Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Topiramate 2 x · 1 trial · 1 indication
Bioequivalence based on Cmax
Bioequivalence based on AUC0-72
Bioequivalence based on AUC0-t
| Arm | Type | Description |
|---|---|---|
| Test First | EXPERIMENTAL | Topiramate 2 x 25 mg Tablet |
| Reference First | ACTIVE_COMPARATOR | Topamax® Tablet 2 x 25 mg |
| Name | Type | Description |
|---|---|---|
| Topiramate 2 x 25 mg tablet | DRUG | - |
| Topamax® Tablet 2 x 25 mg | DRUG | - |
Inclusion Criteria: * Subjects will be females and/or males, non-smokers, 18 years of age or older * Subjects should read, sign and date an Informed Consent Form prior to any study procedures. * Female subjects will be post-menopausal or surgically sterilized. * Post menopausal status is defined as...
Topiramate 2 x is an investigational small molecule developed by Teva Pharmaceutical Industries Limited. It is also known as the Topiramate 2 x 25 mg tablet. The program is in Phase 1 clinical development, and the specific therapeutic indication has not been disclosed.
Topiramate 2 x targets the AMPA and kainate glutamate receptor subunits GRIA1, GRIA2, GRIA3, GRIA4, GRIK1, and GRIK5. It acts as an antagonist at these targets, meaning it blocks receptor activity. This target class places it among compounds that modulate glutamate signaling.
Topiramate 2 x is developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. Teva is the sponsor behind the clinical program for this 25 mg tablet formulation.
Topiramate 2 x is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The program has one completed Phase 1 trial, with no active trials currently listed.
Topiramate 2 x has been studied in one completed Phase 1 trial, NCT00905567, titled Topiramate 25 mg Tablets Under Fed Conditions. The trial enrolled 24 healthy adult volunteers in Canada, was randomized, and used an active-controlled design.