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Drug

Stiripentol

Approved · EMA
Late-stage development
Also known as Diacomit, Estiripentol, 1-(1,3-Benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol, 4,4-Dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol+1 more

Diacomit, Estiripentol, 1-(1,3-Benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol, 4,4-Dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol, Stiripentolum.

1
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Approval: Diacomit (EMA)

Regulatory2007-01-03EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Stiripentol
Aliases & brands
DiacomitEstiripentol1-(1,3-Benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol4,4-Dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-olStiripentolum
RxNorm CUI
2054968
ChEMBL ID
CHEMBL1983350
UNII
R02XOT8V8I
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-01-03
Latest approval
2007-01-03
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-01-03Approval
Approval: Diacomit (EMA)
Indication: Diacomit is indicated for use in conjunction with clobazam and valproate as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with severe myoclonicShow full indication

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.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

5 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
5
registered trials across all phases
LATEST COMPLETION 2025
1
Active studies
1
Recruiting
2
Late-stage (III+)
4
Completed
PHASE DISTRIBUTIONn = 5
Phase 12Phase 21Phase 31Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.