Isoniazid Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 670

Clinical Trials

Numerous clinical trials, spanning Phase 1 through Phase 4 with recruitment statuses ranging from active to completed or withdrawn, evaluate isoniazid for preventing and treating tuberculosis. These studies focus on latent infections, pulmonary disease, HIV co-infections in pediatric and adult populations, and preventative regimens in vulnerable groups like kidney transplant recipients. Sponsored by academic institutions, hospital networks, and national research organizations such as Asan Medical Center and the French National Agency for Research on AIDS and Viral Hepatitis, evaluations encompass pharmacokinetics and targeted prophylaxis.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03785106	ACTIVE_NOT_RECRUITING	HIV-infected Participants With Latent TB Infection in High TB Burden Country	The HIV Netherlands Australia Thailand Research Collaboration	2019-08-15	PHASE3
NCT07656012	NOT_YET_RECRUITING	Tuberculosis	University of Wisconsin, Madison	2026-09	PHASE2
NCT07076225	NOT_YET_RECRUITING	Pulmonary Tuberculosis	Shenzhen Third People's Hospital	2025-07-25	PHASE3
NCT03474029	RECRUITING	Latent Tuberculosis	Centers for Disease Control and Prevention	2019-08-01	PHASE2; PHASE3
NCT07595042	NOT_YET_RECRUITING	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2026-10-30	PHASE2
NCT06526221	ENROLLING_BY_INVITATION	Tuberculosis, Pulmonary; Medication Adherence	Tufts University	2026-04-07
NCT06905522	RECRUITING	Pulmonary Tuberculosis	Shenzhen Third People's Hospital	2025-06-18	PHASE3
NCT06526039	NOT_YET_RECRUITING	Tuberculosis, Pulmonary	Taipei Medical University WanFang Hospital	2024-07	PHASE3
NCT07163143	NOT_YET_RECRUITING	Tuberculosis (TB)	University College, London	2025-11	PHASE3
NCT07086820	RECRUITING	Tuberculosis Infection; Household Contacts; Children; Adolescent; Tuberculosis Infection, Latent; Tuberculosis	Pontificia Universidad Catolica de Chile	2025-10-27
NCT05383742	RECRUITING	Tuberculous Meningitis	National Institute of Allergy and Infectious Diseases (NIAID)	2023-12-07	PHASE2
NCT07124559	NOT_YET_RECRUITING	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2026-10-15	PHASE1; PHASE2
NCT06917495	NOT_YET_RECRUITING	Mild Spinal Tuberculosis	Shandong University	2025-04-05	PHASE2
NCT07773610	NOT_YET_RECRUITING	Tuberculosis, Pulmonary	TASK Applied Science	2026-07-23	PHASE2
NCT07467252	NOT_YET_RECRUITING	Pulmonary Tuberculosis	Ministry of Health, Saudi Arabia	2026-09	PHASE2
NCT05807399	RECRUITING	Pulmonary Tuberculosis; Other Specified Pulmonary Tuberculosis	Michael Hoelscher	2023-04-14	PHASE2
NCT06253715	RECRUITING	Tuberculosis; Tuberculosis, Pulmonary; Tuberculosis, Lymph Node; Mycobacterium Tuberculosis	Johns Hopkins University	2025-01-15	PHASE3
NCT05917340	NOT_YET_RECRUITING	Tuberculous Meningitis	Indian Council of Medical Research	2024-03	PHASE3
NCT06568484	RECRUITING	Tuberculosis, Latent	Johns Hopkins University	2026-05-08	PHASE2; PHASE3
NCT07303699	RECRUITING	Pulmonary Tuberculosis (TB)	Obafemi Awolowo University Teaching Hospital	2026-01-03	PHASE2
NCT06114628	RECRUITING	Pulmonary Tuberculosis	University College, London	2024-01-09	PHASE2
NCT06281834	RECRUITING	Pediatric HIV Infection; Latent Tuberculosis	Brigham and Women's Hospital	2024-11-15	PHASE1
NCT03568383	ACTIVE_NOT_RECRUITING	Tuberculosis, MDR	National Institute of Allergy and Infectious Diseases (NIAID)	2019-06-03	PHASE3
