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    Chemistry

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    Also known as: 1092939-17-7, Jakafi, (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate, Jakavi, Ruxolitinib (phosphate), Ruxolitinib monophosphate
    Molecular Formula
    C17H21N6O4P
    Molecular Weight
    404.4  g/mol
    InChI Key
    JFMWPOCYMYGEDM-XFULWGLBSA-N
    FDA UNII
    436LRU32H5
    Ruxolitinib Phosphate
    Ruxolitinib Phosphate is the phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies.
    1 2D Structure

    Ruxolitinib Phosphate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (3R)-3-cyclopentyl-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric acid
    2.1.2 InChI
    InChI=1S/C17H18N6.H3O4P/c18-7-5-15(12-3-1-2-4-12)23-10-13(9-22-23)16-14-6-8-19-17(14)21-11-20-16;1-5(2,3)4/h6,8-12,15H,1-5H2,(H,19,20,21);(H3,1,2,3,4)/t15-;/m1./s1
    2.1.3 InChI Key
    JFMWPOCYMYGEDM-XFULWGLBSA-N
    2.1.4 Canonical SMILES
    C1CCC(C1)C(CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3.OP(=O)(O)O
    2.1.5 Isomeric SMILES
    C1CCC(C1)[C@@H](CC#N)N2C=C(C=N2)C3=C4C=CNC4=NC=N3.OP(=O)(O)O
    2.2 Other Identifiers
    2.2.1 UNII
    436LRU32H5
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. 3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)pyrazol-1-yl)propanenitrile

    2. Inc-424

    3. Inc424

    4. Inca24

    5. Incb-018424

    6. Incb-018424 Phosphate

    7. Incb-018424 Salt

    8. Incb-18424

    9. Incb-18424 Phosphate

    10. Incb018424

    11. Incb018424 Phosphate

    12. Jakafi

    13. Jakavi

    14. Opzelura

    15. Ruxolitinib

    16. Ruxolitinib (as Phosphate)

    17. Ruxolitinib Monophosphate

    2.3.2 Depositor-Supplied Synonyms

    1. 1092939-17-7

    2. Jakafi

    3. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile Phosphate

    4. Jakavi

    5. Ruxolitinib (phosphate)

    6. Ruxolitinib Monophosphate

    7. Incb018424 Phosphate

    8. Ruxolitinib (as Phosphate)

    9. Incb-018424 Phosphate

    10. Incb-018424 Salt

    11. Ruxolitinib Phosphate [usan]

    12. Incb-18424 Phosphate

    13. Incb018424 Salt

    14. Chebi:66917

    15. 436lru32h5

    16. 1092939-17-7 (phosphate)

    17. (betar)-beta-cyclopentyl-4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazole-1-propanenitrile Phosphate

    18. Incb-18424

    19. Ruxolitinib Phosphate Salt

    20. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile Phosphate

    21. (3r)-3-cyclopentyl-3-(4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-1h-pyrazol-1-yl)propanenitrile Phosphate (1:1)

    22. Phosphenoperoxoic Acid Compound With (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)- 1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile And Dihydrogen (1:1:1)

    23. Opzelura

    24. Unii-436lru32h5

    25. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrilephosphoricacid

    26. Jakafi (tn)

    27. Jakavi (tn)

    28. Ruxolitinib Phosphate(incb018424)

    29. Inc 424 Phosphate

    30. Incb 018424 Phosphate

    31. Incb-424

    32. Schembl1369365

    33. Chembl1795071

    34. Amy5620

    35. Dtxsid00911086

    36. Ruxolitinib Phosphate (jan/usan)

    37. Ruxolitinib Phosphate [mi]

    38. Ruxolitinib Phosphate [jan]

    39. Ex-a2660

    40. Cs1956

    41. Mfcd18452860

    42. S5243

    43. Akos024464417

    44. Ruxolitinib (incb-18424) Phosphate

    45. Ruxolitinib Phosphate [who-dd]

    46. Bcp9000783

    47. Ccg-268687

    48. Cs-0326

    49. 1h-pyrazole-1-propanenitrile, Beta-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(betar)-, Phosphate (1:1)

    50. Ac-30901

    51. As-74723

    52. Hy-50858

    53. Ruxolitinib Phosphate [orange Book]

    54. Ruxolitinib (as Phosphate) [ema Epar]

    55. D09960

    56. J-501793

    57. Q27135517

    58. (3r)-3-cyclopentyl-3-(4-{7h-pyrrolo[2,3-d]pyrimidin-4-yl}-1h-pyrazol-1-yl)propanenitrile; Phosphoric Acid

    59. (3r)-3-cyclopentyl-3-[4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)pyrazol-1-yl]propanenitrile;phosphoric Acid

    60. (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrilephosphate

    61. 1h-pyrazole-1-propanenitrile,.beta.-cyclopentyl-4-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-,(.beta.r)-,phosphate (1:1)

