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daclatasvir

Trade name: daklinza

Small moleculeapprovedFast Track FDA

Approved

Jul 24, 2015

Daclatasvir (BMS-790052) is a direct-acting antiviral agent against Hepatitis C Virus (HCV) used for the treatment of chronic HCV genotype 3 infection. Daclatasvir prevents RNA replication and virion assembly by binding to NS5A, a nonstructural phosphoprotein encoded by HCV. Binding to the N-terminus of the D1 domain of NS5A prevents its interaction with host cell proteins and membranes required for virion replication complex assembly. — NCATS

Clinical trial activity

143 trials · 101 clinical orgs · 1 marketing orgs

Phase 1
27
Phase 2
79
Phase 3
50
Phase 4
15

Earliest trial started Nov 1, 2007 (NCT00546715)

Timeline

2000s

  1. Jan 1, 2007

    Bristol-Myers Squibb — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2008

    Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)

  2. Jul 24, 2015

    Bristol-Myers Squibb — Earliest FDA Approval

  3. Jul 24, 2015

    Bristol-Myers Squibb — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJul 24, 2015

Chemistry & pharmacology

Loading structure…

SMILES

COC(=O)N[C@H](C(=O)N1CCC[C@H]1c1ncc(-c2ccc(-c3ccc(-c4cnc([C@@H]5CCCN5C(=O)[C@@H](NC(=O)OC)C(C)C)[nH]4)cc3)cc2)[nH]1)C(C)C
Mol. weight
738.89 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Discontinued

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • bms-790052
  • bms-790052
  • bms-790052
  • bms-790052
  • bms-790052
  • bms-790052
  • bms-790052-05
  • bms-790052-05
  • bms-790052-05
  • daclatasivr
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir
  • daclatasvir (bms-790052)
  • daclatasvir dihydrochloride
  • daclatasvir dihydrochloride
  • daclatasvir dihydrochloride
  • daclatasvir dihydrochloride
  • daclatasvir dihydrochloride
  • daclatasvir hcl
  • daclatasvir hydrochloride
  • daclatsvir
  • daclinza
  • daklinza
  • daklinza
  • daklinza
  • daklinza

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05992077N/AAug 7, 2023Government of France
NCT05854511Phase 3Jun 5, 2022Ain Shams University, Cairo University
NCT05616598Phase 2/Phase 3 (Phase 3)Mar 1, 2022Benha University
NCT04535869Phase 3Dec 30, 2020Mansoura University
NCT04561063Phase 2Dec 8, 2020University of the Witwatersrand
NCT04468087Phase 2/Phase 3 (Phase 3)Dec 1, 2020Hospital do Coracao
NCT04773756Phase 4Nov 1, 2020Alexandria University
NCT04532931Phase 2Sep 3, 2020Medicines for Malaria Venture, Shin Poong Pharmaceuticals
NCT04460443Phase 2/Phase 3 (Phase 3)Aug 1, 2020Tanta University
NCT04443725Phase 2/Phase 3 (Phase 3)Jul 31, 2020Cairo University
NCT04497649Phase 2/Phase 3 (Phase 3)Jul 1, 2020Cairo University, Tanta University
NCT04320290Phase 4Jun 30, 2020Harvard University
NCT04019717Phase 2Jun 20, 2019Atea Pharmaceuticals, Inc.
NCT03882307Early Phase 1 (Phase 1)May 1, 2019Assiut University
NCT04070235Phase 2/Phase 3 (Phase 3)Mar 29, 2019Jilin University, Nanjing Sanhome Pharmaceutical, Co., Ltd.
NCT03883698Phase 3Mar 15, 2019Sanjay Gandhi Postgraduate Institute of Medical Sciences
NCT03794258Phase 2Mar 1, 2019Humanity & Health Research Centre
NCT03702218Early Phase 1 (Phase 1)Feb 28, 2019University of Maryland
NCT03748745Phase 1Nov 19, 2018Jilin University, Nanjing Sanhome Pharmaceutical, Co., Ltd.
NCT03537196Phase 4Nov 1, 2018Government of France, Hai Phong Medical University, University of Montpellier, University of Nimes
Showing 20 of 143 trials
Page 1 / 8

Organizations

Research & Development (101)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bristol-Myers SquibbFor profit696152007
Humanity & Health Research CentreAcademic/Hospital7732015
Ain Shams UniversityAcademic/Hospital6532014
Johnson and JohnsonFor profit6512012
People's Liberation Army of ChinaGovernment6032015
Tanta UniversityAcademic/Hospital6632016
Assiut UniversityAcademic/Hospital4432017
Cairo UniversityAcademic/Hospital4112016
French National Agency for Research on AIDS and Viral HepatitisGovernment3312012
Genuine Research Center, EgyptFor profit3312015
Isfahan UniversityAcademic/Hospital3322015
Jilin UniversityAcademic/Hospital3022018
Nanjing Sanhome Pharmaceutical, Co., Ltd.For profit3322018
Alexandria UniversityAcademic/Hospital2212017
Beni Suef UniversityAcademic/Hospital2222016
Emory UniversityAcademic/Hospital2012015
Government of FranceGovernment2222018
Government of Punjab, IndiaGovernment2012016
Helwan UniversityAcademic/Hospital2012016
Janssen Pharmaceutica NVFor profit2012013
101 organizations
Page 1 / 6

Marketing (1)

OrganizationOrg typeRelationshipDate
Bristol-Myers SquibbFor profitNDAJul 24, 2015