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    Also known as: 1256388-51-8, Gs-5885, Gs5885, Ledipasvir acetonate, Gs 5885, Ledipasvir [usan]
    Molecular Formula
    C49H54F2N8O6
    Molecular Weight
    889.0  g/mol
    InChI Key
    VRTWBAAJJOHBQU-KMWAZVGDSA-N
    FDA UNII
    013TE6E4WV
    Ledipasvir
    Ledipasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Upon oral administration and after intracellular uptake, ledipasvir binds to and blocks the activity of the NS5A protein. This results in the disruption of the viral RNA replication complex, blockage of 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; HCV infection is associated with the development of hepatocellular carcinoma (HCC).
    Ledipasvir is a Hepatitis C Virus NS5A Inhibitor. The mechanism of action of ledipasvir is as a P-Glycoprotein Inhibitor, and Breast Cancer Resistance Protein Inhibitor.
    1 2D Structure

    Ledipasvir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl N-[(2S)-1-[(6S)-6-[5-[9,9-difluoro-7-[2-[(1R,3S,4S)-2-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-2-azabicyclo[2.2.1]heptan-3-yl]-3H-benzimidazol-5-yl]fluoren-2-yl]-1H-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbamate
    2.1.2 InChI
    InChI=1S/C49H54F2N8O6/c1-24(2)39(56-46(62)64-5)44(60)58-23-48(15-16-48)21-38(58)42-52-22-37(55-42)28-9-13-32-31-12-8-26(18-33(31)49(50,51)34(32)19-28)27-10-14-35-36(20-27)54-43(53-35)41-29-7-11-30(17-29)59(41)45(61)40(25(3)4)57-47(63)65-6/h8-10,12-14,18-20,22,24-25,29-30,38-41H,7,11,15-17,21,23H2,1-6H3,(H,52,55)(H,53,54)(H,56,62)(H,57,63)/t29-,30+,38-,39-,40-,41-/m0/s1
    2.1.3 InChI Key
    VRTWBAAJJOHBQU-KMWAZVGDSA-N
    2.1.4 Canonical SMILES
    CC(C)C(C(=O)N1CC2(CC2)CC1C3=NC=C(N3)C4=CC5=C(C=C4)C6=C(C5(F)F)C=C(C=C6)C7=CC8=C(C=C7)N=C(N8)C9C1CCC(C1)N9C(=O)C(C(C)C)NC(=O)OC)NC(=O)OC
    2.1.5 Isomeric SMILES
    CC(C)[C@@H](C(=O)N1CC2(CC2)C[C@H]1C3=NC=C(N3)C4=CC5=C(C=C4)C6=C(C5(F)F)C=C(C=C6)C7=CC8=C(C=C7)N=C(N8)[C@@H]9[C@H]1CC[C@H](C1)N9C(=O)[C@H](C(C)C)NC(=O)OC)NC(=O)OC
    2.2 Other Identifiers
    2.2.1 UNII
    013TE6E4WV
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gs-5885

    2. Gs5885

    3. Ledipasvir Acetonate

    4. Methyl ((1s)-1-((1r,3s,4s)-3-(5-(9,9-difluoro-7-(2-((6s)-5-(n-(methoxycarbonyl)- L-valyl)-5-azaspiro(2.4)hept-6-yl)-1h-imidazol-4-yl)-9h-fluoren-2-yl)-1h-benzimidazol-2-yl)-2-azabicyclo(2.2.1)heptane-2-carbonyl)-2-methylpropyl)carbamate

    2.3.2 Depositor-Supplied Synonyms

    1. 1256388-51-8

    2. Gs-5885

    3. Gs5885

    4. Ledipasvir Acetonate

    5. Gs 5885

    6. Ledipasvir [usan]

    7. Chebi:85089

    8. Who 9796

    9. 013te6e4wv

    10. Ledipasvir (usan)

    11. Unii-013te6e4wv

    12. Methyl N-[(2s)-1-[(6s)-6-[5-[9,9-difluoro-7-[2-[(1r,3s,4s)-2-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-2-azabicyclo[2.2.1]heptan-3-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbamate

    13. Methyl N-[(2s)-1-[(6s)-6-[5-[9,9-difluoro-7-[2-[(1s,2s,4r)-3-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-3-azabicyclo[2.2.1]heptan-2-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-5-azaspiro[2.4]heptan-5-yl]-3-methyl-1-oxobutan-2-yl]carbamate

    14. Methyl [(2s)-1-{(6s)-6-[4-(9,9-difluoro-7-{2-[(1r,3s,4s)-2-{(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl}-2-azabicyclo[2.2.1]hept-3-yl]-1h-benzimidazol-5-yl}-9h-fluoren-2-yl)-1h-imidazol-2-yl]-5-azaspiro[2.4]hept-5-yl}-3-methyl-1-oxobutan-2-yl]carbamate

