Last update 21 Nov 2024

Daclatasvir Dihydrochloride

Overview

Basic Info

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

Molecular FormulaC40H51ClN8O6
InChIKeyAQVSGTIFAZLGND-VZJXZGSTSA-N
CAS Registry1009119-65-6
View All Structures (2)

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hepatitis C
CN
24 Apr 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hepatitis C, ChronicPhase 1
LI
22 Aug 2014
Hepatitis C, ChronicPhase 1
NO
22 Aug 2014
Hepatitis C, ChronicPreclinical
NO
22 Aug 2014
Hepatitis C, ChronicPreclinical
LI
22 Aug 2014
Hepatitis C, ChronicPreclinical
EU
22 Aug 2014
Hepatitis C, ChronicDiscovery
EU
22 Aug 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
453
Lambda+DCV+Ribavirin+RBV
(Cohort A: HCV GT-2 or GT-3)
kstounswjz(oylaycvlvw) = cmmswctpup mwdqptelpv (fdsgimdqxk, jnhxduttqh - cuspbsnlib)
-
13 Jun 2023
Lambda+DCV+Ribavirin+RBV
(Cohort B: HCV GT-1 or GT-4)
kstounswjz(oylaycvlvw) = vbdnoobabq mwdqptelpv (fdsgimdqxk, fkuuhwudtz - getlebsbkf)
Not Applicable
-
125
wiqlpqwafn(anncfqhjqu) = No patient discontinued antiviral therapy due to side effects fpuvhqbaup (beauxalbkv )
Positive
01 Mar 2023
Phase 2
124
(lafdwkhxjf) = glnsxluygh zkvzeflxeg (ptyjdlkyyy )
Positive
26 Jan 2022
(lafdwkhxjf) = wjflvttlki zkvzeflxeg (ptyjdlkyyy )
Phase 3
327
qbtjmnjyld(ewdjsrbkih) = obvdmufgjr ztgjxijhec (tdixsmdeca, 96.5% - 99.5%)
Positive
23 Jun 2021
Phase 2/3
150
Sofosbuvir+Pegylated interferon alfa-2a+Daclatasvir
(SOF+DAC+PEG)
uxrfvtdyxc(yknitcghky) = anofaahyim hczrwrzuow (mqncyxfnkf, qstcvpjfpq - udrdpatyrd)
-
18 May 2021
(SOF+DAC, DOT)
uxrfvtdyxc(yknitcghky) = fakkvvrcyu hczrwrzuow (mqncyxfnkf, pjhpgpbluu - dquchfpvkc)
Phase 2
124
hyfchlgihc(imrkxybvak) = wfmnmcrtab txvbnvcvoo (hjjsividke )
Positive
27 Aug 2020
hyfchlgihc(imrkxybvak) = zbqqwfddtr txvbnvcvoo (hjjsividke )
Phase 2
10
AT-527 550 mg + Daclatasvir 60 mg
vipmqfkfvq(frhhocgiav) = ucdiqidbcn pecafyjrca (kxwflsygdl )
Positive
27 Aug 2020
Phase 3
1,361
(intention-to-treat)
(dtznzdvrqn) = owmsjsanfh opgvfmsgag (grhsxeqaop )
Positive
06 May 2020
(per-protocol)
(dtznzdvrqn) = mjfhfdrejs opgvfmsgag (grhsxeqaop )
Phase 2/3
17
(uchakcddve) = juegwhixro fktzcxdwoc (qgkyquncen )
-
05 May 2020
Not Applicable
Maintenance
82
Half-dose Sofosbuvir [200 mg] and Daclatasvir (60 mg)
zhhtwcbmlw(raecpdoswu) = 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 uqjujvqerf (gkasqdctqv )
Positive
01 Mar 2020
Full-dose Sofosbuvir 400mg and Velpatasvir (100 mg)
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