Clinical Trials

Multiple clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic profile and pharmacokinetics of danoprevir across indications such as chronic hepatitis C, COVID-19, and safety in healthy volunteers. Sponsored by commercial entities including Hoffmann-La Roche and Ascletis Pharmaceuticals Co., Ltd., as well as clinical institutions like Huoshenshan Hospital and The Ninth Hospital of Nanchang, these efforts display varied recruitment statuses. While several early-stage drug interaction studies have reached completed status, other early investigations were withdrawn during phase progression.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04345276 COMPLETED
COVID-19
Huoshenshan Hospital
 2020-03-18 PHASE4
NCT04291729 COMPLETED
COVID-19
The Ninth Hospital of Nanchang
 2020-02-17 PHASE4
NCT03362814 COMPLETED
HCV
Ascletis Pharmaceuticals Co., Ltd.
 2017-07-01 PHASE2; PHASE3
NCT03288636 COMPLETED
HCV
Ascletis Pharmaceuticals Co., Ltd.
 2017-08-08 PHASE1
NCT03020082 COMPLETED
Chronic Hepatitis C
Ascletis Pharmaceuticals Co., Ltd.
 2016-06 PHASE3
NCT03020004 COMPLETED
Chronic Hepatitis C
Ascletis Pharmaceuticals Co., Ltd.
 2016-01 PHASE2
NCT03020134 COMPLETED
Healthy
Ascletis Pharmaceuticals Co., Ltd.
 2016-07-15 PHASE1
NCT03020095 COMPLETED
Chronic Hepatitis C
Ascletis Pharmaceuticals Co., Ltd.
 2015-08 PHASE2
NCT03019991 COMPLETED
Healthy
Ascletis Pharmaceuticals Co., Ltd.
 2015-10 PHASE1
NCT01749150 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2013-04 PHASE2
NCT01579019 WITHDRAWN
Hepatitis C, Chronic
Hoffmann-La Roche
 2012-07 PHASE2
NCT01185873 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-02 PHASE1
NCT01483742 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2012-04 PHASE2
NCT01714154 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-11 PHASE1
NCT01331850 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2011-05 PHASE2
NCT01220947 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2010-11 PHASE2
NCT01654211 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-07 PHASE1
NCT01714154 Completed
Healthy Volunteer
Hoffmann-La Roche
 2012-11 Phase 1
NCT01278134 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2011-02 PHASE2
NCT01588002 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-04 PHASE1
NCT01592305 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-05 PHASE1
NCT01592318 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-05 PHASE1
NCT01592318 Completed
Healthy Volunteer
Hoffmann-La Roche
 2012-05 Phase 1
NCT01588002 Completed
Healthy Volunteer
Hoffmann-La Roche
 2012-04 Phase 1
NCT01519336 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-02 PHASE1
NCT01531647 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-01 PHASE1
NCT01514968 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-12 PHASE1
NCT01519336 Completed
Healthy Volunteer
Hoffmann-La Roche
 2012-02 Phase 1
NCT00963885 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2009-08 PHASE2
NCT01483729 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-12 PHASE1
NCT01185860 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2009-08 PHASE1
NCT01398293 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-08 PHASE1
NCT01418274 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-08 PHASE1
NCT01392755 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-07 PHASE1
NCT01389544 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2011-06 PHASE1
NCT01164488 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2010-07 PHASE1
NCT00801255 COMPLETED
Hepatitis C, Chronic
Hoffmann-La Roche
 2008-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2020-06-02)

Check the Danoprevir product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Danoprevir selectively binds to and inhibits the viral NS3/4A protease, thereby preventing the cleavage of viral polyproteins essential for replication complex assembly. This enzyme blockade halts viral RNA replication and viral particle maturation within host cells, providing the biological foundation for suppressing viral load in clinical conditions such as chronic hepatitis C and COVID-19.

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.