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    Chemistry

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    Also known as: 496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr
    Molecular Formula
    C29H36N6O6
    Molecular Weight
    564.6  g/mol
    InChI Key
    DJMJHIKGMVJYCW-UHFFFAOYSA-N
    FDA UNII
    4U07F515LG
    Eltrombopag
    Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.
    1 2D Structure

    Eltrombopag

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1H-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic acid
    2.1.2 InChI
    InChI=1S/C25H22N4O4.2C2H7NO/c1-14-10-11-19(12-15(14)2)29-24(31)22(16(3)28-29)27-26-21-9-5-8-20(23(21)30)17-6-4-7-18(13-17)25(32)33;2*3-1-2-4/h4-13,28,30H,1-3H3,(H,32,33);2*4H,1-3H2
    2.1.3 InChI Key
    DJMJHIKGMVJYCW-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC1=C(C=C(C=C1)N2C(=O)C(=C(N2)C)N=NC3=CC=CC(=C3O)C4=CC(=CC=C4)C(=O)O)C.C(CO)N.C(CO)N
    2.2 Other Identifiers
    2.2.1 UNII
    4U07F515LG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-

    2. Ddl-701

    3. Eltrombopag

    4. Promacta

    5. Revolade

    6. Sb-497 115

    7. Sb-497-115

    8. Sb497115

    2.3.2 Depositor-Supplied Synonyms

    1. 496775-62-3

    2. Revolade

    3. Promacta

    4. Eltrombopag (olamine)

    5. Unii-4u07f515lg

    6. Sb-497115-gr

    7. Eltrombopag Diethanolamine Salt

    8. 496775-62-3 (olamine)

    9. Eltrombopag (as Olamine)

    10. 4u07f515lg

    11. Sb-497115gr

    12. Eltrombopag Compd With 2-aminoethanol (1:2)

    13. Eltrombopag Diethanolamine Salt;sb-497115gr

    14. (z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxyiic Acid;2-aminoethan-1-ol (1:2)

    15. 3'-((2z)-2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)diazanyl)-2'-hydroxybiphenyl-3-carboxylic Acid Compound With 2-aminoethanol (1:2)

    16. Promacta Olamine

    17. Eltrombopagolamine

    18. Eltrombopag Olamine [usan:jan]

    19. Promacta (tn)

    20. Sb 497115gr

    21. Schembl210183

    22. Amy267

    23. Chembl3989691

    24. Schembl16207741

    25. Schembl23458316

    26. Eltrombopag Olamine (jan/usan)

    27. Eltrombopag Olamine [jan]

    28. Eltrombopag Olamine [usan]

    29. Bcp07055

    30. Eltrombopag Olamine [mart.]

    31. Eltrombopag Olamine [who-dd]

    32. Hy-15306a

    33. Mfcd22380664

    34. S2229

    35. Akos025396658

    36. Akos037515856

    37. Ccg-270074

    38. Cs-1566

    39. Sb19102

    40. Eltrombopag Olamine [orange Book]

    41. 2-aminoethan-1-ol Hemi((e)-3'-(2-(2-(3,4-dimethylphenyl)-5-methyl-3-oxo-2,3-dihydro-1h-pyrazol-4-yl)hydrazono)-2'-oxo-2',3'-dihydro-[1,1'-biphenyl]-3-carboxylate)

    42. Ac-26286

    43. Bs-17370

    44. Ft-0773802

    45. D03978

    46. A904098

    47. Q27260489

    48. Eltrombopag Compd With 2-aminoethanol (1:2) [mi]

    49. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy, Compound With 2-aminoethanol (1:2)

    50. (1,1'-biphenyl)-3-carboxylic Acid, 3'-((2z)-(1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene)hydrazino)-2'-hydroxy-, Compound With 2-aminoethanol (1:2)

    51. (1,1'-biphenyl)-3-carboxylic Acid, 3'-(2-(1-(3,4-dimethylphenyl)-4,5-dihydro-3-methyl-5-oxo-1h-pyrazol-4-yl)diazenyl)-2'-hydroxy-, Compd. With 2-aminoethanol (1:2)

    52. 2-aminoethan-1-ol Hemi((z)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate)

    53. 2-aminoethanol (e)-3'-(2-(1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1h-pyrazol-4(5h)-ylidene)hydrazinyl)-2'-hydroxy-[1,1'-biphenyl]-3-carboxylate

    54. 2-aminoethanol;3-[3-[[2-(3,4-dimethylphenyl)-5-methyl-3-oxo-1h-pyrazol-4-yl]diazenyl]-2-hydroxyphenyl]benzoic Acid

