Clinical Trials

Numerous clinical trials evaluate the therapeutic application of daclatasvir across early phase 1 through Phase 4 studies. Most research focuses on hepatitis C virus infection, chronic hepatitis C, and HIV or hepatitis B coinfections, alongside exploratory evaluations in COVID-19. Sponsored by pharmaceutical companies, academic medical centers, and global public health organizations, these trials encompass completed, recruiting, active not recruiting, and withdrawn statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05992077 ACTIVE_NOT_RECRUITING
HCV Infection
ANRS, Emerging Infectious Diseases
 2023-08-07
NCT03646396 UNKNOWN
HCV Coinfection
Sherief Abd-Elsalam
 2018-08-01
NCT07702396 COMPLETED
Heptatitis C
Indus Hospital and Health Network
 2024-01-10
NCT05854511 UNKNOWN
HCV
Ain Shams University
 2022-06-05 PHASE3
NCT05992077 Recruiting
HCV Infection
ANRS Emerging Infectious Diseases
 2023-08-07 Not Applicable
NCT03540212 UNKNOWN
Chronic HCV Infection
Ain Shams University
 2017-12-10 PHASE2; PHASE3
NCT05616598 COMPLETED
Male Infertility; HCV
Benha University
 2022-03-01 PHASE2; PHASE3
NCT03882307 UNKNOWN
Hepatitis C, Chronic
Assiut University
 2022-10 EARLY_PHASE1
NCT04561063 COMPLETED
Covid19; SARS-CoV Infection
University of Witwatersrand, South Africa
 2020-12-08 PHASE2
NCT04532931 COMPLETED
COVID-19
Shin Poong Pharmaceutical Co. Ltd.
 2020-09-03 PHASE2
NCT04468087 COMPLETED
COVID-19
Hospital do Coracao
 2021-02-15 PHASE2; PHASE3
NCT04460443 UNKNOWN
COVID
Tanta University
 2020-08-01 PHASE2; PHASE3
NCT02555943 COMPLETED
Chronic Hepatitis C Infection; HBV Coinfection; Hepatitis B Reactivation
Humanity and Health Research Centre
 2015-02 PHASE2; PHASE3
NCT04497649 UNKNOWN
Covid19
Tanta University
 2020-07-01 PHASE2; PHASE3
NCT04535869 UNKNOWN
COVID-19
Mansoura University
 2020-12-28 PHASE3
NCT03166943 UNKNOWN
Hepatitis
Assiut University
 2017-05-10
NCT04852614 Recruiting
Hepatitis C Virus Infection
Ain Shams University
 2020-12-01 --
NCT04773756 COMPLETED
Covid19
Alexandria University
 2020-11-01 PHASE4
NCT03537196 COMPLETED
Hepatitis C; Drug Use; Viral Hepatitis C
ANRS, Emerging Infectious Diseases
 2018-11-13 PHASE4
NCT04773756 Completed
Covid19
Alexandria University
 2020-11-01 Phase 4
NCT04443725 UNKNOWN
COVID-19
Cairo University
 2020-07 PHASE2; PHASE3
NCT03883698 COMPLETED
Kidney Failure, Chronic; Hepatitis C
Sanjay Gandhi Postgraduate Institute of Medical Sciences
 2019-03-15 PHASE3
NCT03163849 UNKNOWN
Chronic Hepatitis c
Assiut University
 2019-09-01 PHASE3
NCT04019717 COMPLETED
Hepatitis C; Hepatitis C, Chronic; Chronic Hepatitis C; Hepatitis C Virus Infection; HCV Infection
Atea Pharmaceuticals, Inc.
 2019-06-20 PHASE2
NCT04070235 UNKNOWN
Hepatitis C, Chronic
Nanjing Sanhome Pharmaceutical, Co., Ltd.
 2019-03-29 PHASE2; PHASE3
NCT04457050 COMPLETED
Insulin Resistance; Hepatitis C
Alexandria University
 2017-10-30 PHASE4
NCT03169348 UNKNOWN
Hepatitis C
Assiut University
 2017-11-01
NCT03706898 COMPLETED
HIV-1-infection; Hepatic Impairment
Viriom
 2018-10-01 PHASE1
NCT03549832 COMPLETED
HCV Coinfection
Assiut University
 2018-01-01
NCT03748745 COMPLETED
Drug Interactions
Nanjing Sanhome Pharmaceutical, Co., Ltd.
