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Eslicarbazepine Acetate (ESLICARBAZEPINE)
Eslicarbazepine Acetate (generic name: ESLICARBAZEPINE) is a Small molecule drug developed by Sumitomo Pharma Am. It is currently FDA-approved (first approved 2023) for partial-onset seizures.
Eslicarbazepine acetate works by stabilizing sodium channels in the brain, reducing the abnormal electrical activity that causes seizures.
At a glance
| Generic name | ESLICARBAZEPINE |
|---|---|
| Sponsor | Sumitomo Pharma Am |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Eslicarbazepine acetate is extensively converted to 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.
Approved indications
- partial-onset seizures
Common side effects
- Dizziness
- Somnolence
- Nausea
- Fatigue
- Vertigo
- Ataxia
- Blurred vision
- Tremor
- Headache
- Diplopia
- Vomiting
- Hyponatremia
Drug interactions
- Carbamazepine
- Phenytoin
- Phenobarbital
- Primidone
- Hormonal Contraceptives
- Clobazam
- Omeprazole
- Simvastatin
- Lovastatin
Key clinical trials
- Anti-epileptogenic Effects of Eslicarbazepine Acetate (PHASE2)
- Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization (PHASE1)
- A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate (PHASE1)
- A Study to Evaluate the Tolerability and Pharmacokinetics of Two Single and Multiple High Dose Regimens of BIA 2-093 In Healthy Volunteers (PHASE1)
- Disposition of Eslicarbazepine Acetate and Its Metabolites S-licarbazepine and R-licarbazepine (PHASE1)
- The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin (PHASE1)
- Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (PHASE1)
- Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Eslicarbazepine Acetate CI brief — competitive landscape report
- Eslicarbazepine Acetate updates RSS · CI watch RSS
- Sumitomo Pharma Am portfolio CI
Frequently asked questions about Eslicarbazepine Acetate
What is Eslicarbazepine Acetate?
How does Eslicarbazepine Acetate work?
What is Eslicarbazepine Acetate used for?
Who makes Eslicarbazepine Acetate?
What is the generic name of Eslicarbazepine Acetate?
When was Eslicarbazepine Acetate approved?
What development phase is Eslicarbazepine Acetate in?
What are the side effects of Eslicarbazepine Acetate?
Related
- Manufacturer: Sumitomo Pharma Am — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for partial-onset seizures
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing