menu
    • menu

    Find Odevixibat manufacturers, exporters & distributors on PharmaCompass

    Suanfarma, at the Core of a Better Life.

    Virtual Booth

    Contact Supplier

    Bloomage is a one-stop source for CEP Sodium Hyaluronate and Hyaluronic Acid// FDA-inspected & GMP-certified.

    Virtual Booth

    Contact Supplier

    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

    Virtual Booth

    Contact Supplier

    Rochem, your partner in developing, sourcing, and supplying pharmaceutical & animal health ingredients of Chinese origin.

    Virtual Booth

    Contact Supplier

    Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

    Virtual Booth

    Contact Supplier

    xyz-pharma-m-2025-01-20

    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

    2

    API Suppliers

    API Suppliers

    0

    USDMF

    US DMFs Filed

    0

    CEP/COS

    CEP/COS Certifications

    0

    JDMF

    JDMFs Filed

    1

    EU WC

    EU WC

    0

    KDMF

    KDMF

    0

    NDC API

    NDC API

    0

    VMF

    NDC API

    1

    Listed Suppliers

    Other Suppliers

    API REF. PRICE (USD/KG)

    $
    $ 0

    MARKET PLACE

    3

    API

    0

    FDF

    0INTERMEDIATES

    FINISHED DOSAGE FORMULATIONS

    8

    FDF Dossiers

    FDF Dossiers

    4

    FDA Orange Book

    FDA (Orange Book)

    0

    Europe

    Europe

    4

    Canada

    Canada

    0

    Australia

    Australia

    0

    South Africa

    South Africa

    0

    Listed Dossiers

    Listed Dossiers

    38DRUGS IN DEVELOPMENT

    FDF Dossiers

    DRUG PRODUCT COMPOSITIONS

    REF. STANDARDS OR IMPURITIES

    0

    EDQM

    0

    USP

    0

    JP

    0

    Others

    PATENTS & EXCLUSIVITIES

    132

    US Patents

    16

    US Exclusivities

    0

    Health Canada Patents

    DIGITAL CONTENT

    1

    Data Compilation #PharmaFlow

    0

    Stock Recap #PipelineProspector

    0

    Weekly News Recap #Phispers

    35

    News #PharmaBuzz

    GLOBAL SALES INFORMATION

    US Medicaid

    1,258,158

    Annual Reports

    80

    Finished Drug Prices

    NA

    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: 501692-44-0, Azd8294, A4250, Ar-h064974, Odevixibat [usan], A-4250
    Molecular Formula
    C37H48N4O8S2
    Molecular Weight
    740.9  g/mol
    InChI Key
    XULSCZPZVQIMFM-IPZQJPLYSA-N
    FDA UNII
    2W150K0UUC
    Odevixibat
    Odevixibat, or A4250, is an ileal sodium/bile acid cotransporter inhibitor indicated for the treatment of pruritus in patients older than 3 months, with progressive familiar intrahepatic cholestasis (PFIC). Odevixibat is the first approved non-surgical treatment option for PFIC. Previous therapies for PFIC included a bile acid sequestrant such as [ursodeoxycholic acid]. Odevixibat was granted FDA approval on 20 July 2021.
    Odevixibat is an Ileal Bile Acid Transporter Inhibitor. The mechanism of action of odevixibat is as an Ileal Bile Acid Transporter Inhibitor.
    1 2D Structure

