Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
NBI-921352 · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Placebo schedule | PLACEBO_COMPARATOR | Participant follows Placebo schedule (13 weeks) |
| Dose schedule A | EXPERIMENTAL | Participant follows Dose schedule A (13 weeks) |
| Dose schedule B | EXPERIMENTAL | Participant follows Dose schedule B (13 weeks) |
| Dose schedule C | EXPERIMENTAL | Participant follows Dose schedule C (13 weeks) |
| Name | Type | Description |
|---|---|---|
| NBI-921352 | DRUG | Tablets for oral administration |
| Placebo | DRUG | Matching placebo tablets for oral administration |
Key Inclusion Criteria: 1. Capable of providing consent and has completed the written informed consent. 2. Male or female, 18 to 65 years of age, inclusive, with a body mass index (BMI) \< 40 kg/m\^2. 3. Diagnosis of focal onset epilepsy according to the International League Against Epilepsy (ILAE)...
NBI-921352 is an investigational small molecule being developed for the treatment of focal onset seizures in adults. It is intended to be used in combination with anti-seizure medications. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
NBI-921352 is being developed by Neurocrine Biosciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker NBIX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with focal onset seizures.
NBI-921352 is in Phase 2 clinical development. A Phase 2 trial has been completed, which investigated the drug's effectiveness, safety, and tolerability when used with anti-seizure medications in adults with focal onset seizures. The drug remains investigational and is not yet approved.
NBI-921352 has one completed Phase 2 clinical trial registered as NCT05159908. This randomized, double-blind, placebo-controlled study enrolled 101 adults with focal onset seizures across multiple countries, including Australia, Belgium, Czechia, France, Hungary, Italy, and Spain.
NBI-921352 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for focal onset seizures. The completed Phase 2 trial was designed to evaluate its effectiveness, safety, and tolerability, but the drug has not yet received regulatory approval.