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 focal onset seizures, also described as focal onset epilepsy. It is intended for use alongside anti-seizure medications in adults. Neurocrine Biosciences is studying it in patients aged 18 years and older, and it has not been approved for any use.
NBI-921352 targets SCN8A, a gene that encodes a sodium channel. By acting on this target, the small molecule is designed to reduce the abnormal neuronal firing that underlies focal onset seizures. SCN8A is the molecular target of interest in the drug's development program.
NBI-921352 is being developed by Neurocrine Biosciences, Inc., which trades on the Nasdaq under the ticker NBIX. The company is the sponsor of the clinical program evaluating the drug in adults with focal onset seizures.
NBI-921352 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory authority. The Phase 2 study in focal onset seizures has been completed, and no trials are currently listed as active.
NBI-921352 has been evaluated in the Phase 2 trial NCT05159908, titled a study to investigate how effective, safe and tolerable the drug is when used with anti-seizure medications in adults with focal onset seizures. The completed trial enrolled 101 participants across Australia, Belgium, Czechia, France, Hungary, Italy and Spain.
Yes. The Phase 2 trial NCT05159908 was randomized, double blind and placebo controlled, and it enrolled 101 adults with focal onset seizures. Participants were 18 years or older, and the study did not enroll healthy volunteers. The trial has been completed.