Daclatasvir
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed chronic hepatitis C virus infection 1 milestone | |||||
| Filed | EU (EMA) | — | chronic hepatitis C virus infection | 2014-01-08 | “Medicines Agency (EMA) has validated the company’s marketing authorization application (MAA) for the use of daclatasvir” bms.com ↗ “EMA validated the company’s marketing authorization application for daclatasvir” bms.com ↗ |
| Filed hepatitis C virus infection 3 milestones | |||||
| Filed | US (FDA) | Daklinza | hepatitis C virus infection | 2015-10-06 | “In October, the FDA accepted for priority review three supplemental New Drug Applications (sNDAs) for Daklinza for use with sofosbuvir with or without ribavirin.” bms.com ↗ “accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza (daclatasvir)” bms.com ↗ |
| Rejected (CRL) | US (FDA) | — | hepatitis C virus infection | 2014-11-26 | “has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir” bms.com ↗ |
| Filed | US (FDA) | — | hepatitis C virus infection | 2014-04-07 | “U.S. application submission marks third major daclatasvir regulatory milestone globally” bms.com ↗ |
| Withdrawn Indication not stated 5 milestones | |||||
| Withdrawn | EU (EMA) | Daklinza | — | 2019-08-26 | europa.eu ↗ |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 ↗ |
| Filed | US (FDA) | — | hepatitis C genotype 3 | 2015-03-12 | “the resubmitted new drug application (NDA) for daclatasvir, an investigational NS5A replication complex inhibitor, has been accepted for review by the U.S.” bms.com ↗ |
| Approved | EU (EMA) | Daklinza | — | 2014-08-22 | europa.eu ↗ |
Trials 108 · started per year
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2017-04-28 | Bristol-Myers Squibb | Regulatory China FDA Approves Country’s First All-Oral Regimen for Chronic Hepatitis C, Daklinza® (daclatasvir) in Combination with Sunvepra® (asunaprevir) bms.com ↗
Daklinza and Sunvepra combination approved for genotype 1b, the most common chronic hepatitis C (HCV) genotype in China; combination has a 91-99% cure rate |
| 2016-02-22 | Bristol-Myers Squibb | Results Data Presented at APASL from First Completed Phase 3 Trial of All-oral Chronic Hepatitis C Regimen in Chinese Patient Population Shows Daclatasvir and Asunaprevir DUAL Therapy Demonstrated High Cure Rates Among HCV Genotype 1b Patients bms.com ↗
In the study, 91% of patients from China achieved SVR24, which rose to 98% of patients without NS5A resistance-associated variants (RAVs) at baseline. |
| 2016-02-05 | Bristol-Myers Squibb | Regulatory U.S. FDA Approves Expanded Use of Bristol-Myers Squibb’s Daklinza (daclatasvir) for Additional Challenging-to-treat Patients with Genotype 1 or Genotype 3 Chronic Hepatitis C bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza ™ (daclatasvir, 60 mg), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA) in combination with sofosbuvir (with or without ribavirin) in genotypes 1 and 3. |
| 2016-01-28 | Bristol-Myers Squibb | Regulatory European Commission Approves Daklinza (daclatasvir) for the Treatment of Genotype 1, 3 and 4 Chronic Hepatitis C Patients with HIV Coinfection, Advanced Cirrhosis and Post-liver Transplant Recurrence of HCV bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved Daklinza for the treatment of chronic hepatitis C (HCV) in three new patient populations. |
| 2015-11-16 | Bristol-Myers Squibb | Results Data from ALLY-3+ Trial Investigating Daklinza (daclatasvir) in Combination with Sofosbuvir and Ribavirin in Chronic Hepatitis C Genotype 3 Patients with Advanced Fibrosis or Cirrhosis Presented at AASLD bms.com ↗
Daclatasvir+sofosbuvir+ribavirin regimen for 12 or 16 weeks achieved SVR12 rates of 88% and 92%, respectively, in genotype 3 patients with advanced fibrosis or cirrhosis |
| 2015-10-15 | Bristol-Myers Squibb | Regulatory NICE Recommends Daklinza (daclatasvir) for Treatment of Certain Patients with Chronic Hepatitis C Genotypes 1, 3 and 4 bms.com ↗
Bristol-Myers Squibb (NYSE:BMY) today announced that the National Institute for Health and Care Excellence (NICE) has recommended Daklinza ( daclatasvir) in England and Wales for the treatment of adult patients with chronic hepatitis C virus (HCV) infection. |
| 2015-10-06 | Bristol-Myers Squibb | Regulatory U.S. FDA Grants Priority Review For Daklinza (daclatasvir) sNDAs bms.com ↗
