Asunaprevir has been evaluated in numerous clinical trials spanning Phase 1 through Phase 4 to investigate treatments for hepatitis C virus (HCV) infections, including chronic HCV, genotype 4, and HCV-HIV co-infection. Featuring recruitment statuses ranging from completed to withdrawn or unknown, these studies assessed direct-acting antiviral combinations across diverse cohorts, such as treatment-naive patients and individuals with chronic renal failure. Major sponsors comprise pharmaceutical companies like Bristol-Myers Squibb alongside academic medical centers and research organizations.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT03208322 | Withdrawn | Hepatitis C |
Bristol-Myers Squibb |
2018-11-30 | -- |
| NCT03004625 | COMPLETED | Hepatitis C |
Kaohsiung Medical University Chung-Ho Memorial Hospital |
2016-11 | PHASE3 |
| NCT02580474 | COMPLETED | Hepatitis C |
Myeong Jun Song |
2016-02 | PHASE4 |
| NCT02639585 | UNKNOWN | Hepatitis C, Chronic |
Pusan National University Hospital |
2015-12 | PHASE4 |
| NCT03004625 | Completed | Hepatitis C |
Kaohsiung Medical University Chung-Ho Memorial Hospital|Chang Gung Memorial Hospital|National Taiwan University Hospital|Taipei Veterans General Hospital Taiwan|China Medical University Hospital|National Cheng-Kung University Hospital |
2016-11 | Phase 3 |
| NCT02865369 | Unknown status | Chronic Hepatitis C |
Sang Gyune Kim|Seoul National University Boramae Hospital|Severance Hospital|Inha University Hospital|Korea University|Gachon University Gil Medical Center|Hanyang University Seoul Hospital|Ewha Womans University Mokdong Hospital|Bristol-Myers Squibb|Soonchunhyang University Hospital |
2016-09 | -- |
| NCT02496078 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2015-08 | PHASE3 |
| NCT02292966 | WITHDRAWN | Hepatitis C, Chronic |
Kirby Institute |
2015-07 | PHASE4 |
| NCT02124044 | COMPLETED | HIV-HCV |
National Institutes of Health Clinical Center (CC) |
2014-02 | PHASE2 |
| NCT02580474 | Completed | Hepatitis C |
Myeong Jun Song|Bristol-Myers Squibb|Soonchunhyang University Hospital|Dankook University|Chungnam National University Hospital|Konyang University Hospital|Eulji University Hospital|Saint Vincent''s Hospital Korea|Konkuk University Hospital|Cheongju St. Mary''s Hospital Cheongju Korea|Severance Hospital|Korea University Guro Hospital|Eulji General Hospital|The Catholic University of Korea |
2016-02 | Phase 4 |
| NCT02098616 | COMPLETED | Hepatitis C |
Timothy Morgan, MD |
2014-07 | |
| NCT02309450 | WITHDRAWN | Hepatitis C Virus Genotype 4 Infection |
ANRS, Emerging Infectious Diseases |
2014-12 | PHASE2 |
| NCT02496078 | Completed | Hepatitis C |
Bristol-Myers Squibb |
2015-08 | Phase 3 |
| 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 |
| NCT02107365 | COMPLETED | Hepatitis C Virus Genotype 4 Infection |
ANRS, Emerging Infectious Diseases |
2013-11 | PHASE2 |
| NCT02323594 | COMPLETED | Hepatitis C Infection |
Bristol-Myers Squibb |
2014-12 | PHASE1 |
| NCT02175966 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-07-28 | PHASE2 |
| NCT02123654 | COMPLETED | Hepatitis C Virus Infection |
Bristol-Myers Squibb |
2014-04 | PHASE3 |
| NCT02309450 | Withdrawn | Hepatitis C Virus Genotype 4 Infection |
ANRS Emerging Infectious Diseases|Bristol-Myers Squibb |
2014-12 | Phase 2 |
| NCT01428063 | COMPLETED | Hepatitis C Virus Infection |
Bristol-Myers Squibb |
2011-09 | PHASE2 |
| NCT01973049 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2013-12 | PHASE3 |
| NCT01979939 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2013-12 | PHASE3 |
| NCT02175602 | COMPLETED | Hepatitis C Infection |
Bristol-Myers Squibb |
2014-06 | PHASE1 |
| NCT02103569 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-04 | PHASE1 |
| NCT02095860 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-04 | PHASE1 |
| NCT02104843 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-04 | PHASE1 |
| NCT02045693 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-02 | PHASE1 |
| NCT01725542 | COMPLETED | HCV-HIV Co-Infection |
ANRS, Emerging Infectious Diseases |
2012-12 | PHASE2 |
| NCT02045966 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2014-02 | PHASE1 |
| NCT01718145 | COMPLETED | Hepatitis C Virus Infection |
Bristol-Myers Squibb |
2012-11 | PHASE3 |
| NCT01581203 | COMPLETED | Hepatitis C Virus |
Bristol-Myers Squibb |
2012-05 | PHASE3 |
| NCT01573351 | COMPLETED | Hepatitis C Virus |
Bristol-Myers Squibb |
2012-05 | PHASE3 |
| NCT01497834 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2012-01 | PHASE3 |
| NCT01886599 | COMPLETED | Hepatitis C |
Bristol-Myers Squibb |
2012-11 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2024-05-22)
Check the
Asunaprevir
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.