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    Chemistry

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    Also known as: 104206-65-7, Orfadin, 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione, Nitisone, Ntbc, 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione
    Molecular Formula
    C14H10F3NO5
    Molecular Weight
    329.23  g/mol
    InChI Key
    OUBCNLGXQFSTLU-UHFFFAOYSA-N
    FDA UNII
    K5BN214699
    Nitisinone
    Nitisinone is a synthetic reversible inhibitor of 4-hydroxyphenylpyruvate dioxygenase. It is used in the treatment of hereditary tyrosinemia type 1. It is sold under the brand name Orfadin.
    Nitisinone is a 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor. The mechanism of action of nitisinone is as a Hydroxyphenylpyruvate Dioxygenase Inhibitor, and Cytochrome P450 2C9 Inhibitor, and Cytochrome P450 2E1 Inducer, and Organic Anion Transporter 1 Inhibitor, and Organic Anion Transporter 3 Inhibitor.
    1 2D Structure

    Nitisinone

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione
    2.1.2 InChI
    InChI=1S/C14H10F3NO5/c15-14(16,17)7-4-5-8(9(6-7)18(22)23)13(21)12-10(19)2-1-3-11(12)20/h4-6,12H,1-3H2
    2.1.3 InChI Key
    OUBCNLGXQFSTLU-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1CC(=O)C(C(=O)C1)C(=O)C2=C(C=C(C=C2)C(F)(F)F)[N+](=O)[O-]
    2.2 Other Identifiers
    2.2.1 UNII
    K5BN214699
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione

    2. 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

    3. Ntbc Cpd

    4. Orfadin

    2.3.2 Depositor-Supplied Synonyms

    1. 104206-65-7

    2. Orfadin

    3. 2-(2-nitro-4-(trifluoromethyl)benzoyl)cyclohexane-1,3-dione

    4. Nitisone

    5. Ntbc

    6. 2-(2-nitro-4-trifluoromethylbenzoyl)-1,3-cyclohexanedione

    7. 2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione

    8. 2-(2-nitro-4-trifluoromethylbenzoyl)cyclohexane-1,3-dione

    9. Sc 0735

    10. Sc-0735

    11. 2-(alpha,alpha,alpha-trifluoro-2-nitro-p-tuluoyl)-1,3-cyclohexanedione

    12. 1,3-cyclohexanedione, 2-[2-nitro-4-(trifluoromethyl)benzoyl]-

    13. 2-{[2-nitro-4-(trifluoromethyl)phenyl]carbonyl}cyclohexane-1,3-dione

    14. Chembl1337

    15. Chebi:50378

    16. 1,3-cyclohexanedione, 2-(2-nitro-4-(trifluoromethyl)benzoyl)-

    17. Mfcd01752192

    18. Sc0735

    19. K5bn214699

    20. Nitisinone [inn]

    21. Nitisinone [usan:inn]

    22. Nitisinona

    23. Nitisinonum

    24. Smr002529592

    25. Orfadin (tn)

    26. Nitisinone (jan/usan/inn)

    27. Unii-k5bn214699

    28. Nityr

    29. Fe-0200

    30. 2-[2-nitro-4-(trifluoromethyl)benzoyl]-1,3-cyclohexanedione

    31. Nitisinone [mi]

    32. Nitisinone [jan]

    33. Nitisinone [usan]

    34. Nitisinone [vandf]

    35. Nitisinone [mart.]

    36. Nitisinone [who-dd]

    37. Bidd:pxr0129

    38. Mls004774025

    39. Mls006011955

    40. Nitisinone [ema Epar]

    41. Schembl338795

    42. Ambz0071

    43. Gtpl6834

    44. Dtxsid9042673

    45. Nitisinone [orange Book]

    46. Nitisinone, >=95% (hplc)

    47. Schembl15996621

    48. Hms3740a15

    49. Hms3870k03

    50. Bcp15276

    51. Hy-b0607

    52. Bdbm50088804

    53. Nsc773149

    54. Rb3134

    55. S5325

    56. Akos015891363

    57. Akos015994590

    58. Zinc100014475

    59. Am62666

    60. Ccg-222085

    61. Db00348

    62. Ex-6233

    63. Nsc-773149

    64. Sb19017

    65. Ncgc00185778-01

    66. Ncgc00185778-02

    67. Ncgc00185778-04

    68. Ncgc00185778-07

    69. Ac-26934

    70. Sy047291

    71. Db-014936

    72. Ft-0672739

    73. D05177

    74. A800922

    75. Sr-01000940576

    76. J-505680

    77. Q3877355

    78. Sr-01000940576-2

    79. Ntbc; Nitisone; Sc0735; Sc 0735; Sc-0735

    80. Z1514110653

    81. 1,3-cyclohexanedione,2-[2-nitro-4-(trifluoromethyl)benzoyl]-

    82. 2-(2-nitro-4-(trifluoromethyl)-benzoyl)cyclohexane-1,3-dione

    83. 2-[2-nitro-4-(trifluoromethyl)benzoyl]cyclohexane-1,3-dione;nitisinone

    84. 2-(.alpha.,.alpha.,.alpha.-trifluoro-2-nitro-p-tuluoyl)-1,3-cyclohexanedione

    2.4 Create Date
    2005-08-08
    3 Chemical and Physical Properties
    Molecular Weight 329.23 g/mol
    Molecular Formula C14H10F3NO5
    XLogP32.3
    Hydrogen Bond Donor Count0
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count2
    Exact Mass329.05110691 g/mol
    Monoisotopic Mass329.05110691 g/mol
    Topological Polar Surface Area97 Ų
    Heavy Atom Count23
    Formal Charge0
    Complexity524
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count1
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameOrfadin
    PubMed HealthNitisinone (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelOrfadin contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to...
    Active IngredientNitisinone
    Dosage FormCapsule
    RouteOral
    Strength5mg; 2mg; 10mg
    Market StatusPrescription
    CompanySwedish Orphan

