Drugs / Stiripentol
Stiripentol
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | DIACOMIT | — | 2022-07-14 | fda.gov ↗ |
| Approved | US (FDA) | DIACOMIT | — | 2018-08-20 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Diacomit | — | 2009-02-11 | europa.eu ↗ |
| Approved | EU (EMA) | Diacomit | — | 2007-01-03 | europa.eu ↗ |
Trials 10
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07176832 | Jun → Aug 2025 | Dravet syndrome, childhood-onset epilepsy syndrome | Biocodex | Completed | No outcome recorded |
| Phase 1 | NCT05735951 | Jul 2023 → Nov 2024 | chronic renal failure syndrome | Biocodex | Completed | No outcome recorded |
| Phase 1 | NCT03866928 | Feb → Apr 2019 | — | Biocodex | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT03819647 | May 2019 → Dec 2020 | primary hyperoxaluria | Biocodex | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06465472 | Aug 2024 → Aug 2030 expected | primary hyperoxaluria type 1, primary hyperoxaluria type 2, primary hyperoxaluria type 3 | Biocodex | Not yet recruiting | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05419180 | Oct 2022 → Jun 2024 | epilepsy | Biocodex | Completed | No outcome recorded |
| Phase not stated4 trials | ||||||
| — | NCT01533506 | Feb 2012 → Feb 2013 | Dravet syndrome | Mayo Clinic | No longer available | No outcome recorded |
| — | NCT01983722 | — | Dravet syndrome | Children's Hospital Medical Center, Cincinnati | Approved for marketing | No outcome recorded |
| — | NCT01835314 | — | Dravet syndrome | University of Colorado, Denver | No longer available | No outcome recorded |
| — | NCT02239276 | — | Dravet syndrome | Cook Children's Health Care System | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 4 | NCT02205931 Comparator | Jan 2015 → Jun 2018 | epilepsy | University College, London | Unknown | No outcome recorded |
Press releases naming this drug 1 release
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 12 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Stiripentol | “Stiripentol” NCT02205931 ↗ |
| Known as | BCX 2600 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1983350 ↗ |
| Known as | Diacomit | “Study of the Interest of the Combination of Stiripentol (Diacomit®) and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies” NCT05419180 ↗2“Stiripentol (Diacomit®) is currently marketed in two dosage forms: capsules (250 and 500 mg) and powder for oral suspension in sachets (250 and 500 mg).” NCT07176832 ↗ “stiripentol (Diacomit)” NCT03819647 ↗ |
| Known as | Estiripentol | ChEMBL registry synonym — accepted as the source's own label CHEMBL1983350 ↗ |
| Modality | Small molecule | — CHEMBL1983350 ↗ |
| Route | Oral | “by mouth” NCT01835314 ↗ |