NDAORALTABLET
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
7/8 — Comprehensive
APTIOM (eslicarbazepine acetate) by Sumitomo Dainippon Pharma is eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. Approved for partial epilepsy, epilepsy. First approved in 2013.
Drug data last refreshed 19h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APTIOM (eslicarbazepine acetate) is an oral anticonvulsant tablet approved by the FDA in November 2013 for partial-onset seizures in patients aged 4 years and older. The drug works by inhibiting voltage-gated sodium channels, though its precise mechanism of anticonvulsant activity remains incompletely understood. APTIOM is positioned as a maintenance therapy option within the competitive antiepileptic drug class, offering an alternative to established agents for patients requiring seizure control.
$0.1BPart D
6.3 years to LOEMechanism of Action
eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. The precise mechanism(s) by which eslicarbazepine exerts anticonvulsant activity is unknown but is thought to involve inhibition of voltage-gated sodium channels.
Indications (2)
Clinical Trials (20)
Anti-epileptogenic Effects of Eslicarbazepine Acetate
Started May 2019
129 enrolled
Post Stroke Epilepsy
Bioequivalence of Two Different Sources of Eslicarbazepine Acetate
Started Dec 2016
24 enrolled
Epilepsy
Eslicarbazepine Acetate (BIA 2-093) as Monotherapy in Patients With Newly Diagnosed Partial-onset Seizures
Started Mar 2016
206 enrolled
Epilepsy
Impact of Eslicarbazepine Acetate on Lipid Metabolism and Cardiovascular Risk Factors
Started Jun 2015
204 enrolled
Epilepsy
A Post-marketing Study Evaluating Eslicarbazepine Acetate (ESL) as Adjunctive Treatment in Partial-Onset Seizures (Study E2093-E044-404) (EPOS)
Started Apr 2012
254 enrolled
Partial Onset Seizures
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.