eslicarbazepine acetate

Trade name: aptiom

Small moleculeapproved

Approved

Nov 8, 2013

Eslicarbazepine acetate is a third generation antiepileptic drug indicated for the treatment of partial-onset seizures. Structurally, it belongs to the dibenzazepine family and is closely related to carbamazepine and oxcarbazepine. Eslicarbazepine acetate was developed by scientists in Portugal. Its main mechanism of action is by blocking the voltage-gated sodium channel. Eslicarbazepine acetate is a pro-drug that is rapidly metabolized almost exclusively into eslicarbazepine (S-licarbazepine), the biologically active drug. It has a favorable pharmacokinetic and drug-drug interaction profile. However, it may induce the metabolism of oral contraceptives and should be used with caution in females of child-bearing age. — NCATS

Clinical trial activity

61 trials · 13 clinical orgs · 12 marketing orgs

Phase 1

Phase 2

Phase 3

Phase 4

Earliest trial started Jul 1, 2000 (NCT02171195)

Timeline

2000s

Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
Jan 1, 2002
Earliest Phase 2 Sponsor(trial)
Jan 1, 2004
Earliest Phase 3 Sponsor(trial)

2010s

Nov 8, 2013
Sunovion — Earliest FDA Approval
Nov 8, 2013
Sunovion — NDA Secondary Org
Nov 8, 2013
Sunovion — NDA Organization
Nov 8, 2013
Sumitomo — Marketing Organization
Nov 8, 2013
Sumitomo Dainippon — NDA Secondary Org
Jan 28, 2019
Alkem Labs Ltd — Marketing Organization

2020s

Jun 29, 2021
Dr. Reddy's Laboratories — Marketing Organization
Oct 21, 2022
Aurobindo Pharma — Marketing Organization
Aug 3, 2023
Hetero Labs Ltd — Marketing Organization
Dec 7, 2023
Apotex — Marketing Organization
Feb 27, 2024
Torrent Pharmaceuticals Limited — Marketing Organization
Mar 27, 2024
Lupin — Marketing Organization
Aug 4, 2025
Jubilant Innovation Ltd. — Marketing Organization
Nov 3, 2025
Shanghai Pharmaceuticals Holding Co., Ltd — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker

Approval history

approvedNov 8, 2013

Chemistry & pharmacology

Loading structure…

SMILES

NC(=O)N1C2=CC=CC=C2C[C@H](O)C3=CC=CC=C13

Mol. weight: 254.2839 g/mol
Lipinski Ro5: Pass
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Availability: Prescription Only

Oral

Parenteral

Topical

Sources

Also known as

10-acetoxy-10,11-dihydro-5h-dibenz(b,f)azepine-5-carboxamide
(10s)-10-acetoxy-10,11-dihydro-5h-dibenz[b,f]azepine-5-carboxamide
(10s)-10-acetoxy-10,11-dihydro-5h-dibenz[b,f]azepine-5-carboxamide
(10s)-10-hydroxy-10,11-dihydro-5h-dibenzo(b,f)azepin-5-carboxamide
(10s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl acetate
(10s)-5-carbamoyl-10,11-dihydro-5h-dibenzo[b,f]azepin-10-yl acetate
aptiom
aptiom
bia 2-093
bia 2-093
bia-2-093
bia-2-093
bia-2-093
bia-2-194
bia-2-194
erelib
esl
esl
eslicarbazepine
eslicarbazepine
eslicarbazepine
eslicarbazepine
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
eslicarbazepine acetate
exelief
pazzul
sep-0002093
sep-0002093
sep-0002093
stedesa
stedesa
stedesa
zebinix
zebinix
zebinix
zebinix

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT04095182	Phase 1	Aug 22, 2019	Seoul National University, Whanin Pharmaceutical Company
NCT06597084	Phase 2	May 29, 2019	Bial, University of London
NCT03116828	Phase 4	Jun 30, 2017	Sunovion
NCT03108729	Phase 3	Jun 30, 2017	Sunovion
NCT03116321	Phase 1	Dec 3, 2016	Bial
NCT02912364	Phase 4	Jul 1, 2016	Stanford University, Sunovion
NCT02484001	Phase 3	Mar 1, 2016	Bial
NCT02556320	N/A	May 1, 2013	Rouen Normandy University
NCT02021461	Phase 2	Dec 1, 2012	Bial
NCT01162460	Phase 3	Dec 1, 2010	Bial
NCT01129960	Phase 3	Nov 1, 2010	Bial
NCT02284880	Phase 1	Oct 1, 2010	Bial
NCT01124097	Phase 3	Sep 1, 2010	Bial
NCT01527513	Phase 2	Aug 1, 2010	Bial
NCT01091662	Phase 3	Jun 1, 2010	Sunovion
NCT01422720	Phase 4	Apr 1, 2010	Bial
NCT00910247	Phase 3	Aug 1, 2009	Sunovion
NCT02284854	Phase 1	Jul 1, 2009	Bial
NCT00987558	Phase 1	Jun 1, 2009	Bial, Biotrial
NCT01820585	Phase 2	Apr 1, 2009	Bial

Showing 20 of 61 trials

Page 1 / 4

Organizations

Research & Development (13)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Bial	For profit	53	53	4	2000
Sunovion	For profit	7	5	2	2008
Biotrial	For profit	1	0	1	2009
Friedrich Wilhelms University	Academic/Hospital	1	0	1	2004
Hospital Ruber Internacional	Academic/Hospital	1	0	1	2004
Hospital Santo António Largo, Porto, Portugal	Academic/Hospital	1	0	1	2004
National Institute of Psychiatry and Neurology, Budapest, Hungary	Academic/Hospital	1	0	1	2004
Rouen Normandy University	Academic/Hospital	1	1	1	2013
Seoul National University	Academic/Hospital	1	0	1	2019
SGS Life Sciences	For profit	1	0	1	2008
Stanford University	Academic/Hospital	1	1	1	2016
University of London	Academic/Hospital	1	0	1	2019
Whanin Pharmaceutical Company	For profit	1	1	1	2019

13 organizations

Page 1 / 1

Marketing (15)

Organization	Org type	Relationship	Date
Alkem Labs Ltd	For profit	MKTG	Jan 28, 2019
Apotex	For profit	MKTG	Dec 7, 2023
Aurobindo Pharma	For profit	MKTG	Oct 21, 2022
Dr. Reddy's Laboratories	For profit	SYN	Jun 29, 2021
Dr. Reddy's Laboratories	For profit	MKTG	Jun 29, 2021
Hetero Labs Ltd	For profit	MKTG	Aug 3, 2023
Jubilant Innovation Ltd.	For profit	MKTG	Aug 4, 2025
Lupin	For profit	MKTG	Mar 27, 2024
Lupin	For profit	SYN	Mar 27, 2024
Shanghai Pharmaceuticals Holding Co., Ltd	For profit	MKTG	Nov 3, 2025
Sumitomo	For profit	MKTG	Nov 8, 2013
Sumitomo Dainippon	For profit	NDA2	Nov 8, 2013
Sunovion	For profit	NDA2	Nov 8, 2013
Sunovion	For profit	NDA	Nov 8, 2013
Torrent Pharmaceuticals Limited	For profit	MKTG	Feb 27, 2024