Cenobamate

The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.

• XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.ICD-10: G40.909

• XCOPRI is contraindicated in patients with: Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI [see Warnings and Precautions ( 5.1 ) and Description ( 11 )] Familial Short QT syndrome [see Warnings and Precautions ( 5.2 )] Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI. ( 4 ) Familial Short QT syndrome.contraindicated

Prior to initiating XCOPRI, obtain serum transaminases (ALT and AST) and total bilirubin, if not recently available (i.e., within 3 months), to establish baseline liver function. ( 2.1 , 5.4 ) The recommended initial dosage of XCOPRI is 12.5 mg once daily, titrated to the recommended maintenance dosage of 200 mg once daily. The recommended titration schedule should not be exceeded. The maximum dosage is 400 mg once daily. ( 2.2 ) Hepatic impairment: For patients with mild or moderate hepatic impairment, the maximum recommended dosage is 200 mg once daily. ( 2.3 , 8.7 , 12.3 ) XCOPRI can be taken whole or the tablets can be crushed. The crushed tablet can be mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. ( 2.4 ) 2.1 Assessments Prior to Initiating XCOPRI Liver Function Tests Prior to initiating XCOPRI, obtain serum transaminases (ALT and AST) and total bilirubin, if not recently available (i.e., within 3 months), to establish baseline liver function [see Warnings and Precautions ( 5.4 )] . For patients with baseline hepatic impairment, dosage modifications are recommended [see Dosage and Administration ( 2.3 )] . 2.2 Recommended Dosage Monotherapy and Adjunctive Therapy XCOPRI is administered orally once daily with or without food. The recommended dosage and titration, which should not be exceeded because of the potential for serious adverse reactions [see Warnings and Precautions ( 5.2 )] , is included in Table 1 .

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multi-Organ Hypersensitivity: Discontinue if no alternate etiology. ( 5.1 ) QT Shortening: Use caution when administering XCOPRI with other drugs that shorten the QT interval ( 5.2 ) Suicidal Behavior and Ideation: Monitor patients for suicidal behavior and ideation. ( 5.3 ) Liver Injury: Clinically significant liver injury has occurred. Obtain serum transaminases (ALT and AST) and total bilirubin before initiating XCOPRI, and during treatment if clinically indicated. Discontinue XCOPRI in patients with evidence of liver injury in the absence of an alternative etiology. ( 5.4 ) Neurological Adverse Reactions: Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained sufficient experience on XCOPRI. Concomitant use with other CNS depressants or alcohol may have additive effects. ( 5.5 ) Withdrawal of Antiepileptic Drugs: XCOPRI should be gradually withdrawn to minimize the potential of increased seizure frequency. ( 5.6 ) 5.1 Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking XCOPRI. DRESS has occurred, including one fatality, when XCOPRI was titrated rapidly (weekly or faster titration). No cases of DRESS were reported in an open-label safety study of 1339 partial-onset seizure patients when XCOPRI was initiated at 12.5 mg once daily and titrated every two weeks.

The following serious adverse reactions are described in more detail in the Warnings and Precautions section of the labeling: Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity [see Warnings and Precautions ( 5.1 )] QT Shortening [see Warnings and Precautions ( 5.2 )] Suicidal Behavior and Ideation [see Warnings and Precautions ( 5.3 )] Liver Injury [see Warnings and Precautions ( 5.4 )] Neurological Adverse Reactions [see Warnings and Precautions ( 5.5 )] Withdrawal of Antiepileptic Drugs [see Warnings and Precautions ( 5.6 )] The most common adverse reactions in patients receiving XCOPRI (at least 10% for XCOPRI and more frequently than placebo) include somnolence, dizziness, fatigue, diplopia, and headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact SK Life Science, Inc. at 1-866-657-5574 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions and for varying durations, adverse reaction frequencies observed in the clinical trials of a drug cannot be directly compared with frequencies in the clinical trials of another drug and may not reflect the frequencies observed in practice. In all controlled and uncontrolled trials performed in adult partial-onset seizure patients, XCOPRI was administered as adjunctive therapy to 1944 patients. Of these patients, 1575 were treated for at least 6 months, 710 for at least 12 months, 349 for at least 24 months, and 320 for at least 36 months.

Pregnancy: Based on animal data, may cause fetal harm. ( 8.1 ) Renal Impairment: Use with caution and dosage reduction may be considered in patients with mild to moderate (CLcr 30 to < 90 mL/min) and severe (CLcr < 30 mL/min) renal impairment. Use not recommended in end-stage renal disease (CLcr < 15 mL/min) undergoing dialysis. ( 8.6 ) Hepatic Impairment: Use with caution in patients with mild to moderate hepatic impairment; lower maximum dosage and additional dosage reduction may be considered. Use of XCOPRI in patients with severe hepatic impairment is not recommended. ( 2.2 , 8.7 , 12.3 ) 8.1 Pregnancy Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), such as XCOPRI, during pregnancy. Encourage women who are taking XCOPRI during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling the toll-free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/. Risk Summary There are no adequate data on the developmental risk associated with the use of XCOPRI in pregnant women.

