Which epilepsy drugs are in Phase 3?

Phase 3 (or later) programs for epilepsy include Azetukalner (XEN1101) and Opakalim (BHV-7000).

What are the next epilepsy trial readouts?

Upcoming catalysts include Azetukalner (XEN1101) (Q3 2026), Azetukalner (XEN1101) (2H 2026) and Opakalim (BHV-7000) (2H 2026).

How many clinical trials are recruiting for epilepsy?

96 drug-interventional epilepsy trials are currently recruiting participants, out of 880 registered interventional trials.

Neurological Disorders

Epilepsy drug pipeline

ICD-11 8A6Z
MeSH D004827

3 compounds from 3 companies are in active clinical development for epilepsy, including 2 at Phase 3 or beyond.

3Compounds

3Companies

2Phase 3+

3Upcoming readouts

104Trials recruiting

Phase 3 2
Discontinued 1

Mechanisms: Small molecule (3)

Pipeline data compiled July 2026 · every fact sourced.

Upcoming readouts & recent results

Q3 2026AnticipatedAzetukalner (XEN1101)Regulatory
FDA NDA submission for azetukalner in focal onset seizures planned for Q3 2026. ↗
2H 2026AnticipatedAzetukalner (XEN1101)Topline dataNCT05716100
X-TOLE3 Phase 3 topline (second pivotal focal-onset-seizure trial) anticipated; primary completion ~Oct 2026. ↗
2H 2026AnticipatedOpakalim (BHV-7000)Topline dataNCT06132893
Top-line results expected from the first of two pivotal Phase 2/3 focal-epilepsy studies to support registration ↗
2026-05-26ReportedOpakalim (BHV-7000)Interim 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 ↗
2026-03-09ReportedAzetukalner (XEN1101)Topline datametNCT05614063
X-TOLE2 Phase 3 POSITIVE: azetukalner cut monthly focal-onset seizure frequency -53.2% at 25 mg (placebo-adjusted -42.7%, p=6e-12) vs -10.4% placebo; supports Q3 2026 NDA. ↗
2024-12-05ReportedDarigabat (CVL-865)Registry resultsterminatedNCT04686786
Open-label extension (NCT04686786) terminated early after REALIZE missed its primary objective ↗
2024-05-21ReportedDarigabat (CVL-865)Full resultsmissedNCT04244175
REALIZE Phase 2 in drug-resistant focal onset seizures FAILED — darigabat did not separate from placebo on the primary Response Ratio (p=0.823 at 7.5 mg BID; p=0.986 at 25 mg BID) ↗

See the full catalyst calendar →

Compounds in development (3)

Compound	Company	Phase	Status	Mechanism
Azetukalner (XEN1101)	Xenon Pharmaceuticals Inc.	Phase 3	Active	Kv7.2 Activator
Opakalim (BHV-7000)	Biohaven Ltd.	Phase 3	Recruiting	Kv7.2 Activator
Darigabat (CVL-865)	AbbVie Inc.	Discontinued	Discontinued	GABA-A receptor alpha-2 PAM

Trials recruiting now (96)

96 drug-interventional epilepsy trials recruiting now, of 880 registered interventional trials. Browse all on ClinicalTrials.gov →

Phase 4Study of the Pharmacokinetics, Safety, and Tolerability of ZONISADE in Children 1 Month to 17 Years of Age With Partial-onset Seizures
Zonisamide Oral Product
Azurity Pharmaceuticalsn=40United States · 2 sitesStarted Sep 2026NCT06534502
Phase 4A Study to Investigate the Transition of Children From 'Artisanal" Cannabidiol (CBD) to Epidiolex
Epidiolex 100 mg/mL Oral Solution
Elizabeth Donnern=25Canada · 1 siteStarted Jun 2026NCT06924827
Phase 4The FINTEPLA as an Anti-SUDEP Therapy in Dravet Syndrome Project
Fenfluramine treatment (Fintepla)
The University of Texas Health Science Center, Houstonn=25United States · 1 siteStarted Apr 2026NCT07112365
Phase 4Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy
Butylphthalide, Placebo
First Affiliated Hospital of Wenzhou Medical Universityn=220China · 1 siteStarted Sep 2025NCT07193277
Phase 4Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Phenytoin, Levetiracetam, Placebo
All India Institute of Medical Sciences, Jodhpurn=1,260India · 3 sitesStarted Jul 2025NCT07072624
Phase 4Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age
fenfluramine
University of Colorado, Denvern=5United States · 1 siteStarted Oct 2024NCT06598449
Phase 4A Clinical Study on the Efficacy and Safety of Zonisamide as a First Add-On Treatment in Epileptic Seizures
Oral Zonisamide Therapy
Affiliated Hospital of Nantong Universityn=30China · 1 siteStarted Aug 2024NCT06967012
Phase 4Effect of Adding Lamotrigine to Sodium Valproate in Childhood Epilepsy: Clinicolabratory Study
Sodium Valproate 500 Mg Prolonged-Release Oral Tablet, Lamotrigine
Assiut Universityn=50Started Jul 2024NCT05881928
Phase 4Seizure Rescue Medication (RM) as Part of a Comprehensive Epilepsy Self-management Package of Care
Valtoco Nasal Product
University Hospitals Cleveland Medical Centern=30United States · 2 sitesStarted Mar 2024NCT06346262
Phase 4Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
Methylphenidate
VA Office of Research and Developmentn=226United States · 4 sitesStarted Aug 2023NCT04419272
Phase 4Pharmacogenetics-Based Study on Individualized Use of Sodium Valproate
sodium valproate
The First Affiliated Hospital of University of South Chinan=312China · 1 siteStarted Dec 2022NCT07046676
Phase 4Effect of GABA on ADHD and Seizures in Children With Epilepsy.
GABA
Sherief Abd-Elsalamn=30Egypt · 1 siteStarted Jul 2018NCT04144439

Showing the 12 most advanced of 96 recruiting drug trials · see all on ClinicalTrials.gov →

Frequently asked

How many drugs are in development for epilepsy?: 3 compounds from 3 companies are in active clinical development for epilepsy, including 2 at Phase 3 or beyond.
Which epilepsy drugs are in Phase 3?: Phase 3 (or later) programs for epilepsy include Azetukalner (XEN1101) and Opakalim (BHV-7000).
What are the next epilepsy trial readouts?: Upcoming catalysts include Azetukalner (XEN1101) (Q3 2026), Azetukalner (XEN1101) (2H 2026) and Opakalim (BHV-7000) (2H 2026).
How many clinical trials are recruiting for epilepsy?: 96 drug-interventional epilepsy trials are currently recruiting participants, out of 880 registered interventional trials.