Daclatasvir
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Withdrawn | EU (EMA) | Daklinza | — | 2019-08-26 | europa.eu ↗ |
| Label expansion | US (FDA) | DAKLINZA | — | 2016-02-05 | fda.gov ↗ |
| Approved | US (FDA) | DAKLINZA | — | 2015-07-24 | fda.gov ↗ |
| Approved | EU (EMA) | Daklinza | — | 2014-08-22 | europa.eu ↗ |
Trials 108 · started per year
Also used as a comparator or background therapy in 25 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT03882307 Comparator | Oct → Nov 2022 | chronic hepatitis C virus infection | Assiut University | Unknown | No outcome recorded |
| Phase 0 | NCT03188276 Comparator | Feb 2016 → May 2017 | chronic hepatitis C virus infection | Third Affiliated Hospital, Sun Yat-Sen University | Completed | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT02045693 Background | Feb → Apr 2014 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT00859053 Comparator | Mar → Sep 2009 | liver disorder | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT04387539 Comparator | Mar → Oct 2017 | chronic hepatitis C virus infection | Beni-Suef University | Completed | No outcome recorded |
| Phase 1/2 | NCT00546715 Comparator | Nov 2007 → May 2008 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT04561063 Comparator | Dec 2020 → Feb 2022 | COVID-19 | University of Witwatersrand, South Africa | Completed | No outcome recorded |
| Phase 2 | NCT02551861 Comparator | Dec 2015 → Jun 2016 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Withdrawn | No outcome recorded |
| Phase 2 | NCT00663208 Comparator | May 2008 → Jun 2009 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT05616598 Comparator | Mar → Nov 2022 | hepatitis C virus infection, male infertility | Benha University | Completed | No outcome recorded |
| Phase 2/3 | NCT03480932 Comparator | Feb → Nov 2018 | chronic hepatitis C virus infection | Johns Hopkins Bloomberg School of Public Health | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT04535869 Comparator | Dec 2020 → Apr 2021 | COVID-19 | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT03883698 Background | Mar 2019 → Aug 2020 | chronic renal failure syndrome, hepatitis C virus infection | Sanjay Gandhi Postgraduate Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 3 | NCT03186313 Comparator | Sep 2016 → May 2017 | chronic hepatitis C virus infection | Egyptian Liver Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02640157 Comparator | Dec 2015 → Oct 2016 | chronic hepatitis C virus infection | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02496078 Comparator | Aug 2015 → Aug 2016 | chronic hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT02576314 Comparator | May 2015 → Dec 2017 | chronic hepatitis C virus infection | Humanity and Health Research Centre | Completed | No outcome recorded |
| Phase 3 | NCT02319031 Comparator | Feb → Oct 2015 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT02123654 Comparator | Apr 2014 → Jan 2015 | hepatitis C virus infection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT02992457 Comparator | Jan 2015 → Dec 2018 | hepatitis C virus infection | Tanta University | Completed | No outcome recorded |
| Phase 4 | NCT03133065 Comparator | Sep 2014 → Dec 2016 | — | Ain Shams University | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT03669835 Background | Mar 2018 → Sep 2019 | hepatitis C virus infection | Asfendiyarov Kazakh National Medical University | Completed | No outcome recorded |
| — | NCT03549832 Comparator | Jan 2018 → Jan 2019 | hepatitis C virus infection | Assiut University | Completed | No outcome recorded |
| — | NCT03481036 Comparator | Jun 2016 → Dec 2020 | chronic hepatitis C virus infection | Post Graduate Institute of Medical Education and Research, Chandigarh | Unknown | No outcome recorded |
| — | NCT03547895 Comparator | Jun 2015 → May 2016 | cirrhosis of liver | Zagazig University | Completed | No outcome recorded |
Press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2014-01-09 | Vertex Pharmaceuticals Incorporated | Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C vrtx.com ↗ |
