Clinical Trials

Darunavir has been evaluated across numerous clinical trials spanning Phase 1 through Phase 4 development. These studies primarily target human immunodeficiency virus (HIV-1) infections, while also assessing healthy subject pharmacokinetics, pediatric formulations, fixed-dose combinations, and cardiovascular outcomes. Encompassing recruitment statuses ranging from completed and active to recruiting, not yet recruiting, and terminated, this research is supported by a diverse array of sponsors including Janssen Research & Development LLC, the National Institute of Allergy and Infectious Diseases (NIAID), and the PENTA Foundation.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07792096 NOT_YET_RECRUITING
HIV Infection
University College, London
 2026-11 PHASE3
NCT06338826 NOT_YET_RECRUITING
HIV Infections; HBV Coinfection
ANRS, Emerging Infectious Diseases
 2025-02-01 PHASE2
NCT06747507 RECRUITING
HIV-1-infection
University of Nairobi
 2025-09-01 PHASE3
NCT07678268 RECRUITING
HIV Infection; Antiretroviral Therapy; Lentivirus Infections
Instituto Mexicano del Seguro Social
 2025-07-10 PHASE4
NCT06907056 RECRUITING
HIV Infection
José Antonio Mata Marín
 2023-11-09 PHASE4
NCT06787976 UNKNOWN
HIV; Insomnia; Anxiety
Instituto Mexicano del Seguro Social
 2025-06-19 PHASE4
NCT06139796 WITHDRAWN
HIV Infections
PENTA Foundation
 2025-02-01 PHASE1; PHASE2
NCT02016924 ACTIVE_NOT_RECRUITING
Acquired Immune Deficiency Syndrome (AIDS); HIV Infections
Gilead Sciences
 2014-01-16 PHASE2; PHASE3
NCT05463783 UNKNOWN
HIV Infections; Obesity
East Carolina University
 2023-03-14 PHASE4
NCT06139796 Not yet recruiting
HIV Infections
PENTA Foundation|AMS-PHPT Research Collaboration|Institut National de la Santé Et de la Recherche Médicale France|Centre Mère et Enfant de la Fondation Chantal Biya|Centre Hospitalier National d''Enfants Albert Royer|University of Zimbabwe Clinical Research Centre (UZCRC)|Baylor College of Medicine
 2024-06 Phase 1|Phase 2
NCT04388904 COMPLETED
HIV-1-infection
The Crofoot Research Center, Inc.
 2021-09-01 PHASE4
NCT03675815 COMPLETED
HIV Infections
Kirby Institute
 2019-12-05 PHASE4
NCT06005610 Recruiting
HIV I Infection
National Institute of Allergy and Infectious Diseases (NIAID)
 2024-01-04 Phase 2
NCT04442737 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2020-07-01 PHASE4
NCT04183738 WITHDRAWN
HIV-infection/Aids; Human Herpesvirus 4 Infections; Cytomegalovirus Infections; Human Herpesvirus 8 Infection; Human Papilloma Virus
Kirby Institute
 2021-02-01 PHASE4
NCT03864406 COMPLETED
Healthy Volunteers
National Institutes of Health Clinical Center (CC)
 2019-06-04 PHASE1
NCT05506605 Active not recruiting
HIV-1-infection
Fundacion Clinic per a la Recerca Biomédica
 2022-12-12 Phase 4
NCT02437110 COMPLETED
Amyotrophic Lateral Sclerosis
National Institute of Neurological Disorders and Stroke (NINDS)
 2019-04-01 PHASE1
NCT03017872 UNKNOWN
HIV Infections
Kirby Institute
 2017-11-23 PHASE4
NCT05378906 COMPLETED
Healthy
Janssen Research & Development, LLC
 2022-06-07 PHASE1
NCT05197075 COMPLETED
Human Immunodeficiency Virus (HIV)
Janssen Research & Development, LLC
 2022-08-03 PHASE1
NCT05197075 Completed
Human Immunodeficiency Virus (HIV)
Janssen Research & Development LLC
 2022-08-03 Phase 1
NCT04040075 TERMINATED
HIV-1-infection
Southampton Healthcare, Inc.
