Overview
Stiripentol is an antiepileptic agent that is an aromatic allylic alcohol drug, which makes it structurally unique from other antiepileptic drugs. The clinical development and marketing of stiripentol were first delayed due to the drug's potent inhibitory effects on hepatic cytochrome P450 (CYP) enzymes. However, its clinical efficacy as adjunctive therapy for epilepsies stems from its inhibitory action on CYP enzymes, as stiripentol reduces the degradation of CYP-sensitive antiepileptic drugs, hence boosting their therapeutic efficacy. Stiripentol may also exhibit direct anticonvulsant properties, although the exact mechanism of action is fully understood. Approved in the US, Canada, and Europe, stiripentol is used to treat seizures associated with Dravet syndrome. It is marketed under the brand name Diacomit.
Indication
In the US, stiripentol is indicated for the treatment of seizures associated with Dravet syndrome in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of stiripentol as monotherapy in Dravet syndrome. In Europe and Canada, stiripentol is indicated for use as adjunctive therapy with clobazam and valproate to refractory generalized tonic-clonic seizures in patients with Dravet syndrome in infancy whose seizures are not adequately controlled with clobazam and valproate alone.
Associated Conditions
- Seizures
- Refractory Grand mal Generalized tonic-clonic seizure
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/08/06 | N/A | Completed | University Hospital Marburg | ||
2024/06/18 | Phase 3 | Not yet recruiting | |||
2023/02/21 | Phase 1 | Recruiting | |||
2022/06/15 | Phase 4 | Completed | |||
2019/03/07 | Phase 1 | Completed | |||
2019/01/28 | Phase 2 | Completed | |||
2017/06/22 | N/A | Recruiting | |||
2014/09/12 | N/A | NO_LONGER_AVAILABLE | |||
2013/11/14 | N/A | APPROVED_FOR_MARKETING | |||
2013/04/18 | N/A | NO_LONGER_AVAILABLE |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| BIOCODEX, INC. | 68418-7942 | ORAL | 500 mg in 1 1 | 7/26/2022 | |
| BIOCODEX, INC. | 68418-7941 | ORAL | 250 mg in 1 1 | 7/26/2022 | |
| BIOCODEX, INC. | 68418-7940 | ORAL | 500 mg in 1 1 | 7/26/2022 | |
| BIOCODEX, INC. | 68418-7939 | ORAL | 250 mg in 1 1 | 7/26/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/3/2007 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Stiripentol for Suspension | 国药准字H20233969 | 化学药品 | 口服混悬剂 | 7/25/2023 | |
| Stiripentol for Suspension | 国药准字H20233970 | 化学药品 | 口服混悬剂 | 7/25/2023 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| DIACOMIT stiripentol 500 mg powder for oral suspension sachet | 281461 | Medicine | A | 9/13/2019 | |
| DIACOMIT stiripentol 250 mg powder for oral suspension sachet | 281460 | Medicine | A | 9/13/2019 | |
| DIACOMIT stiripentol 500mg capsule bottle | 281294 | Medicine | A | 9/13/2019 | |
| DIACOMIT stiripentol 250 mg capsule bottle | 280985 | Medicine | A | 9/13/2019 |
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