menu
    • menu

    Find Tirbanibulin manufacturers, exporters & distributors on PharmaCompass

    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

    Virtual Booth

    Contact Supplier

    Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

    Virtual Booth

    Contact Supplier

    Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

    Virtual Booth

    Contact Supplier

    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

    Virtual Booth

    Contact Supplier

    Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2025-01-06

    Virtual Booth

    Contact Supplier

    ACTIVE PHARMA INGREDIENTS

    DEVELOPMENTS

    FINISHED DOSAGE FORMULATIONS

    DIGITAL CONTENT

    GLOBAL SALES INFORMATION

    MARKET PLACE

    PATENTS & EXCLUSIVITIES

    PharmaCompass

    Synopsis

    Product SearchProduct Search

    Synopsis

    ACTIVE PHARMA INGREDIENTS

    4

    API Suppliers

    API Suppliers

    3

    USDMF

    US DMFs Filed

    0

    CEP/COS

    CEP/COS Certifications

    0

    JDMF

    JDMFs Filed

    0

    EU WC

    EU WC

    0

    KDMF

    KDMF

    0

    NDC API

    NDC API

    0

    VMF

    NDC API

    3

    Listed Suppliers

    Other Suppliers

    API REF. PRICE (USD/KG)

    $
    $ 0

    MARKET PLACE

    1

    API

    0

    FDF

    0INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    2

    FDF Dossiers

    FDF Dossiers

    1

    FDA Orange Book

    FDA (Orange Book)

    1

    Europe

    Europe

    0

    Canada

    Canada

    0

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Listed Dossiers

    Listed Dossiers

    11DRUGS IN DEVELOPMENT

    FDF Dossiers

    DRUG PRODUCT COMPOSITIONS

    REF. STANDARDS OR IMPURITIES

    0

    EDQM

    0

    USP

    0

    JP

    0

    Others

    PATENTS & EXCLUSIVITIES

    8

    US Patents

    2

    US Exclusivities

    0

    Health Canada Patents

    DIGITAL CONTENT

    2

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    8

    News #PharmaBuzz

    GLOBAL SALES INFORMATION

    US Medicaid

    2,124,928

    Annual Reports

    NA

    Finished Drug Prices

    Listed Dossiers

    0RELATED EXCIPIENT COMPANIES

    0EXCIPIENTS BY APPLICATIONS

    Chemistry

    Click the arrow to open the dropdown
    read-moreClick the button for full data set
    read-moreClick the button for full data set
    Also known as: Kx2-391, 897016-82-9, Tirbanibulin, Kx-01, Klisyri, Kx-2-391
    Molecular Formula
    C26H29N3O3
    Molecular Weight
    431.5  g/mol
    InChI Key
    HUNGUWOZPQBXGX-UHFFFAOYSA-N
    FDA UNII
    4V9848RS5G
    Tirbanibulin
    Tirbanibulin is an orally bioavailable small molecule Src kinase inhibitor with potential antineoplastic activity. Unlike other Src kinase inhibitors which bind to the ATP-binding site, tirbanibulin specifically binds to the peptide substrate binding site of Src kinase; inhibition of kinase activity may result in the inhibition of primary tumor growth and the suppression of metastasis. Src tyrosine kinases are upregulated in many tumor cells and play important roles in tumor cell proliferation and metastasis.
    Tirbanibulin is a Microtubule Inhibitor. The physiologic effect of tirbanibulin is by means of Microtubule Inhibition.
    1 2D Structure

    Tirbanibulin

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    N-benzyl-2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]pyridin-2-yl]acetamide
    2.1.2 InChI
    InChI=1S/C26H29N3O3/c30-26(28-19-21-4-2-1-3-5-21)18-24-9-6-23(20-27-24)22-7-10-25(11-8-22)32-17-14-29-12-15-31-16-13-29/h1-11,20H,12-19H2,(H,28,30)
    2.1.3 InChI Key
    HUNGUWOZPQBXGX-UHFFFAOYSA-N
    2.1.4 Canonical SMILES
    C1COCCN1CCOC2=CC=C(C=C2)C3=CN=C(C=C3)CC(=O)NCC4=CC=CC=C4
    2.2 Other Identifiers
    2.2.1 UNII
    4V9848RS5G
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Klisyri

    2. Kx-01

    3. Kx2-391

    4. N-benzyl-2-(5-(4-(2-(4-morpholinyl)ethoxy)phenyl)-2-pyridinyl)acetamide

    5. Tirbanibulin

    2.3.2 Depositor-Supplied Synonyms

    1. Kx2-391

    2. 897016-82-9

    3. Tirbanibulin

    4. Kx-01

    5. Klisyri

    6. Kx-2-391

    7. Kx-2391

    8. Kx01

    9. Tirbanibulin [usan]

    10. Kx2391

    11. Chembl571546

    12. 4v9848rs5g

    13. Kx2-391;kx-01

    14. 2-pyridineacetamide, 5-(4-(2-(4-morpholinyl)ethoxy)phenyl)-n-(phenylmethyl)-

    15. N-benzyl-2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]pyridin-2-yl]acetamide

    16. 2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]pyridin-2-yl]-~{n}-(phenylmethyl)ethanamide

