stiripentol

Trade name: diacomit

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 20, 2018

Stiripentol is an anticonvulsant drug used in the treatment of epilepsy. It recently proved to increase the GABAergic transmission in vitro in an experimental model of immature rat. Clinical studies were based on the fact that STP also acts as an inhibitor of CYP3A4, CYP1A2, and CYP2C19 in vivo in epileptic patients. Side effects are largely due to the increase in plasma concentrations of other anticonvulsants and can be reduced by lowering the dose of those drugs. Nausea and vomiting are particularly noted when used in combination with sodium valproate. It appears to increase the potency of phenobarbital, primidone, phenytoin, carbamazepine, clobazam and diazepam. — NCATS

Clinical trial activity

10 trials · 10 clinical orgs · 1 marketing orgs

Phase 1
3
Phase 2
2
Phase 3
1
Phase 4
1

Earliest trial started Feb 1, 2012 (NCT01533506)

Timeline

2000s

  1. Oct 30, 2008

    Orphan Drug Designation

2010s

  1. Aug 20, 2018

    Biocodex — Earliest FDA Approval

  2. Aug 20, 2018

    Biocodex — NDA Secondary Org

  3. Aug 20, 2018

    Biocodex — NDA Organization

  4. Jan 1, 2019

    Biocodex — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 2019

    Biocodex — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 1, 2024

    Biocodex — Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedPriority reviewAug 20, 2018

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)C(O)C=CC1=CC=C2OCOC2=C1
Mol. weight
234.2909 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-(1,3-benzodioxol-5-yl)-4,4- dimethyl-1-penten-3-ol
  • 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol
  • 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
  • 4,4-dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol
  • bcx 2600
  • bcx 2600
  • bcx-2600
  • bcx-2600
  • brn 1313047
  • brn 1313047
  • d-306
  • diacomit
  • diacomit
  • diacomit
  • estiripentol
  • estiripentol
  • estiripentol
  • estiripentol
  • estiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentol
  • stiripentolum
  • stiripentolum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07176832Phase 1Jun 1, 2025Biocodex
NCT06465472Phase 3Aug 31, 2024Biocodex, Exystat, Monopar Therapeutics
NCT05735951Phase 1Mar 25, 2023Biocodex, Comac Medical
NCT05419180Phase 4Oct 13, 2022Biocodex
NCT03819647Phase 2May 31, 2019Biocodex
NCT03866928Phase 1Feb 12, 2019Biocodex
NCT02239276N/ASep 10, 2014Cook Children's Health Care System, Cook Children's Medical Center
NCT01983722N/ANov 7, 2013University of Cincinnati
NCT01835314N/AApr 15, 2013University of Colorado, University of Colorado, Denver
NCT01533506N/AFeb 1, 2012Mayo Clinic
Showing 10 of 10 trials
Page 1 / 1

Organizations

Research & Development (10)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BiocodexFor profit6642019
Comac MedicalFor profit1012023
Cook Children's Health Care SystemAcademic/Hospital1112014
Cook Children's Medical CenterAcademic/Hospital1012014
ExystatFor profit1012024
Mayo ClinicAcademic/Hospital1112012
Monopar TherapeuticsFor profit1012024
University of CincinnatiAcademic/Hospital1112013
University of ColoradoAcademic/Hospital1012013
University of Colorado, DenverAcademic/Hospital1112013
10 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
BiocodexFor profitNDA2Aug 20, 2018
BiocodexFor profitNDAAug 20, 2018