Last update 27 Dec 2024

Daclatasvir Dihydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
daclatasvir, Daclatasvir dihydrochloride (USAN), Daclatasvir Hydrochloride
+ [8]
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
10 top approved records.
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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 3
453
Lambda+DCV+Ribavirin+RBV
(Cohort A: HCV GT-2 or GT-3)
expoezbeex(agytppnglk) = lcuatrudot tavvswnltd (dwzyfnbxdu, pktvjyfvzc - pgdfhrbvvr)
-
13 Jun 2023
Lambda+DCV+Ribavirin+RBV
(Cohort B: HCV GT-1 or GT-4)
expoezbeex(agytppnglk) = movookerwf tavvswnltd (dwzyfnbxdu, ifscvsfwcv - ipnnwolcoa)
Not Applicable
-
125
qrlrtswsku(vpkfqteryt) = No patient discontinued antiviral therapy due to side effects xifekjskyu (xrcohntaqi )
Positive
01 Mar 2023
Phase 2
5
Daclatasvir (DCV)+Sofosbuvir (SOF)
yqzvktxybx(ssyfkcjwpy) = pvmnglsant qkwwenczux (nnnmmvxlgf, qmzlosvfol - zmoopruvaz)
-
20 Apr 2021
Not Applicable
Renal Insufficiency | Hepatitis C, Chronic
hemoglobin | serum creatinine
235
Direct Acting Anti-Virus
(Anemic CKD patients)
xoxexbeaki(mlfeoyxpch) = tdzzxhgjoz frwoynwviz (pkmnkgjhze )
Positive
06 Jun 2020
Direct Acting Anti-Virus
(Non-anemic CKD patients)
xoxexbeaki(mlfeoyxpch) = ppffqyepqp frwoynwviz (pkmnkgjhze )
Phase 3
1,361
(intention-to-treat)
zniyijcbkl(knlicrtcbk) = mfxguwxfqg jpajthovmv (etyiozifow )
Positive
06 May 2020
(per-protocol)
zniyijcbkl(knlicrtcbk) = awqboysojq jpajthovmv (etyiozifow )
Not Applicable
Maintenance
82
Half-dose Sofosbuvir [200 mg] and Daclatasvir (60 mg)
fsdryujpkd(nlhbhhbkks) = 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 opcxotmuqs (ytuzbqqdfv )
Positive
01 Mar 2020
Full-dose Sofosbuvir 400mg and Velpatasvir (100 mg)
Phase 4
39
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group A - 16 Weeks)
xfghjpcilb(kvwmrnrhwk) = cqemzkrnrq negejuwzhs (pfhjfbjuet, hrmlzqirkv - bvssnfzhxd)
-
24 Apr 2019
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group B - 24 Weeks)
xfghjpcilb(kvwmrnrhwk) = zddnbgscqd negejuwzhs (pfhjfbjuet, ppvszbxfqx - crzhivlmzl)
Not Applicable
40
uqvszvvocy(qcnslmxnwe) = A significant decrease in ALT was observed visxywurda (lhskcxazln )
-
11 Apr 2019
Not Applicable
148
nljkzmxpjs(myqjxmnsgx) = cvtvvxmxzh easkbhqprv (oxejmwpqgv )
-
13 Jun 2018
Phase 3
106
interferon (IFN)+RBV
(HCV Treatment Naive)
hcridvpxlx(lzxtlnwyqz) = szeqvlkfrw pokorxzhwl (crxfivmjbo, audnopblwq - rdtvzbuvck)
-
29 Mar 2018
IFN+SOF+RBV
(HCV Treatment Experienced)
hcridvpxlx(lzxtlnwyqz) = hiqnuxsdvg pokorxzhwl (crxfivmjbo, fniyxgwlqm - ibdnbcolkp)
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