Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TEV-53408 · 2 trials · 2 indications
Vh:Cd is used to assess the severity of celiac disease. It is calculated by dividing the villous height by the crypt depth. A lower ratio indicates more damage.
| Arm | Type | Description |
|---|---|---|
| TEV-53408 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TEV-53408 | DRUG | Solution for subcutaneous (sc) injection |
| Placebo | DRUG | Solution for subcutaneous (sc) injection |
Inclusion Criteria: * Diagnosis of celiac disease at least 12 months prior to screening * On a gluten-free diet for at least 12 months prior to screening * Women must not be pregnant, lactating, breastfeeding, or planning pregnancy during the trial period * Male participants (including vasectomized...
| 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 |
TEV-53408 is an investigational small molecule being developed for celiac disease and vitiligo. It is currently in clinical trials for both conditions, with a Phase 2 study in celiac disease and a Phase 1 study in vitiligo. The drug is not yet approved by regulatory authorities.
TEV-53408 is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with celiac disease and vitiligo.
TEV-53408 is in Phase 2 clinical development for celiac disease, with an active Phase 2 trial (NCT06807463) enrolling 50 adults. It is also being studied in an earlier Phase 1 trial for vitiligo (NCT06625177). The drug remains investigational and has not received FDA approval.
TEV-53408 is being evaluated in two active clinical trials. NCT06807463 is a Phase 2, randomized, double-blind, placebo-controlled trial in adults with celiac disease, conducted in the United States, Australia, and Finland. NCT06625177 is a Phase 1 trial in adults with vitiligo in the United States.
No alternative names for TEV-53408 have been disclosed. The drug is identified solely by its investigational code name TEV-53408 in clinical trial registrations and by its developer, Teva Pharmaceutical Industries. It is not known to be marketed under any other brand name.