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A profile of azetukalner for the treatment of epilepsy: from pharmacology to potential for therapy.

Simona LattanziEugen TrinkaStefano MelettiPasquale StrianoSara MatricardiMauro SilvestriniFrancesco Brigo
Published in: Expert review of clinical pharmacology (2024)
Results from the phase 2b clinical trial strongly support the ongoing clinical development of azetukalner as a new ASM. Its pharmacokinetic properties support convenient once-daily dosing, eliminating the need for titration at initiation or tapering at the conclusion of treatment. CYP3A4 is the main enzyme involved in its metabolism and drug-drug interactions can affect the drug exposure. Preliminary analysis of an ongoing open-label study reveals no reported pigmentary abnormalities. The upcoming Phase 3 clinical trials are expected to provide further insight into the efficacy, tolerability, and safety of azetukalner in treating focal-onset and primary generalized tonic-clonic seizures. Structurally distinct from currently marketed ASMs, azetukalner has the potential to be the only-in-class Kv7.2/7.3 opener on the market upon regulatory approval.
Keyphrases
  • clinical trial
  • open label
  • phase ii
  • phase iii
  • randomized controlled trial
  • study protocol
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  • drug induced
  • placebo controlled