Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Alendronate · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Alendronate Sodium Tablets, 70 mg |
| 2 | ACTIVE_COMPARATOR | Fosamax Tablets, 70 mg |
| Name | Type | Description |
|---|---|---|
| Alendronate Sodium Tablets, 70 mg | DRUG | 1 x 70 mg, single-dose fasting |
| Fosamax Tablets, 70 mg | DRUG | 1 x 70 mg, single-dose fasting |
| Alendronate Sodium Tablets, 10 mg | DRUG | 10 mg, single-dose fasting |
| Fosamax Tablets, 10 mg | DRUG | 10 mg, single-dose fasting |
Inclusion Criteria: * healthy, adult subjects, 18 years and older * able to swallow medication Exclusion Criteria: * institutionalized subjects * history of any significant disease * use of any prescription or OTC medications within 14 days of start of study * received any investigational product...
Alendronate is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an FDPS inhibitor and is listed as being in Phase 1 clinical development. The specific indications being studied are undisclosed, and the therapeutic area is classified as other.
Alendronate targets FDPS, which stands for farnesyl diphosphate synthase. It acts as an inhibitor of this enzyme. FDPS is the molecular target listed for the drug, and this inhibitory activity is the basis for its classification as a small molecule therapeutic.
Alendronate is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company associated with the development of this small molecule FDPS inhibitor, which is currently listed as being in Phase 1 clinical development.
Alendronate is in Phase 1 clinical development. It is an investigational drug and is not described as approved. Two Phase 1 trials have been completed, and there are no active trials listed. The development program has enrolled a total of 222 participants across those completed studies.
Alendronate has been studied in two completed Phase 1 trials. NCT01012934 was a fasting study of alendronate sodium tablets 70 mg versus Fosamax tablets 70 mg with 110 participants. NCT00983996 was a fasting study of alendronate sodium tablets 10 mg versus Fosamax tablets 10 mg with 112 participants. Both enrolled healthy volunteers in the United States.