Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TV-1380 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| TV-1380 150 mg | EXPERIMENTAL | - |
| TV-1380 300 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| TV-1380 150 mg | DRUG | Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents). |
| TV-1380 300 mg | DRUG | Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380. |
| Placebo | DRUG | Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo. |
Inclusion Criteria: * Have the ability to understand, and having understood, provide written informed consent to comply with the treatment protocol. * Male or female aged 18-60 years (inclusive). * Meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition. * Other criteria apply; p...
TV-1380 is an investigational small molecule being studied as a treatment to facilitate abstinence in people with cocaine addiction. It is being developed by Teva Pharmaceutical Industries Limited. It has been tested in a Phase 2 clinical trial in cocaine-dependent subjects, but it is not an approved therapy.
TV-1380 is being developed by Teva Pharmaceutical Industries Limited, which trades under the ticker TEVA. The company sponsored the Phase 2 study of TV-1380 in cocaine addiction. No other developers or partners are listed for this asset.
TV-1380 is in Phase 2 development. One Phase 2 trial has been completed, and there are no active trials. The completed study was a randomized, double-blind, placebo-controlled trial that enrolled 208 participants. TV-1380 is investigational and has not been approved for any indication.
TV-1380 has been studied in one completed Phase 2 trial, NCT01887366, titled Efficacy and Safety of TV-1380 as Treatment for Facilitation of Abstinence in Cocaine-Dependent Subjects. The trial enrolled 208 participants across the United States and Spain. It was randomized, double-blind, and placebo-controlled, with participants aged 18 years and older.