Eslicarbazepine acetate
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed epilepsy, early-onset 1 milestone | |||||
| Filed | EU (EMA) | — | epilepsy, early-onset | — | “ZEBINIX® was submitted to the European Medicines Agency (EMEA) by Bial in March 2008” eisai.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (3) | US (FDA) | APTIOM | — | 2015-08-27 – 2019-03-15 | fda.gov ↗ |
| Approved | US (FDA) | APTIOM | — | 2013-11-08 | fda.gov ↗ |
| Approved | EU (EMA) | Zebinix | — | 2009-04-21 | europa.eu ↗ |
Trials 53
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 129 trials | ||||||
| Phase 1 | NCT04095182 | Aug → Dec 2019 | simple partial epilepsy | Whanin Pharmaceutical Company | Completed | No outcome recorded |
| Phase 1 | NCT02284880 | Oct → Nov 2010 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02284854 | Jul → Nov 2009 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00987558 | Jun → Aug 2009 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00898560 | Sep → Nov 2008 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00971295 | Oct → Dec 2007 | neuropathy, painful | Bial - Portela C S.A. | Completed | Mixed |
| Phase 1 | NCT02777671 | Oct → Dec 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02284828 | Sep → Nov 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02288312 | May → Jul 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02283840 | May → Jun 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02283788 | Mar → Jun 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02283827 | Jan → Mar 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02283814 | Jan → Feb 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01879332 | Dec 2006 → Feb 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02283801 | Nov 2006 → Jan 2007 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02281526 | May 2005 → Feb 2006 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02281448 | Mar → May 2005 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02281422 | Mar 2005 → Jun 2006 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01879345 | Oct → Dec 2004 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02279667 | Feb → Mar 2004 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01679002 | Oct → Dec 2003 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01878578 | Nov 2002 → Mar 2003 | epilepsy | Bial - Portela C S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT02172755 | Jun → Aug 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02287415 | May → Jul 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02172742 | May → Jul 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01678976 | Mar → Apr 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02170649 | Sep → Nov 2001 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02171234 | Feb → Jun 2001 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02171195 | Jul → Oct 2000 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 29 trials · 1 missed | ||||||
| Phase 2 | NCT06597084 | May 2019 → Sep 2023 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01527513 | Aug 2010 → Mar 2012 | focal epilepsy | Bial - Portela C S.A. | Completed | Missed primary |
| Phase 2 | NCT00980746 | Nov 2007 → Nov 2008 | diabetic polyneuropathy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT00981227 | Nov 2007 → Jan 2009 | postherpetic neuralgia | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01825837 | Mar 2006 → Jun 2007 | bipolar I disorder | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01824602 | Feb → Nov 2006 | bipolar I disorder | Bial - Portela C S.A. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT01822678 | Dec 2005 → Nov 2006 | bipolar I disorder | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT02170064 | Jun 2005 → Apr 2006 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT02170077 | Apr → Nov 2002 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 312 trials · 2 missed | ||||||
| Phase 3 | NCT03108729 | Jul → Oct 2017 | epilepsy | Sumitomo Pharma America, Inc. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02484001 | Mar 2016 → Sep 2018 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01162460 | Dec 2010 → Sep 2016 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT01129960 | Nov 2010 → Apr 2012 | diabetic polyneuropathy | Bial - Portela C S.A. | Terminated | Missed primary |
| Phase 3 | NCT01124097 | Sep 2010 → Apr 2012 | postherpetic neuralgia | Bial - Portela C S.A. | Terminated | Missed primary |
| Phase 3 | NCT01091662 | Jun 2010 → Nov 2012 | epilepsy | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01422720 | Apr 2010 → Sep 2013 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00910247 | Aug 2009 → Apr 2017 | epilepsy | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00866775 | Apr 2009 → May 2013 | focal epilepsy | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00957372 | Dec 2004 → Jun 2008 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00957047 | Jul 2004 → Aug 2006 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00957684 | Jul 2004 → Nov 2005 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 42 trials · 1 met primary | ||||||
| Phase 4 | NCT03116828 | Jul 2017 → Jun 2019 | focal epilepsy | Sumitomo Pharma America, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT02912364 | Jul 2016 → Apr 2018 | epilepsy | Stanford University | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT02556320 | May 2013 → Aug 2015 | drug allergy, epilepsy | University Hospital, Rouen | Completed | No outcome recorded |
| Comparator or background therapy7 trials | ||||||