 2018-11-19 PHASE1
NCT02992457 COMPLETED
Hepatitis C
Tanta University
 2015-01 PHASE4
NCT03480932 COMPLETED
Hepatitis C, Chronic
Johns Hopkins Bloomberg School of Public Health
 2018-02-02 PHASE2; PHASE3
NCT03208322 Withdrawn
Hepatitis C
Bristol-Myers Squibb
 2018-11-30 --
NCT03487848 TERMINATED
Hepatitis C; Chronic Hepatitis
Bristol-Myers Squibb
 2018-06-25 PHASE2
NCT03369327 COMPLETED
Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus
Tehran University of Medical Sciences
 2017-01-01 PHASE3
NCT03063879 COMPLETED
Hepatitis C, Chronic; Chronic Renal Failure
Tehran University of Medical Sciences
 2017-04-01 PHASE4
NCT03485846 COMPLETED
Chronic Hepatitis C Genotype 1b
R-Pharm
 2017-11-27 PHASE2
NCT03490097 COMPLETED
Chronic Hepatitis c; Metabolic Syndrome
Ain Shams University
 2017-12-01 PHASE2; PHASE3
NCT03200184 COMPLETED
Hepatitis C
Tehran University of Medical Sciences
 2016-09-01 PHASE4
NCT02580474 COMPLETED
Hepatitis C
Myeong Jun Song
 2016-02 PHASE4
NCT03004625 COMPLETED
Hepatitis C
Kaohsiung Medical University Chung-Ho Memorial Hospital
 2016-11 PHASE3
NCT03080415 COMPLETED
Hepatitis C Genotype 4
Yassin Abdelghaffar Charity Center for Liver Disease and Research
 2017-03-18 PHASE3
NCT02473211 COMPLETED
Chronic Hepatitis C Infection
Humanity and Health Research Centre
 2015-01 PHASE2; PHASE3
NCT02576314 COMPLETED
Chronic Hepatitis C Infection
Humanity and Health Research Centre
 2015-05 PHASE3
NCT02771405 COMPLETED
Hepatitis C, Chronic; Hepatocellular Carcinoma
National Hepatology & Tropical Medicine Research Institute
 2016-03 PHASE3
NCT03686722 COMPLETED
Diabetes Mellitus, Type 2; Hepatitis C; Drug Interactions
Mohamed Raslan
 2017-09-09 PHASE1
NCT02304159 COMPLETED
Hepatitis C; Cirrhosis
Tarek I. Hassanein, M.D., FACP, FAG, AGAF
 2015-01 PHASE4
NCT04387526 COMPLETED
Chronic Hepatitis C Virus Infection
Beni-Suef University
 2016-04-01 PHASE2; PHASE3
NCT03188276 COMPLETED
Chronic Hepatitis C
Third Affiliated Hospital, Sun Yat-Sen University
 2016-02-01 EARLY_PHASE1
NCT03186313 COMPLETED
Hepatitis C
Egyptian Liver Hospital
 2016-09 PHASE3
NCT02673489 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2016-03-15 PHASE3
NCT02624063 COMPLETED
Hepatitis C, Chronic
Federal University of São Paulo
 2015-12 PHASE4
NCT02639585 UNKNOWN
Hepatitis C, Chronic
Pusan National University Hospital
 2015-12 PHASE4
NCT01797848 WITHDRAWN
Hepatitis C
Bristol-Myers Squibb
 2014-06 PHASE3
NCT02640157 COMPLETED
Chronic Hepatitis C; Hepatitis C Virus; Genotype 3 Hepatitis C Virus
AbbVie
 2015-12 PHASE3
NCT02496078 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2015-08 PHASE3
NCT02556086 WITHDRAWN
Hepatitis C
Bristol-Myers Squibb
 2015-12 PHASE2
NCT02551861 WITHDRAWN
Hepatitis C
Bristol-Myers Squibb
 2015-12 PHASE2
NCT02292966 WITHDRAWN
Hepatitis C, Chronic
Kirby Institute
 2015-07 PHASE4
NCT03547895 COMPLETED
Decompensated Cirrhosis
Zagazig University
 2015-06-01
NCT02780362 COMPLETED
Healthy
Genuine Research Center, Egypt
 2016-04 PHASE1
NCT02596880 COMPLETED
Hepatitis C; Cirrhosis
Tehran University of Medical Sciences
 2015-09 PHASE3
NCT02565862 COMPLETED
Hepatitis C; Diabetes Mellitus; Insulin Resistance
Radboud University Medical Center
 2016-01 PHASE1
NCT02124044 COMPLETED
HIV-HCV
National Institutes of Health Clinical Center (CC)
 2014-02 PHASE2
NCT02098616 COMPLETED
Hepatitis C
Timothy Morgan, MD
 2014-07
NCT02349048 COMPLETED
Hepatitis C Virus
Janssen Research & Development, LLC
 2015-01 PHASE2
NCT02756936 COMPLETED
Healthy
Genuine Research Center, Egypt
 2016-02 PHASE1
NCT02397395 WITHDRAWN
Renal Impairment; End-stage Renal Disease
Janssen R&D Ireland
 2015-05 PHASE2
NCT02565888 COMPLETED
Hepatitis C; HIV
Radboud University Medical Center
 2015-11 PHASE1
NCT02268864 COMPLETED
Hepatitis C, Chronic
Janssen-Cilag International NV
 2015-01 PHASE2
NCT02675127 COMPLETED
Healthy
Genuine Research Center, Egypt
 2015-12 PHASE1
NCT02309450 WITHDRAWN
Hepatitis C Virus Genotype 4 Infection
ANRS, Emerging Infectious Diseases
 2014-12 PHASE2
NCT02319031 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2015-02 PHASE3
NCT01866930 TERMINATED
Chronic Hepatitis C Infection
Bristol-Myers Squibb
 2013-07-11 PHASE3
NCT02262728 COMPLETED
Hepatitis C, Chronic
Janssen Research & Development, LLC
 2014-09-30 PHASE2
NCT01995266 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-02-28 PHASE3
NCT02282709 COMPLETED
Chronic Hepatitis C
Foundation for Liver Research
 2014-02 PHASE3
NCT02170727 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2014-06-26 PHASE3
NCT01938625 COMPLETED
Hepatitis C, Chronic
Janssen R&D Ireland
 2013-12-12 PHASE2
NCT02323594 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2014-12 PHASE1
NCT02107365 COMPLETED
