NDAORALTABLET
Approved
Nov 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
APTIOM (eslicarbazepine acetate) by Sumitomo Dainippon Pharma is eslicarbazepine, which is considered to be responsible for therapeutic effects in humans. First approved in 2013.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
APTIOM (eslicarbazepine acetate) is an oral anticonvulsant approved in 2013 for adjunctive treatment of partial-onset seizures. The active metabolite eslicarbazepine is thought to work by inhibiting voltage-gated sodium channels, though the precise mechanism remains incompletely understood. It is administered as a tablet for patients with inadequately controlled epilepsy.
$0.142BPart D
Peak6.2 years to LOEThe product is at peak commercial performance with $142M in 2023 Part D spending, indicating a stable, mature franchise that supports a standard-sized commercial team.
Mechanism 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
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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.