| 2013-04-05 | Vertex Pharmaceuticals Incorporated | Vertex Enters Agreement with Bristol-Myers Squibb for Phase 2 All-Oral Studies of VX-135 in Combination with Daclatasvir for the Treatment of Hepatitis C vrtx.com ↗ |
| 2012-04-19 | Bristol-Myers Squibb | All-Oral Hepatitis C Virus Treatment with Bristol-Myers Squibb’s Investigational Compounds Daclatasvir and Asunaprevir Achieved Sustained Virologic Response in 77% of Difficult-to-Treat Patients bms.com ↗ |
| 2012-04-19 | Bristol-Myers Squibb | All-Oral Combination of Investigational Hepatitis C (HCV) Compounds Daclatasvir and GS-7977 Achieved Sustained Virologic Response (SVR4) in 100% of Genotype 1 and 91% of Genotype 2 and 3 Treatment-Naïve Patients in Phase II Study bms.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 145 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Daclatasvir | “Chinese patients with chronic HCV genotype 1b infection without cirrhosis were randomly allocated by a computer program to one of three treatment groups (sofosbuvir,...” PMID 27917405 ↗ Jul 2016122“For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and...” NCT03669835 ↗ “All participants will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.” NCT02292966 ↗ “To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639 ↗ “Fixed dose combination (daclatasvir \[DCV\] 30 milligrams, asunaprevir \[ASV\] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily” NCT02175602 ↗ “DCV 3DAA FDC (Daclatasvir 30 mg/Asunaprevir 200 mg/BMS-791325 75 mg 3 direct-acting antiviral (3DAA) fixed dose combination tablet) orally twice daily” NCT02045693 ↗ “Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients” NCT01016912 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “whether a rapid reduction in viremia by daclatasvir (DCV) and asunaprevir (ASV) improves the response to pegylated interferon” PMID 26733671 ↗ Jan 2016 “Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 12 weeks” NCT01979939 ↗ “Daclatasvir (DCV) is an NS5A replication complex inhibitor recently approved for chronic hepatitis C virus treatment.” PMID 27450277 ↗ Jul 2016 “26 recipients were treated with sofosbuvir 400mg+Daclatasvir 60mg ± weight based ribavirin for 12 weeks or 24 weeks.” NCT03133065 ↗ “Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966 ↗ “Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day” NCT02098616 ↗ “Sofosbuvir 400 mg once daily plus daclatasvir 100 mg once daily plus ribavirin 1000 mg” NCT03483987 ↗ “1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day” NCT03080415 ↗ “Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860 ↗ “Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination” NCT02170727 ↗ “Daclatasvir (DCV) 60 mg tablet administered orally once daily” NCT02932293 ↗ “Daclatasvir (DCV) 60 mg administered orally once daily” NCT03794258 ↗ “Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)” NCT02673489 ↗ “Daclatasvir (DCV) 60mg tablet administered once daily.” NCT02482077 ↗ “Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks” NCT03488485 ↗ “Sofosbuvir and Daclatasvir” NCT03481036 ↗ “Sofosbuvir + Daclatasvir” NCT02469012 ↗ |
| Known as | BMS 790052-05 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2023898 ↗ |
| Known as | BMS-790052 | “Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients” NCT01016912 ↗17“Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)” NCT01017575 ↗ “Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)” NCT00874770 ↗ “A Multiple Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Genotype 1 Infected Subjects” NCT00663208 ↗ “A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects” NCT00546715 ↗ “Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients” NCT01125189 ↗ “Combination of Simeprevir (TMC435), Daclatasvir (BMS-790052), and Ribavirin (RBV)” NCT01938625 ↗ “Daclatasvir (BMS-790052)” NCT02161939 ↗ “BMS-790052 (Daclatasvir)” NCT01497834 ↗ |
| Known as | Daclatasvir dihydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03748745 ↗ |
| Known as | Daclatasvir hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL2023898 ↗ |
| Known as | Daklinza | “treated with Sofosbuvir 400 mg (Sovaldi) + Daclatasvir 60mg (Daklinza) + Ribavirin 200 mg (Rebetol)” NCT03547895 ↗ |
