Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Licarbazepine · 7 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| licarbazepine | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Licarbazepine | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: 1. written informed consent provided prior to participation in the extension study 2. successful completion of study CLIC477D2301 3. willingness and ability to comply with all study requirements Exclusion Criteria: 1. premature discontinuation from study CLIC477D2301 2. failur...
Licarbazepine is an investigational small molecule being studied for the treatment of manic episodes associated with Bipolar I Disorder. It is also being evaluated in healthy volunteers for pharmacokinetic studies. The drug is in Phase 3 clinical development for bipolar disorder and has not been approved by regulatory authorities.
Licarbazepine is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company has sponsored clinical trials evaluating the drug's safety and tolerability in patients with Bipolar I Disorder.
Licarbazepine is in Phase 3 clinical development for the treatment of manic episodes of Bipolar I Disorder. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trials have been completed, along with additional Phase 1 studies in healthy volunteers.
Licarbazepine has been studied in several clinical trials. NCT00228059 and NCT00238485 are completed Phase 3 open-label extension studies evaluating safety and tolerability in patients with manic episodes of Bipolar I Disorder. NCT00424671 and NCT00426036 are Phase 1 studies in healthy volunteers examining the effects of hepatic and renal impairment on the drug's pharmacokinetics.
Licarbazepine is a small molecule developed for psychiatric use. Its specific molecular target has not been disclosed in the available clinical trial information. The drug is being investigated for its ability to treat manic episodes in patients with Bipolar I Disorder, though its precise mechanism of action remains unspecified.
Licarbazepine is not FDA approved. It is an investigational drug currently in clinical development, with Phase 3 trials completed for Bipolar I Disorder. The drug remains under study and has not received marketing authorization from the U.S. Food and Drug Administration or other regulatory bodies.