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Also known as BHV-8000 10mg
BHV-8000 · 1 trial · 1 indication
To evaluate the efficacy of BHV-8000 compared to placebo. This objective is measured by assessing the time to prespecified worsening on MDS-UPDRS Part II (motor experiences of daily living per self-administered questionnaire). MDS-UPDRS Part II is a 52-point scale with a higher total score representing more severe disability.
| Arm | Type | Description |
|---|---|---|
| BHV-8000 10 mg | EXPERIMENTAL | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000. |
| BHV-8000 20 mg | EXPERIMENTAL | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP. Open-label Phase: Participants will receive BHV-8000. |
| Placebo | PLACEBO_COMPARATOR | Double-blind (DB) Phase (Randomization through Week 48): Participants will receive blinded IP (matching placebo). Open-label Phase: Participants will receive BHV-8000. |
| Name | Type | Description |
|---|---|---|
| BHV-8000 10mg | DRUG | taken orally |
| BHV-8000 20 mg | DRUG | taken orally |
| Placebo | DRUG | taken orally |
Key Inclusion Criteria: * Male or female participants 40 to 80 years of age, inclusive, at the time of informed consent. * Meet the diagnostic criteria for "Probable PD" as assessed on the Movement Disorder Society (MDS) Clinical Diagnostic Criteria for PD as assessed by the Investigator. * Have a ...
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BHV-8000 is an investigational small molecule being developed for the treatment of early Parkinson's Disease in adults. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied to determine if it is effective, safe, and tolerable for this condition.
BHV-8000 targets TYK2 and JAK1, which are kinases involved in cellular signaling pathways. By inhibiting these targets, the drug may modulate inflammatory responses that are thought to contribute to the progression of Parkinson's Disease. This mechanism is being evaluated in clinical trials for its potential therapeutic effect.
BHV-8000 is being developed by Biohaven Ltd., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol BHVN. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with early Parkinson's Disease.
BHV-8000 is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is recruiting participants to assess the drug's effectiveness, safety, and tolerability in adults with early Parkinson's Disease.
BHV-8000 is being studied in a Phase 2 clinical trial with the identifier NCT06976268. This randomized, double-blind, placebo-controlled study is recruiting approximately 550 adults aged 40 years and older with early Parkinson's Disease in the United States. The trial is currently active and enrolling participants.
Yes, BHV-8000 is also known as BHV-8000 10mg. The name BHV-8000 10mg likely refers to a specific dosage strength of the drug being studied in clinical trials. Both names refer to the same investigational compound developed by Biohaven Ltd. for the treatment of early Parkinson's Disease.