 2019-07-01 PHASE4
NCT05378906 Completed
Healthy
Janssen Research & Development LLC
 2022-06-07 Phase 1
NCT03602690 UNKNOWN
HIV/AIDS
ANRS, Emerging Infectious Diseases
 2018-10-04 PHASE2
NCT04630002 COMPLETED
HIV Infections
ViiV Healthcare
 2020-10-28 PHASE1
NCT04303299 COMPLETED
SARS-COV-2 Infections; COVID-19
Department of Medical Services Ministry of Public Health of Thailand
 2020-08-19 PHASE3
NCT02771249 COMPLETED
HIV Infected Population With Latent Tuberculosis
National Institutes of Health Clinical Center (CC)
 2016-06-03 PHASE1
NCT03683524 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2018-11-19 PHASE4
NCT01281813 COMPLETED
HIV-1 Infections
Janssen Sciences Ireland UC
 2011-08-08 PHASE3
NCT04661397 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-01-05 PHASE1
NCT04435587 UNKNOWN
Asymptomatic Infections; SARS-CoV2 Infection
Mahidol University
 2020-07-13 PHASE4
NCT04208061 COMPLETED
Healthy
Janssen Research & Development, LLC
 2019-12-18 PHASE1
NCT04718805 COMPLETED
Healthy
Janssen Research & Development, LLC
 2021-01-26 PHASE1
NCT03988452 UNKNOWN
Human Immunodeficiency Virus
Makerere University
 2019-07-30 PHASE3
NCT04252274 UNKNOWN
Pneumonia, Pneumocystis; Coronavirus
Shanghai Public Health Clinical Center
 2020-01-30 PHASE3
NCT02383108 COMPLETED
HIV Infection
PENTA Foundation
 2016-06 PHASE2; PHASE3
NCT03163277 TERMINATED
Hiv; Neurocognitive Dysfunction
Giovanni Di Perri
 2017-05-15 PHASE4
NCT03685500 COMPLETED
HIV Infections
Fundacion SEIMC-GESIDA
 2018-12-04 PHASE4
NCT03394196 TERMINATED
HIV-2 Infection
University of Washington
 2018-07-04
NCT04236453 TERMINATED
Healthy
Janssen Pharmaceutica N.V., Belgium
 2020-01-23 PHASE1
NCT04006704 COMPLETED
HIV-1
Janssen Pharmaceutica N.V., Belgium
 2019-10-10 PHASE1
NCT02337322 UNKNOWN
Acquired Immune Deficiency Syndrome Virus
Juan A. Arnaiz
 2015-03-31 PHASE4
NCT02987530 COMPLETED
HIV-1 Infection
ANRS, Emerging Infectious Diseases
 2017-04-11 PHASE3
NCT02738502 COMPLETED
Maternal-fetal Infection Transmission
ANRS, Emerging Infectious Diseases
 2016-07-06 PHASE2
NCT04064632 UNKNOWN
HIV Infection
A.O. Ospedale Papa Giovanni XXIII
 2017-02-01 PHASE4
NCT03101644 COMPLETED
Human Immunodeficiency Virus I Infection
Université Catholique de Louvain
 2017-03-23 PHASE4
NCT03589040 UNKNOWN
HIV; Contraception
Makerere University
 2018-09-25 PHASE2
NCT03589027 UNKNOWN
HIV-1-infection; Contraception
Makerere University
 2018-08-07 PHASE2
NCT03472963 COMPLETED
HIV Infections
Emory University
 2018-04-27 PHASE1
NCT03227861 COMPLETED
HIV-1
Janssen Scientific Affairs, LLC
 2017-07-31 PHASE3
NCT01792570 COMPLETED
Human Immunodeficiency Virus
ASST Fatebenefratelli Sacco
 2014-09-30 PHASE3
NCT03892161 TERMINATED
HIV Infections
University of Cape Town
 2018-04-12 PHASE1
NCT02486133 COMPLETED
HIV-Infection
Technical University of Munich
 2015-07 PHASE3
NCT02671383 COMPLETED
HIV Infections
Willem Daniel Francois Venter
 2016-06-30 PHASE3
NCT03094507 COMPLETED
HIV
St Stephens Aids Trust
 2017-04-19 PHASE1
NCT01900106 COMPLETED
HIV Infection
University of Modena and Reggio Emilia
 2013-11 PHASE3
NCT01138605 COMPLETED
HIV-1 Infections
Janssen Sciences Ireland UC
 2010-10-13 PHASE2
NCT02735863 COMPLETED
HIV Infection
Abivax S.A.
