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    Chemistry

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    Also known as: 1377049-84-7, Gs-5816, Gs5816, Kcu0c7rs7z, Gs 5816, Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate
    Molecular Formula
    C49H54N8O8
    Molecular Weight
    883.0  g/mol
    InChI Key
    FHCUMDQMBHQXKK-CDIODLITSA-N
    FDA UNII
    KCU0C7RS7Z
    Velpatasvir
    Velpatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV genotypes 1-6. Although the exact mechanism of action of velpatasvir has not yet been completely determined, upon oral administration and intracellular uptake, it 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.
    Velpatasvir is a Hepatitis C Virus NS5A Inhibitor. The mechanism of action of velpatasvir is as a Breast Cancer Resistance Protein Inhibitor, and P-Glycoprotein Inhibitor, and Organic Anion Transporting Polypeptide 1B1 Inhibitor, and Organic Anion Transporting Polypeptide 1B3 Inhibitor, and Organic Anion Transporting Polypeptide 2B1 Inhibitor.
    1 2D Structure

    Velpatasvir

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    methyl N-[(1R)-2-[(2S,4S)-2-[5-[6-[(2S,5S)-1-[(2S)-2-(methoxycarbonylamino)-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.04,8.014,19]henicosa-1(13),2,4(8),5,9,11,14(19),15,17-nonaen-17-yl]-1H-imidazol-2-yl]-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate
    2.1.2 InChI
    InChI=1S/C49H54N8O8/c1-26(2)41(54-48(60)63-5)47(59)57-27(3)12-17-38(57)45-51-36-16-14-30-20-35-33-15-13-31(19-32(33)25-65-40(35)21-34(30)43(36)53-45)37-22-50-44(52-37)39-18-28(24-62-4)23-56(39)46(58)42(55-49(61)64-6)29-10-8-7-9-11-29/h7-11,13-16,19-22,26-28,38-39,41-42H,12,17-18,23-25H2,1-6H3,(H,50,52)(H,51,53)(H,54,60)(H,55,61)/t27-,28-,38-,39-,41-,42+/m0/s1
    2.1.3 InChI Key
    FHCUMDQMBHQXKK-CDIODLITSA-N
    2.1.4 Canonical SMILES
    CC1CCC(N1C(=O)C(C(C)C)NC(=O)OC)C2=NC3=C(N2)C=CC4=CC5=C(C=C43)OCC6=C5C=CC(=C6)C7=CN=C(N7)C8CC(CN8C(=O)C(C9=CC=CC=C9)NC(=O)OC)COC
    2.1.5 Isomeric SMILES
    C[C@H]1CC[C@H](N1C(=O)[C@H](C(C)C)NC(=O)OC)C2=NC3=C(N2)C=CC4=CC5=C(C=C43)OCC6=C5C=CC(=C6)C7=CN=C(N7)[C@@H]8C[C@@H](CN8C(=O)[C@@H](C9=CC=CC=C9)NC(=O)OC)COC
    2.2 Other Identifiers
    2.2.1 UNII
    KCU0C7RS7Z
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Gs-5816

    2.3.2 Depositor-Supplied Synonyms

    1. 1377049-84-7

    2. Gs-5816

    3. Gs5816

    4. Kcu0c7rs7z

    5. Gs 5816

    6. Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate

    7. Methyl [(2s)-1-[(2s,5s)-2-[9-[2-[(2s,4s)-1-[(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl]-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl]-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl]-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl]carbamate

    8. Methyl N-[(1r)-2-[(2s,4s)-2-[5-[6-[(2s,5s)-1-[(2s)-2-(methoxycarbonylamino)-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.04,8.014,19]henicosa-1(13),2,4(8),5,9,11,14(19),15,17-nonaen-17-yl]-1h-imidazol-2-yl]-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

    9. Unii-kcu0c7rs7z

    10. Velpatasvir [usan:inn]

    11. Verpatasvir

    12. Methyl ((2s)-1-((2s,5s)-2-(9-(2-((2s,4s)-1-((2r)-2-((methoxycarbonyl)amino)-2-phenylacetyl)-4-(methoxymethyl)pyrrolidin-2-yl)-1h-imidazol-5-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl)-3-methyl-1-oxobutan-2-yl)carbamate

