BHV-7000 · program

Opakalim (BHV-7000) for Major depressive disorder

DiscontinuedDiscontinuedBiohaven Ltd. (BHVN)

Indications for BHV-7000: Epilepsy · Phase 3 Bipolar disorder · Discontinued Major depressive disorder · Discontinued

Phase 2 proof-of-concept in MDD. The monotherapy study (NCT06419608, n=336) did not meet its primary MADRS endpoint (reported 24 Dec 2025); Biohaven stated no further psychiatric trials, prioritizing immunology/obesity/epilepsy. (A separate bipolar-mania Phase 2/3, NCT06419582, also missed its YMRS endpoint in Mar 2025.) Epilepsy development continues.

Data current as of

Development timeline

DiscontinuedFeb 2022 – Aug 2026
  1. Licensing dealBiohaven licenses the Kv7 platform, led by opakalim (BHV-7000), to SK Biopharmaceuticals for up to $795M↗
  2. Trial startedBiohaven starts a Phase 1b study of BHV-7000 in inherited erythromelalgia, a new pain indication
  3. missedPhase 2 proof-of-concept MDD study of BHV-7000 misses MADRS primary endpoint; Biohaven exits psychiatric development↗
  4. AcquisitionBiohaven acquires Channel Biosciences' Kv7 platform (BHV-7000)↗
Phase 2May 2024
  1. Phase 2 MDD monotherapy POC study (NCT06419608) started.

Readouts

  • 2025-12-24ReportedTopline datamissed

    Phase 2 proof-of-concept MDD study of BHV-7000 misses MADRS primary endpoint; Biohaven exits psychiatric development ↗

Clinical trials in Major depressive disorder

NCT06423781Phase 2Completedn=233

Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)

Started Aug 2024· Primary completion Mar 2026· 📍 66 sites across 1 country (United States)

NCT06419608BHV7000-305Phase 2Completedn=336

Phase 2 Study of BHV-7000 Monotherapy in Major Depressive Disorder

Started May 2024· Primary completion Nov 2025· 📍 62 sites across 1 country (United States)

missedprimaryMADRS change at Week 6 vs placebo

Did not meet primary endpoint; trends favoring BHV-7000 in more severely depressed subgroups (hypothesis-generating). Reported 24 Dec 2025.

Formulations

FormulationRouteRegimenPharmacokinetics
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)
OralOnce daily—

Mechanism of action (compound-wide)

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).

TargetActionAffinity
Kv7.2primaryKCNQ2ActivatorEC50 0.6 µMⓘ
Kv7.3KCNQ3Activator—ⓘ

← Full BHV-7000 compound page (identity, identifiers, all indications)

Sources

  1. A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia (NCT07262268) — ClinicalTrials.gov
  2. BHV-7000 Phase 2 MDD (NCT06419608) — ClinicalTrials.gov
  3. Biohaven Acquires Kv7 Ion Channel Platform from Channel Biosciences — Biohaven Ltd. (PR Newswire)
  4. Biohaven Ltd. Form 8-K (2026-08-26) — License Agreement with SK Biopharmaceuticals Co., Ltd. for the Kv7 platform — Biohaven Ltd. (SEC EDGAR)
  5. Biohaven Presents New Data with BHV-7000 Once-Daily Extended-Release Formulation at AES 2024 — Biohaven / PR Newswire
  6. Biohaven Provides Update From Phase 2 Proof-of-Concept Study with BHV-7000 in Major Depressive Disorder — Biohaven Ltd.
  7. clinicaltrials.gov — clinicaltrials.gov
  8. Pharmacological characterization of BHV-7000 (Kv7.2/7.3) — American Epilepsy Society