 2016-05 PHASE2
NCT02116660 TERMINATED
HIV Infections
Merck Sharp & Dohme LLC
 2014-09-03 PHASE2
NCT02470650 WITHDRAWN
Patient Compliance; Antiretroviral Therapy Intolerance
Juan A. Arnaiz
 2015-06 PHASE4
NCT02770508 COMPLETED
HIV-1 Infection
Fundación Huésped
 2015-11 PHASE4
NCT03123848 COMPLETED
Healthy
Janssen Pharmaceutical K.K.
 2017-04-14 PHASE4
NCT02603107 COMPLETED
HIV-1 Infection
Gilead Sciences
 2015-11-20 PHASE3
NCT02431247 COMPLETED
Immunodeficiency Virus Type 1, Human
Janssen Sciences Ireland UC
 2015-07-06 PHASE3
NCT02199613 COMPLETED
HIV Infection
University of British Columbia
 2014-10 PHASE4
NCT02984852 COMPLETED
Healthy
Janssen Scientific Affairs, LLC
 2016-12 PHASE1
NCT02269917 COMPLETED
Human Immunodeficiency Virus Type 1
Janssen R&D Ireland
 2015-03 PHASE3
NCT02503462 TERMINATED
AIDS-related Dementia Complex
University Hospital, Basel, Switzerland
 2015-07 PHASE4
NCT01869634 COMPLETED
Human Immunodeficiency Virus Infection
University of California, Davis
 2013-06 PHASE4
NCT01641367 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2013-02-22 PHASE4
NCT02818348 COMPLETED
HIV-1 Infection
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2016-06 PHASE1
NCT02384967 COMPLETED
HIV INFECTION
ANRS, Emerging Infectious Diseases
 2015-03 PHASE2
NCT02275780 COMPLETED
HIV-1
Merck Sharp & Dohme LLC
 2014-12-01 PHASE3
NCT02404233 UNKNOWN
HIV Positive
Therapeutic Concepts
 2015-03 PHASE4
NCT00855335 COMPLETED
HIV; HIV Infections; Pregnancy
Janssen Scientific Affairs, LLC
 2009-04-09 PHASE3
NCT02025868 UNKNOWN
HIV Infection
ANRS, Emerging Infectious Diseases
 2013-03 PHASE2
NCT02499978 WITHDRAWN
HIV/AIDS
Stanford University
 2016-05 PHASE2; PHASE3
NCT02155101 COMPLETED
HIV/AIDS
University of Liverpool
 2014-05 PHASE3
NCT01905059 COMPLETED
HIV Infection
ANRS, Emerging Infectious Diseases
 2014-02 PHASE3
NCT02159599 COMPLETED
HIV Infection
Fundacion SEIMC-GESIDA
 2014-07 PHASE4
NCT02625207 COMPLETED
Healthy Subjects
ViiV Healthcare
 2015-11-06 PHASE1
NCT02589158 COMPLETED
HIV
St Stephens Aids Trust
 2015-11 PHASE1
NCT02578550 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-11 PHASE1
NCT02154360 COMPLETED
HIV Infection
University of Pennsylvania
 2014-05 PHASE1
NCT01680536 COMPLETED
HIV
St Stephens Aids Trust
 2012-11 PHASE4
NCT02475915 COMPLETED
Acute HIV Infection
SEARCH Research Foundation
 2015-01 PHASE1; PHASE2
NCT01367236 COMPLETED
HIV; Impaired Cognition
Imperial College London
 2013-01 PHASE4
NCT02475135 COMPLETED
Healthy
Janssen Sciences Ireland UC
 2015-06-01 PHASE1
NCT01968551 COMPLETED
HIV-1; HIV Infections; Acquired Immunodeficiency Syndrome
Gilead Sciences
 2013-09-03 PHASE3
NCT01367210 TERMINATED
HIV Infection
Catholic University of the Sacred Heart
 2011-06 PHASE4
NCT01736761 COMPLETED
