Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RG2417 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| RG2417 | EXPERIMENTAL | Oral RG2417 taken twice daily for 8 weeks |
| Placebo | PLACEBO_COMPARATOR | Oral placebo taken twice daily for 8 weeks |
| Name | Type | Description |
|---|---|---|
| RG2417 | DRUG | 1g bid dose escalates to 2g bid for weeks 2-8. |
| Placebo | DRUG | Similarly sized placebo pills to be taken in the same fashion as the RG2417 tablets. |
Inclusion Criteria: * Bipolar I Disorder, most recent episode depressed * History of 2 or more manic or mixed episodes, at least one of which required pharmacologic treatment for manic symptoms Exclusion Criteria: * Current manic, hypomanic or mixed episode * Rapid cycling bipolar disorder (4 or ...
RG2417 is an investigational small molecule being studied for the treatment of Bipolar I Depression. It is currently in Phase 2 clinical development and has not been approved by the FDA. The drug is being evaluated for its safety, tolerability, and efficacy in patients with this condition.
RG2417 is being developed by Repligen Corporation, a biopharmaceutical company traded on NASDAQ under the ticker symbol RGEN. The company is conducting clinical trials to evaluate the drug's potential in treating Bipolar I Depression.
RG2417 is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The drug is being studied for its safety and efficacy in patients with Bipolar I Depression, with one Phase 2 trial already completed.
RG2417 has one completed clinical trial registered as NCT00812058, titled 'A Study to Assess the Safety, Tolerability and Efficacy of RG2417 in Bipolar I Depression.' This Phase 2, randomized, double-blind, placebo-controlled study enrolled 180 participants in the United States.
RG2417 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Bipolar I Depression. The drug has completed one clinical trial, but it remains under study and has not been authorized for commercial use.