In short
BHV-8000 is an investigational oral substance being studied as a potential treatment for early Parkinson's disease. The clinical research currently consists of one authorised Phase 4 trial (NCT06976268) that plans to enrol 825 adults. The trial compares two oral doses of BHV-8000 (10 mg and 20 mg) against placebo, measuring the time to a first qualifying worsening event on the Movement Disorder Society–Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II over up to 48 weeks.
Key points
- BHV-8000 is an investigational oral substance studied in early Parkinson's disease.
- The single registered trial is a Phase 4 study with 825 planned adult participants.
- Two oral doses are being compared with placebo: 10 mg and 20 mg.
- The main measure is time to first qualifying worsening event on the MDS-UPDRS Part II scale over up to 48 weeks.
- The trial also uses DaTSCAN, an intravenous imaging agent, to assess dopamine transporter activity.
- The trial status is Authorised, meaning recruitment has not yet been reported as started.
What is BHV-8000?
BHV-8000 is an investigational substance being studied for the treatment of early Parkinson's disease. The full chemical name of the active substance is (2R,5S)-tetrahydro-5-(2-methyl-1H-furo[3,2-b]imidazo[4,5-d]pyridin-1-yl)-2H-pyran-2-acetonitrile. In the clinical registry it appears under the development code BHV-8000, and no trade name or marketing authorisation is recorded for this substance.
The registered trial describes BHV-8000 as an oral drug given at two dose levels, 10 mg and 20 mg, and compares it with a matching placebo. The substance is therefore still in the research stage; no regulatory approval as a medicine is documented in the available registry data.
How does BHV-8000 work?
The registry record for the trial does not state the molecular target or mechanism of action of BHV-8000. The trial is designed to evaluate whether BHV-8000 can delay the time to a first qualifying worsening event in early Parkinson's disease, measured on the MDS-UPDRS Part II scale, which captures motor experiences of daily living as reported by the patient. The trial also uses DaTSCAN, an intravenous solution for injection, which is an imaging agent that visualises dopamine transporter activity in the brain; it is listed as a separate intervention rather than as the studied substance.
Which conditions is BHV-8000 studied for?
- Early Parkinson's disease — the registered trial studies adults living with early Parkinson's disease, a progressive condition that affects movement and daily motor activities.
How is BHV-8000 given?
BHV-8000 is given by mouth as an oral formulation, at two dose levels: 10 mg and 20 mg. The trial also includes an intravenous imaging agent, DaTSCAN 74 MBq/ml solution for injection, administered at a dose of 0.13 micrograms. The registry data does not describe the pharmaceutical form of BHV-8000 beyond the oral route of administration.
What do the clinical trials show?
The clinical research on BHV-8000 consists of one registered trial, NCT06976268, with the official title "A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease". The trial is a Phase 4, interventional, randomised study with a planned enrolment of 825 adults. Its status is Authorised, which means the trial has been approved but the registry does not report that participant recruitment has started.
The study compares two dose levels of BHV-8000, 10 mg and 20 mg taken orally, against placebo. The primary outcome is the time to the first qualifying worsening event on the MDS-UPDRS Part II scale, a 52-point patient-reported scale in which a higher total score represents more severe disability in motor experiences of daily living. The time frame for this measure is up to 48 weeks.
Who can take part in this trial? The registry record identifies adults living with early Parkinson's disease as the target population; specific inclusion and exclusion criteria are not detailed in the available summary data.
What side effects are known?
The registry record for this trial does not provide a list of side effects for BHV-8000. Safety and tolerability are among the aims of the study, but no results or adverse event data are yet available in the registry.