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ledipasvir

Trade name: Harvoni

Small moleculeapprovedFast Track FDABreakthrough Therapy FDA

Approved

Oct 10, 2014

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

Clinical trial activity

105 trials · 93 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
68
Phase 3
26
Phase 4
24

Earliest trial started Aug 1, 2010 (NCT01193478)

Timeline

2010s

  1. Jan 1, 2010

    Gilead Sciences — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2010

    Gilead Sciences — Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2012

    Gilead Sciences — Earliest Phase 3 Sponsor(trial)

  4. Oct 10, 2014

    Earliest FDA Approval

  5. Oct 10, 2014

    Gilead Sciences — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • harvoni

    with sofosbuvir

    Also known as ledipasvir and sofobuvir, ledipasvir and sofosbuvir

Approval history

  • approvedPriority reviewFast trackBreakthroughOct 10, 2014

Chemistry & pharmacology

Loading structure…

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
Mol. weight
888.9999 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • gs-5885
  • gs-5885
  • gs-5885
  • gs-5885
  • gs-5885
  • harvoni
  • harvoni
  • harvoni
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • ledipasvir
  • 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
  • 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

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04460443Phase 2/Phase 3 (Phase 3)Aug 1, 2020Tanta University
NCT04498936Phase 4Jul 15, 2020Assiut University, Helwan University
NCT04530422Phase 3Apr 15, 2020Almaza Military Fever Hospital
NCT03903185Phase 1/Phase 2 (Phase 2)Mar 1, 2019Ain Shams University, Cairo University
NCT03743727Phase 4Aug 1, 2018Yassin Abdelghaffar Charity Center for Liver Disease and Research, Yassin Abdel Ghaffar Charity Center for Liver Disease and Research
NCT04353986Phase 3Jun 11, 2018Ain Shams University
NCT03721627Phase 4Apr 3, 2018Mansoura University
NCT05091008Phase 2Mar 1, 2018Loughborough University, Mansoura University
NCT03483987N/AFeb 10, 2018Ram Manohar Lohia Insitute of Medical Sciences, Sanjay Gandhi Postgraduate Institute of Medical Sciences
NCT03312023Phase 2Feb 1, 2018Gilead Sciences, University of Maryland
NCT04457050Phase 4Oct 30, 2017Alexandria University
NCT03961828Phase 4Oct 1, 2017Tanta University
NCT03261349Phase 2Sep 1, 2017National Taiwan University
NCT03279133Phase 4Sep 1, 2017City of Hope National Medical Center, Kaiser Permanente
NCT03126370Phase 4Jul 1, 2017University of Colorado, Denver
NCT03036839Phase 2Jun 1, 2017Gilead Sciences
NCT03118674Phase 2May 20, 2017Gilead Sciences, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH), Wake Forest University
NCT03343444Phase 3Apr 15, 2017Egyptian Liver Hospital
NCT04039958Phase 1Apr 5, 2017Genuine Research Center, Egypt, MinaPharm Pharmaceuticals
NCT03061032Phase 3Mar 1, 2017Baqiyatallah Medical Sciences University, Iran Hepatitis Network
Showing 20 of 105 trials
Page 1 / 6

Organizations

Research & Development (93)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Gilead SciencesFor profit544242010
Humanity & Health Research CentreAcademic/Hospital5532015
National Institute of Allergy and Infectious Diseases (NIAID)Government5232013
People's Liberation Army of ChinaGovernment5032015
National Institutes of Health (NIH)Government4122013
Tanta UniversityAcademic/Hospital3322017
AIDS Clinical Trials GroupAcademic/Hospital2222014
Ain Shams UniversityAcademic/Hospital2222018
Cairo UniversityAcademic/Hospital2022016
Duke UniversityAcademic/Hospital2122014
French National Agency for Research on AIDS and Viral HepatitisGovernment2212014
Genuine Research Center, EgyptFor profit2212016
Harvard UniversityAcademic/Hospital2122014
Helwan UniversityAcademic/Hospital2012017
Icahn School of Medicine at Mount SinaiAcademic/Hospital2122016
Mansoura UniversityAcademic/Hospital2222018
National Taiwan UniversityAcademic/Hospital2122016
Peter J. Ruane, M.D.Academic/Hospital2222015
Southern Medical UniversityAcademic/Hospital2022015
Stanford UniversityAcademic/Hospital2112015
93 organizations
Page 1 / 5

Marketing (2)

OrganizationOrg typeRelationshipDate
Gilead SciencesFor profitNDA—
Gilead SciencesFor profitNDA2Oct 10, 2014