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Stiripentol

Generic Name
Stiripentol
Brand Names
Diacomit
Drug Type
Small Molecule
Chemical Formula
C14H18O3
CAS Number
49763-96-4
Unique Ingredient Identifier
R02XOT8V8I

Overview

Stiripentol is an antiepileptic agent that is an aromatic allylic alcohol drug, which makes it structurally unique from other antiepileptic drugs. The clinical development and marketing of stiripentol were first delayed due to the drug's potent inhibitory effects on hepatic cytochrome P450 (CYP) enzymes. However, its clinical efficacy as adjunctive therapy for epilepsies stems from its inhibitory action on CYP enzymes, as stiripentol reduces the degradation of CYP-sensitive antiepileptic drugs, hence boosting their therapeutic efficacy. Stiripentol may also exhibit direct anticonvulsant properties, although the exact mechanism of action is fully understood. Approved in the US, Canada, and Europe, stiripentol is used to treat seizures associated with Dravet syndrome. It is marketed under the brand name Diacomit.

Background

Stiripentol is an antiepileptic agent that is an aromatic allylic alcohol drug, which makes it structurally unique from other antiepileptic drugs. The clinical development and marketing of stiripentol were first delayed due to the drug's potent inhibitory effects on hepatic cytochrome P450 (CYP) enzymes. However, its clinical efficacy as adjunctive therapy for epilepsies stems from its inhibitory action on CYP enzymes, as stiripentol reduces the degradation of CYP-sensitive antiepileptic drugs, hence boosting their therapeutic efficacy. Stiripentol may also exhibit direct anticonvulsant properties, although the exact mechanism of action is fully understood. Approved in the US, Canada, and Europe, stiripentol is used to treat seizures associated with Dravet syndrome. It is marketed under the brand name Diacomit.

Indication

In the US, stiripentol 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 stiripentol as monotherapy in Dravet syndrome. In Europe and Canada, stiripentol is indicated for use as adjunctive therapy with clobazam and valproate to refractory generalized tonic-clonic seizures in patients with Dravet syndrome in infancy whose seizures are not adequately controlled with clobazam and valproate alone.

Associated Conditions

  • Seizures
  • Refractory Grand mal Generalized tonic-clonic seizure

FDA Approved Products

Diacomit
Manufacturer:BIOCODEX, INC.
Route:ORAL
Strength:250 mg in 1 1
Approved: 2022/07/26
NDC:68418-7941
Diacomit
Manufacturer:BIOCODEX, INC.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2022/07/26
NDC:68418-7940
Diacomit
Manufacturer:BIOCODEX, INC.
Route:ORAL
Strength:250 mg in 1 1
Approved: 2022/07/26
NDC:68418-7939
Diacomit
Manufacturer:BIOCODEX, INC.
Route:ORAL
Strength:500 mg in 1 1
Approved: 2022/07/26
NDC:68418-7942

Singapore Approved Products

No Singapore products found for this drug

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