Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Paroxetine · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Paroxetine hydrochloride 40 mg tablet |
| 2 | ACTIVE_COMPARATOR | Paxil® 40 mg Tablet |
| Name | Type | Description |
|---|---|---|
| Paroxetine hydrochloride 40 mg tablet | DRUG | 40mg, single dose fed |
| Paxil® 40 mg Tablet | DRUG | 40mg, single dose fed |
| Paxil® 40 mg Table | DRUG | 40mg, single dose fasting |
Inclusion Criteria: 1. Subjects who were informed of the nature of the study and agreed to read, review, and sign the informed consent document prior to Period I dosing. 2. Subjects who completed the screening process within 21 days prior to Period I dosing. 3. Subjects who were healthy adult men a...
Paroxetine is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is also known as paroxetine hydrochloride 40 mg tablet. The specific therapeutic indication for this asset is undisclosed, and it falls within a therapeutic area classified as other. It is currently in Phase 1 clinical development.
Paroxetine targets SLC6A4, the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is the protein responsible for reuptake of serotonin from the synaptic cleft, and inhibition of this target class is the mechanism described for paroxetine in the supplied asset information.
Paroxetine is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company associated with this paroxetine hydrochloride 40 mg tablet asset. The drug is a small molecule and is currently listed as being in Phase 1 development.
Paroxetine is in Phase 1 clinical development. It is an investigational asset and is not described as approved. Two clinical trials are recorded for this asset, both completed, with no active trials currently listed. The trials together enrolled 102 participants.
Two completed trials are recorded for paroxetine: NCT00650403, a food study of paroxetine hydrochloride tablets 40 mg and Paxil tablets 40 mg, and NCT00648193, a fasting study of the same comparison. Both were Phase 1 or early Phase 1 trials in healthy volunteers in the United States, enrolling 66 and 36 participants respectively.