About Cenobamate

Cenobamate (YKP3089) was discovered by SK Biopharmaceuticals and SK life science and is a new U.S. Food and Drug Administration (FDA) approved antiseizure medication (ASM) for the treatment of partial-onset seizures in adults (also known as focal-onset seizures). Cenobamate has been approved in the U.S. where it is commercially available under the trademark XCOPRI®. It is not yet approved by any other regulatory authorities.

Molecular structure

Arvelle Therapeutics has licensed exclusive rights to develop and commercialize cenobamate in Europe from SK Biopharmaceuticals. Arvelle Therapeutics filed a Marketing Authorization Application (MAA) for cenobamate in EU as a treatment for focal-onset seizures in adult patients in March 2020 based on the data generated from SK life science’s global clinical trial program, involving more than 1,900 patients across the Phase 2 and 3 trials.

Cenobamate is a small molecule with a unique dual complementary mechanism of action. It is a positive allosteric modulator of subtypes of the γ-aminobutyric acid (GABAA) ion channel, via a binding site different from benzodiazepines. Cenobamate has also been shown to reduce repetitive neuronal firing by enhancing the inactivation of sodium channels and by inhibiting the persistent component of the sodium current.

We will continue to partner with the epilepsy as well as the broader CNS community in Europe as we work to bring potential therapeutic options to patients.

Ilise Lombardo, M.D.
Founder, Chief Medical Officer
Program
Indication
Phase I
Phase II
Phase III
Regulatory
Timeline
Cenobamate
Epilepsy
Focal-Onset Seizures
Regulatory
MAA filed
Primary Generalized Tonic-Clonic Seizures
Phase III
Expected to complete in 2022
Pediatric / Orphan
Phase I / II
Expected to initiate in 2020
Non-Epilepsy
Bipolar Disorder
Phase II
Under evaluation, programs could begin in late 2020
Neuropathic Pain
Phase II
Under evaluation, programs could begin in late 2020
Anxiety Disorders
Phase II
Under evaluation, programs could begin in late 2020

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