Opakalim

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Opakalim

CAS 2376397-93-0

MF C18H22F2N4O MW 348.4 g/mol

N-(1-tert-butyl-6-cyano-4,7-difluorobenzimidazol-2-yl)-3,3-dimethylbutanamide

N-(1-tert-butyl-6-cyano-4,7-difluoro-1H-1,3-benzimidazol-2-yl)-3,3-dimethylbutanamide
potassium channel activator, antiepileptic, BHV-7000; BHV7 000, BPN-25203, BPN 25203, KB-3061, KB 3061, 73H9J7RBA2

BHV-7000 is under investigation in clinical trial NCT06419608 (Efficacy and Safety Study of BHV-7000 Monotherapy in Major Depression).

Opakalim (also known as BHV-7000) is an investigational, small-molecule medication that acts as a selective activator of Kv7.2 and Kv7.3 potassium channels. Developed by Biohaven Pharmaceuticals, it targets a clinically validated pathway to regulate neuronal hyperexcitability, primarily for the treatment of epilepsy and focal seizures.

Key Characteristics

  • Mechanism of Action: It opens Kv7.2/7.3 potassium channels. This stabilizes electrical activity in the brain. Unlike older class drugs, it has minimal to no (GABA_A) receptor activity.
  • Safety Benefit: Its precision prevents typical central nervous system side effects. Patients experience much lower rates of somnolence, fatigue, and severe dizziness compared to other anti-seizure medications.
  • Administration: It is taken orally once a day. It requires no titration period before reaching therapeutic dosing.

Current Clinical Status

  • Refractory Focal Epilepsy: The drug is undergoing phase 2/3 clinical evaluation. The pivotal RISE 3 study completed patient enrollment, with high-profile top-line efficacy data anticipated in the second half of 2026.
  • Idiopathic Generalized Epilepsy (IGE): Recent clinical data highlights a three-fold prolongation in the time to a second generalized tonic-clonic seizure compared to a placebo.
  • Other Explored Indications: While it is actively tested for conditions like bipolar disorder and erythromelalgia (pain), an exploratory phase 2 trial for major depressive disorder failed to meet its primary goals.

Opakalim (INNTooltip International Nonproprietary Name, USANTooltip United States Adopted Name; developmental code names BHV-7000, BPN-25203, and KB-3061) is a highly selective Kv7.2 and Kv7.3 potassium channel opener which is under development for the treatment of bipolar disorders, epilepsy, partial epilepsies, major depressive disorder, erythromelalgia, pain, infantile spasms, and mood disorders.[1][2][3][4] It is taken orally.[1] The drug was originated by Channel Biosciences and was under development by Biohaven Pharmaceuticals or Biohaven Therapeutics.[1][2] As of April 2026, it is in phase 2/3 clinical trials for bipolar disorders, epilepsy, and partial epilepsies, phase 2 trials for major depressive disorder, and phase 1 trials for erythromelalgia and pain, whereas no recent development has been reported for infantile spasms and mood disorders.[1][2] A phase 2 trial for major depressive disorder failed to meet its primary efficacy endpoint, resulting in focus more on epilepsy instead.[3]

  • Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset EpilepsyCTID: NCT06309966Phase: Phase 2/Phase 3Status: Active, not recruitingDate: 2026-07-01
  • A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset EpilepsyCTID: NCT06132893Phase: Phase 2/Phase 3Status: RecruitingDate: 2026-05-01
  • Long-term Safety and Tolerability of BHV-7000CTID: NCT06443463Phase: Phase 2Status: Enrolling by invitationDate: 2026-05-01
  • A Phase 1b Study of BHV-7000 in Participants With Inherited ErythromelalgiaCTID: NCT07262268Phase: Phase 1Status: Enrolling by invitationDate: 2026-04-08
  • Long-term Safety Study of BHV-7000 in Participants With Major Depressive Disorder (MDD)CTID: NCT06423781Phase: Phase 2Status: CompletedDate: 2026-04-01
  • A Study to Determine if BHV-7000 is Effective and Safe in Adults With Idiopathic Generalized Epilepsy With Generalized Tonic-clonic SeizuresCTID: NCT06425159Phase: Phase 2/Phase 3Status: TerminatedDate: 2026-03-24
  • Efficacy and Safety Study of BHV-7000 Monotherapy in Major DepressionCTID: NCT06419608Phase: Phase 2Status: CompletedDate: 2026-01-07
  • BHV-7000 Acute Treatment of Bipolar ManiaCTID: NCT06419582Phase: Phase 2/Phase 3Status: CompletedDate: 2025-12-16
  • BHV-7000 Open-Label Extension Bipolar Mania StudyCTID: NCT06423794Phase: Phase 2Status: TerminatedDate: 2025-12-16

PAT

[US20230000831]

https://patentscope.wipo.int/search/en/detail.jsf?docId=US383826737&_cid=P20-MRSLRP-32698-1

PAT

https://patentscope.wipo.int/search/en/detail.jsf?docId=WO2025035066&_cid=P20-MRSLVM-39325-2

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References

References

  1.  “Biohaven Pharmaceuticals”. AdisInsight. 15 April 2026. Retrieved 31 May 2026.
  2.  “Delving into the Latest Updates on Opakalim with Synapse”. Synapse. 2 April 2026. Retrieved 31 May 2026.
  3.  Pelorosso C, Balestrini S, Guerrini R (May 2026). “Potassium channel agonists emerging as treatment options for focal epilepsy: are we breaking new ground?”. Expert Opinion on Emerging Drugs: 1–8. doi:10.1080/14728214.2026.2675274. hdl:2158/1473832. PMID 42153277.
  4.  Pong AW (December 2025). “Expanding the toolkit: An update on the evolution of new therapies for Lennox-Gastaut Syndrome”. Seminars in Pediatric Neurology. 56 101242. doi:10.1016/j.spen.2025.101242. PMID 41371876.
Clinical data
Other namesBHV-7000; BHV7000; BPN-25203; BPN25203; KB-3061; KB3061
Routes of
administration		Oral[1]
Drug classKv7.2 and Kv7.3 potassium channel opener
Identifiers
IUPAC name
CAS Number2376397-93-0
PubChem CID139487180
DrugBankDB22041
ChemSpider129910012
UNII73H9J7RBA2
KEGGD13061
Chemical and physical data
FormulaC18H22F2N4O
Molar mass348.398 g·mol−1
3D model (JSmol)Interactive image
SMILES
InChI

////////opakalim, anax labs, potassium channel activator, antiepileptic, BHV-7000; BHV7 000, BPN-25203, BPN 25203, KB-3061, KB 3061, 73H9J7RBA2

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