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    Also known as: 1009119-64-5, Daclatasvir (bms-790052), Bms-790052, Daklinza, 1214735-16-6, Ebp 883
    Molecular Formula
    C40H50N8O6
    Molecular Weight
    738.9  g/mol
    InChI Key
    FKRSSPOQAMALKA-CUPIEXAXSA-N
    FDA UNII
    LI2427F9CI
    Daclatasvir
    Daclatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Although the exact mechanism of action of daclatasvir has yet to be fully determined, this agent, upon oral administration and after intracellular uptake, appears to bind to domain I of the NS5A protein. This inhibits the activity of the NS5A protein and results in the disruption of the viral RNA replication complex, blockage of viral HCV RNA production, and inhibition of viral replication. NS5A, a zinc-binding and proline-rich hydrophilic phosphoprotein, plays a crucial role in HCV RNA replication. HCV is a small, enveloped, single-stranded RNA virus belonging to the Flaviviridae family.
    Daclatasvir is a Hepatitis C Virus NS5A Inhibitor. The mechanism of action of daclatasvir is as a P-Glycoprotein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Breast Cancer Resistance Protein Inhibitor.
    1 2D Structure

    Daclatasvir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl N-[(2S)-1-[(2S)-2-[5-[4-[4-[2-[(2S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1H-imidazol-5-yl]phenyl]phenyl]-1H-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate
    2.1.2 InChI
    InChI=1S/C40H50N8O6/c1-23(2)33(45-39(51)53-5)37(49)47-19-7-9-31(47)35-41-21-29(43-35)27-15-11-25(12-16-27)26-13-17-28(18-14-26)30-22-42-36(44-30)32-10-8-20-48(32)38(50)34(24(3)4)46-40(52)54-6/h11-18,21-24,31-34H,7-10,19-20H2,1-6H3,(H,41,43)(H,42,44)(H,45,51)(H,46,52)/t31-,32-,33-,34-/m0/s1
    2.1.3 InChI Key
    FKRSSPOQAMALKA-CUPIEXAXSA-N
    2.1.4 Canonical SMILES
    CC(C)C(C(=O)N1CCCC1C2=NC=C(N2)C3=CC=C(C=C3)C4=CC=C(C=C4)C5=CN=C(N5)C6CCCN6C(=O)C(C(C)C)NC(=O)OC)NC(=O)OC
    2.1.5 Isomeric SMILES
    CC(C)[C@@H](C(=O)N1CCC[C@H]1C2=NC=C(N2)C3=CC=C(C=C3)C4=CC=C(C=C4)C5=CN=C(N5)[C@@H]6CCCN6C(=O)[C@H](C(C)C)NC(=O)OC)NC(=O)OC
    2.2 Other Identifiers
    2.2.1 UNII
    LI2427F9CI
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Bms-790052

    2. Bms-790052-05

    3. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester

    4. Daclatasvir Dihydrochloride

    5. Daklinza

    2.3.2 Depositor-Supplied Synonyms

    1. 1009119-64-5

    2. Daclatasvir (bms-790052)

    3. Bms-790052

    4. Daklinza

    5. 1214735-16-6

    6. Ebp 883

    7. Bms790052

    8. Bms 790052

    9. Daclatasvir [usan]

    10. Methyl N-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

    11. Chebi:82977

    12. Ebp-883

    13. Daclatasvir (usan)

    14. Carbamic Acid, N,n'-[[1,1'-biphenyl]-4,4'-diylbis[1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl[(1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl]]]bis-, C,c'-dimethyl Ester

    15. Carbamic Acid, N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-(2s)-2,1-pyrrolidinediyl((1s)-1-(1-methylethyl)-2-oxo-2,1-ethanediyl)))bis-, C,c'-dimethyl Ester

    16. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dica

    17. 1009119-65-6

    18. Li2427f9ci

    19. Methyl N-[(1s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methyl-butanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1h-imidazol-2-yl]pyrrolidine-1-carbonyl]-2-methyl-propyl]carbamate

    20. Daclatasvir [mi]

    21. Daclatasvir [inn]

    22. Daclatasvir [who-dd]

    23. Dimethyl (2s,2's)-1,1'-((2s,2's)-2,2'-(4,4'-(biphenyl-4,4'-diyl)bis(1h-imidazole-4,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl)dicarbamate

