Numerous clinical trials evaluate velpatasvir across various conditions, predominantly focusing on hepatitis C virus infection, liver diseases, HIV-1 co-infection, and kidney transplantation using seropositive donors. Spanning Early Phase 1 through Phase 4 alongside non-applicable settings, these studies are sponsored by pharmaceutical companies such as Gilead Sciences, academic medical institutions, and clinical research groups. Recruitment statuses across the portfolio range from completed and active not recruiting to suspended, withdrawn, or not yet recruiting.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07560046 | NOT_YET_RECRUITING | HIV - Human Immunodeficiency Virus; Hepatitis B Virus (HBV); HEPATITIS C (HCV) |
Duke University |
2026-08-01 | PHASE4 |
| NCT07793643 | NOT_YET_RECRUITING | HEPATITIS C (HCV) |
Patrick Grace |
2026-12-01 | PHASE4 |
| NCT06953479 | RECRUITING | HEPATITIS C (HCV); Incarceration; Injection Drug Use; Implementation Science |
Lifespan |
2025-06-11 | PHASE4 |
| NCT07037277 | ACTIVE_NOT_RECRUITING | HEPATITIS C VIRUS CHRONIC INFECTION; Hepatitis C, Chronic; Hepatitis C Virus Infection; Hepatitis C |
Atea Pharmaceuticals, Inc. |
2025-06-02 | PHASE3 |
| NCT06159504 | RECRUITING | Hepatitis C; RDT |
Médecins du Monde |
2024-10-03 | EARLY_PHASE1 |
| NCT06868264 | ACTIVE_NOT_RECRUITING | HEPATITIS C VIRUS CHRONIC INFECTION |
Atea Pharmaceuticals, Inc. |
2025-04-07 | PHASE3 |
| NCT05140941 | ACTIVE_NOT_RECRUITING | Hepatitis C, Chronic; Pregnancy; Infection |
Catherine Anne Chappell |
2022-04-04 | PHASE4 |
| NCT03222531 | COMPLETED | Hepatitis C; Heart Transplant; Cardiac Transplant |
Mary E. Keebler, MD |
2017-08-01 | PHASE2 |
| NCT03809533 | ACTIVE_NOT_RECRUITING | Kidney Transplantation; Hepatitis C |
Amit D Tevar, MD |
2019-05-29 | PHASE2 |
| NCT03949764 | COMPLETED | Hepatitis C; Opioid-Related Disorders; Injection Drug Use |
Jennifer Havens |
2019-09-23 | PHASE4 |
| NCT03520751 | Suspended | Charcot-Marie-Tooth Neuropathy Type 1A |
Nationwide Children''s Hospital |
2025-04 | Phase 1|Phase 2 |
| NCT03819322 | COMPLETED | Liver Transplant; Hepatitis C |
Fernanda P Silveira, MD, MS |
2019-08-15 | PHASE2 |
| NCT06533319 | UNKNOWN | Hepatitis C |
Eastern Idaho Public Health |
2024-08-01 | |
| NCT05310565 | Withdrawn | Colon Cancer Stage III|Colon Cancer Stage IV |
Life University|University of Haifa |
2025-01-01 | Not Applicable |
| NCT05145309 | Not yet recruiting | Hypertension |
University of Texas Southwestern Medical Center |
2024-12-15 | Phase 2 |
| NCT03866954 | Withdrawn | Mitochondrial Diseases|Metabolic Disease|Inborn Errors of Metabolism |
St George''s University of London|Neovii Biotech |
2024-11 | Phase 2 |
| NCT05717400 | TERMINATED | Liver Cancer |
M.D. Anderson Cancer Center |
2023-03-17 | PHASE4 |
| NCT05016609 | UNKNOWN | Hepatitis C |
Macfarlane Burnet Institute for Medical Research and Public Health Ltd |
2022-03-09 | PHASE4 |
| NCT04997564 | UNKNOWN | Chronic Hepatitis C; Chronic Hepatitis B |
Peking University First Hospital |
2021-08 | PHASE4 |
| NCT03086044 | UNKNOWN | Hepatitis C; Awaiting Organ Transplant |
Brigham and Women's Hospital |
2017-03-01 | PHASE4 |
| NCT05467826 | UNKNOWN | Hepatitis C; Cirrhosis |
Peking University People's Hospital |
2022-09-01 | PHASE4 |
| NCT05895448 | UNKNOWN | Chronic Hepatitis C; People Who Inject Drugs |
Center For Hepatitis C, Atlanta, GA |
2018-03-01 | PHASE4 |
| NCT04382404 | COMPLETED | Hepatitis C, Chronic |
Catherine Anne Chappell |
2020-10-22 | PHASE1 |
| NCT04653818 | COMPLETED | Hepatocellular Carcinoma; Hepatitis C; Neoplasm Recurrence; Treatment Complication |
Alexandria University |
2020-10-05 | PHASE4 |
| NCT03057847 | COMPLETED | Hepatitis C, Chronic; Opioid-use Disorder |
Elizabeth Krans, MD |
2018-01-30 | PHASE4 |
| NCT03492112 | COMPLETED | Hepatitis C |
Kirby Institute |
2019-09-10 | |
| NCT04695769 | COMPLETED | Chronic Hepatitis C |
Helwan University |
2020-11-21 | PHASE4 |
| NCT03818308 | COMPLETED | Hepatitis C; Acute Hepatitis C |
Hannover Medical School |
2019-05-28 | PHASE2 |
| NCT03801707 | COMPLETED | Kidney Transplant; Hepatitis C; HCV |
Ohio State University |