    Odevixibat

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-2-[[(2R)-2-[[2-[(3,3-dibutyl-7-methylsulfanyl-1,1-dioxo-5-phenyl-2,4-dihydro-16,2,5-benzothiadiazepin-8-yl)oxy]acetyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]butanoic acid
    2.1.2 InChI
    InChI=1S/C37H48N4O8S2/c1-5-8-19-37(20-9-6-2)24-41(26-13-11-10-12-14-26)29-21-31(50-4)30(22-32(29)51(47,48)40-37)49-23-33(43)39-34(25-15-17-27(42)18-16-25)35(44)38-28(7-3)36(45)46/h10-18,21-22,28,34,40,42H,5-9,19-20,23-24H2,1-4H3,(H,38,44)(H,39,43)(H,45,46)/t28-,34+/m0/s1
    2.1.3 InChI Key
    XULSCZPZVQIMFM-IPZQJPLYSA-N
    2.1.4 Canonical SMILES
    CCCCC1(CN(C2=CC(=C(C=C2S(=O)(=O)N1)OCC(=O)NC(C3=CC=C(C=C3)O)C(=O)NC(CC)C(=O)O)SC)C4=CC=CC=C4)CCCC
    2.1.5 Isomeric SMILES
    CCCCC1(CN(C2=CC(=C(C=C2S(=O)(=O)N1)OCC(=O)N[C@H](C3=CC=C(C=C3)O)C(=O)N[C@@H](CC)C(=O)O)SC)C4=CC=CC=C4)CCCC
    2.2 Other Identifiers
    2.2.1 UNII
    2W150K0UUC
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. (2s)-2-(((2r)-2-((((3,3-dibutyl-7-(methylsulfanyl)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro-1,2,5-benzothiadiazepin-8-yl)oxy)acetyl)amino)-2-(4-hydroxyphenyl)acetyl)amino)butanoic Acid

    2. Bylvay

    2.3.2 Depositor-Supplied Synonyms

    1. 501692-44-0

    2. Azd8294

    3. A4250

    4. Ar-h064974

    5. Odevixibat [usan]

    6. A-4250

    7. 2w150k0uuc

    8. Azd-8294

    9. Odevixibat (usan)

    10. (2s)-2-[[(2r)-2-[[2-[(3,3-dibutyl-7-methylsulfanyl-1,1-dioxo-5-phenyl-2,4-dihydro-1lambda6,2,5-benzothiadiazepin-8-yl)oxy]acetyl]amino]-2-(4-hydroxyphenyl)acetyl]amino]butanoic Acid

    11. (s)-2-((r)-2-(2-((3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydrobenzo[f][1,2,5]thiadiazepin-8-yl)oxy)acetamido)-2-(4-hydroxyphenyl)acetamido)butanoic Acid

    12. Butanoic Acid, 2-(((2r)-((((3,3-dibutyl-2,3,4,5-tetrahydro-7-(methylthio)-1,1-dioxido-5-phenyl-1,2,5-benzothiadiazepin-8-yl)oxy)acetyl)amino)(4-hydroxyphenyl)acetyl)amino)-, (2s)-

    13. Butanoic Acid, 2-(((2r)-2-((2-((3,3-dibutyl-2,3,4,5-tetrahydro-7-(methylthio)-1,1-dioxido-5-phenyl-1,2,5-benzothiadiazepin-8-yl)oxy)acetyl)amino)-2-(4-hydroxyphenyl)acetyl)amino)-, (2s)-

    14. Odevixibat [inn]

    15. Odevixibat [who-dd]

    16. Unii-2w150k0uuc

    17. Schembl946468

    18. Chembl4297588

    19. Odevixibat [orange Book]

    20. Bdbm77040

    21. Gtpl11194

    22. Dtxsid601336860

    23. Ex-a5384

    24. Example 5 [us9694018b1]

    25. Who 10706

    26. At28924

    27. Bo181253

    28. Hy-109120

    29. Unk-d-ntyr-abu-oh (iupac Condensed Name)

    30. Cs-0078340

    31. D11716

    32. Us9694018, 5

    33. (2s)-2-(((2r)-2-((((3,3-dibutyl-7-(methylthio)-1,1-dioxido-5-phenyl-2,3,4,5-tetrahydro- 1,2,5-benzothiadiazepin-8-yl)oxy)acetyl)amino)-2-(4-hydroxyphenyl)acetyl)amino)butanoic Acid

    2.4 Create Date
    2006-10-25
    3 Chemical and Physical Properties
    Molecular Weight 740.9 g/mol
    Molecular Formula C37H48N4O8S2
    XLogP36.8
    Hydrogen Bond Donor Count5
    Hydrogen Bond Acceptor Count11
    Rotatable Bond Count17
    Exact Mass740.29135685 g/mol
    Monoisotopic Mass740.29135685 g/mol
    Topological Polar Surface Area208 Ų
    Heavy Atom Count51
    Formal Charge0
    Complexity1230
    Isotope Atom Count0
    Defined Atom Stereocenter Count2
    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

    Odevixibat is indicated for the treatment of pruritus in patients older than 3 months, with progressive familiar intrahepatic cholestasis (PFIC). It may not be effective in PFIC type 2 with ABCB11 variants. These patients lack a functional bile salt export pump.

