Atazanavir has been evaluated in numerous Phase 1 through 4 clinical trials, encompassing completed, active, and terminated studies. Primarily targeting HIV-1 and AIDS alongside secondary conditions such as Hepatitis C, endotoxemia, sepsis, and HIV-associated lipodystrophy syndrome, these trials are sponsored by pharmaceutical companies like Bristol-Myers Squibb and academic partners such as the University of Liverpool and Radboud University Medical Center. Research across these studies focuses on assessing antiretroviral efficacy, pharmacokinetic profiles, dosage optimization, and metabolic safety.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT02016924 | ACTIVE_NOT_RECRUITING | Acquired Immune Deficiency Syndrome (AIDS); HIV Infections |
Gilead Sciences |
2014-01-16 | PHASE2; PHASE3 |
| NCT04022967 | UNKNOWN | HIV-1-infection |
ANRS, Emerging Infectious Diseases |
2020-09-21 | PHASE3 |
| NCT04452565 | UNKNOWN | Coronavirus Infection; Severe Acute Respiratory Infection; Severe Acute Respiratory Syndrome Coronavirus 2 |
Biomed Industries, Inc. |
2022-06-15 | PHASE2; PHASE3 |
| NCT05680792 | COMPLETED | Drug Interaction |
Obafemi Awolowo University |
2020-09-10 | |
| NCT04184869 | COMPLETED | Solid Tumor; Hematological Malignancies |
Acrotech Biopharma Inc. |
2019-08-05 | PHASE1 |
| NCT05236738 | COMPLETED | Healthy Participants |
Bristol-Myers Squibb |
2022-05-13 | PHASE1 |
| NCT04121195 | COMPLETED | HIV/AIDS; Tuberculosis |
University of Liverpool |
2020-10-30 | PHASE2; PHASE3 |
| NCT02307656 | COMPLETED | HIV in Adults |
Bristol-Myers Squibb |
2014-12-12 | PHASE1 |
| NCT04468087 | COMPLETED | COVID-19 |
Hospital do Coracao |
2021-02-15 | PHASE2; PHASE3 |
| NCT04385719 | COMPLETED | Ebola; HIV/AIDS |
Makerere University |
2021-05-05 | PHASE2 |
| NCT04459286 | TERMINATED | Covid-19 |
Obafemi Awolowo University |
2020-10-09 | PHASE2 |
| NCT04263350 | COMPLETED | Healthy Participants |
Bristol-Myers Squibb |
2020-02-26 | PHASE1 |
| NCT04121195 | Active not recruiting | HIV/AIDS|Tuberculosis |
University of Liverpool|European and Developing Countries Clinical Trials Partnership (Funder)|Joint Clinical Research Centre Kampala Uganda|University of Cape Town Cape Town South Africa|Infectious Diseases Institute Makerere University College of Health Sciences Kampala Uganda|University of Turin Turin Italy |
2020-10-30 | Phase 2|Phase 3 |
| NCT04531072 | COMPLETED | Drug Interaction |
Fogarty International Center of the National Institute of Health |
2018-09-18 | PHASE4 |
| NCT02652793 | COMPLETED | Human Immunodeficiency Virus |
Judit Pich |
2015-11 | |
| NCT03708861 | WITHDRAWN | HIV Infection |
University of Turin, Italy |
2016-01 | PHASE3 |
| NCT02473328 | COMPLETED | HIV-1 Infection |
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida |
2015-06 | PHASE2 |
| NCT02697851 | TERMINATED | HIV |
St Stephens Aids Trust |
2016-07 | PHASE1 |
| NCT02652624 | COMPLETED | HIV-1 Infection |
Gilead Sciences |
2016-02-19 | PHASE3 |
| NCT01829802 | UNKNOWN | Chronic Infection With HIV |
Pedro Cahn |
2014-05 | PHASE4 |
| NCT02116660 | TERMINATED | HIV Infections |
Merck Sharp & Dohme LLC |
2014-09-03 | PHASE2 |
| NCT02386098 | TERMINATED | HIV Infections |
ViiV Healthcare |
2015-07-08 | PHASE2 |
| NCT02603107 | COMPLETED | HIV-1 Infection |
Gilead Sciences |
2015-11-20 | PHASE3 |
| NCT02566707 | TERMINATED | HIV-1 Infection |
Radboud University Medical Center |
2015-08 | PHASE2 |
| NCT01902186 | TERMINATED | HIV Infection; Osteopenia |
Giovanni Di Perri |
2014-09 | PHASE4 |
| NCT02697851 | Terminated | HIV |
St Stephens Aids Trust|Bristol-Myers Squibb |
2016-07 | Phase 1 |
