Simeprevir has been evaluated in numerous Phase 1 through Phase 4 clinical trials covering indications such as chronic hepatitis C virus infection, HIV and hepatitis C coinfection, hepatic impairment, liver cirrhosis, and hepatocellular carcinoma. Sponsored by both industry entities and academic institutions, these studies evaluated pharmacokinetics, drug interactions, and novel combination therapeutic regimens. Across these initiatives, trial records document varied recruitment statuses, encompassing completed studies alongside terminated or withdrawn protocols.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05616598 | COMPLETED | Male Infertility; HCV |
Benha University |
2022-03-01 | PHASE2; PHASE3 |
| NCT03549832 | COMPLETED | HCV Coinfection |
Assiut University |
2018-01-01 | |
| NCT02992457 | COMPLETED | Hepatitis C |
Tanta University |
2015-01 | PHASE4 |
| NCT02569710 | COMPLETED | Chronic Hepatitis C |
Alios Biopharma Inc. |
2015-10-31 | PHASE2 |
| NCT02993250 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2016-12-21 | PHASE2 |
| NCT03099135 | TERMINATED | Hepatitis C |
Janssen Research & Development, LLC |
2017-04-10 | PHASE3 |
| NCT03277755 | WITHDRAWN | Hepatic Impairment |
Janssen Research & Development, LLC |
2017-09-11 | PHASE1 |
| NCT02771405 | COMPLETED | Hepatitis C, Chronic; Hepatocellular Carcinoma |
National Hepatology & Tropical Medicine Research Institute |
2016-03 | PHASE3 |
| NCT03155893 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2017-05-12 | PHASE1 |
| NCT03277755 | Withdrawn | Hepatic Impairment |
Janssen Research & Development LLC |
2017-09-11 | Phase 1 |
| NCT02765490 | COMPLETED | Hepatitis C, Chronic |
Janssen Research & Development, LLC |
2016-11-09 | PHASE2 |
| NCT03059303 | TERMINATED | Healthy |
Janssen Research & Development, LLC |
2017-02-20 | PHASE1 |
| NCT02624063 | COMPLETED | Hepatitis C, Chronic |
Federal University of São Paulo |
2015-12 | PHASE4 |
| NCT02945020 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-11-10 | PHASE1 |
| NCT02885454 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-08 | PHASE1 |
| NCT02404805 | COMPLETED | HIV; Hepatitis C |
University of Colorado, Denver |
2016-02 | |
| NCT02824315 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2016-05 | PHASE1 |
| NCT02455167 | TERMINATED | Hepatitis C |
University of Colorado, Denver |
2015-05 | PHASE3 |
| NCT04385407 | COMPLETED | Chronic Hepatitis C Virus Infection |
Beni-Suef University |
2015-04 | PHASE2 |
| NCT02214420 | COMPLETED | Hepatitis C |
SC Liver Research Consortium, LLC |
2014-10 | PHASE4 |
| NCT03069001 | COMPLETED | HCV |
Ain Shams University |
2015-06 | PHASE4 |
| NCT02404805 | Completed | HIV|Hepatitis C |
University of Colorado Denver |
2016-02 | Not Applicable |
| NCT02397395 | WITHDRAWN | Renal Impairment; End-stage Renal Disease |
Janssen R&D Ireland |
2015-05 | PHASE2 |
| NCT02349048 | COMPLETED | Hepatitis C Virus |
Janssen Research & Development, LLC |
2015-01 | PHASE2 |
| NCT01349465 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2011-07-04 | PHASE3 |
| NCT02485080 | WITHDRAWN | PT-NANBH |
Stanford University |
2015-09 | PHASE4 |
| NCT02268864 | COMPLETED | Hepatitis C, Chronic |
Janssen-Cilag International NV |
2015-01 | PHASE2 |
| NCT02253550 | COMPLETED | Chronic Hepatitis C |
Peter J. Ruane, M.D. |
