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    Also known as: 1446502-11-9, Ag-221, Ag-221 (enasidenib), Enasidenib [inn], Cc-90007 free base, Idhifa
    Molecular Formula
    C19H17F6N7O
    Molecular Weight
    473.4  g/mol
    InChI Key
    DYLUUSLLRIQKOE-UHFFFAOYSA-N
    FDA UNII
    3T1SS4E7AG
    Enasidenib
    Enasidenib is an orally available inhibitor of specific mutant forms of the mitochondrial enzyme isocitrate dehydrogenase type 2 (IDH2), with potential antineoplastic activity. Upon administration, enasidenib specifically inhibits various mutant forms of IDH2, including the IDH2 variants R140Q, R172S, and R172K, which inhibits the formation of 2-hydroxyglutarate (2HG). This may lead to both an induction of cellular differentiation and an inhibition of cellular proliferation in IDH2-expressing tumor cells. IDH2, an enzyme in the citric acid cycle, is mutated in a variety of cancers; it initiates and drives cancer growth by blocking differentiation and the production of the oncometabolite 2HG.
    Enasidenib is an Isocitrate Dehydrogenase 2 Inhibitor. The mechanism of action of enasidenib is as an Isocitrate Dehydrogenase 2 Inhibitor.
    1 2D Structure

    Enasidenib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    2-methyl-1-[[4-[6-(trifluoromethyl)pyridin-2-yl]-6-[[2-(trifluoromethyl)pyridin-4-yl]amino]-1,3,5-triazin-2-yl]amino]propan-2-ol
    2.1.2 InChI
    InChI=1S/C19H17F6N7O/c1-17(2,33)9-27-15-30-14(11-4-3-5-12(29-11)18(20,21)22)31-16(32-15)28-10-6-7-26-13(8-10)19(23,24)25/h3-8,33H,9H2,1-2H3,(H2,26,27,28,30,31,32)
    2.1.3 InChI Key
    DYLUUSLLRIQKOE-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    CC(C)(CNC1=NC(=NC(=N1)C2=NC(=CC=C2)C(F)(F)F)NC3=CC(=NC=C3)C(F)(F)F)O
    2.2 Other Identifiers
    2.2.1 UNII
    3T1SS4E7AG
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Ag-221

    2. Idhifa

    2.3.2 Depositor-Supplied Synonyms

    1. 1446502-11-9

    2. Ag-221

    3. Ag-221 (enasidenib)

    4. Enasidenib [inn]

    5. Cc-90007 Free Base

    6. Idhifa

    7. Ag 221

    8. 2-methyl-1-(4-(6-(trifluoromethyl)pyridin-2-yl)-6-(2-(trifluoromethyl)pyridin-4-ylamino)-1,3,5-triazin-2-ylamino)propan-2-ol

    9. 3t1ss4e7ag

    10. 2-methyl-1-((4-(6-(trifluoromethyl)pyridin-2-yl)-6-((2-(trifluoromethyl)pyridin-4-yl)amino)-1,3,5-triazin-2-yl)amino)propan-2-ol

    11. 2-methyl-1-[(4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl)amino]propan-2-ol

    12. 2-methyl-1-[[4-[6-(trifluoromethyl)pyridin-2-yl]-6-[[2-(trifluoromethyl)pyridin-4-yl]amino]-1,3,5-triazin-2-yl]amino]propan-2-ol

    13. 2-propanol, 2-methyl-1-((4-(6-(trifluoromethyl)-2-pyridinyl)-6-((2-(trifluoromethyl)-4-pyridinyl)amino)-1,3,5-triazin-2-yl)amino)-

    14. 2-propanol, 2-methyl-1-[[4-[6-(trifluoromethyl)-2-pyridinyl]-6-[[2-(trifluoromethyl)-4-pyridinyl]amino]-1,3,5-triazin-2-yl]amino]-

    15. Unii-3t1ss4e7ag

    16. Enasidenibum

    17. Ag221

    18. 2-methyl-1-({4-[6-(trifluoromethyl)pyridin-2-yl]-6-{[2-(trifluoromethyl)pyridin-4-yl]amino}-1,3,5-triazin-2-yl}amino)propan-2-ol

