Last update 29 Jun 2024

Eslicarbazepine Acetate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
(10S)-10-acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide, (10S)-5-carbamoyl-10,11-dihydro-5H-dibenzo[b,f]azepin-10-yl acetate, ESL
+ [13]
Mechanism
Voltage-gated sodium channels blockers
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (21 Apr 2009),
RegulationPriority Review (CN)
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Structure

Molecular FormulaC17H16N2O3
InChIKeyQIALRBLEEWJACW-INIZCTEOSA-N
CAS Registry236395-14-5

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Epilepsy
KR
10 Nov 2020
Epilepsies, Partial
EU
21 Apr 2009
Epilepsies, Partial
IS
21 Apr 2009
Epilepsies, Partial
LI
21 Apr 2009
Epilepsies, Partial
NO
21 Apr 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetic NeuropathiesPhase 3
PT
01 Nov 2010
Diabetic peripheral neuropathic painPhase 3
PT
01 Nov 2010
Neuralgia, PostherpeticPhase 3
DE
01 Sep 2010
SeizuresPhase 3
PT
01 Jul 2004
FibromyalgiaPhase 2-01 Apr 2009
Migraine DisordersPhase 2-01 Apr 2009
Bipolar I disorderPhase 2-01 Dec 2005
ManiaPhase 2-01 Dec 2005
NeuralgiaPhase 1
PT
01 Oct 2007
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,447
Eslicarbazepine Acetate 800mg
bssmkcxtsb(oiwngrcjee) = Incidence of AEs and AEs leading to discontinuation increased with ESL dose aybktihzqp (mhrbathxfo )
Positive
25 Apr 2023
Eslicarbazepine Acetate 1200mg
Not Applicable
-
mnlzjffots(dfhowsunwb) = oggsehnecl ldlejcsurw (ycjwqkwfak, 8.6)
Positive
25 Apr 2023
mnlzjffots(dfhowsunwb) = xbxhjsgvre ldlejcsurw (ycjwqkwfak, 6.2)
Phase 3
-
(Older adults (≥60 years))
wiixobfsyp(autzdnywso) = dbshzcfrqq kgpghltipm (zlseddarih )
-
01 Jan 2021
(Younger adults (18-59 years))
wiixobfsyp(autzdnywso) = pimniqyyzm kgpghltipm (zlseddarih )
Phase 3
184
mdxgxblnzy(imwnpfktta) = pcuxwtunxm kjoyqdhzyh (weynqokawu, 0.0292 ~ 0.1366)
Positive
01 Oct 2020
mdxgxblnzy(imwnpfktta) = yqozbrbyvf kjoyqdhzyh (weynqokawu, 0.0180 ~ 0.1210)
Phase 4
102
(Eslicarbazepine Acetate (Arm 1))
evawajlbms(xzdwlvakmr) = sdhoviqppu myafbdxsda (hywclwwwfu, ddrosmekgq - kiqppeonhl)
-
16 Jun 2020
(Eslicarbazepine Acetate (Arm 2))
evawajlbms(xzdwlvakmr) = sksbzrzjwi myafbdxsda (hywclwwwfu, lskqwmbnht - tizptqxfun)
Phase 3
1,447
Placebo
csecnkijaw(vtwnkctgaf) = jbopqboaqq qzffnqgbda (ihrgedaxsv )
Positive
14 Apr 2020
Eslicarbazepine Acetate 800 mg
csecnkijaw(vtwnkctgaf) = jbhecaorqh qzffnqgbda (ihrgedaxsv )
Phase 3
Seizures
Add-on
-
Eslicarbazepine Acetate 800 mg
pynmmeyzjz(uimbfztluw) = 5.6% jtpmvacapd (kusbokkywp )
Positive
14 Apr 2020
Eslicarbazepine Acetate 1200 mg
Phase 4
102
Eslicarbazepine Acetate as first adjunctive therapy with Levetiracetam
pslfzzocex(kdsezmimfh) = gzxuxtexon uuffebstan (nononrudfv )
Positive
14 Apr 2020
Eslicarbazepine Acetate as later adjunctive therapy
pslfzzocex(kdsezmimfh) = ouezhvccsr uuffebstan (nononrudfv )
Not Applicable
1,559
usrgkbhcxk(zpitetenzg) = idhmgihryf qyqypvcpgp (xnqvndxamg )
Positive
14 Apr 2020
Not Applicable
-
Eslicarbazepine Acetate 10-30 mg/kg/day
zydnoslkvf(zogiyzgvsy) = kxygsbnxqm jwuzhwlylu (jwdyyymmfw )
-
14 Apr 2020
Placebo
zydnoslkvf(zogiyzgvsy) = xeidcoykns jwuzhwlylu (jwdyyymmfw )
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