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    Chemistry

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    Also known as: 49763-96-4, Diacomit, Bcx 2600, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol, 137767-55-6, Bcx-2600
    Molecular Formula
    C14H18O3
    Molecular Weight
    234.29  g/mol
    InChI Key
    IBLNKMRFIPWSOY-FNORWQNLSA-N
    FDA UNII
    R02XOT8V8I
    Stiripentol
    Stiripentol is an anticonvulsant drug used in the treatment of epilepsy as an adjunct therapy along with [DB00349] and [DB00313]. This drug is currently approved in the USA, Canada, and European countries as oral tablets marketed as Diacomit. FDA approval of this drug was granted on August 20, 2018,. Unrelated to other anticonvulsants, stiripentol belongs to the group of aromatic allylic alcohols and may potentiate the effect of other antiepileptic drugs (AEDs) due to pharmacokinetic interactions. It elevates the levels of gamma-aminobutyric acid (GABA), a major inhibitory neurotransmitter that regulates electrical activity in the central nervous system.
    1 2D Structure

    Stiripentol

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (E)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol
    2.1.2 InChI
    InChI=1S/C14H18O3/c1-14(2,3)13(15)7-5-10-4-6-11-12(8-10)17-9-16-11/h4-8,13,15H,9H2,1-3H3/b7-5+
    2.1.3 InChI Key
    IBLNKMRFIPWSOY-FNORWQNLSA-N
    2.1.4 Canonical SMILES
    CC(C)(C)C(C=CC1=CC2=C(C=C1)OCO2)O
    2.1.5 Isomeric SMILES
    CC(C)(C)C(/C=C/C1=CC2=C(C=C1)OCO2)O
    2.2 Other Identifiers
    2.2.1 UNII
    R02XOT8V8I
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. D-306

    2. Diacomit

    2.3.2 Depositor-Supplied Synonyms

    1. 49763-96-4

    2. Diacomit

    3. Bcx 2600

    4. 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol

    5. 137767-55-6

    6. Bcx-2600

    7. 1-(benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

    8. 4,4-dimethyl-1-((3,4-methylenedioxy)phenyl)-1-penten-3-ol

    9. (1e)-1-(2h-1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

    10. Ncgc00185769-01

    11. Estiripentol

    12. 1-penten-3-ol, 4,4-dimethyl-1-(3,4-methylenedioxyphenyl)-

    13. (e)-1-(benzo[d][1,3]dioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

    14. 1-penten-3-ol, 1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-

    15. Stiripentolum

    16. Stiripentol [mi]

    17. Stiripentol [inn]

    18. Stiripentol [jan]

    19. Stiripentol [usan:inn]

    20. Stiripentol [usan]

    21. Stiripentolum [inn-latin]

    22. Estiripentol [inn-spanish]

    23. Stiripentol [mart.]

    24. 4,4-dimethyl-1-(3,4-methylenedioxyphenyl)-1-penten-3-ol

    25. Smr000449279

    26. Stiripentol [who-dd]

    27. Stiripentol [ema Epar]

    28. R02xot8v8i

    29. Einecs 256-480-9

    30. Mfcd00869310

    31. Brn 1313047

    32. (e)-1-(1,3-benzodioxol-5-yl)-4,4-dimethylpent-1-en-3-ol

    33. Diacomit (tn)

    34. Me-2080

    35. Cpd000449279

    36. Dsstox_cid_28994

    37. Dsstox_rid_83259

    38. Dsstox_gsid_49068

    39. 5-19-02-00640 (beilstein Handbook Reference)