    2 of 2  
    Drug NameOrfadin
    PubMed HealthNitisinone (By mouth)
    Drug ClassesGastrointestinal Agent
    Drug LabelOrfadin contains nitisinone, which is a hydroxyphenyl-pyruvate dioxygenase inhibitor indicated as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1 (HT-1). Nitisinone occurs as white to...
    Active IngredientNitisinone
    Dosage FormCapsule
    RouteOral
    Strength5mg; 2mg; 10mg
    Market StatusPrescription
    CompanySwedish Orphan

    4.2 Drug Indication

    Used as an adjunct to dietary restriction of tyrosine and phenylalanine in the treatment of hereditary tyrosinemia type 1.

    FDA Label

    Hereditary tyrosinemia type 1 (HT 1)

    Orfadin is indicated for the treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.

    Alkaptonuria (AKU)

    Orfadin is indicated for the treatment of adult patients with alkaptonuria (AKU).

    Treatment of adult and paediatric patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT-1) in combination with dietary restriction of tyrosine and phenylalanine.

    Treatment of adult and paediatric (in any age range) patients with confirmed diagnosis of hereditary tyrosinemia type 1 (HT 1) in combination with dietary restriction of tyrosine and phenylalanine.

    Treatment of tyrosinemia type 1

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Hereditary tyrosinemia type 1 occurs due to a deficiency in fumarylacetoacetase (FAH), the final enzyme in the tyrosine catabolic pathway. Nitisinone inhibits catabolism of tyrosine by preventing the catabolic intermediates. In patients with HT-1, these catabolic intermediates are converted to the toxic metabolites succinylacetone and succinylacetoacetate, which are responsible for the observed liver and kidney toxicity. Succinylacetone can also inhibit the porphyrin synthesis pathway leading to the accumulation of 5-aminolevulinate, a neurotoxin responsible for the porphyric crises characteristic of HT-1.

    5.2 MeSH Pharmacological Classification

    Enzyme Inhibitors

    Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. (See all compounds classified as Enzyme Inhibitors.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    NITISINONE
    5.3.2 FDA UNII
    K5BN214699
    5.3.3 Pharmacological Classes
    Cytochrome P450 2C9 Inhibitors [MoA]; Cytochrome P450 2E1 Inducers [MoA]; Hydroxyphenylpyruvate Dioxygenase Inhibitors [MoA]; Organic Anion Transporter 1 Inhibitors [MoA]; Organic Anion Transporter 3 Inhibitors [MoA]; 4-Hydroxyphenyl-Pyruvate Dioxygenase Inhibitor [EPC]
    5.4 ATC Code

    A16AX04

    A16AX04

    A16AX04

    A - Alimentary tract and metabolism

    A16 - Other alimentary tract and metabolism products

    A16A - Other alimentary tract and metabolism products

    A16AX - Various alimentary tract and metabolism products

    A16AX04 - Nitisinone

    5.5 Absorption, Distribution and Excretion

    Absorption

    The capsule and liquid formulations are bioequivalent in both the plasma concentration-time curve and maximum plasma concentration (Cmax).

    5.6 Biological Half-Life

    ~54 hours

    5.7 Mechanism of Action

    Nitisinone is a competitive inhibitor of 4-hydroxyphenyl-pyruvate dioxygenase, an enzyme upstream of fumarylacetoacetate hydrolyase (FAH) in the tyrosine catabolic pathway. By inhibiting the normal catabolism of tyrosine in patients with hereditary tyrosinemia type 1 (HT-1), nitisinone prevents the accumulation of the catabolic intermediates maleylacetoacetate and fumarylacetoacetate.

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    ABOUT THIS PAGE

    Nitisinone Manufacturers

    A Nitisinone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nitisinone, including repackagers and relabelers. The FDA regulates Nitisinone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nitisinone 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 Nitisinone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    Nitisinone Suppliers

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

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

    Nitisinone USDMF

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

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

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

    Nitisinone WC

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

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

    Nitisinone 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 Nitisinone as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for Nitisinone 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 Nitisinone 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 Nitisinone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nitisinone NDC to their finished compounded human drug products, they may choose to do so.

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

    Nitisinone GMP

    Nitisinone 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 Nitisinone 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 Nitisinone GMP manufacturer or Nitisinone GMP API supplier for your needs.

    Nitisinone CoA

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

    Nitisinone CoA mostly includes findings from lab analyses of a specific batch. For each Nitisinone 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.

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