HIV
St Stephens Aids Trust
 2012-12 PHASE4
NCT02277600 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-11-05 PHASE1
NCT02489487 COMPLETED
HIV-infection
Viriom
 2014-09 PHASE1
NCT02203461 COMPLETED
Insulin Resistance
Technical University of Munich
 2014-07 PHASE1
NCT01605084 WITHDRAWN
HIV
Bristol-Myers Squibb
 2012-06-30 PHASE3
NCT01258439 COMPLETED
HIV; Cardiovascular Disease
St Vincent's Hospital, Sydney
 2010-11 PHASE4
NCT02159352 COMPLETED
Hepatitis C
Bristol-Myers Squibb
 2014-06 PHASE1
NCT01400412 COMPLETED
HIV-1 Infection
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2012-01-17 PHASE2
NCT01448707 COMPLETED
Human Immunodeficiency Virus (HIV) Infections; Acquired Immunodeficiency Syndrome (AIDS) Virus
Janssen-Cilag International NV
 2012-03-15 PHASE3
NCT02063360 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2014-02-01 PHASE1
NCT01343225 UNKNOWN
HIV
East Carolina University
 2011-05 PHASE4
NCT01423812 COMPLETED
HIV
Ruth M. Rothstein CORE Center
 2012-01 PHASE4
NCT02097381 UNKNOWN
HIV Infection
University of Roma La Sapienza
 2010-04
NCT00525733 COMPLETED
HIV Infections
Rockefeller University
 2007-10
NCT00855413 TERMINATED
Acute HIV Infection; HIV Infections
University of North Carolina, Chapel Hill
 2009-03 PHASE4
NCT01066962 COMPLETED
HIV Infections
ANRS, Emerging Infectious Diseases
 2010-08 PHASE3
NCT00928187 COMPLETED
HIV; HIV Infections
ANRS, Emerging Infectious Diseases
 2009-11 PHASE3
NCT01516970 COMPLETED
Human Immunodeficiency Virus (HIV)
Janssen-Cilag G.m.b.H
 2011-11-25 PHASE3
NCT01565889 COMPLETED
Hepatitis C; HIV
Gilead Sciences
 2012-03 PHASE1; PHASE2
NCT01345630 TERMINATED
HIV-1
ViiV Healthcare
 2011-09 PHASE3
NCT01033760 COMPLETED
HIV-1 Infections
ANRS, Emerging Infectious Diseases
 2010-04 PHASE3
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
NCT01118871 TERMINATED
HIV; HIV Infections
Imperial College London
 2010-05 PHASE4
NCT01449929 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
 2011-10-31 PHASE3
NCT00877591 COMPLETED
Opioid Dependency; HIV Infections
University of California, San Francisco
 2008-04 PHASE1
NCT00993148 COMPLETED
HIV-1 Infection; HIV Infections
Northwestern University
 2010-05 PHASE2
NCT01695954 COMPLETED
Hyperlipidemia; HIV
NYU Langone Health
 2012-05 PHASE1
NCT01565850 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2012-04 PHASE2
NCT00823979 TERMINATED
HIV-1
Pfizer
 2009-03-25 PHASE2
NCT01199939 COMPLETED
Human Immunodeficiency Virus (HIV)
Tibotec, Inc
 2010-05 PHASE2
NCT00994344 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2009-10 PHASE4
NCT00677300 COMPLETED
HIV Infections
Dallas VA Medical Center
 2009-01 PHASE4
NCT01619527 COMPLETED
Healthy Participants
Janssen R&D Ireland
 2012-04 PHASE1
NCT01440569 COMPLETED
