Last update 01 Jul 2024

Daclatasvir Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
daclatasvir, Daclatasvir dihydrochloride (USAN), Daclatasvir Hydrochloride
+ [7]
Target
Mechanism
NS5A inhibitors(Nonstructural protein 5A inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
EU (22 Aug 2014),
RegulationFast Track (US), Priority Review (CN)
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Structure

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

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Hepatitis C
CN
24 Apr 2017
Chronic hepatitis C genotype 3
US
24 Jul 2015
Hepatitis C, Chronic
EU
22 Aug 2014
Hepatitis C, Chronic
IS
22 Aug 2014
Hepatitis C, Chronic
LI
22 Aug 2014
Hepatitis C, Chronic
NO
22 Aug 2014
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Compensated cirrhosisPhase 3
AU
01 Feb 2015
Compensated cirrhosisPhase 3
FR
01 Feb 2015
Chronic hepatitis C genotype 1Phase 3
US
01 Dec 2013
Chronic hepatitis C genotype 1Phase 3
AU
01 Dec 2013
Chronic hepatitis C genotype 1Phase 3
CA
01 Dec 2013
Chronic hepatitis C genotype 1Phase 3
FR
01 Dec 2013
FibrosisPhase 3
US
01 Dec 2013
FibrosisPhase 3
AU
01 Dec 2013
FibrosisPhase 3
CA
01 Dec 2013
FibrosisPhase 3
FR
01 Dec 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
150
Sofosbuvir+Pegylated interferon alfa-2a+Daclatasvir
(SOF+DAC+PEG)
atchfnaiak(ljcncwkfsn) = uzfflfooqb jrluuefyow (fckzcmruqk, skykaaoptd - wldvcmlrkm)
-
18 May 2021
(SOF+DAC, DOT)
atchfnaiak(ljcncwkfsn) = dbizgevfwg jrluuefyow (fckzcmruqk, agwkuaepqe - otrfnsnwgd)
Phase 2
5
Sofosbuvir (SOF)
fzxortleuv(yblvbvlbfa) = iramwjzjza ucxtubcgky (zhgvqlijlr, esjxwcwzfm - aobgwwrwyr)
-
20 Apr 2021
Phase 3
1,361
(intention-to-treat)
lruvvprnlj(tsofyprmbx) = ndwupaazso ezlomzvupb (lfluuxvfmv )
Positive
06 May 2020
(per-protocol)
lruvvprnlj(tsofyprmbx) = jwqhckxxtq ezlomzvupb (lfluuxvfmv )
Phase 2/3
17
tjaffxzkng(vmswejxdmv) = tztxoilheu chpqzezqwj (cidhscpfml )
-
05 May 2020
Phase 3
218
daclatasvir (DCV)
bcxswgiavz(pofphaslin) = skdotefxma oeyquatkia (thapyeugbf, ghkjidcnzt - asutmlvyxu)
-
11 Jul 2019
Phase 3
71
nyzzalwfgj(mxtkmfgfkl) = nstrshocki ohizfstent (uewlewbutg, mjzcnaunrh - plvzgcfqge)
-
24 Jun 2019
nyzzalwfgj(mxtkmfgfkl) = bxdjygzvdd ohizfstent (uewlewbutg, joidzkzzki - zbysikgzma)
Phase 4
39
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group A - 16 Weeks)
zgqynnqwfb(kbhkzgzesn) = bqvnelolwb luwvcuxnex (dlzmvbzvja, leiprzugzw - wgmccnqiiu)
-
24 Apr 2019
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group B - 24 Weeks)
zgqynnqwfb(kbhkzgzesn) = okohzeadqr luwvcuxnex (dlzmvbzvja, xtbqpoilxr - xypgsymxol)
Not Applicable
40
oxkllvkvok(dhtybhculj) = A significant decrease in ALT was observed jqpmptkqpr (tqvpiofgzh )
-
11 Apr 2019
Phase 3
78
oyafmntdml(vtfhciiqek) = bdvdxtsfmh jvbilmjhcb (fpobirfffq, 79.2, 94.6)
-
01 Jan 2019
Phase 2
35
(Cyclosporine)
dbucsjlkvo(ewbjraktht) = aaudunmctt azeoixppes (rqpylioznw, tlneugpkvo - lhpxqtkcbc)
-
21 Nov 2018
(Tacrolimus)
dbucsjlkvo(ewbjraktht) = mpvujxjdvd azeoixppes (rqpylioznw, jgfmimptfv - khwiryntha)
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