BHV-7000 · program
Opakalim (BHV-7000) for Bipolar disorder
Indications for BHV-7000: Epilepsy · Phase 3 Major depressive disorder · Discontinued Bipolar disorder · Discontinued
Phase 2/3 registrational study (NCT06419582) of BHV-7000 75 mg once daily for the acute treatment of manic episodes (with or without mixed features) in Bipolar I Disorder. Topline reported 2025-03-03 in Biohaven's Q4/FY2024 earnings release: BHV-7000 did not statistically differentiate from placebo on the primary endpoint (change in YMRS total score from baseline to Day 21). The drug was safe and well-tolerated (75 mg QD, no treatment-emergent serious adverse events). Biohaven subsequently deprioritized psychiatry, focusing on immunology, obesity, and epilepsy; no further psychiatric trials of BHV-7000 are planned.
Development timeline
- Upcoming↗
- Phase 2/3 registrational acute bipolar mania study (NCT06419582) started; YMRS day-21 primary endpoint, BHV-7000 75 mg QD vs placebo, inpatient.
Readouts
- 2025-03-03AnticipatedTopline dataNCT06419582
Clinical trials in Bipolar disorder
NCT06419582Phase 2/3Completedn=274
A Phase 2/3, Multicenter, Inpatient, Placebo-Controlled, Double-blind Trial of BHV-7000 for the Acute Treatment of Manic Episodes, With or Without Mixed Features, Associated With Bipolar I Disorder
missedprimaryChange in YMRS total score from baseline to Day 21 vs placebo
BHV-7000 75 mg once daily did not statistically differentiate from placebo on the primary endpoint (change in Young Mania Rating Scale total score from baseline to Day 21). The drug was safe and well-tolerated, with no treatment-emergent serious adverse events. Topline reported 2025-03-03 in Biohaven's Q4/FY2024 earnings release.
Formulations
| Formulation | Route | Regimen | Pharmacokinetics |
|---|---|---|---|
| BHV-7000 once-daily extended-release (oral)extended-release Once-daily extended-release oral formulation; doses up to 75 mg daily evaluated in Phase 2/3 (Phase 1 demonstrated safety/tolerability up to 120 mg daily for 15 days) | Oral | Once daily | — |
Mechanism of action
Selective Kv7.2/Kv7.3 (KCNQ2/3) potassium-channel opener; EC50 ~0.6 µM for the heteromer, no GABA-A or cardiac channel activity (unlike retigabine).
| Target | Action | Affinity |
|---|---|---|
| Kv7.2primaryKCNQ2 | Activator | EC50 0.6 µMⓘ |
| Kv7.3KCNQ3 | Activator | —ⓘ |
← Full BHV-7000 compound page (identity, identifiers, all indications)
Sources
- BHV-7000 Acute Treatment of Bipolar Mania (NCT06419582) — ClinicalTrials.gov
- Biohaven Presents New Data with BHV-7000 Once-Daily Extended-Release Formulation at AES 2024 — Biohaven / PR Newswire
- Biohaven Reports Recent Business Developments and Q4/FY2024 Financial Results (BHV-7000 bipolar mania topline; primary endpoint not met) — Biohaven / PR Newswire
- Pharmacological characterization of BHV-7000 (Kv7.2/7.3) — American Epilepsy Society