TheraRadar
Data updated: May 26, 2026

DIACOMIT (stiripentol)

Orphan Drug Priority Review
CNS Approved 2018-08-20

DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) 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 DIACOMIT as monotherapy in Dravet syndrome. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.

Source: FDA Label • BIOCODEX SA
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
1
Priority Reviews
7
Years on Market

Details

Status
Prescription
First Approved
2018-08-20
Patent Cliff
2029

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Routes
ORAL
Dosage Forms
CAPSULE, FOR SUSPENSION

Companies

BIOCODEX SA
Active Ingredient: STIRIPENTOL

DIACOMIT Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2018 to 2026 · 1 indication expansions
Apr 2026 SUPPL
Label · Labeling
FDA Letter Label
Jul 2022 SUPPL
Efficacy
FDA Letter Label
Aug 2018 ORIGINAL Priority
New Drug · Type 1 - New Molecular Entity
FDA Letter Label

What DIACOMIT Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT05419180 CARBASTIR (STP225) Ph 4 completed Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
NCT03866928 STP199 Ph 1 completed Pharmacokinetic Study of Stiripentol and Its Metabolites After Multiple Dose Oral Administration in Healthy Male Volunteers
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DIACOMIT FDA Label Details

Indications & Usage

FDA Label (PDF)

DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) 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 DIACOMIT as monotherapy in Dravet syndrome. DIACOMIT 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 DIACOMIT as monotherapy in Dravet syndrome.

DIACOMIT Patents & Exclusivity

Exclusivity: Jul 2029

Exclusivity

ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
ODE-403 Until Jul 2029
Source: FDA Orange Book

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Data Sources

FDA Approval: NDA206709 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.