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Diacomit(stiripentol)
Diacomit (stiripentol) is a small molecule pharmaceutical. Stiripentol was first approved as Diacomit on 2007-01-03. It is used to treat seizures in the USA. It has been approved in Europe to treat juvenile myoclonic epilepsy.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Diacomit
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Stiripentol
Tradename
Company
Number
Date
Products
DIACOMITBiocodexN-206709 RX2018-08-20
2 products, RLD, RS
DIACOMITBiocodexN-207223 RX2018-08-20
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
diacomitNew Drug Application2020-05-15
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
seizuresHP_0007359D012640G40.4
Agency Specific
FDA
EMA
Expiration
Code
STIRIPENTOL, DIACOMIT, BIOCODEX SA
2029-07-14ODE-403
2025-08-20ODE-198
2025-07-14M-281, NPP
2023-08-20NCE
Patent Expiration
No data
ATC Codes
N: Nervous system drugs
— N03: Antiepileptics
— N03A: Antiepileptics
— N03AX: Other antiepileptics in atc
— N03AX17: Stiripentol
HCPCS
No data
Clinical
Clinical Trials
9 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Primary hyperoxaluriaD006960E72.53—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myoclonic epilepsiesD004831EFO_1001900G40.4————44
EpilepsyD004827EFO_0000474G40.9————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameSTIRIPENTOL
INNstiripentol
Description
1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol is a phenylpropanoid.
Classification
Small molecule
Drug class—
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CC(C)(C)C(O)/C=C/c1ccc2c(c1)OCO2
Identifiers
PDB—
CAS-ID49763-96-4
RxCUI2054968
ChEMBL IDCHEMBL1983350
ChEBI ID—
PubChem CID5311454
DrugBankDB09118
UNII IDR02XOT8V8I (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 887 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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28,770 adverse events reported
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