    13. Methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl}-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

    14. Velpatasvir [inn]

    15. Velpatasvir(gs5816)

    16. Velpatasvir [mi]

    17. Velpatasvir [jan]

    18. Velpatasvir; Gs-5816

    19. Velpatasvir [usan]

    20. Velpatasvir [who-dd]

    21. Velpatasvir (jan/usan/inn)

    22. Schembl8756902

    23. Chembl3545062

    24. Schembl19236068

    25. Gtpl11269

    26. Amy4211

    27. Dtxsid70722565

    28. Velpatasvir [orange Book]

    29. Chebi:133009

    30. Epclusa (sofosbuvir + Velpatasvir)

    31. Vosevi Component Velpatasvir

    32. Bcp13813

    33. Epclusa Component Velpatasvir

    34. Ex-a2320

    35. Bdbm50521720

    36. Mfcd28411371

    37. S3724

    38. Velpatasvir Component Of Vosevi

    39. Zinc203686879

    40. Ccg-270553

    41. Cs-5977

    42. Db11613

    43. Velpatasvir Component Of Epclusa

    44. Ncgc00522503-01

    45. Ncgc00522503-02

    46. Ac-28744

    47. As-35237

    48. Hy-12530

    49. Ft-0700879

    50. J3.631.686a

    51. D10806

    52. Gs-5816;gs5816;gs 5816

    53. Vosevi (sofosbuvir + Velpatasvir + Voxilaprevi)

    54. A886410

    55. Q25018296

    56. Carbamic Acid, N-[(1r)-2-[(2s,4s)-2-[5-[1,11-dihydro-2-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methyl-1-oxobutyl]-5-methyl-2-pyrrolidinyl][2]benzopyrano[4,3:6,7]naphth[1,2-d]imidazol-9-yl]-1h-imidazol-2-yl]-4-(methoxymethyl)-1-pyrrolidinyl]-2-oxo-1-phenylethyl]-, Methyl Ester

    57. Methyl {(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-4-yl}-1,11-dihydro[2]benzopyrano[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

    58. Methyl N-[(1r)-2-[(2s,4s)-2-(5-{6-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.0?,??.0?,?.0??,??]henicosa-1,3,6,8,10,12,14,16,18-nonaen-17-yl}-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

    59. Methyl N-[(1r)-2-[(2s,4s)-2-(5-{6-[(2s,5s)-1-[(2s)-2-[(methoxycarbonyl)amino]-3-methylbutanoyl]-5-methylpyrrolidin-2-yl]-21-oxa-5,7-diazapentacyclo[11.8.0.03,11.0?,?.01?,1?]henicosa-1,3,6,8,10,12,14,16,18-nonaen-17-yl}-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl]-2-oxo-1-phenylethyl]carbamate

    60. Methyl{(2s)-1-[(2s,5s)-2-(9-{2-[(2s,4s)-1-{(2r)-2-[(methoxycarbonyl)amino]-2-phenylacetyl}-4-(methoxymethyl)pyrrolidin-2-yl]-1h-imidazol-5-yl}-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-2-yl)-5-methylpyrrolidin-1-yl]-3-methyl-1-oxobutan-2-yl}carbamate

    2.4 Create Date
    2012-11-30
    3 Chemical and Physical Properties
    Molecular Weight 883.0 g/mol
    Molecular Formula C49H54N8O8
    XLogP36.2
    Hydrogen Bond Donor Count4
    Hydrogen Bond Acceptor Count10
    Rotatable Bond Count13
    Exact Mass882.40646071 g/mol
    Monoisotopic Mass882.40646071 g/mol
    Topological Polar Surface Area193 Ų
    Heavy Atom Count65
    Formal Charge0
    Complexity1690
    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 Information
    1 of 2  
    Drug NameEPCLUSA
    Active IngredientSOFOSBUVIR; VELPATASVIR
    CompanyGILEAD SCIENCES INC (Application Number: N208341. Patents: 7964580, 8334270, 8575135, 8580765, 8618076, 8633309, 8735372, 8889159, 8921341, 8940718, 9085573, 9284342, 9757406)

    2 of 2  
    Drug NameVOSEVI
    Active IngredientSOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
    CompanyGILEAD SCIENCES INC (Application Number: N209195. Patents: 7964580, 8334270, 8575135, 8580765, 8618076, 8633309, 8735372, 8889159, 8921341, 8940718, 9085573, 9284342, 9296782, 9585906)

    4.2 Drug Indication

    Velpatasvir is used in combination therapy with other antiviral medications to treat chronic hepatitis C virus (HCV) infected patients with HCV genoptypes 1-6, and to treat HCV and HIV co-infected patients. Depending on the level of cirrhosis or decompensation, combination therapy can also include therapy with [DB00811]. When used in combination with [DB08934] as the combination product Epclusa, Velpatasvir is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or in combination with [DB00811] if associated with decompensated cirrhosis.