    15. Ledipasvir Acetonate [jan]

    16. Ledipasvir [usan:inn]

    17. Ledipasvir [mi]

    18. Ledipasvir [inn]

    19. Ledipasvir [vandf]

    20. Ledipasvir [who-dd]

    21. Schembl2706494

    22. Chembl2374220

    23. Ledipasvir [orange Book]

    24. Schembl15116943

    25. Gtpl11271

    26. Dtxsid90154829

    27. Ex-a411

    28. Harvoni (ledipasvir + Sofosbuvir)

    29. Harvoni Component Ledipasvir

    30. Bdbm50505966

    31. Mfcd25976756

    32. Ledipasvir Component Of Harvoni

    33. Zinc150338819

    34. Cs-1653

    35. Db09027

    36. Ncgc00378990-02

    37. Ncgc00378990-05

    38. Ac-28378

    39. As-56214

    40. Hy-15602

    41. Methyl ((1s)-1-((1r,3s,4s)-3-(5-(9,9-difluoro-7-(2-((6s)-5-(n-(methoxycarbonyl)- L-valyl)-5-azaspiro(2.4)hept-6-yl)-1h-imidazol-4-yl)-9h-fluoren-2-yl)-1h-benzimidazol-2-yl)-2-azabicyclo(2.2.1)heptane-2-carbonyl)-2-methylpropyl)carbamate

    42. (non-isotopelabelled)ledipasvir-13c2, D6

    43. D10442

    44. Q15409409

    45. Carbamic Acid, N-((1s)-1-(((6s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((2s)-2-((methoxycarbonyl)amino)-3-methyl-1-oxobutyl)-2-azabicyclo(2.2.1)hept-3-yl)-1h-benzimidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro(2.4)hept-5-yl)carbonyl)-2-methylpropyl)-, Methyl Ester

    46. Methyl ((s)-1-((s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((methoxycarbonyl)-l-valyl)-2-azabicyclo[2.2.1]heptan-3-yl)-1h-benzo[d]imidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro[2, Aldrichcpr

    47. Methyl ((s)-1-((s)-6-(5-(9,9-difluoro-7-(2-((1r,3s,4s)-2-((methoxycarbonyl)-l-valyl)-2-azabicyclo[2.2.1]heptan-3-yl)-1h-benzo[d]imidazol-6-yl)-9h-fluoren-2-yl)-1h-imidazol-2-yl)-5-azaspiro[2.4]heptan-5-yl)-3-methyl-1-oxobutan-2-yl)carbamate

    48. Methyl N-[(1s)-1-[(5s)-5-[5-[9,9-difluoro-7-[2-[(1s,2s,4r)-3-[(2s)-2-(methoxycarbonylamino)-3-methyl-butanoyl]-3-azabicyclo[2.2.1]heptan-2-yl]-3h-benzimidazol-5-yl]fluoren-2-yl]-1h-imidazol-2-yl]-6-azaspiro[2.4]heptane-6-carbonyl]-2-methyl-propyl]carbamate

    49. Methyl=[(2s)-1-[(6s)-6-[5-[9,9-difluoro-7-[2-[(1r,3s,4s)-2-[n-(methoxycarbonyl)-l-valyl]-2-azabicyclo[2.2.1]heptane-3-yl]-1h-benzoimidazole-6-yl]-9h-fluorene-2-yl]-1h-imidazole-2-yl]-5-azaspiro[2.4]heptane-5-yl]-3-methyl-1-oxobutane-2-yl]carbamate

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 889.0 g/mol
    Molecular Formula C49H54F2N8O6
    XLogP37.4
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count12
    Exact Mass888.41343780 g/mol
    Monoisotopic Mass888.41343780 g/mol
    Topological Polar Surface Area175 Ų
    Heavy Atom Count65
    Formal Charge0
    Complexity1820
    Isotope Atom Count0
    Defined Atom Stereocenter Count6
    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

    When used in combination with the antiviral medication [sofosbuvir] as the commercially available product Harvoni, ledipasvir is indicated for the treatment of HCV genotypes 1, 4, 5, and 6 with or without [ribavirin] depending on the level of liver damage or cirrhosis. Its use has also proven successful in the treatment of HCV in patients co-infected with HIV.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Ledipasvir acts against HCV and is categorized as a direct-acting antiviral agent (DAA). At a dose of 120 mg twice daily (2.67 times the maximum recommended dosage), ledipasvir does not prolong QTc interval to any clinically relevant extent.

    5.2 MeSH Pharmacological Classification

    Antiviral Agents

    Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. (See all compounds classified as Antiviral Agents.)

    5.3 FDA Pharmacological Classification
    5.3.1 Active Moiety
    LEDIPASVIR
    5.3.2 FDA UNII
    013TE6E4WV
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Breast Cancer Resistance Protein Inhibitors
    5.4 Absorption, Distribution and Excretion

    Absorption

    When given orally, ledipasvir reaches its maximum plasma concentration in about 4 to 4.5 hours with a maximum concentration (Cmax) of 323 ng/mL.