| NCT02542852 | COMPLETED | HIV-1 Infection |
Castagna Antonella |
2015-09 | PHASE2 |
| NCT01599364 | COMPLETED | Human Immunodeficiency Virus |
Catholic University of the Sacred Heart |
2014-04 | PHASE4 |
| NCT02589158 | COMPLETED | HIV |
St Stephens Aids Trust |
2015-11 | PHASE1 |
| NCT01003990 | COMPLETED | HIV |
Bristol-Myers Squibb |
2002-10 | PHASE3 |
| NCT02246998 | COMPLETED | HIV-1 Infection |
Gilead Sciences |
2014-12-15 | PHASE4 |
| NCT02565888 | COMPLETED | Hepatitis C; HIV |
Radboud University Medical Center |
2015-11 | PHASE1 |
| NCT02154360 | COMPLETED | HIV Infection |
University of Pennsylvania |
2014-05 | PHASE1 |
| NCT01367236 | COMPLETED | HIV; Impaired Cognition |
Imperial College London |
2013-01 | PHASE4 |
| NCT01910402 | COMPLETED | Infection, Human Immunodeficiency Virus; HIV Infections |
ViiV Healthcare |
2013-08-22 | PHASE3 |
| NCT03019783 | COMPLETED | HIV |
Brigham and Women's Hospital |
2011-12 | PHASE2; PHASE3 |
| NCT01967940 | COMPLETED | HIV; HIV Infections; Acquired Immunodeficiency Syndrome |
Gilead Sciences |
2013-10-25 | PHASE3 |
| NCT00074581 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2005-02 | PHASE3 |
| NCT01705574 | COMPLETED | Acquired Immunodeficiency Syndrome; HIV Infections |
Gilead Sciences |
2012-10-24 | PHASE3 |
| NCT01351740 | COMPLETED | HIV Infection |
University of British Columbia |
2011-07 | PHASE4 |
| NCT02442700 | COMPLETED | HIV; Dyslipidemia |
Ramathibodi Hospital |
2014-05 | PHASE4 |
| NCT01159223 | COMPLETED | HIV Infections |
The HIV Netherlands Australia Thailand Research Collaboration |
2011-05 | PHASE4 |
| NCT01803074 | COMPLETED | Infection, Human Immunodeficiency Virus; HIV Infections |
ViiV Healthcare |
2013-04-04 | PHASE2 |
| NCT02034838 | COMPLETED | HIV Infection |
Ottawa Hospital Research Institute |
2014-01 | PHASE1 |
| NCT01691794 | COMPLETED | HIV, Pediatric |
Bristol-Myers Squibb |
2012-11-30 | PHASE4 |
| NCT01335698 | COMPLETED | HIV |
Bristol-Myers Squibb |
2011-05-27 | PHASE3 |
| NCT01605084 | WITHDRAWN | HIV |
Bristol-Myers Squibb |
2012-06-30 | PHASE3 |
| NCT01307488 | COMPLETED | HIV Infection |
Fundacion SEIMC-GESIDA |
2011-09 | PHASE4 |
| NCT02102048 | UNKNOWN | HIV |
University of Roma La Sapienza |
2009-01 | |
| NCT01479361 | COMPLETED | HIV; PCP; Toxoplasmosis |
National Institutes of Health Clinical Center (CC) |
2011-10-31 | PHASE1 |
| NCT01421355 | COMPLETED | Type 1 Diabetes Mellitus |
Brigham and Women's Hospital |
2012-05 | PHASE1 |
| NCT01759875 | COMPLETED | Healthy |
University of California, San Francisco |
2013-01 | PHASE1 |
| NCT00940771 | COMPLETED | Pediatric HIV; HIV Infections |
Phoenix Children's Hospital |
2009-08-26 | PHASE4 |
| NCT01332227 | COMPLETED | HIV, Combination Therapy |
Bristol-Myers Squibb |
2011-10 | PHASE4 |
| NCT01565889 | COMPLETED | Hepatitis C; HIV |
Gilead Sciences |
2012-03 | PHASE1; PHASE2 |
| NCT01511809 | COMPLETED | HIV-1 Infection |
IRCCS San Raffaele |
2010-09 | PHASE3 |
| NCT00491556 | COMPLETED | HIV Infections |
University of North Carolina, Chapel Hill |
2007-10 | |
| NCT01837719 | COMPLETED | Human Immunodeficiency Virus Type 1 (HIV-1) |
Bristol-Myers Squibb |
2013-04 | PHASE1 |
| NCT00811954 | COMPLETED | HIV Infection |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2009-05 | PHASE3 |
| NCT01274780 | COMPLETED | HIV-1 |
Juan A. Arnaiz |
2011-05 | PHASE4 |
| NCT00814879 | COMPLETED | Acquired Immune Deficiency Syndrome; AIDS; Human Immunodeficiency Virus; HIV Infections |
Yale University |
2009-05 | |
| NCT01255371 | WITHDRAWN | HIV |
ANRS, Emerging Infectious Diseases |
2012-03 | PHASE3 |
