Is Stiripentol approved by the US FDA?

Drugs@FDA lists 2 application product lines for Stiripentol, including DIACOMIT (Prescription); DIACOMIT (Prescription).

Is Stiripentol authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Stiripentol: Diacomit.

Are there safety signals or safety updates for Stiripentol?

US FDA: 2 entries (latest 2026-04-15).

Active substance

Stiripentol

US FDA 2
EMA 1
Health Canada 3
NHS prices 4
Safety 2

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DIACOMIT	250MG; 500MG	capsule · oral	BIOCODEX SA	Prescription	20 Aug 2018
DIACOMIT	250MG/PACKET; 500MG/PACKET	for suspension · oral	BIOCODEX SA	Prescription	20 Aug 2018

EMA European Union — centrally authorised medicines

Diacomit Biocodex · Authorised · authorised 3 Jan 2007 · ATC N03AX17

Therapeutic indication (EMA)

Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonic epilepsy in infancy (SMEI, Dravet's syndrome) whose seizures are not adequately controlled with clobazam and valproate.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DIACOMIT	02398958	250 MG	CAPSULE · ORAL	BIOCODEX SAS
DIACOMIT	02398966	500 MG	CAPSULE · ORAL	BIOCODEX SAS
DIACOMIT	02398974	250 MG / SACHET	POWDER FOR SUSPENSION · ORAL	BIOCODEX SAS

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Stiripentol 250mg capsules	£284.00	60 capsule	1 Oct 2026
NHS Drug Tariff	Stiripentol 250mg oral powder sachets	£284.00	60 sachet	1 Oct 2026
NHS Drug Tariff	Stiripentol 500mg capsules	£493.00	60 capsule	1 Oct 2026
NHS Drug Tariff	Stiripentol 500mg oral powder sachets	£493.00	60 sachet	1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

US FDA 15 Apr 2026 DIACOMIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 15 Apr 2026 DIACOMIT — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for stiripentol →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.