    FDA Label

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Velpatasvir is a small molecule direct-acting antiviral used in the treatment of hepatitis C in combination with sofosbuvir. Velpatasvir prevents viral replication by inhibiting non-structural protein 5A (NS5A). At a dose 5 times the recommended dose, velpatasvir 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
    VELPATASVIR
    5.3.2 FDA UNII
    KCU0C7RS7Z
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Organic Anion Transporting Polypeptide 2B1 Inhibitors
    5.4 Absorption, Distribution and Excretion

    Absorption

    Oral bioavailability of 25-30%.

    Route of Elimination

    94% excreted in feces with 77% as parent compound. 0.4% excreted in urine.

    Volume of Distribution

    1.4-1.6 L/kg.

    Clearance

    Estimated 0.12 L/h/kg [A19175.

    5.5 Metabolism/Metabolites

    Some metabolism by CYP2B6, CYP2C8, and CYP3A4.

    5.6 Biological Half-Life

    15h.

    5.7 Mechanism of Action

    Velpatasvir's mechanism of action is likely similar to other selective NS5A inhibitors which bind domain I of NS5A consisting of amino acids 33-202. NS5A inhibitors compete with RNA for binding at this site. It is also thought that NS5A inhibitors bind the target during its action in replication when the binding site is exposed. Inhibition of NS5A is also known to produce redistribution of the protein to lipid droplets. The exact role of NS5A in RNA replication is not yet understood although it is known to be an important component.

    API Reference Price

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    11-Jan-2022
    05-Sep-2025
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    Drugs in Development

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    Study of Simplified vs Standard Test & Treat Strategy for Hepatitis C in Cameroon

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Hepatitis C.


    Lead Product(s): Sofosbuvir,Velpatasvir,Vosevi,Voxilaprevir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: IRD, Epidemiology and Prevention, Montpellier, France | SESSTIM (IRD, Inserm, Université Aix-Marseille) | Center for Research on Emerging and Re-Emerging Diseases | Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Camero

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 01, 2025

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    01

    ANRS, Emerging Infectious Diseases

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    Lead Product(s) : Sofosbuvir,Velpatasvir,Vosevi,Voxilaprevir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : IRD, Epidemiology and Prevention, Montpellier, France | SESSTIM (IRD, Inserm, Université Aix-Marseille) | Center for Research on Emerging and Re-Emerging Diseases | Faculté de Médecine et des Sciences Biomédicales, Université de Yaoundé I, Yaoundé, Camero

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Study of Simplified vs Standard Test & Treat Strategy for Hepatitis C in Cameroon

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Hepatitis C.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    August 01, 2025

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    ACTG Announces Publication of Pivotal Hepatitis C Study in Clinical Infectious Diseases

    Details:

    ACTG 5360 is a combination of sofosbuvir which is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, whereas velpatasvir is an inhibitor of the HCV NS5A protein, both required for viral replication. Currently being studied for chronic hepatitis C treatment.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable March 23, 2023

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    AIDS Clinical Trials Group

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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    ACTG Announces Publication of Pivotal Hepatitis C Study in Clinical Infectious Diseases

    Details : ACTG 5360 is a combination of sofosbuvir which is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, whereas velpatasvir is an inhibitor of the HCV NS5A protein, both required for viral replication. Currently being studied for chronic hepatitis C...

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    March 23, 2023

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    Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C, Chronic.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Catherine Anne Chappell

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 02, 2021

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    03

    Gilead Sciences

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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Catherine Anne Chappell

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C, Chronic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 02, 2021

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    Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis C, Chronic.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IProduct Type: Miscellaneous

    Sponsor: Catherine Anne Chappell

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 11, 2020

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    04

    Gilead Sciences

    U.S.A
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    Gilead Sciences

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    • EDQM
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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase I

    Partner/Sponsor/Collaborator : Catherine Anne Chappell

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Hepatitis C, Chronic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 11, 2020

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    Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (S...

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hepatitis C.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable December 26, 2019

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    05

    Gilead Sciences

    U.S.A
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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combin...

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hepatitis C.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    December 26, 2019

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    Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Comp...

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hepatitis C.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Miscellaneous

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable October 02, 2019

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    06

    Gilead Sciences

    U.S.A
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    Gilead Sciences

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    Not Confirmed
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    • EDQM
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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for ...

