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STIRIPENTOL
Stiripentol is a marketed drug primarily indicated for the treatment of epilepsy, holding a niche position in the market. Its key strength lies in its unique mechanism of action, which differentiates it from other antiepileptic drugs. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | STIRIPENTOL |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 2007 |
Approved indications
Common side effects
Key clinical trials
- Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
- A Study to Investigate the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder (PHASE3)
- Population Pharmacokinetics of Antiepileptic in Pediatrics
- Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ) (PHASE1)
- Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function (PHASE1)
- Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of Age (PHASE4)
- Stiripentol for the Treatment of Refractory Status Epilepticus
- Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- STIRIPENTOL CI brief — competitive landscape report
- STIRIPENTOL updates RSS · CI watch RSS