NDAORALSUSPENSION
Approved
May 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
19
Data completeness
4/8 — Partial
TRILEPTAL (oxcarbazepine) by Novartis. Approved for anti-epileptic agent [epc]. First approved in 2001.
Drug data last refreshed 20h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRILEPTAL (oxcarbazepine) is an oral anti-epileptic agent approved by the FDA in May 2001 and manufactured by Novartis. It treats seizure disorders by blocking voltage-sensitive sodium channels and stabilizing hyperexcited neural membranes, with additional effects on potassium conductance and high-voltage activated calcium channels. The drug's active metabolite (MHD) is responsible for its anticonvulsant effects, which work to prevent seizure spread and inhibit repetitive neuronal firing. It occupies a mature position in the anti-epileptic market as a well-established second-line or adjunctive therapy option.
$0.0BPart D
Mechanism of Action
Pharmacologic Class:
Anti-epileptic Agent
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (19)
Oxtellar Extended Release (Oxcarbazepine Extended Release) Patients With Trigeminal Neuralgia
Started Dec 2018
0Trigeminal Neuralgia
A Study in Participants With Epilepsy, to Evaluate the Pharmacokinetics, Safety and Tolerability of Oxcarbazepine on Padsevonil
Started Sep 2018
31 enrolled
Epilepsy
Protective Role of Oxcarbazepine in Multiple Sclerosis
Started Oct 2014
30 enrolled
Multiple Sclerosis
Evaluate Retention Rate of Topiramate, Levetiracetam and Oxcarbazepine in a Long-term Epilepsy Treatment
Started Mar 2014
2,500 enrolled
Epilepsy
Levetiracetam Versus Oxcarbazepine as Monotherapy to Evaluate Efficacy and Safety in Subjects With Newly or Recently Diagnosed Partial Epilepsy
Started Jun 2011
353 enrolled
Epilepsy
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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.