Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Baclofen · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Baclofen | DRUG | Single-dose 20 mg immediate-release oral tablets |
Inclusion Criteria: Subjects meeting all of the following criteria may be included in the study: Availability of subject for the entire study period and willingness to adhere to protocol requirements as evidenced by the informed consent form duly signed by the subject Males aged from 18 to 55 year...
Baclofen is a small molecule drug being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, with a completed bioavailability study in healthy male subjects. The drug is being developed by Viatris Inc. (NASDAQ: VTRS).
Baclofen is being developed by Viatris Inc., a pharmaceutical company traded on NASDAQ under the ticker VTRS. The drug is currently in Phase 1 clinical development for use in healthy volunteers.
Baclofen is in Phase 1 clinical development. It has one completed Phase 1 trial, with no active trials currently ongoing. The drug is investigational and has not been approved for any indication.
Baclofen has one completed clinical trial, NCT00647738, titled 'Comparative Bioavailability Study of Baclofen 20 mg Tablets in Healthy Male Volunteers / Fasting State.' This Phase 1 study enrolled 27 healthy male participants in Canada and was completed.
Baclofen is not FDA approved for the indication being studied. It is an investigational drug currently in Phase 1 clinical development. The completed trial was a bioavailability study in healthy volunteers, and the drug has not yet progressed to later-stage trials.