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Aptiom (ESLICARBAZEPINE ACETATE)
Aptiom (generic name: ESLICARBAZEPINE ACETATE) is a eslicarbazepine acetate Small molecule drug developed by Sumitomo Pharma Am. It is currently FDA-approved (first approved 2013) for Partial seizure.
Aptiom works by blocking sodium channels in the brain to reduce the frequency of seizures.
Aptiom (eslicarbazepine acetate) is a small molecule drug developed by Sunovion Pharm Inc and currently owned by Sumitomo Pharma Am. It targets the sodium channel alpha subunit to treat partial seizures. Aptiom is a non-epileptic drug class, FDA-approved in 2013, and has multiple generic manufacturers. The commercial status of Aptiom is not explicitly stated, but it is likely to be off-patent given the number of generic manufacturers. Key safety considerations include the need for further research on its long-term effects.
At a glance
| Generic name | ESLICARBAZEPINE ACETATE |
|---|---|
| Sponsor | Sumitomo Pharma Am |
| Drug class | eslicarbazepine acetate |
| Target | Sodium channel alpha subunit |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | FDA-approved |
| First approval | 2013 |
Mechanism of action
APTIOM 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 seizure
Common side effects
- Dizziness
- Somnolence
- Nausea
- Headache
- Diplopia
- Vomiting
- Fatigue
- Vertigo
- Ataxia
- Blurred vision
- Tremor
- Hyponatremia
Key clinical trials
- Anti-epileptogenic Effects of Eslicarbazepine Acetate (PHASE2)
- A Open-label, Drug Interaction Study Between Eslicarbazepine Acetate and Topiramate (PHASE1)
- Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization (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)
- Steady-state Pharmacokinetics of BIA 2-093 and Oxcarbazepine in Healthy Volunteers (PHASE1)
- The Effect of BIA 2-093 on the Steady-state Pharmacokinetics of Digoxin (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:
- Aptiom CI brief — competitive landscape report
- Aptiom updates RSS · CI watch RSS
- Sumitomo Pharma Am portfolio CI
Frequently asked questions about Aptiom
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Related
- Drug class: All eslicarbazepine acetate drugs
- Target: All drugs targeting Sodium channel alpha subunit
- Manufacturer: Sumitomo Pharma Am — full pipeline
- Therapeutic area: All drugs in Neuroscience
- Indication: Drugs for Partial seizure
- Compare: Aptiom vs similar drugs
- Pricing: Aptiom cost, discount & access