    40. Mls000758313

    41. Mls001424144

    42. Schembl216436

    43. Stiripentol (jan/usan/inn)

    44. Gtpl5469

    45. Schembl2533815

    46. Chembl1983350

    47. Chebi:94435

    48. Stiripentol, >=98% (hplc)

    49. Dtxsid80860609

    50. Stiripentol [orange Book]

    51. Hms2052k07

    52. Hms2232p06

    53. Hms3886m17

    54. Bcp10434

    55. Tox21_113622

    56. Bdbm50504273

    57. S5266

    58. Akos025149123

    59. Akos027255159

    60. Ccg-101092

    61. Ccg-266819

    62. Cs-7801

    63. Db09118

    64. Nc00342

    65. Ncgc00185769-02

    66. Bs-16863

    67. Cas-49763-96-4

    68. Hy-103392

    69. D05928

    70. W10731

    71. Bcx2600; Bcx-2600; Bcx 2600

    72. 763s964

    73. Q412182

    74. (1e)-1-(1,3-benzodioxol-5-yl)-4,4-dimethyl-1-penten-3-ol

    75. (e)-1-(3,4-methylenedioxyphenyl)-4,4-dimethyl-1-penten-3-ol

    76. 131206-47-8

    2.4 Create Date
    2005-09-13
    3 Chemical and Physical Properties
    Molecular Weight 234.29 g/mol
    Molecular Formula C14H18O3
    XLogP33.6
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count3
    Rotatable Bond Count3
    Exact Mass234.125594432 g/mol
    Monoisotopic Mass234.125594432 g/mol
    Topological Polar Surface Area38.7 Ų
    Heavy Atom Count17
    Formal Charge0
    Complexity280
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count1
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Indication

    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, Dravets syndrome) whose seizures are not adequately controlled with clobazam and valproate.

    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.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Stiripentol is an orphan drug that effectively reduces seizure frequency in infantile epilepsy as an adjunct therapy and also exhibits a therapeutic advantage in improving the efficacy of other antiepileptic drugs. It potentiates GABA transmission by elevating the levels of the inhibitory neurotransmitters in the brain. Stiripentol is a positive allosteric modulator of GABA-A receptors in the brain that enhances the opening duration of the channel by binding to a site different than the benzodiazepine binding site. Reduced synaptosomal uptake of GABA and/or inhibition of GABA transaminase may also explain the role of stiripentol in reducing the events of seizure. The anticonvulsant activity of stiripentol is age-dependent, with increased efficacy in younger patients.

    5.2 MeSH Pharmacological Classification

    Anticonvulsants

    Drugs used to prevent SEIZURES or reduce their severity. (See all compounds classified as Anticonvulsants.)

    5.3 ATC Code

    N03AX17

    N - Nervous system

    N03 - Antiepileptics

    N03A - Antiepileptics

    N03AX - Other antiepileptics

    N03AX17 - Stiripentol

    5.4 Absorption, Distribution and Excretion

    Absorption

    Absorption of stiripentol is quick with the peak plasma concentration reached within 1.5 hours following oral administration. The systemic exposure increases in a dose-proportional relationship. It is rapidly taken up into the brain and enters the cerebellum and medulla. It displays low bioavailability due to water insolubility and metabolism.

    Route of Elimination

    Renal elimination is mainly responsible for excretion of stiripentol. About 73% of total administered dose is found in urine as metabolites, while further 13-24% of the total dose is recovered in faeces as unchanged substance.

    Volume of Distribution

    The average volume of distribution is 1.03 L/kg but does not display a dose-dependent relationship. It is expected to be distributed into the extravascular space and with a high degree of tissue binding.

    Clearance

    Plasma clearance decreases markedly at high doses; it falls from approximately 40 L/kg/day at the dose of 600 mg/day to about 8 L/kg/day at the dose of 2,400 mg. Decreased clearance is probably explained by inhibition of the cytochrome P450 isoenzymes that catalyzes stiripentol metabolism.

    5.5 Metabolism/Metabolites

    There are 13 metabolites from extensive metabolism stiripentol that are found in urine. The predominant metabolic pathways involve demethylenation and glucuronidation. Other metabolic pathways are oxidative cleavage of the methylenedioxy ring system, O-methylation of catechol metabolites, hydroxylation of the t-butyl group and conversion of the allylic alcohol side-chain to the isomeric 3-pentanone structure. Based on in vitro studies, phase I metabolism of stiripentol involves enzymatic activity of CYP1A2, CYP2C19 and CYP3A4.