    24. Mls006011140

    25. Ebp883

    26. Schembl2756027

    27. Chembl2023898

    28. Schembl17897804

    29. Gtpl11266

    30. Ex-a410

    31. Dtxsid901026404

    32. Amy36655

    33. Dimethyl ((2s,2's)-((2s,2's)-2,2'-(5,5'-([1,1'-biphenyl]-4,4'-diyl)bis(1h-imidazole-5,2-diyl))bis(pyrrolidine-2,1-diyl))bis(3-methyl-1-oxobutane-2,1-diyl))dicarbamate

    34. Dimethyl N,n'-(biphenyl-4,4'-diylbis{1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1- Diyl)((1s)-1-(1-methylethyl)-2-oxoethane-2,1-diyl)})dicarbamate

    35. Bdbm50387084

    36. Mfcd17129086

    37. S1482

    38. Zinc68204830

    39. Ccg-270425

    40. Cs-0588

    41. Db09102

    42. Ncgc00346533-07

    43. Ncgc00346533-09

    44. Ac-28958

    45. As-75298

    46. Hy-10466

    47. Smr004702917

    48. Sw219754-1

    49. D10065

    50. J-520204

    51. Q5207712

    52. Dimethyl N,n'-((1,1'-biphenyl)-4,4'-diylbis(1h-imidazole-5,2-diyl-((2s)-pyrrolidine-2,1-diyl)((1s)-3-methyl-1-oxobutane-1,2-diyl)))dicarbamate

    53. Methyl ((s)-1-((s)-2-(5-(4'-(2-((s)-1-((methoxycarbonyl)-l-valyl)pyrrolidin-2-yl)-1h-imidazol-5-yl)-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl)pyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamate

    54. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-pyrrolidinyl]-1h-imidazol-4-yl}-4-biphenylyl)-1h-imidazol-2-yl]-1-pyrrolidinyl}-3-methyl-1-oxo-2-butanyl]carbamate

    55. Methyl [(2s)-1-{(2s)-2-[4-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-4-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate

    56. Methyl [(2s)-1-{(2s)-2-[5-(4'-{2-[(2s)-1-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}pyrrolidin-2-yl]-1h-imidazol-5-yl}biphenyl-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl}-3-methyl-1-oxobutan-2-yl]carbamate

    57. Methyl N-[(2s)-1-[(2s)-2-[5-(4'-{2-[(2s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]pyrrolidin-2-yl]-1h-imidazol-5-yl}-[1,1'-biphenyl]-4-yl)-1h-imidazol-2-yl]pyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

    58. Methyl-n-[(2s)-1-[(2s)-2-[5-[4-[4-[2-[(2s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl] Pyrrolidin-2-yl]-1h-imidazol-5-yl]phenyl]phenyl]-1himidazol-2-yl]pyrrolidin-1-yl]3-methyl-1-oxobutan-2-yl]carbamate

    2.4 Create Date
    2009-02-23
    3 Chemical and Physical Properties
    Molecular Weight 738.9 g/mol
    Molecular Formula C40H50N8O6
    XLogP35.1
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count8
    Rotatable Bond Count13
    Exact Mass738.38533134 g/mol
    Monoisotopic Mass738.38533134 g/mol
    Topological Polar Surface Area175 Ų
    Heavy Atom Count54
    Formal Charge0
    Complexity1190
    Isotope Atom Count0
    Defined Atom Stereocenter Count4
    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

    Indicated for use with sofosbuvir, with or without ribavirin, for the treatment of chronic HCV genotype 1a/b or 3 infection. The dosing regimen of 60mg daclatasvir 60 mg with 400mg sofosbuvir once a day is recommended for both genontypes. Resistance: Reduced susceptibility to daclatasvir was associated with the polymorphisms at NS5A amino acid positions M28, Q30, L31, and Y93 in genotypes 1a, 1b, and 3a patients. NS5A Resistance Testing is recommended for HCV genotype 1a-infected patients with cirrhosis prior to the initiaition of the treatment, as the risk of resistance development is higher in genotype 1a patients.

    FDA Label

    Daklinza is indicated in combination with other medicinal products for the treatment of chronic hepatitis C virus (HCV) infection in adults (see sections 4. 2, 4. 4 and 5. 1).

    For HCV genotype specific activity, see sections 4. 4 and 5. 1.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Daclatasvir is a direct-acting antiviral agent that targets the NS5A and causes a decrease in serum HCV RNA levels. It disrupts HCV replication by specifically inhibiting the critical functions of an NS5A protein in the replication complex. It is shown to cause downregulation of the hyperphosphorylation of NS5A. It does not appear to prolong the QT interval even when given at 3 times the maximum recommended dose.