    Route of Elimination

    Following a single 90 mg oral dose of [14C]-ledipasvir, mean total recovery of the [14C]-radioactivity in feces and urine was approximately 87%, with most of the radioactive dose recovered from feces (approximately 86%). Unchanged ledipasvir excreted in feces accounted for a mean of 70% of the administered dose and the oxidative metabolite M19 accounted for 2.2% of the dose. These data indicate that biliary excretion of unchanged ledipasvir is a major route of elimination, with renal excretion being a minor pathway (approximately 1%).

    5.5 Metabolism/Metabolites

    In vitro, no detectable metabolism of ledipasvir was observed by human CYP1A2, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4. Evidence of slow oxidative metabolism via an unknown mechanism has been observed. Following a single dose of 90 mg [14C]-ledipasvir, systemic exposure was almost exclusively to the parent drug (>98%). Unchanged ledipasvir is the major species present in feces.

    5.6 Biological Half-Life

    The median terminal half-life of ledipasvir is 47 hours.

    5.7 Mechanism of Action

    Ledipasvir is an inhibitor of the Hepatitis C Virus (HCV) NS5A protein required for viral RNA replication and assembly of HCV virions. Although its exact mechanism of action is unknown, it is postulated to prevent hyperphosphorylation of NS5A which is required for viral production.

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    Jiangsu Yutian Pharmaceutical Co., Ltd. is located in Dapu Pharmaceutical Zone of Lianyungang City in Jiangsu Province. It is a new and high-tech enterprise engaged in research and production of bulk pharmaceutical chemicals, medical high-grade intermediate and other fine chemicals. We make efforts to provide wide customers with superior quality product. Covering an area of 66400 square meters and a construction area of 37600 square meters, our company has 8 synthesis plants, 1 GMP and FDA standard cleaning shop, modern and advanced production equipment, leading grade laboratory and excellent quality control center. In addition, there is outstanding technology development, production and management talents. Due to high quality and superior service, our products have been exported to Japan, South Korea, India and Europe. We sincerely welcome wide customers to visit us and pay guidance on our work! We would like to create brilliant future hand in hand with you!
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    Synergene Active Ingredients Pvt Lt...

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    Ledipasvir

    About the Company : Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals...

    Synergene Active Ingredients Pvt.Ltd was incorporated in 2006 and commercial operations began in the same year. The Company is a manufacturer and supplier of Active Pharmaceuticals Ingredients (API'S) for wide range of therapeutic categories. Therapeutic segments of focus are Anti Fungals, Anti Depressants, and Anti Hypertensive. Synergene manufacturing facilities are cGMP compliant meeting global standards in terms of infrastructure and systems. The company has two manufacturing facilities located at Hyderabad & Vishakhapatnam manufacturing Active Pharmaceutical Ingredients and Intermediates.
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    Teva Pharmaceutical Industries

    Israel
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    Ledipasvir

    About the Company : Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and...

    Teva was established in 1901. Our global headquarters are based in Israel. Today we have a portfolio of more than 3,500 medicines, and produce approximately 120 billion tablets and capsules a year at 70 manufacturing facilities. We rank among the leading pharmaceutical companies in the world and are active in 60 countries. Approximately 43,000 employees around the world are dedicated to our mission. Building on our strong global footprint, size and scale, Teva is reaffirming its commitment to place people at the center of our strategy, and enable as many as possible to live better, healthier days.
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    ABOUT THIS PAGE

    Looking for 1256388-51-8 / Ledipasvir API manufacturers, exporters & distributors?

    Ledipasvir manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Ledipasvir API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ledipasvir manufacturer or Ledipasvir supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ledipasvir manufacturer or Ledipasvir supplier.

    PharmaCompass also assists you with knowing the Ledipasvir API Price utilized in the formulation of products. Ledipasvir API Price is not always fixed or binding as the Ledipasvir Price is obtained through a variety of data sources. The Ledipasvir Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Ledipasvir

    Synonyms

    1256388-51-8, Gs-5885, Gs5885, Ledipasvir acetonate, Gs 5885, Ledipasvir [usan]

    Cas Number

    1256388-51-8

    Unique Ingredient Identifier (UNII)

    013TE6E4WV

    About Ledipasvir

    Ledipasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV. Upon oral administration and after intracellular uptake, ledipasvir binds to and blocks the activity of the NS5A protein. This results in the disruption of the viral RNA replication complex, blockage of 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; HCV infection is associated with the development of hepatocellular carcinoma (HCC).

    Ledipasvir Manufacturers

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

    Ledipasvir Suppliers

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

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

    Ledipasvir USDMF

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

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

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

    Ledipasvir WC

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

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

    Ledipasvir 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 Ledipasvir as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Ledipasvir GMP

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

    Ledipasvir CoA

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

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

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