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Abstract Details

Azetukalner, a Novel, Potent KV7 Channel Opener, in Adults with Focal Epilepsy: =42-Month Interim Analysis of the Ongoing 7-year X-TOLE Open-label Extension
Epilepsy/Clinical Neurophysiology (EEG)
P11 - Poster Session 11 (11:45 AM-12:45 PM)
10-001
To provide the latest X-TOLE interim open-label extension (OLE) results 
Azetukalner, a novel, potent KV7 channel opener, is in development for focal onset seizures (FOS), primary generalized tonic-clonic seizures, major depressive disorder, and bipolar depression. The efficacy and safety of azetukalner in FOS have been reported from the randomized, placebo-controlled phase 2b X-TOLE trial and the ongoing 7-year OLE. We report the latest interim OLE results (April 1, 2025).
Eligible participants from the double-blind period (DBP) started the OLE on azetukalner 20 mg once daily with food. Treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and were assessed.
In total, 275 participants (96.5%) enrolled in the OLE from the DBP. Baseline median monthly FOS frequency was 13.5; 52.4% were taking 3 concomitant antiseizure medications. As of April 1, 2025, 182, 165, and 135 participants received treatment for ≥12, ≥24, and ≥42 months, respectively; 123 (44.7%) are ongoing. The most common reasons for discontinuation were lack of efficacy (18.2%) and study withdrawal (16.7%). The most common TEAEs were dizziness (23.3%), headache (18.2%), COVID-19 (17.1%), somnolence (16.4%), fall (14.2%), weight increased (11.3%), and memory impairment (10.5%). In total, 15.6% of participants reported ≥1 SAE; 2.5% were considered treatment related. During the DBP and OLE, 2 deaths were reported (sudden unexpected death in epilepsy and viral pneumonia, n=1 each), neither considered treatment related. The MPC in seizure frequency was −87% in participants continuing at 42 months in the OLE. Updated safety and efficacy data will be presented.
In the ongoing X-TOLE OLE, azetukalner was generally well tolerated, with no new safety signals. These data support the long-term safety and efficacy of azetukalner in a difficult-to-treat population of patients with FOS.
Authors/Disclosures
Jacqueline French, MD, FAAN (NYU Comprehensive Epilepsy Ctr)
PRESENTER 		Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as an officer or member of the Board of Directors for Epilepsy Foundation. The institution of Dr. French has received research support from Epilepsy Study Consortium/ Epilepsy Foundation (Funded by UCB). The institution of Dr. French has received research support from GW/One8 Foundation/FACES. The institution of Dr. French has received research support from NINDS. The institution of Dr. French has received research support from Xenon. The institution of Dr. French has received research support from Cerevel. The institution of Dr. French has received research support from FACES. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Epilepsy Study Consortium. The institution of Dr. French has received research support from UCB. The institution of Dr. French has received research support from Praxis. Dr. French has received personal compensation in the range of $50,000-$99,999 for serving as a Chief Medical/Innovation Officer with Epilepsy Foundation. Dr. French has a non-compensated relationship as a Consultant with Acadia Pharmaceuticals Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Access Industries that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Acuta Capital Partners LLC that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with AFASCI Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Agrithera, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Alkermes that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Alterity Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Angelini Pharma S.p.A. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Autifony Therapeutics Limited that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Axonis Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bain Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Beacon Biosciences that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biogen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Biohaven Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Bloom Science, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Bright Minds Biosciences, Inc. that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Capsidia Biotherapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Cerebral Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cerecin, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with Cerevel that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, SAB with Cognizance Biomarkers that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ceribell that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Cowen that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Crossject that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with EcoR1 Capital that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EG 427 that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant, Advisory Board with Eisai that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Encoded Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant/Advisory Board with Engrail that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Epitel, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with EpiMinder that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Grin Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Harmony that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Advisory Board with Ionis Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with iQure Pharma, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with IQVIA that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Janssen Pharma that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Jazz Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Leal Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, with Livanova that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, SAB with London Research & Pharmaceuticals that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Longboard Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Maplight Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Marinus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Medscape/Web MD that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Modulight Bio that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Montara Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Mosaica Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neumarker that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Neumirna Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Neurelis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, Advisory Board with Neurocrine that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consultant with Neuropace that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with NeuroPro Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neuroventis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Neurona Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Neuvarti that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Noema that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Ono Pharmaceutical that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting, Advisory Board with Otsuka that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a consulting, Advisory Board with Ovid Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consulting with Praxis that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with PureTech LYT Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with QurAlis Corp that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Rapport Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Receptor Holdings, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Rivervest Venture Partners that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Sage Therapeutics, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with SK Life Science that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stoke that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Stream Neuroscience that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Supernus that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Takeda that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Taysha Gene Therapies that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with UCB, Inc that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with uniQure that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Ventus Therapeutics that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant with Vida Ventures Management that is relevant to AAN interests or activities. Dr. French has a non-compensated relationship as a Consultant, Advisory Board with Xenon Pharmaceuticals that is relevant to AAN interests or activities.
Roger J. Porter, MD, FAAN Dr. Porter has received personal compensation in the range of $5,000-$9,999 for serving as a Consultant for Xenon. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Neurocrine. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Longboard. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Engrail. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Axonis. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bright MInds Bioscience. Dr. Porter has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Autobah. Dr. Porter has received publishing royalties from a publication relating to health care.
Emilio Perucca Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving as a Consultant for SKB Life Sciences. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Xenon Pharma. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for GRIN Therapeutics. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Sun Pharma. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Takeda. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Eisai. Emilio Perucca has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for Xenon Pharma. Emilio Perucca has received publishing royalties from a publication relating to health care. Emilio Perucca has received publishing royalties from a publication relating to health care.
Martin Brodie Martin Brodie has nothing to disclose.
Cynthia L. Harden, MD (Xenon Pharmaceuticals Inc) Dr. Harden has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Dr. Harden has stock in Xenon Pharmaceuticals Inc.. Dr. Harden has received intellectual property interests from a discovery or technology relating to health care.
Jenny Qian Jenny Qian has nothing to disclose.
Constanza Luzon Constanza Luzon has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc.. Constanza Luzon has stock in Xenon Pharmaceuticals.
Christopher Kenney No disclosure on file
Gregory N. Beatch, PhD Dr. Beatch has received personal compensation for serving as an employee of Xenon Pharmaceuticals Inc. Dr. Beatch has stock in Xenon Pharmaceuticals Inc. Dr. Beatch has received intellectual property interests from a discovery or technology relating to health care.