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Hepatitis C.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    October 02, 2019

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    A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Failure, Chronic.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Nephrology Brand Name: Undisclosed

    Study Phase: Phase IIProduct Type: Miscellaneous

    Sponsor: Gilead Sciences | National Institute of Diabetes and Digestive and Kidney Diseases

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable September 03, 2019

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    07

    University of Pennsylvania

    Country
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    DDL Conference
    Not Confirmed

    University of Pennsylvania

    Country
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    Not Confirmed
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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Nephrology

    Highest Development Status : Phase II

    Partner/Sponsor/Collaborator : Gilead Sciences | National Institute of Diabetes and Digestive and Kidney Diseases

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Kidney Failure, Chronic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    September 03, 2019

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    Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

    Details:

    Velpatasvir is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hepatitis C, Chronic.


    Lead Product(s): Velpatasvir,Sofosbuvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: UndisclosedProduct Type: Miscellaneous

    Sponsor: Ministry of Health, Brazil | State Secretary of Health of Rio Grande do Sul | TelessaúdeRS / UFRGS

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable July 31, 2019

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    08

    Hospital de Clinicas de Porto Alegre

    Country
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    DDL Conference
    Not Confirmed

    Hospital de Clinicas de Porto Alegre

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    DDL Conference
    Not Confirmed
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    Lead Product(s) : Velpatasvir,Sofosbuvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Undisclosed

    Partner/Sponsor/Collaborator : Ministry of Health, Brazil | State Secretary of Health of Rio Grande do Sul | TelessaúdeRS / UFRGS

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System ...

    Details : Velpatasvir is a Other Small Molecule drug candidate, which is currently being evaluated in clinical studies for the treatment of Hepatitis C, Chronic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    July 31, 2019

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    The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C, Chronic.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Gilead Sciences

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 17, 2019

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    09

    University of California, San Francisco

    Country
    arrow
    DDL Conference
    Not Confirmed

    University of California, San Francisco

    Country
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    DDL Conference
    Not Confirmed
    • fda
    • EDQM
    • WHO-GMP
    Virtual Booth Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Gilead Sciences

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Tr...

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C, Chronic.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    June 17, 2019

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    The Kentucky Viral Hepatitis Treatment Study

    Details:

    Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C.


    Lead Product(s): Sofosbuvir,Velpatasvir

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Miscellaneous

    Sponsor: Jennifer Havens

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable May 14, 2019

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    10

    Gilead Sciences

    U.S.A
    arrow
    DDL Conference
    Not Confirmed

    Gilead Sciences

    U.S.A
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    DDL Conference
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    Lead Product(s) : Sofosbuvir,Velpatasvir

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Jennifer Havens

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    The Kentucky Viral Hepatitis Treatment Study

    Details : Sofosbuvir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Hepatitis C.

    Product Name : Undisclosed

    Product Type : Miscellaneous

    Upfront Cash : Inapplicable

    May 14, 2019

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    ABOUT THIS PAGE

    Looking for 1377049-84-7 / Velpatasvir API manufacturers, exporters & distributors?

    Velpatasvir manufacturers, exporters & distributors 1

    41

    PharmaCompass offers a list of Velpatasvir 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 Velpatasvir manufacturer or Velpatasvir supplier for your needs.

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

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

    API | Excipient name

    Velpatasvir

    Synonyms

    1377049-84-7, Gs-5816, Gs5816, Kcu0c7rs7z, Gs 5816, Methyl ((r)-2-((2s,4s)-2-(5-(2-((2s,5s)-1-((methoxycarbonyl)-l-valyl)-5-methylpyrrolidin-2-yl)-1,11-dihydroisochromeno[4',3':6,7]naphtho[1,2-d]imidazol-9-yl)-1h-imidazol-2-yl)-4-(methoxymethyl)pyrrolidin-1-yl)-2-oxo-1-phenylethyl)carbamate

    Cas Number

    1377049-84-7

    Unique Ingredient Identifier (UNII)

    KCU0C7RS7Z

    About Velpatasvir

    Velpatasvir is an orally available inhibitor of the hepatitis C virus (HCV) non-structural protein 5A (NS5A) replication complex, with potential activity against HCV genotypes 1-6. Although the exact mechanism of action of velpatasvir has not yet been completely determined, upon oral administration and intracellular uptake, it 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.

    Velpatasvir Manufacturers

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

    Velpatasvir Suppliers

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

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

    Velpatasvir KDMF

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

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

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

    click here to find a list of Velpatasvir suppliers with KDMF on PharmaCompass.

    Velpatasvir WC

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

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

    Velpatasvir 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 Velpatasvir as an active pharmaceutical ingredient (API).

    Finished drug products

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

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

    Velpatasvir GMP

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

    Velpatasvir CoA

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

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

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