2014-10 | PHASE2 |
| NCT02702739 | COMPLETED | Liver Cirrhosis |
Azienda Ospedaliera San Camillo Forlanini |
2015-01 | PHASE4 |
| NCT02250807 | COMPLETED | Chronic Hepatitis C; Genotype 4 Chronic Hepatitis C |
Janssen R&D Ireland |
2015-01 | PHASE3 |
| NCT02421211 | COMPLETED | Hepatitis C, Chronic |
Janssen Sciences Ireland UC |
2015-05-19 | PHASE2 |
| NCT02165189 | COMPLETED | Hepatitits C |
Janssen Scientific Affairs, LLC |
2014-08 | PHASE2 |
| NCT02569710 | Completed | Chronic Hepatitis C |
Alios Biopharma Inc. |
2015-10-31 | Phase 2 |
| NCT02278419 | COMPLETED | Hepatitis C |
Janssen-Cilag International NV |
2014-12 | PHASE2 |
| NCT02385071 | COMPLETED | Healthy |
Janssen Sciences Ireland UC |
2015-04-28 | PHASE1 |
| NCT02206932 | WITHDRAWN | Hepatitis C, Chronic; HIV CDC Category A1 |
University of California, San Francisco |
2014-08 | PHASE4 |
| NCT02512562 | COMPLETED | Chronic Hepatitis C |
Alios Biopharma Inc. |
2015-07-31 | PHASE1 |
| NCT02262728 | COMPLETED | Hepatitis C, Chronic |
Janssen Research & Development, LLC |
2014-09-30 | PHASE2 |
| NCT01846832 | COMPLETED | Hepatitis C, Chronic; Infection |
Janssen-Cilag International NV |
2013-09 | PHASE3 |
| NCT02512562 | Completed | Chronic Hepatitis C |
Alios Biopharma Inc.|Alexion Pharmaceuticals Inc. |
2015-07-31 | Phase 1 |
| NCT01938625 | COMPLETED | Hepatitis C, Chronic |
Janssen R&D Ireland |
2013-12-12 | PHASE2 |
| NCT01852604 | COMPLETED | Chronic Hepatitis C Virus |
Merck Sharp & Dohme LLC |
2013-03 | PHASE2 |
| NCT01323244 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2011-12 | PHASE3 |
| NCT02114151 | COMPLETED | Hepatitis C Virus Infection |
Janssen Infectious Diseases BVBA |
2014-04 | PHASE3 |
| NCT02114177 | COMPLETED | Hepatitis C Virus Infection |
Janssen Infectious Diseases BVBA |
2014-04 | PHASE3 |
| NCT02168361 | COMPLETED | Chronic Hepatitis C |
Center For Hepatitis C, Atlanta, GA |
2013-12 | PHASE4 |
| NCT01724086 | COMPLETED | Chronic Hepatitis C |
Janssen R&D Ireland |
2012-10 | PHASE2 |
| NCT01725529 | COMPLETED | Hepatitis C, Chronic |
Janssen R&D Ireland |
2012-11 | PHASE3 |
| NCT02071355 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2014-04 | PHASE1 |
| NCT02064842 | COMPLETED | Healthy |
Janssen R&D Ireland |
2014-02 | PHASE1 |
| NCT01485991 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2012-02 | PHASE3 |
| NCT01567735 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2012-03-27 | PHASE3 |
| NCT02018536 | COMPLETED | Healthy |
Janssen R&D Ireland |
2013-10 | PHASE1 |
| NCT01466790 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2012-01 | PHASE2 |
| NCT01907724 | COMPLETED | Hepatitis C, Chronic |
Merck Sharp & Dohme LLC |
2013-05 | PHASE1 |
| NCT01628692 | COMPLETED | Hepatitis C Virus |
Bristol-Myers Squibb |
2012-07 | PHASE2 |
| NCT01479868 | COMPLETED | Hepatitis C Virus Genotype-1 |
Janssen R&D Ireland |
2011-10 | PHASE3 |
| NCT01813513 | COMPLETED | Chronic Hepatitis C Infection |
Merck Sharp & Dohme LLC |
2013-01 | PHASE1 |
| NCT01281839 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2011-02 | PHASE3 |
| NCT01290679 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2011-03 | PHASE3 |
| NCT01289782 | COMPLETED | Hepatitis C |
Janssen R&D Ireland |
2011-02 | PHASE3 |
| NCT01707342 | COMPLETED | Healthy Male Participants |
Janssen R&D Ireland |