| NCT01818856 | COMPLETED | Hepatitis C, Chronic; HIV Infection |
Hospitales Universitarios Virgen del Rocío |
2012-12 | PHASE1 |
| NCT00878306 | COMPLETED | HIV Infections; Drug Abuse |
University of California, San Francisco |
2008-11 | PHASE1 |
| NCT01384734 | COMPLETED | Infection, Human Immunodeficiency Virus |
ViiV Healthcare |
2011-07-26 | PHASE2 |
| NCT01656109 | COMPLETED | HIV |
The HIV Netherlands Australia Thailand Research Collaboration |
2011-07 | PHASE2 |
| NCT01620944 | TERMINATED | HIV |
Bristol-Myers Squibb |
2012-07-31 | PHASE3 |
| NCT01105611 | UNKNOWN | HIV Infections; Hepatitis C |
St. James's Hospital, Ireland |
2010-08 | PHASE4 |
| NCT00540137 | COMPLETED | HIV Infections |
Imperial College London |
2007-07 | PHASE4 |
| NCT00762892 | COMPLETED | HIV Infections |
The University of Texas Health Science Center, Houston |
2009-01 | PHASE4 |
| NCT00532168 | COMPLETED | HIV Infections |
Juan A. Arnaiz |
2007-09 | PHASE4 |
| NCT01099579 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2010-10-13 | PHASE3 |
| NCT01225705 | WITHDRAWN | HIV; Hepatitis C |
University Hospital, Bonn |
2010-10 | PHASE4 |
| NCT01102972 | COMPLETED | Infection, Human Immunodeficiency Virus |
ViiV Healthcare |
2010-04 | PHASE4 |
| NCT01592305 | COMPLETED | Healthy Volunteer |
Hoffmann-La Roche |
2012-05 | PHASE1 |
| NCT01602822 | TERMINATED | HIV |
Kenneth H. Mayer, MD |
2012-02 | PHASE4 |
| NCT02404259 | COMPLETED | HIV |
The HIV Netherlands Australia Thailand Research Collaboration |
2010-06 | |
| NCT00896051 | COMPLETED | HIV Infections; Acquired Immunodeficiency Syndrome |
Janssen R&D Ireland |
2009-08 | PHASE2 |
| NCT01475227 | COMPLETED | HIV Infection |
St Stephens Aids Trust |
2011-12 | PHASE4 |
| NCT00931801 | COMPLETED | HIV |
Community Research Initiative of New England |
2009-12 | PHASE4 |
| NCT00544128 | COMPLETED | HIV Infections |
International Medical Center of Japan |
2007-10 | PHASE4 |
| NCT01194856 | TERMINATED | HIV Infection; Mitochondrial Dysfunction |
The Cleveland Clinic |
2010-10 | PHASE4 |
| NCT01108510 | COMPLETED | HIV; HIV Infections |
Gilead Sciences |
2010-04 | PHASE3 |
| NCT01591850 | COMPLETED | Healthy Volunteer |
Hoffmann-La Roche |
2011-09 | PHASE1 |
| NCT00006604 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2000-11 | PHASE1; PHASE2 |
| NCT01106586 | COMPLETED | HIV; HIV Infections |
Gilead Sciences |
2010-04 | PHASE3 |
| NCT01404572 | COMPLETED | HIV |
Bristol-Myers Squibb |
2011-08 | PHASE1 |
| NCT00874523 | COMPLETED | HIV Infection |
Kirby Institute |
2009-07 | PHASE3 |
| NCT01232127 | COMPLETED | HIV |
Bristol-Myers Squibb |
2011-02 | PHASE4 |
| NCT00756730 | COMPLETED | HIV Infections |
Community Research Initiative of New England |
2008-09 | PHASE4 |
| NCT01458769 | COMPLETED | Healthy Volunteers |
Concert Pharmaceuticals |
2010-12 | PHASE1 |
| NCT01928407 | COMPLETED | HIV-1 Infection; Immunosuppression-related Infectious Disease |
Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba |
2011-02-23 | PHASE4 |
| NCT00335322 | COMPLETED | Human Immunodeficiency Virus (HIV) |
Kirby Institute |
2007-02 | PHASE4 |
| NCT00389207 | COMPLETED | HIV Infections |
Boehringer Ingelheim |
2006-10 | PHASE3 |
| NCT00869960 | COMPLETED | Healthy |
University of Alabama at Birmingham |
2009-03 | PHASE4 |
| NCT00525239 | UNKNOWN | HIV Infections |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
2004-03 | |
| NCT00943540 | COMPLETED | HIV Infection; HIV Infections |
Radboud University Medical Center |
2009-07 | PHASE2 |
| NCT00827112 | COMPLETED | Human Immunodeficiency Virus-1 |
ViiV Healthcare |
2009-03 | PHASE2 |
