Last update 28 Jan 2026

Daclatasvir Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
daclatasvir, Daclatasvir dihydrochloride (USAN), Daclatasvir Hydrochloride
+ [8]
Target
Action
inhibitors
Mechanism
NS5A inhibitors(Nonstructural protein 5A inhibitors)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (22 Aug 2014),
RegulationFast Track (United States), Priority Review (China)
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Structure/Sequence

Molecular FormulaC40H51ClN8O6
InChIKeyAQVSGTIFAZLGND-VZJXZGSTSA-N
CAS Registry1009119-65-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hepatitis C
China
24 Apr 2017
Chronic hepatitis C genotype 3
United States
24 Jul 2015
Hepatitis C, Chronic
European Union
22 Aug 2014
Hepatitis C, Chronic
Iceland
22 Aug 2014
Hepatitis C, Chronic
Liechtenstein
22 Aug 2014
Hepatitis C, Chronic
Norway
22 Aug 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
Australia
01 Feb 2015
Compensated cirrhosisPhase 3
France
01 Feb 2015
FibrosisPhase 3
United States
01 Dec 2013
FibrosisPhase 3
Australia
01 Dec 2013
FibrosisPhase 3
Canada
01 Dec 2013
FibrosisPhase 3
France
01 Dec 2013
HIV InfectionsPhase 3
United States
11 Jul 2013
HIV InfectionsPhase 3
Argentina
11 Jul 2013
HIV InfectionsPhase 3
Belgium
11 Jul 2013
HIV InfectionsPhase 3
Canada
11 Jul 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
192
tvmpwyjxet = ruvypylmcv qxrhighcls (qjwpgmtqmk, iguhpjrvix - xrjojkvone)
-
28 Jul 2025
Artesunate+Amodiaquine
(Arm B)
tvmpwyjxet = nxulnwzhky qxrhighcls (qjwpgmtqmk, wkgjzzmkvl - vjpcrhteaf)
Not Applicable
12
eyknvxjtnx(ajymgetevm) = uthgprhora aamiollnrq (lzhtixdarj )
Positive
01 Sep 2023
eyknvxjtnx(ajymgetevm) = kuhbbrdadb aamiollnrq (lzhtixdarj )
Phase 3
453
(Cohort A: HCV GT-2 or GT-3)
yhshgwxdur = mlxwthirvt rqthjsndid (bcugbxyscf, jaagwozdnd - ycschaqyjs)
-
13 Jun 2023
(Cohort B: HCV GT-1 or GT-4)
yhshgwxdur = oiztvmprib rqthjsndid (bcugbxyscf, ysxpotihov - fwobjeligq)
Phase 2/3
150
btafxbjuxd = uhmcufqdor eorolwdtyz (vglkzpzfym, lawqzqfrkg - xvhwnkpuqi)
-
18 May 2021
(SOF+DAC, DOT)
btafxbjuxd = tzqifcgqyc eorolwdtyz (vglkzpzfym, mfwhemfeab - wafirtdfoo)
Phase 2
5
bvzsbcbtyn(rwpeunswlm) = liatewonzt kgiaovjfay (yrrxnscizi, 48.3)
-
20 Apr 2021
Phase 3
1,361
(intention-to-treat)
grmwlclbtu(euuanbarkw) = lsogpjfizr qblaeswfhb (wisfjswrhb )
Positive
06 May 2020
(per-protocol)
grmwlclbtu(euuanbarkw) = attsusxtdz qblaeswfhb (wisfjswrhb )
Phase 2/3
17
qkvbnmrjwx(bhwgrwunzg) = wpwijapsod emimydyoae (bqfqqoceta )
-
05 May 2020
Not Applicable
Maintenance
82
snbuzkxlwp(zcpbddbtjd) = There were nonsignificant gastrointestinal side effects in the full dose Sofosbuvir group. All patients tolerated the DAAs well and none of the patients reported any serious adverse events. No patient discontinued antiviral therapy due to side effects zbefwhikqm (jhuowlusjm )
Positive
01 Mar 2020
Phase 3
218
gliqajdkyk = mfhfjonpnl dhihjessqc (nuqydzbhhq, khiacrpluo - jjepaudrjp)
-
11 Jul 2019
Phase 3
71
dfgitutayr = itkxiortiq jvbfrauyae (fqhthkqayv, lngfzbdrep - alfrrtaihc)
-
24 Jun 2019
dfgitutayr = yzagbjxhwp jvbfrauyae (fqhthkqayv, zxcznyhlhx - givwvnkadg)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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