The FDA will review the three Daklinza sNDAs within a six-month timeframe. |
| 2015-09-10 | Bristol-Myers Squibb | Regulatory Updated Label for Daklinza (daclatasvir) for the 12-week Treatment of Non-cirrhotic Patients with Chronic Hepatitis C Genotype 3 Approved by the European Commission bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that the European Commission has approved an updated label for Daklinza for the treatment of genotype 3 chronic hepatitis C (HCV). |
| 2015-07-24 | Bristol-Myers Squibb | Regulatory FDA Approves Daklinza (daclatasvir) for the Treatment of Patients with Chronic Hepatitis C Genotype 3 bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that Daklinza ™ (daclatasvir), an NS5A replication complex inhibitor, has been approved by the U.S. Food and Drug Administration (FDA). |
| 2015-05-20 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Amended U.S. FDA Breakthrough Therapy Designation for Investigational Daclatasvir-based Hepatitis C Regimen bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients. |
| 2015-04-25 | Bristol-Myers Squibb | Results ALLY-1 Trial Results Show Investigational Daclatasvir-Based Regimen Cures 94% of Post-Liver Transplant Patients with Hepatitis C and Up to 94% of Hepatitis C Patients with Cirrhosis (Child-Pugh Class A or B) bms.com ↗
The study’s primary endpoints were reached, with 95% of post-transplant genotype 1 patients and 82% of genotype 1 patients with advanced cirrhosis achieving SVR12. |
| 2015-03-12 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Announces Acceptance of New Drug Application for Investigational Daclatasvir for FDA Review for the Treatment of Hepatitis C Genotype 3 bms.com ↗
The FDA will now review the submission within a six-month timeframe. |
| 2015-02-26 | Bristol-Myers Squibb | Results ALLY Trial Demonstrates 97% Hepatitis C Cure Rates Among Patients Coinfected with HIV After Ribavirin-Free Investigational 12-Week Regimen of Daclatasvir and Sofosbuvir bms.com ↗
Among ALLY-2 patients treated for 12 weeks (treatment-naïve and -experienced), 97% (n=149/153) achieved cure (sustained virologic response 12 weeks after treatment; SVR12). |
| 2014-11-26 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Complete Response Letter from U.S. Food and Drug Administration for Daclatasvir, an Investigational Treatment for Hepatitis C bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for daclatasvir, an NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C (HCV). |
| 2014-11-08 | Bristol-Myers Squibb | Results Phase 3 UNITY Trials Demonstrate High Cure Rates for Investigational, All-Oral Daclatasvir TRIO Fixed-Dose Combination in Genotype 1 Hepatitis C Patients, Including Those with Cirrhosis bms.com ↗
Daclatasvir TRIO achieves 98% cure rate in treatment-naïve and 93% cure rate in treatment-experienced genotype 1 patients with cirrhosis when used with ribavirin, as shown in UNITY 2 |
| 2014-11-08 | Bristol-Myers Squibb | Results ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients bms.com ↗
The ALLY-3 results demonstrate the possibility of bringing a cure to genotype 3 patients in an all-oral, 12-week regimen. |
| 2014-08-27 | Bristol-Myers Squibb | Regulatory European Commission Approves Bristol-Myers Squibb’s Daklinza (daclatasvir) Across Multiple Genotypes for the Treatment of Chronic Hepatitis C Infection bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) today announced that the European Commission has approved Daklinza (daclatasvir), a potent, pan-genotypic NS5A replication complex inhibitor ( in vitro ), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults. |
| 2014-07-07 | Bristol-Myers Squibb | Regulatory Japan Approves First All-Oral, Interferon- and Ribavirin-Free Hepatitis C Treatment, Daklinza® (daclatasvir) and Sunvepra® (asunaprevir) Dual Regimen bms.com ↗
The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients. |
| 2014-06-27 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Positive CHMP Opinion for Daklinza® (daclatasvir) for Treatment of Chronic Hepatitis C in the European Union bms.com ↗
This is the first positive opinion given by the CHMP for an NS5A complex inhibitor and will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU). |
