Stiripentol

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
Stiripentol for the Treatment of Refractory Status Epilepticus	2024/08/06	NCT06540378	N/A	Completed	University Hospital Marburg
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3	2024/06/18	NCT06465472	Phase 3	Not yet recruiting	Biocodex
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function	2023/02/21	NCT05735951	Phase 1	Recruiting	Biocodex
Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies	2022/06/15	NCT05419180	Phase 4	Completed	Biocodex
Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers	2019/03/07	NCT03866928	Phase 1	Completed	Biocodex
Evaluation of the Efficacy of Stiripentol (Diacomit) as Monotherapy for the Treatment of Primary Hyperoxaluria	2019/01/28	NCT03819647	Phase 2	Completed	Biocodex
Population Pharmacokinetics of Antiepileptic in Pediatrics	2017/06/22	NCT03196466	N/A	Recruiting	Assistance Publique - Hôpitaux de Paris
Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies	2014/09/12	NCT02239276	N/A	NO_LONGER_AVAILABLE	Cook Children's Health Care System
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome	2013/11/14	NCT01983722	N/A	APPROVED_FOR_MARKETING	Children's Hospital Medical Center, Cincinnati
Compassionate Use of Stiripentol in Dravet Syndrome	2013/04/18	NCT01835314	N/A	NO_LONGER_AVAILABLE	University of Colorado, Denver

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Diacomit	BIOCODEX, INC.	68418-7942	ORAL	500 mg in 1 1	7/26/2022
Diacomit	BIOCODEX, INC.	68418-7941	ORAL	250 mg in 1 1	7/26/2022
Diacomit	BIOCODEX, INC.	68418-7940	ORAL	500 mg in 1 1	7/26/2022
Diacomit	BIOCODEX, INC.	68418-7939	ORAL	250 mg in 1 1	7/26/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Diacomit	Biocodex,22 rue des Aqueducs,94250 Gentilly,France	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
No NMPA approvals found for this drug.

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	Chiesi Australia Pty Ltd	Medicine	A	9/13/2019
DIACOMIT stiripentol 250 mg powder for oral suspension sachet	281460	Chiesi Australia Pty Ltd	Medicine	A	9/13/2019
DIACOMIT stiripentol 500mg capsule bottle	281294	Chiesi Australia Pty Ltd	Medicine	A	9/13/2019
DIACOMIT stiripentol 250 mg capsule bottle	280985	Chiesi Australia Pty Ltd	Medicine	A	9/13/2019

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
DIACOMIT	Biocodex SAS	02398966	Capsule - Oral	500 MG	5/1/2013
DIACOMIT	Biocodex SAS	02398958	Capsule - Oral	250 MG	5/1/2013
DIACOMIT	Biocodex SAS	02398974	Powder For Suspension - Oral	250 MG / SACHET	5/1/2013
DIACOMIT	Biocodex SAS	02398982	Powder For Suspension - Oral	500 MG / SACHET	5/1/2013

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
ESTIRIPENTOL BILLEV 500 MG CAPSULAS DURAS EFG	Billev Pharma Aps	90248	CÁPSULA DURA	Diagnóstico Hospitalario	Not Commercialized
ESTIRIPENTOL BILLEV 250 MG POLVO PARA SUSPENSION ORAL EN SOBRES EFG	Billev Pharma Aps	90249	POLVO PARA SUSPENSIÓN ORAL	Diagnóstico Hospitalario	Not Commercialized
DIACOMIT 500 mg CAPSULAS DURAS	Biocodex	06367005	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized
DIACOMIT 250 mg POLVO PARA SUSPENSION ORAL	Biocodex	06367008	POLVO PARA SUSPENSIÓN ORAL	Diagnóstico Hospitalario	Commercialized
DIACOMIT 500 mg POLVO PARA SUSPENSION ORAL	Biocodex	06367011	POLVO PARA SUSPENSIÓN ORAL	Diagnóstico Hospitalario	Commercialized
ESTIRIPENTOL BILLEV 500 MG POLVO PARA SUSPENSION ORAL EN SOBRES EFG	Billev Pharma Aps	90250	POLVO PARA SUSPENSIÓN ORAL	Diagnóstico Hospitalario	Not Commercialized
DIACOMIT 250 mg CAPSULAS DURAS	Biocodex	06367002	CÁPSULA DURA	Diagnóstico Hospitalario	Commercialized
DIACOMIT 100 MG CAPSULAS DURAS	Biocodex	1060367013	CÁPSULA DURA	Diagnóstico Hospitalario	Not Commercialized
ESTIRIPENTOL BILLEV 250 MG CAPSULAS DURAS EFG	Billev Pharma Aps	90247	CÁPSULA DURA	Diagnóstico Hospitalario	Not Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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