| Known as | Daklinza is a trade name of daclatasvir | “Daklinza is a trade name of daclatasvir” NCT04387539 ↗ |
| Known as | DCV | “METHODS: A subanalysis of efficacy and safety for a daclatasvir (DCV) and sofosbuvir (SOF) regimen, with or without ribavirin (RBV), was undertaken in HIV-HCV-coinfected...” PMID 27845298 ↗ Nov 201635“This phase III study (ALLY-3; ClinicalTrials.gov: NCT02032901) evaluated the 12-week regimen of daclatasvir (DCV; pangenotypic nonstructural protein [NS]5A inhibitor) plus...” PMID 25614962 ↗ Mar 2015 “BACKGROUND: Daclatasvir (DCV) is a potent, pangenotypic, hepatitis C virus (HCV) non-structural protein 5A inhibitor with low potential for drug interactions with...” PMID 28210927 ↗ Feb 2017 “To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet” NCT02108639 ↗ “We evaluated the efficacy and safety of daclatasvir (DCV) and asunaprevir (ASV) in patients with chronic hepatitis C virus (HCV) infection on hemodialysis.” PMID 30400729 ↗ Mar 2019 “To investigate the efficacy and safety of sofosbuvir (SOF) plus daclatasvir (DCV) or simeprevir (SMV) in a randomized, open-label, noninferiority trial” PMID 29906601 ↗ Jun 2018 “The efficacy of daclatasvir (DCV), asunaprevir (ASV), pegylated interferon and ribavirin (Peg-IFN/RBV) association was investigated in these patients.” PMID 29271782 ↗ Mar 2018 “The current recommendation for treating hepatitis C virus (HCV) in HIV patients includes the combination of sofosbuvir (SOF) and daclatasvir (DCV).” PMID 33930223 ↗ May 2021 “Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients” NCT02124044 ↗ “UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination” NCT01979939 ↗ “Experienced participants who had HCV GT4 infection were treated with Sofosbuvir/Simeprevir/Daclatasvir/Ribavirin (SOF/SMV/DCV/RBV)” NCT04387539 ↗ “whether a rapid reduction in viremia by daclatasvir (DCV) and asunaprevir (ASV) improves the response to pegylated interferon” PMID 26733671 ↗ Jan 2016 “Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection” NCT03487848 ↗ “Daclatasvir (DCV) is an NS5A replication complex inhibitor recently approved for chronic hepatitis C virus treatment.” PMID 27450277 ↗ Jul 2016 “Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.” NCT02175966 ↗ “The combination of daclatasvir (DCV, pan-genotypic NS5A inhibitor) plus asunaprevir (ASV; NS3 protease inhibitor)” PMID 27287851 ↗ Jun 2016 “In India, four DAAs are available (sofosbuvir [SOF], daclatasvir [DCV], ledipasvir [LDV] and velpatasvir [VEL]).” NCT03483987 ↗ “daclatasvir (DCV), which is a highly selective nonstructural protein 5A (NS5A) inhibitor” PMID 24468783 ↗ Jan 2014 “Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.” NCT02397395 ↗ “Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325” NCT02095860 ↗ “Asunaprevir (ASV) and Daclatasvir (DCV) to Telaprevir (TVR) included therapy” NCT01718145 ↗ “combination therapy with daclatasvir (DCV) and sofosbuvir (SOF) for 8 weeks” NCT02556086 ↗ “Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination” NCT02170727 ↗ “Daclatasvir (DCV) 60 mg tablet administered orally once daily” NCT02470858 ↗ “Daclatasvir (DCV) 60 mg tablet administered orally once daily” NCT02932293 ↗ “Daclatasvir (DCV) 60mg tablet administered once daily.” NCT02482077 ↗ “Daclatasvir (DCV) + Sofosbuvir (SOF) + Ribavirin (RBV)” NCT02673489 ↗ “Daclatasvir (DCV) 60 mg administered orally once daily” NCT03794258 ↗ “Sofosbuvir (SOF)+ Daclatasvir (DCV) for 12-weeks” NCT03488485 ↗ “Sofosbuvir (SOF)+Daclatasvir (DCV) for 12 weeks” NCT03481036 ↗ “Daclatasvir (DCV)/Asunaprevir (ASV)/BMS-791325” NCT02123654 ↗ “Daclatasvir (DCV) 60 mg once daily” NCT03686722 ↗ “2. Daclatasvir (DCV)” NCT04468087 ↗ “daclatasvir \[DCV\]” NCT02175602 ↗ “Daclatasvir (DCV)” NCT01581203 ↗ “Daclatasvir (DCV)” NCT01866930 ↗ |
| Known as | EBP 883 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2023898 ↗ |
| Action | Inhibit | “a potent NS5A replication complex inhibitor” PMID 22714001 ↗ Jun 2012 |
| Modality | Small molecule | — CHEMBL2023898 ↗ |
| Route | Oral | “Oral Solution, Oral, Single Dose” NCT00546715 ↗ |