About Cebrius

What is CEBRIUS?

Cenobamate is a tetrazole-derived antiseizure medication (ASM) with a dual and complementary mechanism of action. It enhances fast and slow inactivation of voltage-gated sodium channels, preferentially inhibiting the persistent (late) sodium current, and acts as a positive allosteric modulator of the γ-aminobutyric acid (GABAA) ion channel at extrasynaptic, non-benzodiazepine sites — helping reduce the neuronal hyperexcitability that drives drug-resistant seizures.

Key Features

  • Once-daily oral administration.
  • May be taken with or without food; tablets should be swallowed whole and not crushed or chewed.
  • Studied as adjunctive therapy in adults with drug-resistant focal (partial-onset) epilepsy inadequately controlled despite ≥2 prior antiseizure medications.
  • Dual sodium-channel / GABAA mechanism designed to deliver high seizure-freedom rates through a deliberately slow, individualized titration protocol.

Indications / Uses

Drug-Resistant Focal (Partial-Onset) Epilepsy - Adjunctive Therapy (Indian FDA / DCGI approval):

  • Add-on treatment of focal-onset seizures, with or without secondary generalization, in adults inadequately controlled despite treatment with two or more antiseizure medications.
  • Demonstrated significant reductions in seizure frequency — including sustained seizure freedom in a meaningful subset of patients — across the pivotal C013, C017 and C021 trials.
  • Supports long-term seizure control and, in real-world use, has allowed reduction of concomitant ASM drug load in appropriately selected patients.

Based on clinical response and tolerability, dosage may be further increased in increments of 50 mg once daily every 2 weeks, up to a maximum of 400 mg once daily.

*Titration must never be accelerated beyond the recommended schedule — more rapid titration has been associated with serious hypersensitivity reactions, including DRESS.

*Refer to the approved Prescribing Information for complete dosing recommendations.