2012-10 | PHASE1 |
| NCT01366638 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2011-05 | PHASE3 |
| NCT01292239 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2011-02 | PHASE3 |
| NCT01288209 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2011-02 | PHASE3 |
| NCT01689623 | COMPLETED | Healthy Participants |
Janssen Research & Development, LLC |
2012-06 | PHASE1 |
| NCT01290731 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2011-01 | PHASE3 |
| NCT01799603 | COMPLETED | Healthy |
Janssen Research & Development, LLC |
2012-05 | PHASE1 |
| NCT01571570 | COMPLETED | Healthy Volunteers |
Janssen R&D Ireland |
2012-03 | PHASE1 |
| NCT01486004 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2011-11 | PHASE1 |
| NCT01479881 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2011-10 | PHASE1 |
| NCT01202825 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2010-04 | PHASE1 |
| NCT00980330 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2009-10 | PHASE2 |
| NCT01269294 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2011-01 | PHASE1 |
| NCT01046058 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-01 | PHASE1 |
| NCT01288742 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2011-01 | PHASE1 |
| NCT01124799 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-07 | PHASE1 |
| NCT01241773 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-10 | PHASE1 |
| NCT01205139 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-11 | PHASE1 |
| NCT01224197 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2010-10 | PHASE1 |
| NCT00996476 | COMPLETED | Hepatitis C, Chronic |
Janssen Pharmaceutical K.K. |
2009-07 | PHASE2 |
| NCT01090700 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-05 | PHASE1 |
| NCT01134718 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-06 | PHASE1 |
| NCT01022125 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2010-01 | PHASE1 |
| NCT00882908 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2009-06 | PHASE2 |
| NCT00915564 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2009-09 | PHASE1 |
| NCT00812331 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2009-03 | PHASE2 |
| NCT00866853 | COMPLETED | Hepatitis C; Viruses |
Tibotec Pharmaceuticals, Ireland |
2009-03 | PHASE1 |
| NCT00752648 | COMPLETED | Hepatitis C; HCV |
Tibotec Pharmaceuticals, Ireland |
2008-07 | PHASE1 |
| NCT00741169 | COMPLETED | Hepatitis C; HCV; Tuberculosis; Rifampin; Pharmacokinetics |
Tibotec Pharmaceuticals, Ireland |
2008-06 | PHASE1 |
| NCT00561353 | COMPLETED | Hepatitis C, Chronic |
Tibotec Pharmaceuticals, Ireland |
2008-01 | PHASE2 |
| NCT00752544 | COMPLETED | HCV |
Tibotec Pharmaceuticals, Ireland |
2008-08 | PHASE1 |
| NCT01891851 | COMPLETED | Healthy |
Tibotec Pharmaceuticals, Ireland |
2007-10 | PHASE1 |
| NCT00938899 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2007-01 | PHASE1 |
| NCT01381835 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2011-07 | PHASE1 |
| NCT01323257 | COMPLETED | Hepatitis C Virus |
Tibotec Pharmaceuticals, Ireland |
2011-03 | PHASE1 |
| NCT01308606 | COMPLETED | Hepatitis C |
Tibotec Pharmaceuticals, Ireland |
2011-03 | PHASE1 |
(data from https://clinicaltrials.gov, updated on 2023-02-08)
Check the
Simeprevir
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.