Hepatitis C Virus Genotype 4 Infection
ANRS, Emerging Infectious Diseases
 2013-11 PHASE2
NCT01741545 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2013-03-31 PHASE3
NCT02175966 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-07-28 PHASE2
NCT02123654 COMPLETED
Hepatitis C Virus Infection
Bristol-Myers Squibb
 2014-04 PHASE3
NCT02032875 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-03 PHASE3
NCT01718158 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2013-01 PHASE3
NCT02032888 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-02 PHASE3
NCT01428063 COMPLETED
Hepatitis C Virus Infection
Bristol-Myers Squibb
 2011-09 PHASE2
NCT02032901 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-01 PHASE3
NCT02175602 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2014-06 PHASE1
NCT01973049 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2013-12 PHASE3
NCT01979939 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2013-12 PHASE3
NCT01309932 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2011-03 PHASE2
NCT02159352 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-06 PHASE1
NCT02103569 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-04 PHASE1
NCT01616524 COMPLETED
Hepatitis C Virus (HCV)
Bristol-Myers Squibb
 2012-07 PHASE3
NCT01471574 COMPLETED
Hepatitis C, Genotype 1
Bristol-Myers Squibb
 2011-12 PHASE3
NCT02095860 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-04 PHASE1
NCT02082808 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-03 PHASE1
NCT02104843 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-04 PHASE1
NCT01842451 COMPLETED
Chronic Hepatitis C; CHC; HCV; Hepatitis C
Vertex Pharmaceuticals Incorporated
 2013-06 PHASE2
NCT01725542 COMPLETED
HCV-HIV Co-Infection
ANRS, Emerging Infectious Diseases
 2012-12 PHASE2
NCT02045966 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-02 PHASE1
NCT01795911 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2013-03 PHASE2
NCT02045693 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-02 PHASE1
NCT01455090 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2011-11-30 PHASE2
NCT01629732 WITHDRAWN
Hepatitis C Virus
Bristol-Myers Squibb
 2013-03 PHASE2
NCT01718145 COMPLETED
Hepatitis C Virus Infection
Bristol-Myers Squibb
 2012-11 PHASE3
NCT01492426 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2012-01 PHASE3
NCT01581203 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2012-05 PHASE3
NCT01448044 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2011-12 PHASE3
NCT01573351 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2012-05 PHASE3
NCT01389323 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2011-09 PHASE3
NCT01628692 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2012-07 PHASE2
NCT01425970 TERMINATED
Hepatitis C
Bristol-Myers Squibb
 2012-05 PHASE2
NCT01830205 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2012-09 PHASE1
NCT01497834 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2012-01 PHASE3
NCT01359644 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2011-06 PHASE2
NCT01012895 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2009-12 PHASE2
NCT01170962 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2010-08 PHASE2
NCT01257204 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2010-12 PHASE2
NCT01125189 COMPLETED
Hepatitis C Virus
Bristol-Myers Squibb
 2010-07 PHASE2
NCT01017575 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2009-12 PHASE2
NCT01051414 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2010-04 PHASE2
NCT01016912 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2009-12 PHASE2
NCT00983957 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2009-10 PHASE1
NCT00874770 COMPLETED
Hepatitis C Infection
Bristol-Myers Squibb
 2009-06 PHASE2
NCT00859053 COMPLETED
Hepatic Insufficiency
Bristol-Myers Squibb
 2009-03 PHASE1
NCT00904059 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2009-05 PHASE1
NCT00663208 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2008-05 PHASE2
NCT00546715 COMPLETED
Chronic Hepatitis C
Bristol-Myers Squibb
 2007-11 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2025-12-04)

Check the Daclatasvir (BMS-790052) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Daclatasvir selectively binds to the hepatitis C virus (HCV) nonstructural protein 5A (NS5A), disrupting the assembly and function of the viral replication complex to inhibit intracellular RNA synthesis and viral particle secretion. This molecular blockade drives a rapid reduction in circulating viral load, providing direct therapeutic efficacy against chronic hepatitis C virus infection studied across clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.