cenobamate

Trade name: Xcopri

Small moleculeapproved

Approved

Nov 21, 2019

Cenobamate (also known as YKP3089) is a small molecule sodium channel blocker in development for the treatment of partial-onset seizures in adult patients. In mice and rats, Cenobamate displayed an anticonvulsant activity in the maximal electroshock test and prevented seizures induced by chemical convulsants such as pentylenetetrazol and picrotoxin. In addition, Cenobamate was reported to be effective in two models of focal seizure, the hippocampal kindled rat and the mouse 6 Hz psychomotor seizure models. Two completed adequate and well-controlled clinical studies demonstrated a significant reduction in focal seizures with Cenobamate in patients with epilepsy, and a long-term open-label phase 3 safety clinical trial is currently ongoing. Cenobamate is considered a new generation antiepileptic therapy and clinical trials have shown that it may be more effective and safer than existing drugs. If licensed, Cenobamate will offer a new adjunctive treatment option for patients with partial focal epilepsy. — NCATS

Clinical trial activity

21 trials · 6 clinical orgs · 3 marketing orgs

Phase 1
8
Phase 2
11
Phase 3
6
Phase 4
1

Earliest trial started Aug 1, 2007 (NCT00616148)

Timeline

2000s

  1. Jan 1, 2007

    Arvelle — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2016

    Arvelle — Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2017

    Arvelle — Earliest Phase 1 Sponsor(trial)

  3. Nov 21, 2019

    Arvelle — Earliest FDA Approval

  4. Nov 21, 2019

    Arvelle — NDA Organization

  5. Nov 21, 2019

    Arvelle — Marketing Organization

2020s

  1. Jun 2, 2025

    ZENARA — Marketing Organization

  2. Apr 28, 2026

    Aurobindo Pharma — Marketing Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedNov 21, 2019

Chemistry & pharmacology

Loading structure…

SMILES

NC(=O)O[C@@H](CN1N=CN=N1)C2=CC=CC=C2Cl
Mol. weight
267.672 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • ykp3089

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06453213Phase 4Oct 14, 2024Arvelle
NCT06352723Early Phase 1 (Phase 1)Apr 30, 2024Harvard University
NCT06590896Phase 2Nov 4, 2022Ono Pharmaceuticals
NCT05572255Phase 1Sep 27, 2022Arvelle
NCT06579573Phase 3Jul 12, 2022Ono Pharmaceuticals
NCT05067634Phase 3Jan 31, 2022Arvelle
NCT04791553Phase 1Jun 17, 2021Arvelle
NCT04903314Phase 1May 27, 2021Arvelle
NCT04557085Phase 3Feb 28, 2021Arvelle
NCT04690751Phase 1Dec 21, 2020Arvelle
NCT03961568Phase 3May 31, 2019Arvelle
NCT03686033Phase 2Nov 2, 2018Eisai
NCT03678753Phase 3Sep 30, 2018Arvelle
NCT03402178Phase 1Dec 21, 2017Eisai
NCT03509285Phase 1Mar 8, 2017Arvelle
NCT03234699Phase 1Feb 22, 2017Arvelle
NCT02535091Phase 3Jul 1, 2016Arvelle
NCT01866111Phase 2Jul 1, 2013Arvelle
NCT01397968Phase 2May 1, 2011Arvelle
NCT00616148Phase 2Aug 1, 2007Arvelle, New York University, The Epilepsy Study Consortium
Showing 20 of 21 trials
Page 1 / 2

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
ArvelleFor profit161652007
EisaiFor profit2222017
Ono PharmaceuticalsFor profit2222022
Harvard UniversityAcademic/Hospital1112024
New York UniversityAcademic/Hospital1012007
The Epilepsy Study ConsortiumAcademic/Hospital1012007
6 organizations
Page 1 / 1

Marketing (5)

OrganizationOrg typeRelationshipDate
ArvelleFor profitNDANov 21, 2019
ArvelleFor profitMKTGNov 21, 2019
ArvelleFor profitSYNNov 21, 2019
Aurobindo PharmaFor profitMKTGApr 28, 2026
ZENARAFor profitMKTGJun 2, 2025