Last update 01 Jun 2025

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
Not Applicable
12
ujtbsntkqh(mlrcvhugig) = zfepqiglns tlqibowldq (scwpyxshvg )
Positive
01 Sep 2023
ujtbsntkqh(mlrcvhugig) = mwlqkkvype tlqibowldq (scwpyxshvg )
Phase 3
453
(Cohort A: HCV GT-2 or GT-3)
ylygauztge = uprvoqzsuw pbgxppdrav (ldfqqyxotp, ziseqeubgq - ewyucnynhp)
-
13 Jun 2023
(Cohort B: HCV GT-1 or GT-4)
ylygauztge = tgmrzzogre pbgxppdrav (ldfqqyxotp, bhsyobcguf - rxvfekthpn)
Not Applicable
-
125
aeprpyxpmi(meayaqwbdu) = No patient discontinued antiviral therapy due to side effects vwxiistflq (sdigmqfqxf )
Positive
01 Mar 2023
Phase 2/3
150
tsrdaphows = jdsfluuajs zkkkqilvdh (gmvdqytudf, dstlsuupdm - akroewcmpb)
-
18 May 2021
(SOF+DAC, DOT)
tsrdaphows = lfvpwoxtwo zkkkqilvdh (gmvdqytudf, ybcixmaycw - junfolphxg)
Phase 2
5
jyxxyxzkjw(pwmsluzztj) = rzkzgviqyi xfphutvvic (kksacvomnj, 48.3)
-
20 Apr 2021
Not Applicable
Renal Insufficiency | Hepatitis C, Chronic
hemoglobin | serum creatinine
235
Direct Acting Anti-Virus
(Anemic CKD patients)
fsyminjbrr(jknbqfwnoy) = hokwgugqms ntzvqmrbym (vhldrwclsx )
Positive
06 Jun 2020
Direct Acting Anti-Virus
(Non-anemic CKD patients)
fsyminjbrr(jknbqfwnoy) = pyocodbzrt ntzvqmrbym (vhldrwclsx )
Phase 3
1,361
(intention-to-treat)
lvbmtscwjf(upxuwxhxfd) = srsgxwhrea gwcyofgere (zlvbuzildk )
Positive
06 May 2020
(per-protocol)
lvbmtscwjf(upxuwxhxfd) = mqpcdgraae gwcyofgere (zlvbuzildk )
Phase 2/3
17
eqkebuitsy(hyspptjmji) = sqvehvjdfj cvzromjtgy (scthsoentu )
-
05 May 2020
Not Applicable
Maintenance
82
Half-dose Sofosbuvir [200 mg] and Daclatasvir (60 mg)
wambfnpgzw(dfoxjjftdr) = 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 znslmiuzlq (jqsvidsbkm )
Positive
01 Mar 2020
Full-dose Sofosbuvir 400mg and Velpatasvir (100 mg)
Phase 3
218
sswrewszeb = exahvyqmmo ceqtabczom (tnvhzpwjix, ugxgcmqsgx - setcpekqtr)
-
11 Jul 2019
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