ledipasvir (Harvoni) Report issue

Small molecule Approved FDA First in Class Fast Track FDA Priority Review FDA
AACT ChEMBL DrugBank Drug Central KEGG MeSH PubChem repoDB

Active Ingredient History

NOW
  • Now
Ledipasvir is an inhibitor of the Hepatitis C Virus (HCV) NS5A protein required for viral RNA replication and assembly of HCV virions. Approved in October 2014 by the FDA, ledipasvir and sofosbuvir (tradename Harvoni) are direct-acting antiviral agents indicated for the treatment of HCV genotype 1 with or without cirrhosis.   NCATS

Chemistry

  • SMILES: COC(=O)N[C@@H](C(C)C)C(=O)N1CC2(CC2)C[C@H]1C3=NC=C(N3)C4=CC=C5C(=C4)C(F)(F)C6=C5C=CC(=C6)C7=CC8=C(C=C7)N=C(N8)[C@@H]9[C@H]%10CC[C@H](C%10)N9C(=O)[C@@H](NC(=O)OC)C(C)C
  • InChIKey: VRTWBAAJJOHBQU-KMWAZVGDSA-N
  • Mol. Mass: 888.9999
  • ALogP: 8.61
  • ChEMBL Molecule:
    ledipasvir  
More Chemistry

Pharmacology

  • Mechanism of Action:
  • Multi-specific: Missing data
  • Black Box: No
  • Availability: Prescription Only
  • Delivery Methods: Oral
  • Pro Drug: No

Combination drugs

( ledipasvir (Harvoni), sofosbuvir (sovaldi) - other name: ledipasvir and sofobuvir )

Alternative names

gs-5885 | harvoni | ledipasvir | ledipasvir (gs5885) | ledipasvir - sofosbuvir | ledipasvir, sofosbuvir drug combination | ledispavir 90 mg / sofosbuvir 400 mg | 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

Organizations (93)

Research & Development (93)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Marketing (1)

Organization Org Type FDA approvals Clinical Trials involvement Org ID Force Sort

Indications (27)

Approved Indications (2)


 

Hepatitis C

Hepatitis C, Chronic

Experimental Indications - Clinical Trial Phases 1-4 (27)


 

beta-Thalassemia (Phase 4)

Carcinoma, Hepatocellular (Phase 4)

COVID-19 (Phase 4)

Cryoglobulinemia (Phase 2/Phase 3)

Fibrosis (Phase 4)

Gaucher Disease (Phase 4)

Healthy Volunteers (Phase 1)

Heart Failure (Phase 4)

Hematologic Neoplasms (Phase 1/Phase 2)

Hematopoietic Stem Cell Transplantation (Phase 4)

Hepacivirus (Phase 3)

Hepatitis (Phase 1)

Hepatitis B (Phase 2/Phase 3)

Hepatitis C ()

Hepatitis C, Chronic ()

HIV (Phase 4)

HIV Infections (Phase 4)

Insulin Resistance (Phase 4)

Liver Cirrhosis (Phase 3)

Liver Diseases (Phase 4)

Lung Diseases, Interstitial (Phase 4)

Lymphoma (Phase 2)

Lymphoma, B-Cell (Phase 2)

Porphyria Cutanea Tarda (Phase 2)

Pregnancy (Phase 1)

Pulmonary Disease, Chronic Obstructive (Phase 4)

Substance Abuse, Intravenous (Phase 3)

Overview

  • Highest Phase: Phase 4
  • # of Trials: 105
  • # of Trial Organizations: 93

Trials by Phase

Trial Phase Start Date Organizations Indications

Feedback

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