    17. Unii-4v9848rs5g

    18. N-benzyl-2-(5-(4-(2-morpholin-4-ylethoxy)phenyl)pyridin-2-yl)acetamide

    19. Kx 01

    20. Tirbanibulin (usan/inn)

    21. Tirbanibulin [inn]

    22. Kx2-391 (tirbanibulin)

    23. Tirbanibulin (kx2-391)

    24. Mls006011272

    25. Schembl153779

    26. Tirbanibulin [who-dd]

    27. Gtpl7957

    28. Dtxsid30237862

    29. Hms3656j15

    30. Hms3673e15

    31. Tirbanibulin [orange Book]

    32. Bcp02845

    33. Ex-a2434

    34. Xkb01682

    35. Bdbm50303801

    36. Nsc756643

    37. Nsc800779

    38. S2700

    39. Who 10864

    40. Zinc43152787

    41. N-benzyl-2-(5-{4-[2-(morpholin-4-yl)ethoxy]phenyl}pyridin-2-yl)acetamide

    42. Bcp9000828

    43. Ccg-264983

    44. Cs-0248

    45. Db06137

    46. Kx2-391; Kx-01

    47. Nsc-756643

    48. Nsc-800779

    49. Sb16619

    50. Ncgc00346644-01

    51. Ncgc00346644-05

    52. Ac-35458

    53. As-73245

    54. Hy-10340

    55. Kx 2-391

    56. Smr004703022

    57. Db-119272

    58. Sw219670-1

    59. C77028

    60. D11691

    61. A915990

    62. Brd-k29968218-001-01-6

    63. Q27888424

    64. 2-(5-(4-(2-morpholinoethoxy)phenyl)pyridin-2-yl)-n-benzylacetamide

    65. 2-(5-(4-(2-morpholinoethoxyl)phenyl)pyridin-2-yl)-n-benzylacetamide

    66. 2-[5-[4-(2-morpholin-4-ylethoxy)phenyl]pyridin-2-yl]-n-(phenylmethyl)acetamide

    67. 2-pyridineacetamide,5-[4-[2-(4-morpholinyl)ethoxy]phenyl]-n-(phenylmethyl)-

    68. 5-[4-[2-(4-morpholinyl)ethoxy]phenyl]-n-(phenylmethyl)-2-pyridineacetamide

    69. Dn0

    2.4 Create Date
    2008-01-07
    3 Chemical and Physical Properties
    Molecular Weight 431.5 g/mol
    Molecular Formula C26H29N3O3
    XLogP32.9
    Hydrogen Bond Donor Count1
    Hydrogen Bond Acceptor Count5
    Rotatable Bond Count9
    Exact Mass431.22089180 g/mol
    Monoisotopic Mass431.22089180 g/mol
    Topological Polar Surface Area63.7 Ų
    Heavy Atom Count32
    Formal Charge0
    Complexity540
    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 Indication

    Tirbanibulin is indicated for the topical treatment of actinic keratosis on the face or scalp.

    Klisyri is indicated for the field treatment of non-hyperkeratotic, non-hypertrophic actinic keratosis (Olsen grade 1) of the face or scalp in adults.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    In clinical trials composed comprising patients with actinic keratosis of the face or scalp, tirbanibulin promoted complete clearance of actinic keratosis lesions at day 57 in treated areas in 44-54% of patients compared to 5-13% of patients who received the placebo. Actinic keratosis is a chronic, pre-malignant condition characterized by lesions and proliferation of neoplastic keratinocytes. Tirbanibulin mediates an anti-proliferative effect by inhibiting tubulin polymerization and Src kinase signalling. Tirbanibulin inhibited primary tumour growth and metastasis in many preclinical animal models of cancer. In human triple-negative breast cancer, or estrogen receptor (ER)/progesterone receptor (PR)/human epidermal growth factor receptor 2 (HER2)-negative tumour, xenografts, tirbanibulin suppressed tumour growth and metastasis. Tirbanibulin was also shown to restore functional ER expression in ER-negative breast tumours. Tirbanibulin promoted synergistic tumour growth inhibition of breast cancer cell lines when used in combination with tamoxifen and paclitaxel. In a clinical trial comprising patients with advanced solid tumours, dose-limiting toxicities of tirbanibulin included elevated liver transaminases, neutropenia and fatigue.

