Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Clomipramine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals) |
| 2 | ACTIVE_COMPARATOR | Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel) |
| Name | Type | Description |
|---|---|---|
| Clomipramine Hydrochloride 25 mg Capsules (Geneva Pharmaceuticals) | DRUG | - |
| Anafranil Clomipramine Hydrochloride 25 mg Capsules (Basel) | DRUG | - |
Inclusion Criteria: * No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: * Positive test results for HIV or hepatitis B or C. * Treatment for drug or alcohol dependence.
Clomipramine is a small molecule drug in the psychiatry therapeutic area that is used for depression. It is being developed by Novartis AG under the ticker NVS. The drug is currently in Phase 1 clinical development, with one completed trial evaluating its bioavailability.
Clomipramine targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. By inhibiting SLC6A4, clomipramine modulates serotonergic neurotransmission, which is relevant to its use in depression.
Clomipramine is made by Novartis AG, which trades under the ticker NVS. The specific product referenced is Clomipramine Hydrochloride 25 mg Capsules by Geneva Pharmaceuticals, a Novartis affiliate.
Clomipramine is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for the depression indication described here. The development program includes one completed Phase 1 trial.
Clomipramine has been studied in one completed Phase 1 trial, NCT00913783. This trial enrolled 36 healthy male volunteers aged 18 years and older to demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg clomipramine hydrochloride capsules under fasted conditions. The trial was randomized and active-controlled.