    5.2 FDA Pharmacological Classification
    5.2.1 Active Moiety
    DACLATASVIR
    5.2.2 FDA UNII
    LI2427F9CI
    5.2.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Breast Cancer Resistance Protein Inhibitors
    5.3 ATC Code

    J05AP07

    J - Antiinfectives for systemic use

    J05 - Antivirals for systemic use

    J05A - Direct acting antivirals

    J05AP - Antivirals for treatment of hcv infections

    J05AP07 - Daclatasvir

    5.4 Absorption, Distribution and Excretion

    Absorption

    Studies demonstrated that peak plasma concentrations typically occurred within 2 hours after administration of multiple oral doses ranging from 1 - 100 mg once daily. Steady state is reached after approximately 4 days of once-daily daclatasvir administration. The absolute bioavailability of the tablet formulation is 67%.

    Route of Elimination

    Approximately 88% of total dose of daclatasvir is eliminated into bile and feces in which 53% remains as unchanged form, while 6.6% of the total dose is eliminated primarily unchanged in the urine.

    Volume of Distribution

    The approximate volume of distribution of daclatasvir is 47 L in patients who was orally administered 60 mg tablet followed by 100 g [13C,15N]-daclatasvir intravenously.

    Clearance

    In subjects who received daclatasvir 60 mg tablet orally followed by 100 g radiolabeled daclatasvir intravenously, the total clearance was 4.2 L/h.

    5.5 Metabolism/Metabolites

    Daclastavir is a substrate of CYP3A enzymes where its metabolism is predominantly mediated by CYP3A4 isoform. Oxidative pathways included -oxidation of the pyrrolidine moiety, resulting in ring opening to an aminoaldehyde intermediate followed by an intramolecular reaction between the aldehyde and the proximal imidazole nitrogen atom. High proportion of the drug in the plasma (greater than 97%) is in the unchanged form.

    5.6 Biological Half-Life

    Following multiple dose administration of daclatasvir in HCV-infected subjects, with doses ranging from 1 mg to 100 mg once daily, the terminal elimination half-life of daclatasvir ranged from approximately 12 to 15 hours.

    5.7 Mechanism of Action

    NS5A is a viral nonstructural phospoprotein that is part of a functional replication complex in charge of viral RNA genome amplification on endoplasmic reticulum membranes. It has the ability to bind to HCV RNA. It is shown to have two distinct functions in HCV RNA replication based on phosphorylated states. Maintaining the HCV replication complex is mediated by the cis-acting function of basally phosphorylated NS5A and the trans-acting function of hyperphosphorylated NS5A modulates HCV assembly and infectious particle formation. Daclatasvir is shown to disrupt hyperphosphorylated NS5A proteins thus interfere with the function of new HCV replication complexes. It is also reported that daclatasvir also blocks both intracellular viral RNA synthesis and virion assembly/secretion in vivo.

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AMBEKAR MARG, WADALA","city":"MUMBAI, MAHARASHTRA","supplier":"HANGZHOU YAXIN PHARMACEUTICAL ","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"FREDUN PHARMACEUTICALS LTD.","customerCountry":"INDIA","quantity":"1.00","actualQuantity":"1","unit":"KGS","unitRateFc":"700","totalValueFC":"712.6","currency":"USD","unitRateINR":"52115","date":"01-Jan-2021","totalValueINR":"52115","totalValueInUsd":"712.6","indian_port":"BOMBAY AIR","hs_no":"29420090","bill_no":"2200067","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"","customerAddress":"26, MANOJ INDUSTRIAL ESTATE,G.D. AMBEKAR MARG, WADALA"}]
    01-Jan-2021
    07-Nov-2024
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    ABOUT THIS PAGE

    Daclatasvir Dihydrochloride Manufacturers

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

    Daclatasvir Dihydrochloride Suppliers

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

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

    Daclatasvir Dihydrochloride USDMF

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

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

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

    Daclatasvir Dihydrochloride WC

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

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

    Daclatasvir Dihydrochloride 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 Daclatasvir Dihydrochloride as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Daclatasvir Dihydrochloride GMP

    Daclatasvir Dihydrochloride 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 Daclatasvir Dihydrochloride 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 Daclatasvir Dihydrochloride GMP manufacturer or Daclatasvir Dihydrochloride GMP API supplier for your needs.

    Daclatasvir Dihydrochloride CoA

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

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

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