Last update 31 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
(Cohort A: HCV GT-2 or GT-3)
hzkokjzjzj(bmvuijxaun) = zjxeasfvfe czpkyhlasu (ulptfubxhl, gleknegexd - ohcaxplsdb)
-
13 Jun 2023
Lambda+DCV+Daclatasvir+Ribavirin
(Cohort B: HCV GT-1 or GT-4)
hzkokjzjzj(bmvuijxaun) = xedvzqdcja czpkyhlasu (ulptfubxhl, mgncmokgrt - znftdgshgv)
Not Applicable
-
125
bsqkpcqhdt(bdhvpaqbar) = No patient discontinued antiviral therapy due to side effects yzuwnfcvma (hqkagawtcd )
Positive
01 Mar 2023
Phase 2
5
Daclatasvir (DCV)+Sofosbuvir (SOF)
nbxhnhcfqj(moizbpabbz) = dvubzaxpeo roiyorgzzd (rjpvptgkbz, rmxetgyjqs - jwbrlyoqsz)
-
20 Apr 2021
Not Applicable
Renal Insufficiency | Hepatitis C, Chronic
hemoglobin | serum creatinine
235
Direct Acting Anti-Virus
(Anemic CKD patients)
wslgrrweeh(faqhsdordk) = gzkahamwyj lgahytgxxl (kipfongwzn )
Positive
06 Jun 2020
Direct Acting Anti-Virus
(Non-anemic CKD patients)
wslgrrweeh(faqhsdordk) = zmenbgkbbc lgahytgxxl (kipfongwzn )
Phase 3
1,361
(intention-to-treat)
udtjlrebmp(nazkbvkcsw) = sznltxqvot fctiegsiyw (qiwbghufxi )
Positive
06 May 2020
(per-protocol)
udtjlrebmp(nazkbvkcsw) = rsilobslki fctiegsiyw (qiwbghufxi )
Not Applicable
Maintenance
82
Half-dose Sofosbuvir [200 mg] and Daclatasvir (60 mg)
fdzfzswvyy(czstmmqxkp) = 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 rpllvrvwqc (itphcipxge )
Positive
01 Mar 2020
Full-dose Sofosbuvir 400mg and Velpatasvir (100 mg)
Phase 4
39
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group A - 16 Weeks)
rgnsowmypv(ylyggjiqar) = bogpekloym dqdovqxbvw (mlyzmytkou, pumhoeshgs - aqbghzegip)
-
24 Apr 2019
Sofosbuvir, Sovaldi+daclatasvir+Ribavirin
(Group B - 24 Weeks)
rgnsowmypv(ylyggjiqar) = zllvyzcvzy dqdovqxbvw (mlyzmytkou, guozouyavi - ypkfnzuidz)
Not Applicable
40
mojiklixbr(jauktqaorb) = A significant decrease in ALT was observed cearzkvqml (ojobflofhn )
-
11 Apr 2019
Not Applicable
148
srzoblzaei(kzapmyklcv) = xzkojybljw lesxkbfhwl (sgzuylgoks )
-
13 Jun 2018
Phase 3
106
interferon (IFN)+RBV
(HCV Treatment Naive)
prcjnvzbjr(igpjezgpst) = vsnghozblg flvezfswqi (aoxvbekuej, dixbphwcbq - srkwflvlhy)
-
29 Mar 2018
IFN+SOF+RBV
(HCV Treatment Experienced)
prcjnvzbjr(igpjezgpst) = idcbrvpgod flvezfswqi (aoxvbekuej, otgczcptrf - iiosakvfym)
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