Approval Probability
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Adjusted LOA
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Modafinil · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Modafinil Tablets 200 mg |
| 2 | ACTIVE_COMPARATOR | Provigil® Tablets 200 mg |
| Name | Type | Description |
|---|---|---|
| Modafinil Tablets 200 mg | DRUG | 200mg, single dose fasting |
| Provigil® Tablets 200 mg | DRUG | 200mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female 1. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administratio...
Modafinil is a small molecule drug candidate that Viatris Inc. is developing. It is also known as Modafinil Tablets 200 mg. The specific medical condition it is intended to treat has not been disclosed, and it falls under a general therapeutic area. It is currently in Phase 1 clinical development.
Modafinil targets SLC6A3, a protein also known as the dopamine transporter. It acts as an inhibitor of this target. By inhibiting SLC6A3, Modafinil modulates dopamine reuptake, which is its primary mechanism of action.
Modafinil is being developed by Viatris Inc., which trades on the Nasdaq under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.
Modafinil is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 1 program includes two completed trials that evaluated the drug in healthy volunteers.
Modafinil has been studied in two completed Phase 1 clinical trials: NCT00650286, a food-effect study with 20 healthy participants, and NCT00650000, a fasting study with 32 healthy participants. Both trials were active-controlled, randomized, and conducted in the United States.