    62. Phosphoric Acid--3-cyclopentyl-3-[4-(1h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl]propanenitrile (1/1)

    2.4 Create Date
    2009-01-19
    3 Chemical and Physical Properties
    Molecular Weight 404.4 g/mol
    Molecular Formula C17H21N6O4P
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count4
    Exact Mass404.13619017 g/mol
    Monoisotopic Mass404.13619017 g/mol
    Topological Polar Surface Area161 Ų
    Heavy Atom Count28
    Formal Charge0
    Complexity503
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameJakafi
    PubMed HealthRuxolitinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Active IngredientRuxolitinib phosphate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyIncyte

    2 of 2  
    Drug NameJakafi
    PubMed HealthRuxolitinib (By mouth)
    Drug ClassesAntineoplastic Agent
    Active IngredientRuxolitinib phosphate
    Dosage FormTablet
    RouteOral
    Strengtheq 5mg base; eq 20mg base; eq 15mg base; eq 10mg base; eq 25mg base
    Market StatusPrescription
    CompanyIncyte

    4.2 Drug Indication

    * Myelofibrosis (MF):

    Jakavi is indicated for the treatment of disease related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.

    * Polycythaemia vera (PV):

    Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.

    * Graft versus host disease (GvHD):

    Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies (see section 5. 1).

    Treatment of chronic Graft versus Host Disease (cGvHD)

    Treatment of acute graft-versus-host disease (aGvHD)

    Treatment of vitiligo

    5 Pharmacology and Biochemistry
    5.1 ATC Code

    L01EJ01

    API Reference Price

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    04-Feb-2021
    12-Feb-2025
    KGS
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    Australia

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    01

    Novartis Pharmaceuticals Australia Pty L...

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    German Wound Congress
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    Novartis Pharmaceuticals Australia Pty L...

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    Regulatory Info :

    Registration Country : Australia

    Ruxolitinib

    Brand Name : Jakavi

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    02

    Novartis Pharmaceuticals Australia Pty L...

    Country
    German Wound Congress
    Not Confirmed
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    Novartis Pharmaceuticals Australia Pty L...

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    German Wound Congress
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    Regulatory Info :

    Registration Country : Australia

    Ruxolitinib

    Brand Name : Jakavi

    Dosage Form :

    Dosage Strength :

    Packaging : 56

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

    blank

    Portfolio PDF

    Product Web Link

    Virtual Booth

    Digital Content

    Website

    Corporate PDF

    03

    Novartis Pharmaceuticals Australia Pty L...

    Country
    German Wound Congress
    Not Confirmed
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    Novartis Pharmaceuticals Australia Pty L...

    Country
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    German Wound Congress
    Not Confirmed
    • fda
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    ABOUT THIS PAGE

    Looking for 1092939-17-7 / Ruxolitinib Phosphate API manufacturers, exporters & distributors?

    Ruxolitinib Phosphate manufacturers, exporters & distributors 1

    22

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

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ruxolitinib Phosphate manufacturer or Ruxolitinib Phosphate supplier.

    PharmaCompass also assists you with knowing the Ruxolitinib Phosphate API Price utilized in the formulation of products. Ruxolitinib Phosphate API Price is not always fixed or binding as the Ruxolitinib Phosphate Price is obtained through a variety of data sources. The Ruxolitinib Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Ruxolitinib Phosphate

    Synonyms

    1092939-17-7, Jakafi, (r)-3-(4-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-1h-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate, Jakavi, Ruxolitinib (phosphate), Ruxolitinib monophosphate

    Cas Number

    1092939-17-7

    Unique Ingredient Identifier (UNII)

    436LRU32H5

    About Ruxolitinib Phosphate

    Ruxolitinib Phosphate is the phosphate salt form of ruxolitinib, an orally bioavailable Janus-associated kinase (JAK) inhibitor with potential antineoplastic and immunomodulating activities. Ruxolitinib specifically binds to and inhibits protein tyrosine kinases JAK 1 and 2, which may lead to a reduction in inflammation and an inhibition of cellular proliferation. The JAK-STAT (signal transducer and activator of transcription) pathway plays a key role in the signaling of many cytokines and growth factors and is involved in cellular proliferation, growth, hematopoiesis, and the immune response; JAK kinases may be upregulated in inflammatory diseases, myeloproliferative disorders, and various malignancies.

    Ruxolitinib Phosphate Manufacturers

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

    Ruxolitinib Phosphate Suppliers

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

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

    Ruxolitinib Phosphate USDMF

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

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

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

    Ruxolitinib Phosphate KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a Ruxolitinib Phosphate Drug Master File in Korea (Ruxolitinib Phosphate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ruxolitinib Phosphate. The MFDS reviews the Ruxolitinib Phosphate KDMF as part of the drug registration process and uses the information provided in the Ruxolitinib Phosphate KDMF to evaluate the safety and efficacy of the drug.

    After submitting a Ruxolitinib Phosphate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ruxolitinib Phosphate API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of Ruxolitinib Phosphate suppliers with KDMF on PharmaCompass.

    Ruxolitinib Phosphate WC

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

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

    Ruxolitinib Phosphate 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 Ruxolitinib Phosphate as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ruxolitinib Phosphate GMP

    Ruxolitinib Phosphate 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 Ruxolitinib Phosphate 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 Ruxolitinib Phosphate GMP manufacturer or Ruxolitinib Phosphate GMP API supplier for your needs.

    Ruxolitinib Phosphate CoA

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

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

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