Acquired Immunodeficiency Syndrome; HIV Infections
Gilead Sciences
 2011-09 PHASE3
NCT00537394 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2008-01 PHASE3
NCT01519336 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
 2012-02 PHASE1
NCT01294761 COMPLETED
HIV Infections
National Center for Global Health and Medicine, Japan
 2011-02
NCT01348763 COMPLETED
HIV
Imperial College London
 2011-10 PHASE1
NCT01876966 COMPLETED
HIV
Janssen Pharmaceutica N.V., Belgium
 2011-03 PHASE1
NCT01374802 COMPLETED
HIV Infections
Boehringer Ingelheim
 2011-06 PHASE1
NCT01346982 COMPLETED
HIV
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
 2011-03 PHASE4
NCT00936793 COMPLETED
HIV; Asthma
National Institutes of Health Clinical Center (CC)
 2009-07-06 PHASE1
NCT00849160 COMPLETED
HIV-1 Infection; HIV Infections
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida
 2009-05 PHASE3
NCT01422369 COMPLETED
Healthy
Kowa Research Institute, Inc.
 2011-04 PHASE4
NCT00756730 COMPLETED
HIV Infections
Community Research Initiative of New England
 2008-09 PHASE4
NCT01391013 COMPLETED
Human Immunodeficiency Virus 1
Janssen-Cilag S.p.A.
 2009-06 PHASE2
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
NCT00915655 COMPLETED
HIV-1 Infection
Tibotec Pharmaceuticals, Ireland
 2009-07 PHASE2
NCT00919854 COMPLETED
Human Immunodeficiency Virus 1
Tibotec Pharmaceuticals, Ireland
 2009-09 PHASE2
NCT00765154 TERMINATED
HIV
St Stephens Aids Trust
 2008-10 PHASE4
NCT01073761 COMPLETED
HIV; HIV Infections
St Stephens Aids Trust
 2010-04 PHASE1
NCT00421551 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2007-03 PHASE3
NCT01052883 COMPLETED
HIV Infections
Tibotec Pharmaceuticals, Ireland
 2010-03 PHASE1
NCT00885495 COMPLETED
HIV Infections
University of Cincinnati
 2009-01 PHASE1; PHASE2
NCT01046890 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2010-01 PHASE4
NCT00543101 COMPLETED
HIV Infections
Community Research Initiative of New England
 2007-10 PHASE4
NCT00855088 COMPLETED
HIV/AIDS; HIV Infections
University of North Carolina, Chapel Hill
 2009-07 PHASE1
NCT00782301 WITHDRAWN
Hepatitis B; Human Immunodeficiency Virus; Hepatitis C, Chronic
ViiV Healthcare
 2009-03 PHASE4
NCT00830804 COMPLETED
HIV-1 Infections
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
 2009-04 PHASE2
NCT00307502 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2005-01 PHASE1
NCT01047995 COMPLETED
HIV Infections
St Stephens Aids Trust
 2009-06 PHASE1
NCT00920088 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2009-06 PHASE1
NCT00630734 COMPLETED
HIV Infections; Hyperlipidemia
University of Colorado, Denver
 2008-02 PHASE4
NCT00838760 COMPLETED
HIV-1
Tibotec Pharmaceuticals, Ireland
 2009-02 PHASE1
NCT00757783 COMPLETED
HIV
Tibotec, Inc