    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
    TIRBANIBULIN
    5.3.2 FDA UNII
    4V9848RS5G
    5.3.3 Pharmacological Classes
    Established Pharmacologic Class [EPC] - Microtubule Inhibitor
    5.4 ATC Code

    D06BX03

    D - Dermatologicals

    D06 - Antibiotics and chemotherapeutics for dermatological use

    D06B - Chemotherapeutics for topical use

    D06BX - Other chemotherapeutics

    D06BX03 - Tirbanibulin

    5.5 Absorption, Distribution and Excretion

    Absorption

    Tirbanibulin demonstrates good oral bioavailability. Following topical administration of doses ranging from 54 to 295 mg on the face or scalp, the steady-state concentration of tirbanibulin was achieved by 72 hours. At five days following initial administration, the mean Cmax was 0.340.30 ng/mL in subjects who received topical treatment on the face and 0.180.10 ng/mL in subjects who received topical treatment on the scalp. The mean AUC24 was 5.03.9 h x ng/mL in subjects who received topical treatment on the face and 3.21.9 h x ng/mL in subjects who received topical treatment on the scalp. The median Tmax was about seven hours.

    Route of Elimination

    There is limited information on the route of elimination of tirbanibulin.

    Volume of Distribution

    There is limited information on the volume of distribution of tirbanibulin. In mouse HT29 xenograft studies, the tissue to plasma ration of tirbanibulin was 1.52.

    Clearance

    There is limited information on the clearance rate of tirbanibulin.

    5.6 Metabolism/Metabolites

    _In vitro_, tirbanibulin is mainly metabolized by CYP3A4, and to a lesser extent, CYP2C8. In adult subjects with actinic keratosis, detected metabolites were KX2-5036 and KX2-5163, which were pharmacologically inactive metabolites with the highest plasma concentrations of 0.09 ng/mL and 0.12 ng/mL, respectively.

    5.7 Biological Half-Life

    The half-life is about 4 hours.

    5.8 Mechanism of Action

    Src tyrosine kinases regulate normal cell growth: the expression of Src kinase is upregulated during the normal hair cycle during the proliferative anagen phase. Additionally, Src tyrosine kinases act as key modulators of cancer cell proliferation, survival, angiogenesis, migration, invasion and metastasis. Src is frequently upregulated in various epithelial tumours including colon, breast and pancreas compared with the adjacent normal tissues. The expression and activity of Src are also enhanced in human actinic keratosis, which is characterized by hyperproliferative premalignant skin lesions. The pathogenesis of actinic keratosis commonly involves skin inflammation, oxidative stress, immunosuppression, impaired apoptosis, mutagenesis, dysregulation of keratinocyte growth and proliferation, and tissue remodelling. _In vitro_ studies suggest that Src plays a predominant role in the early stages of human skin tumour development, rather than at later stages of tumour progression. The exact mechanism of tirbanibulin as a topical treatment of actinic keratosis has not been fully elucidated; however, it mainly works by inhibiting fast proliferating cells. Tirbanibulin is a non-ATP competitive Src kinase inhibitor and tubulin polymerization inhibitor. It binds to the peptide substrate binding site of Src, a primary target of tirbanibulin, and blocking its downstream signalling pathways that promote cancer cell migration, proliferation, and survival. Tublin is responsible for cell migration, protein transport, and mitosis: tibranibulin directly binds to the colchicine-binding site of beta-tubulin and causes induces tubulin depolymerization. It is also hypothesized that inhibition of Src can also contribute to the inhibitory effects on microtubule polymerization. At low nanomolar concentrations, tirbanibulin induces G2/M phase cell cycle arrest in a reversible and dose-dependent manner. By inhibiting microtubule polymerization, tirbanibulin also induces mitotic catastrophe.

    API SUPPLIERS

    read-more
    read-more
    Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

    Digital Content read-more

    Create Content with PharmaCompass, ask us

    DATA COMPILATION #PharmaFlow

    read-more
    read-more

    NEWS #PharmaBuzz

    read-more
    read-more

    Global Sales Information

    Do you need Business Intel? Ask us

    Market Place

    Do you need sourcing support? Ask us

    Patents & EXCLUSIVITIES

    Check the patents & exclusivity for this product

    ABOUT THIS PAGE

    Tirbanibulin Manufacturers

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

    Tirbanibulin Suppliers

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

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

    Tirbanibulin USDMF

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

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

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

    Tirbanibulin GMP

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

    Tirbanibulin CoA

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

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

    Tirbanibulin may be tested according to a variety of international standards, such as European Pharmacopoeia (Tirbanibulin EP), Tirbanibulin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tirbanibulin 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.
    Ask Us for Pharmaceutical Supplier and Partner
    Ask Us, Find A Supplier / Partner
    No Commissions, No Strings Attached, Get Connected for FREE

    What are you looking for?

    How can we help you?

    The request can't be empty

    Please read our Privacy Policy carefully

    You must agree to the privacy policy

    The name can't be empty
    The company can't be empty.
    The email can't be empty Please enter a valid email.
    The mobile can't be empty

    Market Place

    Market Place

    PharmaCompass

    Home

    Market Place

    Menu

    Post Enquiry

    Post Enquiry

    Market Place

    Market Place

    Search