| NCT00440947 | COMPLETED | Infection, Human Immunodeficiency Virus I; HIV Infection |
ViiV Healthcare |
2007-03 | PHASE3 |
| NCT00833482 | COMPLETED | Human Immunodeficiency Virus Type 1 (HIV-1); HIV Infections |
Bristol-Myers Squibb |
2009-09 | PHASE1 |
| NCT01073761 | COMPLETED | HIV; HIV Infections |
St Stephens Aids Trust |
2010-04 | PHASE1 |
| NCT00885482 | COMPLETED | HIV Infections |
Catholic University of the Sacred Heart |
2009-05 | PHASE4 |
| NCT00084136 | COMPLETED | HIV Infections |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2005-05 | PHASE4 |
| NCT00916448 | COMPLETED | Endotoxemia; Inflammation; Multi Organ Dysfunction Syndrome; Sepsis |
Radboud University Medical Center |
2009-05 | |
| NCT00552240 | COMPLETED | HIV Infections |
Boehringer Ingelheim |
2007-09 | PHASE4 |
| NCT00242216 | COMPLETED | HIV Infections |
The University of Texas Health Science Center, Houston |
2004-05 | PHASE4 |
| NCT00768989 | TERMINATED | HIV |
Bristol-Myers Squibb |
2008-11 | PHASE2 |
| NCT00307502 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2005-01 | PHASE1 |
| NCT01445223 | COMPLETED | HIV |
Göteborg University |
2004-04 | PHASE4 |
| NCT00892437 | COMPLETED | HIV-1 Infection |
Gilead Sciences |
2009-05 | PHASE2 |
| NCT00118898 | COMPLETED | HIV Infections |
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
2005-09 | PHASE3 |
| NCT00751153 | UNKNOWN | HIV Infections |
Peter J. Ruane, M.D., Inc. |
2008-03 | PHASE4 |
| NCT00280969 | COMPLETED | HIV Infection |
International Medical Center of Japan |
2005-09 | PHASE3 |
| NCT00385645 | COMPLETED | HIV Infections |
Hospital Clinic of Barcelona |
2006-05 | PHASE4 |
| NCT00757783 | COMPLETED | HIV |
Tibotec, Inc |
2008-10 | PHASE4 |
| NCT00883935 | COMPLETED | Healthy Volunteer |
GlaxoSmithKline |
2009-04 | PHASE1 |
| NCT00260078 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2006-02 | PHASE1; PHASE2 |
| NCT00696722 | COMPLETED | Type 2 Diabetes Mellitus Related Endothelial Dysfunction |
Radboud University Medical Center |
2008-06 | PHASE2 |
| NCT00326716 | COMPLETED | HIV Infection |
Bristol-Myers Squibb |
2006-06 | PHASE1 |
| NCT00718536 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2008-08 | PHASE4 |
| NCT00413153 | COMPLETED | HIV Infections |
Massachusetts General Hospital |
2006-05 | |
| NCT00528060 | COMPLETED | HIV Infections |
French National Agency for Research on AIDS and Viral Hepatitis |
2008-01 | PHASE2 |
| NCT00646776 | COMPLETED | Antivirals/HIV |
Bristol-Myers Squibb |
2008-04 | PHASE1 |
| NCT00225017 | COMPLETED | HIV Infection; Hyperlipidemia |
Northwestern University |
2005-06 | PHASE3 |
| NCT01388543 | COMPLETED | HIV |
University of Colorado, Denver |
2006-09 | PHASE4 |
| NCT00337467 | COMPLETED | Human Immunodeficiency Virus (HIV) Infections |
Bristol-Myers Squibb |
2006-06 | PHASE3 |
| NCT00355719 | COMPLETED | HIV Infections |
Germans Trias i Pujol Hospital |
2007-01 | PHASE4 |
| NCT00411957 | COMPLETED | HIV Infections |
The HIV Netherlands Australia Thailand Research Collaboration |
2007-01 | PHASE1; PHASE2 |
| NCT00518297 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2007-08 | PHASE1 |
| NCT00384904 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-12 | PHASE4 |
| NCT00420355 | TERMINATED | HIV Infection |
University of Oklahoma |
2007-04 | PHASE4 |
| NCT00207142 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2005-11 | PHASE4 |
| NCT00135356 | COMPLETED | HIV-Associated Lipodystrophy Syndrome |
Bristol-Myers Squibb |
2005-07 | PHASE4 |
| NCT00272779 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2005-11 | PHASE3 |
| NCT00160329 | COMPLETED | Hyperlipidemia; HIV Infections |