 2008-10 PHASE4
NCT00524368 COMPLETED
Human Immunodeficiency Virus - Type 1
Tibotec Pharmaceuticals, Ireland
 2007-10 PHASE3
NCT00611039 COMPLETED
HIV Infections
Germans Trias i Pujol Hospital
 2008-02 PHASE4
NCT00783484 COMPLETED
Healthy Volunteers
Pfizer
 2008-10 PHASE1
NCT00867152 COMPLETED
Healthy Volunteer
ViiV Healthcare
 2009-04 PHASE1
NCT00260078 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2006-02 PHASE1; PHASE2
NCT00458302 COMPLETED
HIV Infections; AIDS Virus; Human Immunodeficiency Virus; Acquired Immunodeficiency Syndrome Virus
Janssen-Cilag International NV
 2007-06 PHASE3
NCT00774735 COMPLETED
Healthy Subjects; Infection, Human Immunodeficiency Virus
GlaxoSmithKline
 2008-10 PHASE1
NCT00744887 COMPLETED
HIV; AIDS
Tibotec Pharmaceuticals, Ireland
 2008-08 PHASE1
NCT00531557 COMPLETED
HIV Infections
St Stephens Aids Trust
 2007-09 PHASE4
NCT00381303 COMPLETED
HIV; Infectious
Tibotec, Inc
 2006-11 PHASE3
NCT00775125 COMPLETED
Hepatitis C; Telaprevir; HIV
Tibotec BVBA
 2008-06 PHASE1
NCT00765271 COMPLETED
HIV
St Stephens Aids Trust
 2008-05 PHASE1
NCT00460746 COMPLETED
HIV
Tibotec, Inc
 2007-05 PHASE3
NCT00517192 TERMINATED
HIV Infections
Boehringer Ingelheim
 2007-09 PHASE3
NCT00752310 COMPLETED
Pharmacokinetics
Tibotec Pharmaceuticals, Ireland
 2008-04 PHASE1
NCT01810887 COMPLETED
Healthy
Janssen Pharmaceutical K.K.
 2008-05 PHASE4
NCT02251795 COMPLETED
Healthy
Boehringer Ingelheim
 2007-08 PHASE1
NCT00534352 COMPLETED
HIV-1 Infection
Tibotec, Inc
 2008-01 PHASE2
NCT00460382 COMPLETED
HIV Infections
French National Agency for Research on AIDS and Viral Hepatitis
 2007-05 PHASE2
NCT00513513 TERMINATED
HIV Infections
Tibotec Pharmaceuticals, Ireland
 2006-09 PHASE2
NCT00326963 COMPLETED
HIV Infections
Hoffmann-La Roche
 2006-03 PHASE4
NCT00650832 COMPLETED
HIV
Tibotec Pharmaceuticals, Ireland
 2003-10 PHASE2
NCT00964327 COMPLETED
HIV Infections
Tibotec Pharmaceuticals, Ireland
 2001-08 PHASE2
NCT01013987 UNKNOWN
HIV-1 Adults Patients; AIDS; Triple Class Failure
Fundación Huésped
 2010-02 PHASE4
NCT01308658 COMPLETED
Healthy
Tibotec Pharmaceuticals, Ireland
 2011-01 PHASE1
NCT01323257 COMPLETED
Hepatitis C Virus
Tibotec Pharmaceuticals, Ireland
 2011-03 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-08-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Darunavir functions as a nonpeptidic HIV protease inhibitor that selectively binds to the active site of viral HIV-1 protease, thereby blocking the cleavage of Gag and Gag-Pol polyproteins. This target inhibition prevents viral precursor processing and maturation into infectious particles, halting viral replication to effectively suppress viral burden in patients with HIV infection.

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.