NDAORALCAPSULEPriority Review
Approved
Aug 2018
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
10
Data completeness
5/8 — Partial
Priority Review
DIACOMIT (stiripentol) by Biocodex is unknown. Approved for dravet syndrome. First approved in 2018.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DIACOMIT (stiripentol) is an oral antiepileptic agent approved in 2018 for Dravet syndrome and pharmacoresistant focal epilepsies. The mechanism of action remains partially unclear but likely involves direct GABA-A receptor effects and indirect inhibition of cytochrome P450 activity, increasing blood levels of clobazam and its active metabolite.
$0.001BPart D
Peak3.2 years to LOEDIACOMIT is at peak commercial phase with modest Part D utilization (229 claims, $1M spend in 2023), indicating a niche orphan/rare epilepsy franchise with stable but limited commercial scale.
Mechanism of Action
unknown. Possible mechanisms of action include direct effects mediated through the gamma-aminobutyric acid (GABA) A receptor and indirect effects involving inhibition of cytochrome P450 activity with resulting increase in blood levels of clobazam and its active metabolite.
Indications (1)
Clinical Trials (10)
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
Started Jun 2025
24 enrolled
Dravet SyndromeEpilepsyChildhood+2 more
Evaluation of the Efficacy and Safety of Stiripentol in Patients 6 Years and Older With Primary Hyperoxaluria Type 1, 2 or 3
Started Aug 2024
42 enrolled
Primary Hyperoxaluria Type 1Primary Hyperoxaluria Type 2Primary Hyperoxaluria Type 3
Pharmacokinetic Parameters of Stiripentol in Renal Impaired Patients and Matching Controls With Normal Renal Function
Started Jul 2023
39 enrolled
Chronic Renal Insufficiency
Study of Interest of Stiripentol and Carbamazepine in the Treatment of Patients With Pharmacoresistant Focal Epilepsies
Started Oct 2022
52 enrolled
Pharmacoresistant Focal Epilepsies
Retrospective Non-interventional Study of Stiripentol Use in Dravet Patients in the USA
Started Apr 2022
100 enrolled
Dravet Syndrome
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.