NCT07129629	NOT_YET_RECRUITING	Tuberculosis, Pulmonary; Drug-Susceptible Pulmonary Tuberculosis	Shanghai Pulmonary Hospital, Shanghai, China	2025-08-20	PHASE2
NCT05766267	ACTIVE_NOT_RECRUITING	Tuberculosis, Pulmonary; Tuberculosis Infection	Centers for Disease Control and Prevention	2023-11-21	PHASE2; PHASE3
NCT06191692	NOT_YET_RECRUITING	Tuberculosis Infection	Freundeskreis Für Internationale Tuberkulosehilfe e.V	2025-08-01	PHASE3
NCT06192160	RECRUITING	Pulmonary Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2025-03-11	PHASE2
NCT07069582	NOT_YET_RECRUITING	Tuberculosis Infection; Healthy Volunteer; Breastfeeding	McGill University Health Centre/Research Institute of the McGill University Health Centre	2026-04-01	PHASE1
NCT07073638	RECRUITING	Pulmonary Tuberculoses	Thirty Respiratory Limited	2025-10-13	PHASE2
NCT06022146	RECRUITING	Tuberculosis; Latent Tuberculosis	Huashan Hospital	2023-09-01	PHASE3
NCT05994742	COMPLETED	Severe Acute Malnutrition; HIV; Comorbidities and Coexisting Conditions; Child Malnutrition	Queen Mary University of London	2024-07-15	PHASE3
NCT07708779	RECRUITING	Tuberculosis	University Medical Center Groningen	2025-12-01	PHASE1
NCT06748937	RECRUITING	Tuberculosis	TASK Applied Science	2025-03-03	PHASE2
NCT06199921	RECRUITING	Pulmonary Tuberculosis; Tuberculosis; Koch's Disease	Obafemi Awolowo University Teaching Hospital	2024-01-03	PHASE2
NCT05411744	ACTIVE_NOT_RECRUITING	Latent Tuberculosis; End Stage Renal Disease; Renal Transplant Candidate for Right Kidney; Renal Transplant Candidate for Left Kidney	Rutgers, The State University of New Jersey	2022-07-01	PHASE4
NCT04951986	ACTIVE_NOT_RECRUITING	Disseminated Tuberculosis; HIV	University of Cape Town	2021-08-11	PHASE3
NCT06618573	RECRUITING	Tuberculosis; Systemic Lupus Erythematosus	Universitas Padjadjaran	2022-08-15	PHASE2; PHASE3
NCT07058090	NOT_YET_RECRUITING	Drug Induced Liver Injury; Tuberculosis (TB)	Liaquat National Hospital & Medical College	2025-07	PHASE1
NCT04600167	UNKNOWN	Diabetes Mellitus; Tuberculosis	Dr. Nyanda Elias Ntinginya	2022-06-17	PHASE3
NCT05122026	ACTIVE_NOT_RECRUITING	HIV Seropositivity; Pregnancy; Tuberculosis Infection	The Aurum Institute NPC	2024-01-17	PHASE1; PHASE2
NCT04485156	NOT_YET_RECRUITING	Tuberculosis, Pulmonary	Seoul National University Hospital	2020-09	PHASE3
NCT05118490	ACTIVE_NOT_RECRUITING	HIV Seropositivity; Tuberculosis; Household Contact	The Aurum Institute NPC	2023-07-19	PHASE4
NCT05122767	ACTIVE_NOT_RECRUITING	Tuberculosis; HIV	The Aurum Institute NPC	2023-05-24	PHASE1; PHASE2
NCT05454345	UNKNOWN	Tuberculosis, Pulmonary	First Affiliated Hospital of Zhejiang University	2022-10-01	PHASE3
NCT05556746	ACTIVE_NOT_RECRUITING	Tuberculosis, Pulmonary; HIV	Brigham and Women's Hospital	2023-11-24	PHASE2
NCT06214910	COMPLETED	Tuberculosis; HIV I Infection	University of Washington	2024-02-20
NCT05021731	UNKNOWN	Latent Tuberculosis; Kidney Failure	Miguel Santín	2024-04-20	PHASE4
NCT04930744	COMPLETED	Tuberculosis; Pulmonary Tuberculosis; HIV Coinfection	University of Massachusetts, Worcester	2022-03-04	PHASE2
NCT05413551	COMPLETED	Tuberculosis Infection; Isoniazid Adverse Reaction	Stanford University	2023-03-23	PHASE1
NCT05971602	TERMINATED	Pulmonary Tuberculosis	Gates Medical Research Institute	2023-07-26	PHASE2