| 2014-04-10 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Presents Phase III Data Demonstrating that Investigational All-oral Daclatasvir and Asunaprevir Therapy Achieved SVR12 Rates of up to 90% Among Broad Range of Genotype 1b Hepatitis C Patients bms.com ↗
In the study the DCV+ASV regimen was generally well tolerated. |
| 2014-04-07 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Submits NDAs for Daclatasvir and Asunaprevir to US FDA for the Treatment of Hepatitis C bms.com ↗
Bristol-Myers Squibb Company (NYSE:BMY) announced today that they have submitted new drug applications (NDAs) with the U.S. Food and Drug Administration (FDA) for the investigational products daclatasvir (DCV), an NS5A replication complex inhibitor, and asunaprevir (ASV), a NS3 protease inhibitor. |
| 2014-02-24 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives U.S. FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C bms.com ↗
FDA grants Designation request for investigational daclatasvir (DCV) and asunaprevir (ASV) combination therapy for treatment of genotype 1b chronic hepatitis C (HCV) infection |
| 2014-01-09 | Vertex Pharmaceuticals Incorporated | Results Vertex Announces Sustained Viral Response Rate (SVR4) Data from All-Oral Study of VX-135 in Combination with Daclatasvir in Hepatitis C vrtx.com ↗
In an intent-to-treat analysis, the sustained viral response rate four weeks after the completion of treatment (SVR4) was 83 percent (10 of 12) in treatment-naïve genotype 1 patients who received 200 mg of VX-135 in combination with daclatasvir. |
| 2014-01-08 | Bristol-Myers Squibb | Regulatory Daclatasvir Marketing Authorization Application for Treatment of Chronic Hepatitis C Validated for Accelerated Regulatory Review by the European Medicines Agency bms.com ↗
The MAA validation marks the start of an accelerated regulatory review process for DCV, which has the potential, when used in combination with other agents, to address a high unmet need in the European Union (EU), where an estimated 9 million people are living with hepatitis C. |
| 2013-11-02 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Submits First All-Oral, Interferon-Free and Ribavirin-Free Treatment Regimen for Regulatory Review in Japan for Patients with Chronic Hepatitis C Infection bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced the submission of a New Drug Application (NDA) to Japan’s Pharmaceutical and Medical Devices Agency seeking the world’s first interferon-free and ribavirin-free treatment regimen for patients with chronic hepatitis C. |
| 2013-10-01 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present Range of New Hepatitis C Data at the 2013 American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗
Daclatasvir Pharmacokinetics in Healthy Subjects: No Clinically-Significant Drug-Drug Interactions with Cyclosporine or Tacrolimus |
| 2013-04-23 | Bristol-Myers Squibb | Results High Rates of SVR Demonstrated in Phase II Study with Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection bms.com ↗ |
| 2012-11-12 | Bristol-Myers Squibb | Results Investigational Triple DAA Regimen of Daclatasvir, Asunaprevir and BMS-791325 Achieved SVR12 of 94% in Treatment-Naïve Patients with Genotype 1 Chronic Hepatitis C Infection in Phase II Trial bms.com ↗
The remaining one patient had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR 24 . |
| 2012-11-12 | Bristol-Myers Squibb | Results Bristol-Myers Squibb’s Investigational Hepatitis C Compounds Lambda and Daclatasvir Plus Ribavirin Achieved SVR12 in 93% of Genotype 1b Treatment-Naive Patients In Phase IIb Study bms.com ↗
The SVR12 rate for all genotype 1 infected patients in the Lambda/RBV/DCV group was 76% (28/37). |
| 2012-11-11 | Bristol-Myers Squibb | Results Investigational Hepatitis C Quad Therapy Regimen of Daclatasvir and Asunaprevir Plus Interferon Alfa and Ribavirin Achieved SVR24 in 93% of Difficult-to-Treat Genotype 1a/b Prior Null Responders in Expanded Phase II Study bms.com ↗ |
| 2012-11-11 | Bristol-Myers Squibb | Results Investigational Hepatitis C Dual DAA Regimen of Daclatasvir and Asunaprevir Achieved SVR12 in 78% of Difficult-to-Treat Genotype 1b Prior Null Responders In Expanded Phase II Study bms.com ↗