    5.6 Biological Half-Life

    Elimination half life is approximately ranges from 4.5 to 13 hours, in a dose-dependent manner.

    5.7 Mechanism of Action

    Stiripentol enhances GABAergic inhibition and prolongs the open duration of GABA-A receptor chloride channels by a barbiturate-like mechanism. It binds to GABA-A receptors containing any of the , , , or -subunits but displays strongest potency when bound to receptors containing 3 or subunits. Stiripentol is an inhibitor of lactate dehydrogenase (LDH), which plays a physiological role in energy metabolism of neurons and regulation of neuronal excitation. It binds to the site separate from lactate and pyruvate binding sites of the enzyme and inhibits both pyruvate-to-lactate conversion and lactate-to-pyruvate conversion. LDH inhibitors including stiripentol as antiepileptic treatments mimic ketogenic diet, where the energy source in the brain is switched from glucose to mainly ketone bodies. The ketone bodies directly regulate neuronal excitation and seizures via ATP-sensitive potassium channels and vesicular glutamate transporters. As a potent inhibitor of hepatic cytochrome P450 enzymes, mainly CYP3A4 and CYP2C19, stiripentol co-administration with other antiepileptic drugs elevates the free unchanged active drugs (such as carbamazepine, sodium valproate, phenytoin, phenobarbital and many benzodiazepines) in the circulation to mediate their therapeutic actions.

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    ABOUT THIS PAGE

    Stiripentol Manufacturers

    A Stiripentol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Stiripentol, including repackagers and relabelers. The FDA regulates Stiripentol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Stiripentol API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of Stiripentol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Stiripentol Suppliers

    A Stiripentol supplier is an individual or a company that provides Stiripentol active pharmaceutical ingredient (API) or Stiripentol finished formulations upon request. The Stiripentol suppliers may include Stiripentol API manufacturers, exporters, distributors and traders.

    click here to find a list of Stiripentol suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    Stiripentol USDMF

    A Stiripentol DMF (Drug Master File) is a document detailing the whole manufacturing process of Stiripentol active pharmaceutical ingredient (API) in detail. Different forms of Stiripentol DMFs exist exist since differing nations have different regulations, such as Stiripentol USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A Stiripentol DMF submitted to regulatory agencies in the US is known as a USDMF. Stiripentol USDMF includes data on Stiripentol's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Stiripentol USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of Stiripentol suppliers with USDMF on PharmaCompass.

    Stiripentol WC

    A Stiripentol written confirmation (Stiripentol WC) is an official document issued by a regulatory agency to a Stiripentol manufacturer, verifying that the manufacturing facility of a Stiripentol active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Stiripentol APIs or Stiripentol finished pharmaceutical products to another nation, regulatory agencies frequently require a Stiripentol WC (written confirmation) as part of the regulatory process.

    click here to find a list of Stiripentol suppliers with Written Confirmation (WC) on PharmaCompass.

    Stiripentol NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Stiripentol as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Stiripentol API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture Stiripentol as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain Stiripentol and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Stiripentol NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of Stiripentol suppliers with NDC on PharmaCompass.

    Stiripentol GMP

    Stiripentol Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of Stiripentol GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Stiripentol GMP manufacturer or Stiripentol GMP API supplier for your needs.

    Stiripentol CoA

    A Stiripentol CoA (Certificate of Analysis) is a formal document that attests to Stiripentol's compliance with Stiripentol specifications and serves as a tool for batch-level quality control.

    Stiripentol CoA mostly includes findings from lab analyses of a specific batch. For each Stiripentol CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    Stiripentol may be tested according to a variety of international standards, such as European Pharmacopoeia (Stiripentol EP), Stiripentol JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Stiripentol USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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