Asset profile
Azetukalner
Small molecule
Evidence outlook · lead readout
X-TOLE2 (NCT05614063) · Focal Onset Seizures
The completed lead evidence has the design features that historically survive confirmatory trials: randomized, controlled, and adequately powered against a prespecified clinically accepted endpoint.
X-TOLE2 (NCT05614063): This was a randomized, double-blind, placebo-controlled Phase 3 trial in 380 adults with focal epilepsy. Both azetukalner doses produced a significantly greater reduction in monthly seizure frequency than placebo, 25 mg: -53.2% vs -10.4%; 15 mg: -34.5% vs -10.4%, meeting the trial primary comparison.
Caveat: this result is taken from a company announcement or a news report of one, not from the trial registry or a peer-reviewed publication. Treat the figures as the sponsor's own statement, not as independently verified evidence.
Also in development:Major Depressive Disorder · Phase 3Focal Onset Seizures · Phase 3Primary Generalized Tonic-Clonic Seizures · Phase 3
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
122 competitors in this universe: 2 direct rivals (same mechanism and indication), 0 same-class, 120 same-indication; 52 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Azetukalner: this drug | Phase 3 | Small molecule | Kv7 potassium channel | ||
| Ezogabine (Potiga) | Approved | Small molecule | Kv7 potassium channel | ||
| Opakalim | Phase 2/3 | Small molecule | Kv7 potassium channel | ||
| Brexpiprazole (Rexulti) | Approved | Small molecule | Dopamine D2/D3 and serotonin 5-HT1A receptor | ||
| Brivaracetam | Approved | Small molecule | Synaptic vesicle glycoprotein 2A (SV2A) | ||
| Cannabidiol (Epidiolex) | Approved | Small molecule | GPR55 / TRPV1 / adenosine transport (multi-target), cannabinoid | ||
| Carbamazepine | Approved | Small molecule | Sodium channels | ||
| Cariprazine (Vraylar) | Approved | Small molecule | Dopamine D3/D2 receptor (partial agonist) | ||
| Cenobamate (Xcopri) | Approved | Small molecule | Sodium channels + GABA-A receptors | ||
| Clobazam (Onfi) | Approved | Small molecule | GABA-A receptor | ||
| Clobazam (Sympazan) | Approved | Small molecule | GABA-A receptor (benzodiazepine site) | ||
| Cyclobenzaprine (Tonmya) | Approved | Small molecule | 5-HT2A, α1-adrenergic, H1-histaminergic, and M1-muscarinic acetylcholine receptors (functional antagonism) | ||
| Dextromethorphan / Bupropion (Auvelity) | Approved | Small molecule | sigma-1/NMDA | ||
| Diastat | Approved | Combination | GABA-A receptor | ||
| Diazepam (Valium) | Approved | Small molecule | GABA-A receptor | ||
| Diazepam (Valtoco) | Approved | Small molecule | GABA-A receptor |
…and 107 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
Upcoming events
(6 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (3)
January 2027 (1)
What to watch
April 2027 (1)
May 2027 (1)
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2028 (1)
June 2028 (1)
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2029 (1)
June 2029 (1)
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2033 (1)
April 2033 (1)
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All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.