Treats seizures associated with Dravet syndrome (DS). Sold as Diacomit. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Stiripentol (sold as Diacomit), first approved Aug 20, 2018, with 2 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Diacomit | Part D | $2.7M | +54% | 40 |
| Assessment of Safety of the Use of Fenfluramine in Children With Dravet Syndrome Under 24 Months of AgeDravet Syndrome (DS), Children Under 2 Years · University of Colorado, Denver | Phase 4 | Recruiting | Sep 19, 2024 |
| Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3Primary Hyperoxaluria Type 1, Primary Hyperoxaluria Type 2 · Biocodex | Phase 3 | Recruiting | Jun 18, 2024 |
| A Phase 3 Study to Examine the Efficacy and Safety of ZX008 in Subjects With CDKL5 Deficiency Disorder.CDKL5 Deficiency Disorder, Generalized Tonic Clonic Seizure · Zogenix, Inc. | Phase 3 | Active, not recruiting | Oct 1, 2021 |
| Aug 20, 2018 | DiacomitNDA 206709 · New molecular entity | Biocodex SA | 2 | Marketed |
| Aug 20, 2018 | DiacomitNDA 207223 · New dosage form | Biocodex SA | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