Stanford University |
2004-01 | PHASE3 |
| NCT00312754 | TERMINATED | HIV Infections |
Bristol-Myers Squibb |
2005-06 | PHASE4 |
| NCT00224445 | COMPLETED | HIV Infections |
Gilead Sciences |
2005-09 | PHASE4 |
| NCT00393328 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-11 | PHASE1 |
| NCT00362726 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-09 | PHASE1 |
| NCT00357604 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-07 | PHASE1 |
| NCT00720590 | COMPLETED | Endothelial Dysfunction |
Indiana University |
2003-11 | |
| NCT00357188 | COMPLETED | HIV Infections; Protease Inhibitor |
Bristol-Myers Squibb |
2006-07 | PHASE1 |
| NCT00357721 | COMPLETED | HIV Infections; Protease Inhibitor |
Bristol-Myers Squibb |
2006-06 | PHASE1 |
| NCT00084253 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2004-06 | PHASE4 |
| NCT00357240 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-06 | PHASE1 |
| NCT00162149 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2005-10 | PHASE1 |
| NCT00365339 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2006-04 | PHASE1 |
| NCT00120393 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2004-01 | PHASE3 |
| NCT00192608 | COMPLETED | HIV Infections |
Kirby Institute |
2004-11 | |
| NCT00082394 | COMPLETED | Infection, Human Immunodeficiency Virus I; HIV Infection |
GlaxoSmithKline |
2004-04-26 | PHASE4 |
| NCT00135395 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2004-05 | PHASE3 |
| NCT00135343 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2004-04 | PHASE3 |
| NCT02253836 | COMPLETED | Healthy |
Boehringer Ingelheim |
2005-01 | PHASE1 |
| NCT00135434 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2004-09 | PHASE1 |
| NCT00067782 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2002-12 | PHASE3 |
| NCT02257008 | COMPLETED | Healthy |
Boehringer Ingelheim |
2003-03 | PHASE1 |
| NCT00028301 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2001-02 | PHASE3 |
| NCT00035932 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2001-11 | PHASE3 |
| NCT00013897 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
2001-02 | PHASE3 |
| NCT00028067 | TERMINATED | HIV Infections |
Bristol-Myers Squibb |
2001-08 | PHASE3 |
| NCT00004584 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
1999-12 | PHASE2 |
| NCT00002240 | COMPLETED | HIV Infections |
Bristol-Myers Squibb |
1999-03 | PHASE2 |
| NCT00028314 | COMPLETED | HIV Infections; Lipodystrophy; Wasting Disease |
National Institute of Allergy and Infectious Diseases (NIAID) |
2002-03 | |
| NCT00122577 | TERMINATED | HIV Infections |
French National Agency for Research on AIDS and Viral Hepatitis |
2002-03 | PHASE2 |
| NCT01368783 | UNKNOWN | Atazanavir |
Asan Medical Center |
2011-06 | PHASE1 |
| NCT00007202 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00013520 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00447070 | COMPLETED | HIV Infections; Dyslipidemia |
Foundation for Cardiovascular Research, Zurich |
2004-08 | PHASE4 |
| NCT00389402 | COMPLETED | HIV Infections |
International Antiviral Therapy Evaluation Center |
2006-07 | PHASE4 |
| NCT00084019 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
2004-07 | |
| NCT00426296 | UNKNOWN | HIV Infections; Lipodystrophy |
Clinical Alliance for Research & Education - Infectious Diseases, LLC. |
2006-08 | PHASE4 |
| NCT00096850 | COMPLETED | HIV Infections; Tuberculosis |
National Institute of Allergy and Infectious Diseases (NIAID) |
(data from https://clinicaltrials.gov, updated on 2026-04-21)
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>).