placebo | PLACEBO_COMPARATOR | placebo capsules TID |
| Name | Type | Description |
|---|---|---|
| Larazotide Acetate | DRUG | gelatin capsule |
| placebo | DRUG | gelatin capsule |
Inclusion Criteria: * Male and female adults with biopsy proven and serology-confirmed celiac disease on a gluten-free diet for at least 12 months * measurable serology at screening * CeD GSRS score of ≥ 2.0 prior to randomization * experiencing symptoms (ie, diarrhea, abdominal pain, bloating, nau...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Amlitelimab |
| Forte Biosciences Inc. | FBRX | 1 | PHASE2 | FB102 |
| Teva Pharmaceutical Industries Limited Sponsored ADR | TEVA | 1 | PHASE2 | TEV-53408 |
| Barinthus Biotherapeutics plc Sponsored ADR | BRNS | 1 | EARLY_PHASE1 | VTP-1000 |
| TScan Therapeutics, Inc. | TCRX | 1 | - | Undisclosed |
Larazotide is an investigational small molecule being developed for the treatment of Celiac Disease. It is designed to reduce the intestinal permeability and immune response triggered by gluten in patients with the condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
Larazotide is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is an investigational small molecule intended for the treatment of Celiac Disease and is currently in Phase 2 clinical development.
Larazotide is in Phase 2 clinical development. It has completed one Phase 2 trial for Celiac Disease, and the drug remains investigational, meaning it has not yet received regulatory approval for any use.
Larazotide has been studied in a completed Phase 2 clinical trial registered as NCT01396213. This was a double-blind, placebo-controlled study that enrolled 342 participants with Celiac Disease across the United States and Canada. The trial evaluated the safety and efficacy of larazotide acetate for the treatment of the condition.
Yes, Larazotide is also known as Larazotide Acetate. The clinical trial NCT01396213 specifically evaluated larazotide acetate for the treatment of Celiac Disease. Both names refer to the same investigational drug being developed by Teva Pharmaceutical Industries Limited.