    Treatment of biliary atresia

    Treatment of Progressive Familial Intrahepatic Cholestasis

    Bylvay is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older (see sections 4. 4 and 5. 1).

    Treatment of Alagille syndrome

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Odevixibat, or A4250, is an ileal sodium/bile acid cotransporter inhibitor indicated for the treatment of pruritus in patients older than 3 months, with progressive familiar intrahepatic cholestasis (PFIC). It has a moderate duration of action as it is given once daily. Odevixibat has a wide therapeutic index as patients were given single doses up to 10 mg while the maximum therapeutic dose is 6 mg daily. Patients should be counselled regarding the risks of elevated liver function tests, diarrhea, and fat soluble vitamin defiencies.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    ODEVIXIBAT
    5.2.2 FDA UNII
    2W150K0UUC
    5.2.3 Pharmacological Classes
    Ileal Bile Acid Transporter Inhibitors [MoA]; Ileal Bile Acid Transporter Inhibitor [EPC]
    5.3 ATC Code

    A05AX

    A - Alimentary tract and metabolism

    A05 - Bile and liver therapy

    A05A - Bile therapy

    A05AX - Other drugs for bile therapy

    A05AX05 - Odevixibat

    5.4 Absorption, Distribution and Excretion

    Absorption

    A 7.2 mg single oral dose of odevixibat in adults reaches a Cmax of 0.47 ng/mL, with an AUC0-24h of 2.19 h\*ng/mL. The majority of adult and pediatric patients, given a therapeutic dose, do not have detectable plasma concentrations of odevixibat.

    Route of Elimination

    Odevixibat is 82.9% recovered in the feces and <0.002% recovered in the urine. The dose recovered in the feces is 97% unchanged parent compound.

    Volume of Distribution

    The majority of adult and pediatric patients, given a therapeutic dose, do not have detectable plasma concentrations of odevixibat. Therefore, a volume of distribution has not been calculated.

    Clearance

    The majority of adult and pediatric patients, given a therapeutic dose, do not have detectable plasma concentrations of odevixibat. Therefore, the clearance has not been calculated.

    5.5 Metabolism/Metabolites

    Odevixibat is largely unmetabolized, however a small amount is metabolized _in vitro_ by mono-hydroxylation. The exact structure of the metabolite has not been characterized as a primary endpoint of the clinical trial was to characterize the structure of metabolites accounting for >10% of the dose in plasma, urine, or feces. No metabolites have been identified at such a high concentration.

    5.6 Biological Half-Life

    A 7.2 mg oral dose of odevixibat has a mean half life of 2.36 hours in adults.

    5.7 Mechanism of Action

    Progressive familiar intrahepatic cholestasis (PFIC) is a group of autosomal recessive disorders leading to cholestasis, fibrosis, and eventually a need for liver transplantation. Patients with PFIC require liver transplants or develop hepatocellular carcinomas in their first few years of life. Many of these patients experience severe pruritus. The exact mechanism of pruritus is PFIC is not known, but lower concentrations of bile acids have been shown to reduce pruritus. Patients with certain forms of PFIC type 2, associated with a non-functional or absent bile salt export pump, are not expected to benefit from odevixibat treatment. The ileal sodium/bile acid cotransporter is a transport glycoprotein responsible for reabsorption of 95% of bile acids in the distal ileum. Odevixibat is a reversible inhibitor of the ileal sodium/bile acid contransporter. Patients taking odevixibat for a week experienced a 56% reduction in bile acid area under the curve with a 3 mg once daily dose. A 1.5 mg daily dose lead to a 43% reduction in bile acid area under the curve. The decreased reabsorption of bile acids, leads to reduced stimulation of FXR, which reduces expression of FGF19, reducing binding of FGF19 to FGF4R, decreasing inhibition of bile acid synthesis. Further synthesis of bile acids that will not be reabsorbed in the intestine contributes to lowering low density lipoprotein levels.

    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

    Odevixibat Manufacturers

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

    Odevixibat Suppliers

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

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

    Odevixibat WC

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

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

    Odevixibat GMP

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

    Odevixibat CoA

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

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

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