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    Chemistry

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    Also known as: 1420477-60-6, Acp-196, Calquence, Acalabrutinib (acp-196), Acalabrutinib [inn], I42748elqw
    Molecular Formula
    C26H23N7O2
    Molecular Weight
    465.5  g/mol
    InChI Key
    WDENQIQQYWYTPO-IBGZPJMESA-N
    FDA UNII
    I42748ELQW
    Acalabrutinib
    Acalabrutinib is an orally available inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon administration, acalabrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway. This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B lymphocyte development, activation, signaling, proliferation and survival.
    Acalabrutinib is a Kinase Inhibitor. The mechanism of action of acalabrutinib is as a Tyrosine Kinase Inhibitor.
    1 2D Structure

    Acalabrutinib

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    4-[8-amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide
    2.1.2 InChI
    InChI=1S/C26H23N7O2/c1-2-6-21(34)32-15-5-7-19(32)25-31-22(23-24(27)29-14-16-33(23)25)17-9-11-18(12-10-17)26(35)30-20-8-3-4-13-28-20/h3-4,8-14,16,19H,5,7,15H2,1H3,(H2,27,29)(H,28,30,35)/t19-/m0/s1
    2.1.3 InChI Key
    WDENQIQQYWYTPO-IBGZPJMESA-N
    2.1.4 Canonical SMILES
    CC#CC(=O)N1CCCC1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5
    2.1.5 Isomeric SMILES
    CC#CC(=O)N1CCC[C@H]1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5
    2.2 Other Identifiers
    2.2.1 UNII
    I42748ELQW
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Acp-196

    2. Calquence

    2.3.2 Depositor-Supplied Synonyms

    1. 1420477-60-6

    2. Acp-196

    3. Calquence

    4. Acalabrutinib (acp-196)

    5. Acalabrutinib [inn]

    6. I42748elqw

    7. 4-[8-amino-3-[(2s)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-n-pyridin-2-ylbenzamide

    8. Benzamide, 4-(8-amino-3-((2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl)imidazo(1,5-a)pyrazin-1-yl)-n-2-pyridinyl-

    9. (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide

    10. Acalabrutinib(acp196)

    11. Acalabrutinib [usan:inn]

    12. Acalabrutinibum

    13. Unii-i42748elqw

    14. Calquence (tn)

    15. Benzamide, 4-[8-amino-3-[(2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-n-2-pyridinyl-

    16. Acp-196;acalabrutinib

    17. Acalabrutinib [mi]

    18. Acalabrutinib [jan]

    19. Acalabrutinib [usan]

    20. Acalabrutinib [who-dd]

    21. Gtpl8912

    22. Acalabrutinib (jan/usan/inn)

    23. Chembl3707348

    24. Schembl14637368

    25. Acp 196

    26. Amy5290

    27. Ex-a881

    28. Chebi:167707

    29. Dtxsid401026209

    30. Acalabrutinib [orange Book]

    31. Bdbm50175583

    32. Mfcd29472294

    33. Nsc791164

    34. Nsc800976

    35. S8116

    36. Zinc208774715

    37. Ccg-269407

    38. Cs-5356

    39. Db11703

    40. Ds-3326

    41. Nsc-791164

    42. Nsc-800976

    43. Ncgc00479074-01

    44. Hy-17600

    45. Example 6 [us20140155385 A1]

    46. D10893

    47. A857446

    48. J-690166

    49. Q23668732

    50. (s)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide;acalabrutinib

    51. (s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide

    52. 4-[8-amino-3-[(2s)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-n-2-pyridinyl-benzamide

    53. 4-[8-amino-3-[(2s)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-n-(2-pyridyl)benzamide

    54. 4-{8-amino-3-[(2s)-1-(but-2-ynoyl)pyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl}-n-(pyridin-2-yl)benzamide

    2.4 Create Date
    2013-03-21
    3 Chemical and Physical Properties
    Molecular Weight 465.5 g/mol
    Molecular Formula C26H23N7O2
    XLogP33
    Hydrogen Bond Donor Count2
    Hydrogen Bond Acceptor Count6
    Rotatable Bond Count4
    Exact Mass465.19132300 g/mol
    Monoisotopic Mass465.19132300 g/mol
    Topological Polar Surface Area119 Ų
    Heavy Atom Count35
    Formal Charge0
    Complexity845
    Isotope Atom Count0
    Defined Atom Stereocenter Count1
    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 NameCALQUENCE
    Active IngredientACALABRUTINIB
    CompanyASTRAZENECA (Application Number: N210259. Patents: 9290504, 9758524, 9796721)

    4.2 Drug Indication

    Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy. It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.

    FDA Label

    Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).

    Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Acalabrutinib is a Bruton Tyrosine Kinase inhibitor that prevents the proliferation, trafficking, chemotaxis, and adhesion of B cells. It is taken every 12 hours and can cause other effects such as atrial fibrillation, other malignancies, cytopenia, hemorrhage, and infection.

    5.2 MeSH Pharmacological Classification

    Antineoplastic Agents

    Substances that inhibit or prevent the proliferation of NEOPLASMS. (See all compounds classified as Antineoplastic Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    ACALABRUTINIB
    5.3.2 FDA UNII
    I42748ELQW
    5.3.3 Pharmacological Classes
    Tyrosine Kinase Inhibitors [MoA]; Kinase Inhibitor [EPC]
    5.4 ATC Code

    L01XE51

    L - Antineoplastic and immunomodulating agents

    L01 - Antineoplastic agents

    L01E - Protein kinase inhibitors

    L01EL - Bruton's tyrosine kinase (btk) inhibitors

    L01EL02 - Acalabrutinib

    5.5 Absorption, Distribution and Excretion

    Absorption

    The geometric mean absolute bioavailability of acalabrutinib is 25% with a median time to peak plasma concentrations (Tmax) of 0.75 hours.

    Route of Elimination

    After administration of a single 100 mg radiolabelled acalabrutinib dose in healthy subjects, 84% of the dose was recovered in the feces and 12% of the dose was recovered in the urine. An irradiated dose of acalabrutinib was 34.7% recovered as the metabolite ACP-5862; 8.6% was recovered as unchanged acalabrutinub; 10.8 was recovered as a mixture of the M7, M8, M9, M10, and M11 metabolites; 5.9% was the M25 metabolite; 2.5% was recovered as the M3 metabolite.

    Volume of Distribution

    The mean steady-state volume of distribution is approximately 34 L.

    Clearance

    Acalabrutinib's mean apparent oral clearance (CL/F) is observed to be 159 L/hr with similar PK between patients and healthy subjects, based on population PK analysis.

    5.6 Metabolism/Metabolites

    Acalabrutinib is mainly metabolized by CYP3A enzymes. ACP-5862 is identified to be the major active metabolite in plasma with a geometric mean exposure (AUC) that is about 2-3 times greater than the exposure of acalabrutinib. ACP-5862 is about 50% less potent than acalabrutinib in regards to the inhibition of BTK.

    5.7 Biological Half-Life

    After administering a single oral dose of 100 mg acalabrutinib, the median terminal elimination half-life of the drug was found to be 0.9 (with a range of 0.6 to 2.8) hours. The half-life of the active metabolite, ACP-5862, is about 6.9 hours.

    5.8 Mechanism of Action

    Mantle Cell Lymphoma (MCL) is a rare yet aggressive type of B-cell non-Hodgkin lymphoma (NHL) with poor prognosis. Subsequently, relapse is common in MCL patients and ultimately represents disease progression. Lymphoma occurs when immune system lymphocytes grow and multiply uncontrollably. Such cancerous lymphocytes may travel to many parts of the body, including the lymph nodes, spleen, bone marrow, blood, and other organs where they can multiply and form a mass(es) called a tumor. One of the main kinds of lymphocytes that can develop into cancerous lymphomas are the body's own B-lymphocytes (B-cells). Bruton Tyrosine Kinase (BTK) is a signalling molecule of the B-cell antigen receptor and cytokine receptor pathways. Such BTK signaling causes the activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. Acalabrutinib is a small molecule inhibitor of BTK. Both acalabrutinib and its active metabolite, ACP-5862, act to form a covalent bond with a cysteine residue (Cys481) in the BTK active site, leading to inhibition of BTK enzymatic activity. As a result, acalabrutinib inhibits BTK-mediated activation of downstream signaling proteins CD86 and CD69, which ultimately inhibits malignant B-cell proliferation and survival Whereas ibrutinib is typically recognized as the first-in-class BTK inhibitor, acalabrutinib is considered a second generation BTK inhibitor primarily because it demonstrates highter selectivity and inhibition of the targeted activity of BTK while having a much greater IC50 or otherwise virtually no inhibition on the kinase activities of ITK, EGFR, ERBB2, ERBB4, JAK3, BLK, FGR, FYN, HCK, LCK, LYN, SRC, and YES1. In effect, acalabrutinib was rationally designed to be more potent and selective than ibrutinib, all the while demonstrating fewer adverse effects - in theory - because of the drug's minimized off target effects.

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    ABOUT THIS PAGE

    Acalabrutinib Manufacturers

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

    Acalabrutinib Suppliers

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

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

    Acalabrutinib USDMF

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

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

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    Acalabrutinib KDMF

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

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

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

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    Acalabrutinib WC

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

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    Acalabrutinib 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 Acalabrutinib as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Acalabrutinib GMP

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

    Acalabrutinib CoA

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

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

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