In this study, the DCV/ASV Dual regimen achieved SVR 12 in 78% (14/18) and 65% (13/20) of GT1b patients when asunaprevir was dosed twice daily (Group A1) or once daily (Group A2), respectively. |
| 2012-10-16 | Bristol-Myers Squibb | Results Bristol-Myers Squibb to Present New Data Demonstrating Company’s Continuing Commitment to Research and Development in Liver Disease at The American Association for the Study of Liver Diseases (AASLD) Annual Meeting bms.com ↗ |
| 2012-04-26 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Delivers a Solid First Quarter with Strong Operating Results and Key R&D Milestones bms.com ↗
Data from a Phase II study that showed an all-oral combination of daclatasvir and asunaprevir, the Company’s NS3 protease inhibitor, achieved SVR24 in 77% of difficult-to-treat patients with genotype 1b. |
| 2012-04-19 | Bristol-Myers Squibb | Results 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 | Results 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 ↗
In this interim analysis, a combination of the two oral, once-daily investigational compounds taken for 24 weeks, with or without ribavirin, achieved a rapid and sustained viral response. |
| 2012-01-18 | Bristol-Myers Squibb | Results First Hepatitis C Treatment Data Demonstrating Proof of Principle with Direct-Acting Antiviral-only Therapy Published bms.com ↗
The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible with a direct-acting antiviral (DAA)-only combination containing daclatasvir and asunaprevir (4/11 patients, including two of two patients infected with HCV genotype 1b). |
| 2011-11-08 | Bristol-Myers Squibb | Results 12-Week On-Treatment Results from Large Phase IIb Study (COMMAND-1) of Bristol-Myers Squibb’s NS5A Inhibitor Daclatasvir Support Anti-HCV Activity and Safety Profile Observed in Earlier Studies bms.com ↗
Of the 365 patients with HCV genotype 1 in the study, 54% in each of the daclatasvir dose groups (20 mg and 60 mg) achieved eRVR vs. 14% in the control group. |
| 2011-11-07 | Bristol-Myers Squibb | Results All-Oral Treatment Regimen of Bristol-Myers Squibb’s Investigational NS5A and NS3 Inhibitors Achieved 90% Sustained Virologic Response (SVR12) in Phase II Study Sentinel Cohort of Genotype 1b Null Responders bms.com ↗
Results add to data suggesting that SVR can be achieved with the combination of daclatasvir (BMS-790052) and asunaprevir (BMS-650032) in HCV genotype 1b patients |
| 2011-09-17 | Bristol-Myers Squibb | Results BMS-790052 Plus Peginterferon Alfa and Ribavirin Demonstrated up to 83% Sustained Virologic Response 24 Weeks Post-Treatment (SVR24) in Phase II Study of Genotype 1 Hepatitis C Patients bms.com ↗
In this Phase II study, adding BMS-790052 once daily to peginterferon alfa and ribavirin produced SVR rates and safety findings that warranted further development of BMS-790052. |
| 2011-03-31 | Bristol-Myers Squibb | Results Investigational Direct-Acting Antiviral BMS-790052 Plus PEG-Interferon Alfa and Ribavirin Achieved Up to 92% Sustained Virologic Response in Phase II Dose-Ranging Study of Treatment-Naïve Hepatitis C Patients bms.com ↗ |
| 2011-03-07 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Investigational Hepatitis C Compounds to be Presented at The International Liver Congress 2011 bms.com ↗
Quadruple therapy with BMS-790052, BMS-650032 and PEG-IFN/RBV for 24 weeks results in 100% SVR12 in HCV Genotype 1 null responders |
| 2010-10-01 | Bristol-Myers Squibb | Results New Data on Multiple Bristol-Myers Squibb Compounds to be Presented at AASLD 2010 bms.com ↗
BMS-790052, a First-in-Class Potent Hepatitis C Virus NS5A Inhibitor, Demonstrates Multiple-Dose Proof-of-Concept in Subjects with Chronic Genotype 1 HCV Infection |
All press releases naming this drug 52 releases
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 |
| 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 in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)” NCT01017575 ↗17“Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients” NCT01016912 ↗ “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 ↗ “BMS-790052 (Daclatasvir)” NCT01497834 ↗ “Daclatasvir (BMS-790052)” NCT02161939 ↗ |
| 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 ↗ |
| 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 ↗ |