Product Description
Opakalim (BHV-7000) is a potent, selective activator of Kv7.2/7.3 potassium channels, a clinically validated target to regulate the hyperexcitable state in epilepsy. (Sourced from: https://www.biohaven.com/pipeline/innovation-engine/kv7/)
Mechanisms of Action: KV7.2/7.3 Activator
Novel Mechanism: Yes
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Company: SK Biopharmaceuticals
Company Location: Asia Pacific
Company Founding Year: None
Additional Commercial Interests: Biohaven Pharmaceuticals
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Chile, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Italy, Mexico, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Switzerland, United Kingdom, United States
Active Clinical Trial Count: 11
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Biohaven announced they will present P2 Epilepsy results in 2H26 for Opakalim
- Clinical Outcomes Reported - Biohaven presented P2 Epilepsy results on 2026-05-26 for Opakalim
- Clinical Outcomes Reported - Biohaven presented P2 Epilepsy|Epilepsy, Generalized|Epileptic Encephalopathy results on 2026-05-27 for Opakalim
Highest Development Phases
Phase 3: Bipolar Disorder|Drug Resistant Epilepsy|Epilepsies, Partial|Epilepsy|Epilepsy, Generalized|Epilepsy, Tonic-Clonic
Phase 2: Consciousness Disorders
Phase 1: Erythromelalgia|Neuralgia|Seizures, Febrile
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07262268 |
BHV7000-119 | P1 |
Active, not recruiting |
Erythromelalgia|Epilepsy, Generalized|Neuralgia|Seizures, Febrile |
2027-11-01 |
65% |
2026-10-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-508813-18-00 |
BHV7000-201 | P2 |
Recruiting |
Epilepsy |
2026-12-30 |
54% |
2025-05-02 |
Treatments |
NCT06423781 |
BHV7000-203 | P2 |
Completed |
Depressive Disorder, Major |
2026-03-18 |
46% |
2026-04-02 |
Primary Endpoints |
NCT06419608 |
BHV7000-305 | P2 |
Completed |
Consciousness Disorders|Depressive Disorder, Major |
2025-11-07 |
50% |
2026-01-08 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-508812-45-00 |
BHV7000-304 | P3 |
Recruiting |
Epilepsy, Generalized|Epilepsy, Tonic-Clonic |
2027-11-30 |
47% |
2025-05-02 |
Treatments |
NCT06132893 |
RISE 2 | P3 |
Active, not recruiting |
Epilepsies, Partial|Drug Resistant Epilepsy |
2026-12-01 |
40% |
2026-10-01 |
Primary Endpoints|Treatments|Trial Status |
NCT06419582 |
BHV7000-204 | P3 |
Completed |
Bipolar Disorder |
2025-01-15 |
45% |
2025-03-06 |
Primary Endpoints |
2023-508539-30-00 |
BHV7000-302 | P3 |
Recruiting |
Epilepsy |
2025-08-18 |
2025-05-02 |
Treatments |
|
NCT06443463 |
BHV7000-201 | P2 |
Enrolling by invitation |
Epilepsies, Partial |
2026-12-01 |
54% |
2024-07-23 |
Primary Endpoints |
NCT06309966 |
RISE 3 | P3 |
Active, not recruiting |
Drug Resistant Epilepsy|Epilepsies, Partial |
2026-10-01 |
38% |
2026-07-02 |
Primary Endpoints |
2023-508811-21-00 |
BHV7000-303 | P3 |
Recruiting |
Epilepsy |
2025-09-30 |
2025-05-02 |
Treatments |