2019-03-22 | PHASE2; PHASE3 |
| NCT04112303 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2019-10-16 | PHASE3 |
| NCT04039698 | UNKNOWN | Chronic Hepatitis C |
Hospital de Clinicas de Porto Alegre |
2019-08-23 | |
| NCT04211909 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2020-01-03 | PHASE3 |
| NCT03512210 | COMPLETED | Hepatitis C; HIV-1-infection; Liver Diseases |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2018-10-22 | PHASE4 |
| NCT03549312 | UNKNOWN | HIV-1-infection; Hepatitis C, Chronic; Methadone Dependence; Opioid Dependence; Bone Diseases, Metabolic; HIV/AIDS; Co-infection; Buprenorphine Dependence; HCV Coinfection |
Saskatchewan Health Authority - Regina Area |
2018-02-01 | PHASE4 |
| NCT03888729 | UNKNOWN | Hepatitis C, Chronic |
Partners in Health |
2019-08-26 | PHASE4 |
| NCT02836925 | COMPLETED | Indolent B-cell Lymphoma; Hepatitis C |
Fondazione Italiana Linfomi - ETS |
2016-03 | PHASE2 |
| NCT03112044 | ACTIVE_NOT_RECRUITING | Lung Transplant Infection; Hepatitis C |
University Health Network, Toronto |
2017-09-19 | EARLY_PHASE1 |
| NCT03313414 | WITHDRAWN | Hepatitis C |
Massachusetts General Hospital |
2019-08-13 | PHASE4 |
| NCT03619837 | COMPLETED | Hepatitis C; Transplantation Disease Transmission |
University of California, San Francisco |
2018-07-15 | PHASE4 |
| NCT03820258 | TERMINATED | Hepatitis C Virus Infection |
Gilead Sciences |
2019-01-28 | PHASE2 |
| NCT03022981 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-01-26 | PHASE2 |
| NCT02064049 | COMPLETED | Hepatitis C |
Kirby Institute |
2014-10 | PHASE4 |
| NCT02938013 | COMPLETED | HCV Coinfection; Liver Disease; HIV |
Johns Hopkins University |
2017-01 | PHASE4 |
| NCT03235154 | COMPLETED | Hepatitis C, Chronic; Hepatitis C; Opiate Dependence |
Community Research Initiative of New England |
2017-10-11 | PHASE4 |
| NCT03389061 | WITHDRAWN | HCV |
Radboud University Medical Center |
2018-04-01 | PHASE4 |
| NCT03501550 | COMPLETED | Chronic Hepatitis C |
Cocrystal Pharma, Inc. |
2018-06-26 | PHASE2 |
| NCT03513393 | COMPLETED | Hepatitis C; Swallowing Disorder |
Radboud University Medical Center |
2018-08-01 | PHASE1 |
| NCT02745535 | COMPLETED | Chronic Hepatitis C |
University of Maryland, Baltimore |
2016-05 | PHASE2 |
| NCT02994056 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-01-23 | PHASE2 |
| NCT03036852 | COMPLETED | Chronic Hepatitis C |
Gilead Sciences |
2017-03-22 | PHASE2 |
| NCT03032666 | COMPLETED | Thalassemia; Hepatitis C |
Ala'a Sharara |
2017-05-01 | PHASE4 |
| NCT03118843 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-04-25 | PHASE3 |
| NCT02996682 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-12-26 | PHASE3 |
| NCT03074331 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2017-03-23 | PHASE3 |
| NCT02728206 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-06-12 | PHASE2 |
| NCT02781558 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-29 | PHASE2 |
| NCT02781571 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-27 | PHASE2 |
| NCT03250910 | COMPLETED | Hepatitis C Virus Infection, Response to Therapy of; Human Immunodeficiency Virus |
National Taiwan University Hospital |
2016-08-01 | PHASE4 |
| NCT02722837 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-04-04 | PHASE3 |
| NCT02822794 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2016-07-25 | PHASE3 |
| NCT02639338 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-12-23 | PHASE3 |
| NCT02607800 | COMPLETED | Hepatitis C |
Gilead Sciences |
2015-11-16 | PHASE3 |
| NCT02607735 | COMPLETED | Hepatitis C |
Gilead Sciences |
2015-11-11 | PHASE3 |
| NCT02639247 | COMPLETED | Hepatitis C Virus Infection |
Gilead Sciences |
2015-12-23 | PHASE3 |
| NCT02533427 | COMPLETED | HCV Infection |
Gilead Sciences |
2015-10-29 | PHASE1 |
| NCT02002767 | COMPLETED | Hepatitis C Virus |
Gilead Sciences |
2013-12-16 | PHASE1 |
| NCT01740791 | COMPLETED | Chronic Hepatitis C Virus |
Gilead Sciences |
2012-11-06 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2026-05-05)
Check the
Velpatasvir
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
Note: Technical data last updated: Sep 1, 2026.