BHV-7000 · program
Opakalim (BHV-7000) for Epilepsy
Indications for BHV-7000: Epilepsy · Phase 3 Bipolar disorder · Discontinued Major depressive disorder · Discontinued
Lead indication for BHV-7000 (opakalim), an oral selective Kv7.2/7.3 (KCNQ2/3) potassium-channel opener restoring the M-current. Two pivotal global Phase 2/3 randomized, double-blind, placebo-controlled adjunctive studies in refractory focal onset epilepsy support registration: NCT06132893 and NCT06309966 (both recruiting), with a long-term safety open-label extension (NCT06443463). Biohaven is on track for top-line results in 2H 2026 from the first of the two pivotal focal-epilepsy studies. A separate Phase 2/3 proof-of-concept in idiopathic generalized epilepsy with generalized tonic-clonic seizures (NCT06425159, SHINE) was terminated early at n=27 (sponsor decision; enrollment challenges + portfolio prioritization) but showed a ~3-fold prolongation in median time to second GTC seizure (141 vs 47 days) without formal statistics.
Development timeline
- UpcomingTop-line results expected from the first of two pivotal Phase 2/3 focal-epilepsy studies to support registration↗
- Licensing dealBiohaven licenses the Kv7 platform, led by opakalim (BHV-7000), to SK Biopharmaceuticals for up to $795M↗
- Enrollment completeBiohaven completes enrollment in RISE3, the pivotal Phase 2/3 focal-epilepsy study of opakalim (BHV-7000)↗
- metOpakalim focal-epilepsy open-label extension: ≥50% seizure reduction in 54% of six-month completers (75 mg QD)↗
- metOpakalim IGE proof-of-concept topline: median time to 2nd generalized tonic-clonic seizure 141 vs 47 days (placebo)↗
- terminatedIGE proof-of-concept (SHINE) terminated early; ~3-fold prolongation in median time to second GTC seizure (141 vs 47 days), no formal statistics↗
- Trial startedBiohaven starts a Phase 1b study of BHV-7000 in inherited erythromelalgia, a new pain indication
- Second pivotal Phase 2/3 focal-epilepsy study (NCT06309966) started.
- First pivotal Phase 2/3 study in refractory focal onset epilepsy (NCT06132893) started (registered as Phase 2/3).
Readouts
- 2H 2026AnticipatedTopline dataNCT06132893
Top-line results expected from the first of two pivotal Phase 2/3 focal-epilepsy studies to support registration ↗
- 2026-05-27ReportedInterim analysismet
Opakalim focal-epilepsy open-label extension: ≥50% seizure reduction in 54% of six-month completers (75 mg QD) ↗
- 2026-05-27ReportedTopline datamet
Opakalim IGE proof-of-concept topline: median time to 2nd generalized tonic-clonic seizure 141 vs 47 days (placebo) ↗
- 2026-05-26ReportedInterim analysisterminatedNCT06425159
IGE proof-of-concept (SHINE) terminated early; ~3-fold prolongation in median time to second GTC seizure (141 vs 47 days), no formal statistics ↗
Clinical trials in Epilepsy
NCT06425159SHINEPhase 2/3Discontinuedn=27
A Phase 2/3 Study of BHV-7000 as Adjunctive Therapy in Subjects With Idiopathic Generalized Epilepsy With Generalized Tonic-Clonic Seizures (SHINE)
terminatedprimaryMedian time to second day with a generalized tonic-clonic (GTC) seizure over 24-week double-blind period — 141 days (opakalim 75 mg QD) vs 47 days (placebo), ~3-fold prolongation
Time-to-event proof-of-concept signal favoring opakalim; study terminated early (n=27: 15 opakalim, 12 placebo) due to enrollment challenges and portfolio prioritization, so no formal statistical testing was performed. Reported 26 May 2026.
NCT06309966Phase 2/3Recruitingn=390
A Phase 2/3 Study to Evaluate Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
NCT06132893Phase 2/3Recruitingn=390
A Phase 2/3 Study to Evaluate Efficacy, Safety and Tolerability of BHV-7000 in Subjects With Refractory Focal Onset Epilepsy
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
- A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia (NCT07262268) — ClinicalTrials.gov
- BHV-7000 Phase 2/3 in idiopathic generalized epilepsy with GTC seizures (NCT06425159, SHINE) — terminated — ClinicalTrials.gov
- BHV-7000 Phase 2/3 in refractory focal onset epilepsy (NCT06132893) — ClinicalTrials.gov
- BHV-7000 Phase 2/3 in refractory focal onset epilepsy (NCT06309966) — ClinicalTrials.gov
- Biohaven Acquires Kv7 Ion Channel Platform from Channel Biosciences — Biohaven Ltd. (PR Newswire)
- Biohaven Completes Enrollment in RISE 3 Pivotal Focal Epilepsy Study with Opakalim, a Selective Kv7.2/7.3 Activator — Biohaven, Ltd.
- Biohaven Ltd. Form 8-K (2026-08-26) — License Agreement with SK Biopharmaceuticals Co., Ltd. for the Kv7 platform — Biohaven Ltd. (SEC EDGAR)
- Biohaven Presents New Data with BHV-7000 Once-Daily Extended-Release Formulation at AES 2024 — Biohaven / PR Newswire
- Biohaven R&D Day press release (8-K exhibit): opakalim epilepsy data updates — Biohaven / SEC EDGAR
- Biohaven reports new epilepsy clinical data with opakalim; 2H 2026 topline guidance for first pivotal focal-epilepsy study — Biohaven / PR Newswire
- Pharmacological characterization of BHV-7000 (Kv7.2/7.3) — American Epilepsy Society