| Phase 1 | NCT00900237 Comparator | Nov → Dec 2008 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT02281591 Comparator | Jun → Jul 2006 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT02021461 Background | Dec 2012 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01820585 Comparator | Apr 2009 → Sep 2010 | fibromyalgia | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00988429 Comparator | Dec 2008 → Jan 2012 | focal epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 3 | NCT00988156 Comparator | Dec 2007 → Aug 2012 | epilepsy | Bial - Portela C S.A. | Completed | No outcome recorded |
| — | NCT03636958 Background | Feb 2021 → Jul 2025 | epilepsy | Assistance Publique Hopitaux De Marseille | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2013-09-12 | Eisai Inc. | Regulatory EISAI ANNOUNCES LAUNCH OF ANTICANCER AGENT HALAVEN® AS COMPANY'S FIRST PRODUCT IN RUSSIA eisai.com ↗
Eisai established Limited Liability Company Eisai (“Eisai Russia”) as a pharmaceutical sales company in Moscow in April 2013 and has also received local marketing approval for the antiepileptic agents Zonegran® (zonasamide) and Exalief® (eslicarbazepine acetate; brand name in the EU: Zebinix®). |
| 2010-01-28 | Sumitomo Pharma America, Inc. | Regulatory FDA extends PDUFA action date for STEDESA new drug application sumitomo-pharma.com ↗ |
| 2009-04-28 | Eisai Inc. | Regulatory Novel Anti-epileptic ZEBINIX® Approved in the European Union New Option for Treatment of Patients with Partial-Onset Seizures eisai.com ↗
Zebinix® (eslicarbazepine acetate), for which Eisai Europe obtained rights from Bial to market in Europe, was approved by the European Commission on April 21 st , as an adjunctive therapy in adult patients with partial-onset seizures, with or without secondary generalisation. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2013-09-12 | Eisai Inc. | EISAI ANNOUNCES LAUNCH OF ANTICANCER AGENT HALAVEN® AS COMPANY'S FIRST PRODUCT IN RUSSIA eisai.com ↗ |
| 2010-01-28 | Sumitomo Pharma America, Inc. | FDA extends PDUFA action date for STEDESA new drug application sumitomo-pharma.com ↗ |
| 2009-04-28 | Eisai Inc. | Novel Anti-epileptic ZEBINIX® Approved in the European Union New Option for Treatment of Patients with Partial-Onset Seizures eisai.com ↗ |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 62 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Eslicarbazepine acetate | “This study aims to assess if eslicarbazepine acetate (ESL) treatment (started within 96 hours after stroke occurrence and continued for 30 days) changes the incidence of...” NCT06597084 ↗32“On the Study Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were...” NCT02021461 ↗ “Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)” NCT02556320 ↗ “multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.” NCT02777671 ↗ “All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1.” NCT02484001 ↗ “Clinical Trial for Zebinix (Eslicarbazepine Acetate) in Healthy Korean and Caucasian Adult” NCT04095182 ↗ “One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)” NCT02283840 ↗ “Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093);” NCT02281591 ↗ “Eslicarbazepine acetate (BIA 2-093)” NCT01820585 ↗ |
| Known as | BIA 2-093 | “Efficacy and Safety of Eslicarbazepine Acetate (BIA 2 093) as Therapy for Patients With Painful Diabetic Neuropathy: a Double-blind, Double-dummy, Randomised,...” NCT00980746 ↗31“Efficacy and Safety of Eslicarbazepine Acetate (BIA 2-093) as Adjunctive Therapy for Refractory Partial Seizures in a Double-blind, Randomised, Placebo-controlled,...” NCT00957684 ↗ “One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)” NCT02283840 ↗ “Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093);” NCT02281591 ↗ “Eslicarbazepine acetate (ESL), BIA 2-093” NCT00957047 ↗ “BIA 2-093 (Eslicarbazepine acetate)” NCT02170064 ↗ “Eslicarbazepine acetate (BIA 2-093)” NCT01527513 ↗ “Eslicarbazepine acetate (BIA 2-093)” NCT00988156 ↗ |
| Known as | ESL | “This study aims to assess if eslicarbazepine acetate (ESL) treatment (started within 96 hours after stroke occurrence and continued for 30 days) changes the incidence of...” NCT06597084 ↗8“On the Study Day, all children will be given 3 different flavoured samples of Eslicarbazepine acetate (ESL) oral suspension for tasting, in the sequence to which they were...” NCT02021461 ↗ “OBJECTIVE: To investigate the safety and tolerability of eslicarbazepine acetate (ESL), a once-daily oral anti-seizure drug (ASD), in older and younger adult patient populations.” PMID 33338829 ↗ Oct 2020 “Eslicarbazepine acetate (ESL) is a new voltage-gated sodium channel blocker currently in development for the treatment of neuropathic pain, including that of diabetic origin.” PMID 19356391 ↗ Apr 2009 “Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD.” NCT01820585 ↗ “multiple-dose administration of eslicarbazepine acetate (ESL, BIA 2-093) affects the pharmacokinetics of gliclazide.” NCT02777671 ↗ “All subjects will receive Eslicarbazepine acetate (ESL) under open-label conditions at Visit 1.” NCT02484001 ↗ “400mg/day Eslicarbazepine acetate (ESL) or 200mg/day Carbamazepine” NCT01162460 ↗ “Group 1 = 900 mg of eslicarbazepine acetate (ESL, BIA 2-093);” NCT02281591 ↗ |
| Known as | ESL, Eslicarbazepine acetate | “ESL, Eslicarbazepine acetate” NCT02172742 ↗1“ESL, Eslicarbazepine acetate” NCT02287415 ↗ |
| Known as | Eslicarbazepine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02912364 ↗ |
| Known as | Eslicarbazepine acetate (BIA 2-093) | “Eslicarbazepine acetate (BIA 2-093)” NCT01820585 ↗1“Eslicarbazepine acetate, BIA 2-093” NCT06597084 ↗ |
| Known as | Eslicarbazepine acetate (ESL) | “Eslicarbazepine acetate (ESL)” NCT02021461 ↗ |
| Known as | S-licarbazepine | “Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin,...” NCT03636958 ↗ |
| Known as | Zebinix | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04095182 ↗ |
| Action | Inhibit | “voltage-gated sodium channel blocker” PMID 19356391 ↗ Apr 2009 |
| Route | Oral | “eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.” NCT00898560 ↗ |