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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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24-Feb-2021
24-Feb-2021
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ABOUT THIS PAGE

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.

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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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