Metabolism

Cenobamate AUC increases in a greater than dose-proportional manner following single oral doses from 5 to 750 mg (0.0125 to 1.88 times the maximum recommended dosage). Cenobamate C max increases in a dose proportional manner.

There is limited clinical experience with XCOPRI overdose in humans. There is no specific antidote for overdose with XCOPRI. In the event of overdose, standard medical practice for the management of any overdose should be used. An adequate airway, oxygenation and ventilation should be ensured; monitoring of cardiac rate and rhythm and vital signs is recommended. A certified poison control center should be contacted for updated information on the management of overdose with XCOPRI. There are no data on the removal of XCOPRI using dialysis.

• Nov 21, 2019NDANDA212839Sk Life

1. 1Seizure2,33229%
2. 2Product Dose Omission Issue1,80622%
3. 3Fatigue81610%
4. 4Somnolence7969.9%
5. 5Dizziness6387.9%
6. 6Off Label Use6157.6%
7. 7Product Use Issue5847.3%
8. 8Fall4255.3%
9. 9Headache3734.6%
10. 10Wrong Technique In Product Usage Process3684.6%
11. 11Drug Ineffective3374.2%
12. 12Drug Interaction3344.1%
13. 13Feeling Abnormal2923.6%
14. 14Gait Disturbance2763.4%
15. 15Balance Disorder2513.1%

The 10 most recently updated of 27 ClinicalTrials.gov registrations naming Cenobamate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS
  Completed · Phase 3 · Interventional · 519 enrolled · SK Life Science, Inc.
  NCT04557085updated 2026-06-03
• A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year Olds
  Recruiting · Phase 3 · Interventional · 20 enrolled · Ono Pharmaceutical Co., Ltd.
  NCT07594158updated 2026-05-18
• Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures
  Active not recruiting · Phase 3 · Interventional · 140 enrolled · SK Life Science, Inc.
  NCT05067634updated 2026-04-03
• Dose-Escalation Study of Cenobamate (YKP3089) in Pediatric Subjects With Partial-Onset Seizures
  Completed · Phase 1 · Interventional · 26 enrolled · SK Life Science, Inc.
  NCT04903314updated 2026-03-31
• Cenobamate in the Intensive Care Unit
  Not yet recruiting · Early phase 1 · Interventional · 10 enrolled · Brigham and Women's Hospital
  NCT06352723updated 2026-03-30
• Cenobamate Efficacy in Individuals With Autoimmune Epilepsy
  Enrolling by invitation · Observational · 30 enrolled · Fondazione Policlinico Universitario Agostino Gemelli IRCCS
  NCT07474285updated 2026-03-16
• Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy
  Active not recruiting · Phase 4 · Interventional · 49 enrolled · SK Life Science, Inc.
  NCT06453213updated 2026-02-27
• Cenobamate Open-Label Extension Study for YKP3089C025
  Enrolling by invitation · Phase 3 · Interventional · 145 enrolled · SK Life Science, Inc.
  NCT03961568updated 2026-01-07
• REACH: RWE Retrospective Study to Evaluate Cenobamate Impact on Health Care Resource Utilization
  Recruiting · Observational · 200 enrolled · Aziende Chimiche Riunite Angelini Francesco S.p.A
  NCT06922175updated 2025-10-02
• Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain
  Recruiting · Observational · 300 enrolled · Aziende Chimiche Riunite Angelini Francesco S.p.A
  NCT06716801updated 2025-09-19

Frequently asked questions

How does Cenobamate work?

The precise mechanism by which cenobamate exerts its therapeutic effects in patients with partial-onset seizures is unknown. Cenobamate has been demonstrated to reduce repetitive neuronal firing by inhibiting voltage-gated sodium currents.

What is Cenobamate used for?

According to FDA labeling, Cenobamate carries indications including: XCOPRI is indicated for the treatment of partial-onset seizures in adult patients. XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cenobamate?

Cenobamate is classified as Other antiepileptics, Cytochrome P450 2B6 Inducers, Cytochrome P450 2B6 Inhibitors, Cytochrome P450 2C19 Inhibitors, Cytochrome P450 2C8 Inducers, Cytochrome P450 3A Inhibitors, Cytochrome P450 3A4 Inducers, GABA A Modulators, GABA A Receptor Positive Modulators, Sodium Channel Antagonists, Increased Central Nervous System GABA Activity.

What are the brand names for Cenobamate?

Cenobamate is marketed under brand names including Xcopri.

What are the contraindications for Cenobamate?

Cenobamate labeling lists contraindications including: XCOPRI is contraindicated in patients with: Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI [see Warnings and Precautions ( 5.1 ) and Description ( 11 )] Familial Short QT syndrome [see Warnings and Precautions ( 5.2 )] Hypersensitivity to cenobamate or any of the inactive ingredients in XCOPRI. ( 4 ) Familial Short QT syndrome.. Always consult the full prescribing information and a clinician.