    19. Ag-221(enasidenib)

    20. Ag-221; Enasidenib

    21. Enasidenib; Ag-221

    22. Enasidenib [mi]

    23. Enasidenib (usan/inn)

    24. Enasidenib [usan:inn]

    25. Enasidenib [usan]

    26. Enasidenib [who-dd]

    27. Gtpl8960

    28. Ag 221 [who-dd]

    29. Chembl3989908

    30. Schembl15102202

    31. Ex-a654

    32. Chebi:145374

    33. Dtxsid801027942

    34. Hms3873d03

    35. Amy38698

    36. Bcp16041

    37. Bdbm50503251

    38. Mfcd29472245

    39. Nsc788120

    40. S8205

    41. Akos026750439

    42. Zinc222731806

    43. Ccg-269476

    44. Cs-5017

    45. Db13874

    46. Nsc-788120

    47. Sb19193

    48. Ncgc00479249-03

    49. Ncgc00479249-05

    50. Ac-31318

    51. As-75164

    52. Hy-18690

    53. Ft-0700204

    54. D10901

    55. A857662

    56. J-690181

    57. Q27077182

    58. B0084-470859

    59. Ag-221; Ag 221; Ag221; Cc-90007; Cc 90007; Cc90007

    60. 1802003-09-3

    61. 69q

    2.4 Create Date
    2015-02-13
    3 Chemical and Physical Properties
    Molecular Weight 473.4 g/mol
    Molecular Formula C19H17F6N7O
    XLogP33.5
    Hydrogen Bond Donor Count3
    Hydrogen Bond Acceptor Count14
    Rotatable Bond Count6
    Exact Mass473.13987716 g/mol
    Monoisotopic Mass473.13987716 g/mol
    Topological Polar Surface Area109 Ų
    Heavy Atom Count33
    Formal Charge0
    Complexity635
    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 1  
    Drug NameIDHIFA
    Active IngredientENASIDENIB MESYLATE
    CompanyCELGENE CORP (Application Number: N209606. Patents: 9512107, 9732062, 9738625)

    4.2 Drug Indication

    Indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-2 (IDH2) mutation.

    FDA Label

    Treatment of acute myeloid leukaemia

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In a study involving adult patients with relapsed or refractory AML, overall response rate of 40.3% was achieved in enasidenib therapy which was associated with cellular differentiation and maturation, typically without evidence of aplasia. Enasidenib is not shown to cause QTc prolongation.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    ENASIDENIB
    5.2.2 FDA UNII
    3T1SS4E7AG
    5.2.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Isocitrate Dehydrogenase 2 Inhibitors
    5.3 ATC Code

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01X - Other antineoplastic agents

    L01XX - Other antineoplastic agents

    L01XX59 - Enasidenib

    5.4 Absorption, Distribution and Excretion

    Absorption

    Following a single oral dose of 100mg enasidenib, the peak plasma concentration of 1.3 mcg/mL is reached at 4 hours after ingestion. The absolute bioavailability is aproximately 57% and the steady-state plasma levels are reached within 29 days of once-daily dosing.

    Route of Elimination

    Elimination of enasidenib involves 89% of fecal excretion and 11% of renal excretion. Unchanged drug accounts for 34% and 0.4% of the total drug detected in the feces and urine, respectively.

    Volume of Distribution

    The mean volume of distribution is 55.8L.

    Clearance

    Enasidenib displays a mean total body clearance (CL/F) of 0.74 L/hour.

    5.5 Metabolism/Metabolites

    Enasidenib undergoes N-dealkylation mediated by multiple CYP (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and UGT (UGT1A1, UGT1A3, UGT1A4, UGT1A9, UGT2B7, and UGT2B15) enzymes to form AGI-16903, as suggested by in vitro studies. AGI-16903 can be further metabolized by CYP1A2, CYP2C19, CYP3A4, UGT1A1, UGT1A3, and UGT1A9. The parent drug accounts for 89% of total detectable drug in the circulation, while AGI-16903 represents 10% of circulating total drug.

    5.6 Biological Half-Life

    Enasidenib has a terminal half-life of 137 hours.

    5.7 Mechanism of Action

    Enasidenib is a selective inhibitor of IDH2, a mitochondria-localized enzyme involved in diverse cellular processes, including adaptation to hypoxia, histone demethylation and DNA modification. Wild-type IDH proteins play a cruicial role in the Krebs/citric acid cycle where it catalyzes the oxidative decarboxylation of isocitrate to -ketoglutarate. In comparison, mutant forms of IDH2 enzyme mediates a neomorphic activity and catalyze reduction of -KG to the (R) enantiomer of 2-hydroxyglutarate, which is associated with DNA and histone hypermethylation, altered gene expression and blocked cellular differentiation of hematopoietic progenitor cells. Enasidenib primarily targets the mutant IDH2 variants R140Q, R172S, and R172K with higher potency than the wild type enzyme form. Inhibition of the enzyme leads to decreased levels of 2-hydroxyglutarate (2-HG) and promotion of proper differentiation and clonal proliferation of cells of the myeloid lineage.

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    ABOUT THIS PAGE

    Enasidenib Manufacturers

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

    Enasidenib Suppliers

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

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

    Enasidenib GMP

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

    Enasidenib CoA

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

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

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