    55. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

    56. 3'-[(2z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol4-ylidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic Acid Bis-(monoethanolamine)

    57. 3'-{(2z)-2-[1-(3,4-dimethylphenyl)-3-methyl-5-oxo-1,5-dihydro-4h-pyrazol-4-ylidene]hydrazino}-2'-hydroxy-3-biphenylcarboxylic Acid 2-aminoethanol (1:2)

    2.4 Create Date
    2019-01-15
    3 Chemical and Physical Properties
    Molecular Weight 564.6 g/mol
    Molecular Formula C29H36N6O6
    Hydrogen Bond Donor Count7
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count7
    Exact Mass564.26963289 g/mol
    Monoisotopic Mass564.26963289 g/mol
    Topological Polar Surface Area207 Ų
    Heavy Atom Count41
    Formal Charge0
    Complexity822
    Isotope Atom Count0
    Defined Atom Stereocenter Count0
    Undefined Atom Stereocenter Count0
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count3
    4 Drug and Medication Information
    4.1 Drug Indication

    Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

    Revolade is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e. g. corticosteroids, immunoglobulins) (see sections 4. 2 and 5. 1).

    Revolade is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4. 4 and 5. 1).

    Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5. 1).

    5 Pharmacology and Biochemistry
    5.1 FDA Pharmacological Classification
    5.1.1 Pharmacological Classes
    Increased Megakaryocyte Maturation [PE]; Increased Platelet Production [PE]; Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]; Thrombopoietin Receptor Agonist [EPC]; Thrombopoietin Receptor Agonists [MoA]; UGT1A1 Inhibitors [MoA]; UGT1A3 Inhibitors [MoA]; UGT1A4 Inhibitors [MoA]; UGT1A6 Inhibitors [MoA]; UGT1A9 Inhibitors [MoA]; UGT2B15 Inhibitors [MoA]; UGT2B7 Inhibitors [MoA]; Breast Cancer Resistance Protein Inhibitors [MoA]
    5.2 ATC Code

    B02BX05

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    05-Jan-2022
    31-May-2025
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federa...DOSAGE - TABLET;ORAL - EQ 100MG ACID **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 22291

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    DOSAGE - TABLET;ORAL - EQ 12.5MG ACID

    USFDA APPLICATION NUMBER - 22291

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    DOSAGE - TABLET;ORAL - EQ 25MG ACID

    USFDA APPLICATION NUMBER - 22291

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    DOSAGE - TABLET;ORAL - EQ 50MG ACID

    USFDA APPLICATION NUMBER - 22291

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    DOSAGE - TABLET;ORAL - EQ 75MG ACID

    USFDA APPLICATION NUMBER - 22291

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    ABOUT THIS PAGE

    Looking for 496775-62-3 / Eltrombopag API manufacturers, exporters & distributors?

    Eltrombopag manufacturers, exporters & distributors 1

    69

    PharmaCompass offers a list of Eltrombopag 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 Eltrombopag manufacturer or Eltrombopag supplier for your needs.

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

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

    API | Excipient name

    Eltrombopag

    Synonyms

    496775-62-3, Revolade, Promacta, Eltrombopag (olamine), Unii-4u07f515lg, Sb-497115-gr

    Cas Number

    496775-62-3

    Unique Ingredient Identifier (UNII)

    4U07F515LG

    About Eltrombopag

    Eltrombopag Olamine is the orally active ethanolamine salt of eltrombopag, a small-molecule, nonpeptide thrombopoietin receptor agonist with megakaryopoiesis-stimulating activity. Eltrombopag binds to and stimulates the transmembrane domain of the platelet thrombopoietin receptor (TPO-R or CD110), a member of the hematopoietin receptor superfamily. Activation of TPO-R leads to the proliferation and differentiation of cells in the megakaryocytic lineage and an increase in platelet production.

    Promacta Manufacturers

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

    Promacta Suppliers

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

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

    Promacta USDMF

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

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

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

    Promacta JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The Promacta Drug Master File in Japan (Promacta JDMF) empowers Promacta API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the Promacta JDMF during the approval evaluation for pharmaceutical products. At the time of Promacta JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of Promacta suppliers with JDMF on PharmaCompass.

    Promacta KDMF

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

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

    After submitting a Promacta 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 Promacta API can apply through the Korea Drug Master File (KDMF).

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

    Promacta WC

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

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

    Promacta 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 Promacta as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Promacta GMP

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

    Promacta CoA

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

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

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