Cenobamate

Treats partial-onset seizures. Sold as Xcopri. Every FDA application for this active ingredient: 1 branded and 2 generic.

As of Nov 15, 2026, FDA lists 3 applications for Cenobamate (sold as Xcopri), first approved Nov 21, 2019, with 0 new uses approved and 0 published complete response letters.

First approved: Nov 21, 2019
Applications: 3
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $221M
First approved in the EU: Mar 26, 2021

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Xcopri	Part D	$221M	+34%	15,747

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

XCOPRI 100 MG TABLET: $39.86 per unitBrand · +3% in a year
XCOPRI 12.5-25 MG TITRATION PK: $3.91 per unitBrand · +3% in a year
XCOPRI 150 MG TABLET: $39.86 per unitBrand · +3% in a year
XCOPRI 150-200 MG TITRATION PK: $42.91 per unitBrand · +4% in a year
XCOPRI 200 MG TABLET: $39.87 per unitBrand · +3% in a year
XCOPRI 25 MG TABLET: $39.88 per unitBrand · +3% in a year
XCOPRI 250 MG DAILY DOSE PACK: $21.37 per unitBrand · +3% in a year
XCOPRI 350 MG DAILY DOSE PACK: $42.70 per unitBrand · +3% in a year
XCOPRI 50 MG TABLET: $39.84 per unitBrand · +3% in a year
XCOPRI 50-100 MG TITRATION PAK: $42.72 per unitBrand · +3% in a year

FDA Drug Safety Communications

One communication since 2020 that name this drug; see all communications

Studies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaseMar 31, 2021

Approvals in the EU (EMA)

First approved in the EU 16 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ontozry, new substanceAngelini Pharma S.p.A · Mar 26, 2021

Clinical Trials

6 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


A Study to Evaluate the Safety, Efficacy, and PK of ONO-2017 in Japanese Patients With POS 2 to 17 Year OldsPartial Epilepsy · Ono Pharmaceutical Co., Ltd.	Phase 3	Recruiting	May 18, 2026
Cenobamate Efficacy in Individuals With Autoimmune EpilepsyAutoimmune Epilepsy · Fondazione Policlinico Universitario Agostino Gemelli IRCCS	—	Enrolling by invitation	Mar 16, 2026
Safety of Cenobamate in Japanese Subjects With Partial Onset SeizuresEpilepsies, Partial · Ono Pharmaceutical Co., Ltd.	Phase 2	Recruiting	Sep 19, 2024
ONO-2017 Study Japanese Patients With Primary Generalized Tonic Clonic Seizures.Epilepsy, Generalized · Ono Pharmaceutical Co., Ltd.	Phase 3	Recruiting	Aug 30, 2024
Open-label Study of Cenobamate Monotherapy in Adult Subjects With Newly Diagnosed or Recurrent Partial-Onset EpilepsyFocal Onset Seizure · SK Life Science, Inc.	Phase 4	Active, not recruiting	Jun 11, 2024
Cenobamate in the Intensive Care UnitEpilepsy, Neurologic Disorder · Brigham and Women's Hospital	Early phase 1	Not yet recruiting	Apr 8, 2024

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Nov 21, 2019	XcopriNDA 212839 · New molecular entity	Sk Life	7	Marketed
—	CenobamateANDA 219403	Zenara Pharma Private Ltd	0	Discontinued
—	CenobamateANDA 219473	Aurobindo Pharma Limited	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA