BHV-8000 · program

BHV-8000 for Parkinson's disease

Phase 2/3RecruitingBiohaven Ltd. (BHVN)

Pivotal global Phase 2/3, randomized, double-blind, placebo-controlled study (NCT06976268 / BHV8000-301) of BHV-8000 10 mg and 20 mg once daily vs placebo in early Parkinson's disease. Primary endpoint: time to first qualifying worsening on MDS-UPDRS Part II (up to 48 weeks). ~550 participants, ages 40-85, across ~185 sites in 13 countries (US, Canada, 11 European nations). First patient enrolled May 2025. NOTE: in March 2026 Biohaven announced a more focused execution plan concentrating on a select number of US sites and deprioritized PD relative to its lead degrader programs.

Data current as of

Development timeline

Phase 2/3May 2025 – Aug 2027
  1. UpcomingAnticipated Phase 2/3 topline in early Parkinson's disease (primary endpoint: time to first qualifying worsening on MDS-UPDRS Part II)
  2. First patient enrolled in pivotal Phase 2/3 trial (NCT06976268) in early Parkinson's disease.
Phase 1Mar 2023
  1. Biohaven acquired exclusive license to BHV-8000 (formerly TLL-041) from Hangzhou Highlightll Pharmaceutical (global rights excluding China regions); planned Phase 1 in 2023. Phase 1 (58 healthy adults) subsequently reported safe/well-tolerated with robust brain penetration and biomarker engagement.↗

Readouts

  • 2H 2027AnticipatedTopline dataNCT06976268

    Anticipated Phase 2/3 topline in early Parkinson's disease (primary endpoint: time to first qualifying worsening on MDS-UPDRS Part II)

Clinical trials in Parkinson's disease

NCT06976268BHV8000-301Phase 2/3Recruitingn=550

A Phase 2/3, Double-Blind, Placebo-Controlled Study of BHV-8000 in Participants With Early Parkinson's Disease

Started May 2025· Primary completion Aug 2027· 📍 15 sites across 1 country (United States)

Formulations

FormulationRouteRegimenPharmacokinetics
BHV-8000 oral (once-daily)
Oral once-daily dosing. Phase 2/3 Parkinson's disease study evaluates 10 mg and 20 mg once daily (up to 48 weeks). Phase 1 studied single doses of 10/20/30 mg and multiple once-daily doses of 6/10/20 mg over 7-14 days.
OralOnce dailyt½ 12.5 h · Tmax 5 h

Mechanism of action (compound-wide)

Oral, brain-penetrant, highly selective dual TYK2/JAK1 inhibitor that dampens JAK-STAT signaling driven by pro-inflammatory cytokines (e.g., type I interferon / Th17 pathways) in CNS microglia, with selectivity over JAK2 and JAK3. Anti-neuroinflammatory rationale for early Parkinson's disease. Phase 1 showed robust brain penetration (~50% of plasma exposure available as unbound drug in the CNS) and reductions in inflammatory biomarkers (IP-10, hsCRP, IFN-gamma).

TargetActionAffinity
TYK2primaryTYK2Inhibitor—ⓘ
JAK1JAK1Inhibitor—ⓘ

← Full BHV-8000 compound page (identity, identifiers, all indications)

Sources

  1. A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease (NCT06976268) — ClinicalTrials.gov
  2. BHV-8000, a selective brain-penetrant TYK2/JAK1 inhibitor... demonstrates favorable pharmacokinetics/pharmacodynamics and safety in phase 1 studies (AAN 2025 poster P9-010) — Biohaven Pharmaceuticals / American Academy of Neurology
  3. Biohaven Acquires Exclusive License for Oral, Brain-Penetrant, Dual TYK2/JAK1 Inhibitor for Immune-Mediated Brain Disorders — Biohaven / PR Newswire