Xcopri

(Cenobamate)

ApprovedSmall molecule

SSK Life Science, Inc.

Xcopri is one of 72 small molecule programs targeting Focal-onset seizure. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Focal-Onset SeizureActive, not recruiting

SeizureRecruiting

EpilepsyActive, not recruiting

Intensive Care UnitNot yet recruiting

Focal-Onset SeizureApproved

Active, not recruiting

SeizurePhase 3

Recruiting

EpilepsyApproved

Active, not recruiting

Intensive Care UnitPhase 1

Not yet recruiting

Competition

Competitive Landscape

87 competitors in Epilepsy

#DrugCompanyPhaseTrials

Keppra

UCB

Approved

45 2

Tegretol

Novartis

Approved

11 3

Trileptal

Novartis

Approved

7 4

Topamax

WWim Janssens

Approved

20 5

Fycompa

CCatalyst Biosciences

Approved

14 6

Lexapro

AbbVie

Approved

2 7

Xcopri

SSK Life Science, Inc.

Approved

14 8

Avelox

Thalomid

Briviact

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 3Recruiting

Seizure

NCT06579573

Phase 2Recruiting

Seizure

NCT06590896

Recruiting

Pain

NCT06716801

Q3 2027

ApprovedActive, not recruiting

Focal-Onset Seizure

NCT06453213

Clinical

Trials by Indication[1]

Seizure2 trials

ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 3·NCT06579573·15 enrolled

Safety of Cenobamate in Japanese Subjects With Partial Onset Seizures

Recruiting· Ono Pharmaceutical Co. Ltd logo

Ono Pharmaceutical Co. Ltd·Phase 2·NCT06590896·100 enrolled

Intensive Care Unit1 trial

Cenobamate in the Intensive Care Unit

Not yet recruiting·—·Phase 1·NCT06352723·10 enrolled

Efficacy and Safety1 trial

Randomized, Double-blind Study to Evaluate Efficacy and Safety of Cenobamate Adjunctive Therapy in POS

Unknown status·SSK Life Science, Inc.·Phase 3·NCT04557085·540 enrolled

Pain1 trial

Real-world Clinical Response to Cenobamate Early add-on in France, Germany and Spain

Recruiting·AAziende Chimiche Riunite Angelini Francesco S.p.A··NCT06716801·300 enrolled

Drug Interactions1 trial

Assess the Influence of Cenobamate on the PK of Cytochrome P450 (CYP) Probe Drugs As a Means of Predicting Drug-drug Interactions

Completed·SSK Life Science, Inc.·Phase 1·NCT03234699·24 enrolled

8 more indications

Oral1 trial

Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet

Completed·SSK Life Science, Inc.·Phase 1·NCT04690751·28 enrolled

Randomized1 trial

A Randomized, Open-label, Three-way Crossover Study to Evaluate the Relative Bioavailability of 200 Mg Cenobamate Administered Orally

Completed·SSK Life Science, Inc.·Phase 1·NCT05572255·24 enrolled

Hepatic Impairment1 trial

Safety Study of Cenobamate in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

Completed·SSK Life Science, Inc.·Phase 1·NCT04791553·15 enrolled

Drug1 trial

A Study of the Abuse Liability Potential of Cenobamate in Recreational Drug Users

Completed·SSK Life Science, Inc.·Phase 1·NCT03509285·53 enrolled

Focal-onset seizure1 trial

Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset Epilepsy

Active, not recruiting·SSK Life Science, Inc.·Approved·NCT06453213·49 enrolled

Partial Epilepsy1 trial

Open-Label Safety and Efficacy Study of Cenobamate in Pediatric Subjects 2-17 Years of Age With Partial-onset (Focal) Seizures

Completed·SSK Life Science, Inc.·Phase 3·NCT05067634·154 enrolled

Primary Generalized Epilepsy1 trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Cenobamate Adjunctive Therapy in Subjects With PGTC Seizures

Completed·SSK Life Science, Inc.·Phase 3·NCT03678753·169 enrolled

Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy1 trial

A Multicenter Open-Label Extension Study to Evaluate the Long-Term Safety of Cenobamate Adjunctive Therapy in Subjects With Primary Generalized Tonic-Clonic Seizures

Completed·SSK Life Science, Inc.·Phase 3·NCT03961568·147 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 10, 2020

XCOPRI

NDA NDA212839

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for Cenobamate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Cenobamate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Cenobamate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA212839). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Xcopri. U.S. Food & Drug Administration.
[6]
SEC EDGAR — SK Life Science, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SSK Life Science, Inc.

Patent Landscape[5]

Patent Cliff

Oct 30, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7598279Oct 30, 2032

11654133Jun 16, 2039

Xcopri

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q3 2027

Trials by Indication[1]

Seizure2 trials

Intensive Care Unit1 trial

Efficacy and Safety1 trial

Pain1 trial

Drug Interactions1 trial

Oral1 trial

Randomized1 trial

Hepatic Impairment1 trial

Drug1 trial

Focal-onset seizure1 trial

Partial Epilepsy1 trial

Primary Generalized Epilepsy1 trial

Primary Generalized Tonic Clonic Seizures in the Setting of Idiopathic Generalized Epilepsy1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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