Cenobamate is under clinical development by SK Life Science and currently in Phase III for Tonic-Clonic (Grand Mal) Seizure. According to GlobalData, Phase III drugs for Tonic-Clonic (Grand Mal) Seizure have a 93% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Cenobamate’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Cenobamate overview

Cenobamate (Xcopri / Ontozry) is an anti-epileptic agent. It is formulated as tablets and film coated tablets for oral route of administration. Xcopri is indicated to treat partial-onset seizures in adults 18 years of age and older and hepatic impairment. Ontozry is indicated for the adjunctive treatment of focal-onset seizures with or without secondary generalization in adult patients with epilepsy who have not been adequately controlled despite a history of treatment with at least 2 anti-epileptic medicinal products. It is also under development for the treatment of Lennox-Gastaut syndrome in pediatrics.

Cenobamate (YKP-3089) is under development for the treatment of partial seizures, simple partial seizure, complex partial seizure, generalized seizure and tonic-clonic seizures. It is a next-generation carbamate. The drug candidate is administered through the oral route in the form of the capsule and tablets. It acts as an anxiolytic well as an anti-epileptic drug compound. The drug candidate is a sodium channel blocke and positive allosteric GABAA modulator. It was also under development for the treatment of anxiety, neuropathic pain and bipolar disorders

SK Life Science overview

SK Life Science (SK Life) a subsidiary of SK Biopharmaceuticals Co Ltd is a developer of medicinal products. The company develops technologies in the areas of biology and discovery, medicinal chemistry and pharmacology. Its biology and discovery research provide lead compound discovery and optimization that indentifies and validates signal and molecular targets. SK Life develops drugs for epilepsy, sleep disorder, neuropathic pain, Alzheimer’s dementia, anxiety, depression, and schizophrenia. The company’s technical expertise includes continuous flow process and chiral chemistry. It develops drugs through partnerships with universities, government organizations, pharmaceutical and biotech companies. SK Life is headquartered in Fair Lawn, New Jersey, the US.

For a complete picture of Cenobamate’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.