NCT03730181	COMPLETED	Latent Tuberculosis	Centers for Disease Control and Prevention	2019-11-12	PHASE1; PHASE2
NCT04311502	TERMINATED	HIV; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2021-11-05	PHASE2
NCT04703075	COMPLETED	Tuberculosis	Johns Hopkins University	2022-03-24	PHASE4
NCT06281834	Not yet recruiting	Pediatric HIV Infection\|Latent Tuberculosis	Brigham and Women''s Hospital\|APIN Public Health Initiatives\|University of Cape Town	2024-05	Phase 1
NCT06874725	ACTIVE_NOT_RECRUITING	Latent Tuberculosis Infection	Taichung Veterans General Hospital	2018-04-18	PHASE4
NCT05473195	COMPLETED	Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)	TASK Applied Science	2022-12-06	PHASE2
NCT04062201	COMPLETED	Tuberculosis; Pre-XDR-TB; Extensively Drug-Resistant Tuberculosis; Multi Drug Resistant Tuberculosis; Rifampicin Resistant Tuberculosis	Wits Health Consortium (Pty) Ltd	2019-08-22	PHASE3
NCT05221502	COMPLETED	Pulmonary TB	Otsuka Pharmaceutical Development & Commercialization, Inc.	2022-04-12	PHASE2
NCT03089983	COMPLETED	Opioid Dependence; Addiction; HIV/AIDS; Tuberculosis; Hepatitis	Yale University	2017-08-21
NCT06512831	COMPLETED	Kidney Transplantation; Tuberculosis; Isoniazid Toxicity	West China Hospital	2023-06-01
NCT04856644	UNKNOWN	Tuberculosis, Pulmonary	Kaohsiung Veterans General Hospital.	2020-01-01	PHASE3
NCT03315962	COMPLETED	Tuberculosis; HIV/AIDS	University of California, San Francisco	2017-11-15
NCT04094012	COMPLETED	Latent Tuberculosis Infection	National Taiwan University Hospital	2019-09-24	PHASE3
NCT05655702	Recruiting	Tuberculosis	ANRS Emerging Infectious Diseases\|Haiphong University of Medicine and Pharmacy\|Expertise France\|Université Montpellier\|New York University\|CENTER FOR SUPPORTING COMMUNITY DEVELOPMENT INITIATIVES	2023-10-02	Not Applicable
NCT05592223	COMPLETED	Tuberculosis	Fred Hutchinson Cancer Center	2022-12-06	PHASE1
NCT05249699	UNKNOWN	Kidney Transplant Infection; Tuberculosis; Isoniazid Toxicity	West China Hospital	2022-04-01
NCT04830462	COMPLETED	Latent Tuberculosis; Diabetes Mellitus, Type 2	Herlev and Gentofte Hospital	2021-04-15	PHASE4
NCT03266991	TERMINATED	Compliance, Patient	Aarhus University Hospital	2017-10-27	PHASE4
NCT04187469	UNKNOWN	Pulmonary Tuberculosis	Fifth Affiliated Hospital, Sun Yat-Sen University	2020-03-01
NCT03435146	COMPLETED	Respiratory Tract Infections; HIV Infections	The Aurum Institute NPC	2018-01-18	PHASE1; PHASE2
NCT03510468	COMPLETED	Healthy Volunteers	National Institutes of Health Clinical Center (CC)	2018-06-12	PHASE1
NCT03934931	COMPLETED	Tuberculosis; Latent Tuberculosis; HIV/AIDS	University of California, San Francisco	2020-07-13
NCT03891901	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2020-10-27	PHASE2
NCT02409290	COMPLETED	MDR-TB	IUATLD, Inc	2016-03	PHASE3
NCT02256696	COMPLETED	Pulmonary Tuberculosis	Johns Hopkins University	2015-04-29	PHASE2
NCT05124678	UNKNOWN	Tuberculosis	Makerere University	2021-12-07	PHASE2
NCT03474198	COMPLETED	Tuberculosis, Pulmonary	University College, London	2018-03-21	PHASE2; PHASE3
NCT03900858	UNKNOWN	Silicosis Tuberculosis	Huashan Hospital	2018-12-01
NCT02581527	COMPLETED	Pulmonary Tuberculosis	St George's, University of London	2017-02-01	PHASE3
NCT03787940	UNKNOWN	Tuberculous Meningitis	Beijing Chest Hospital	2019-03-04
NCT04272242	TERMINATED	HIV Infection; LTBI	National Institute of Allergy and Infectious Diseases (NIAID)	2021-02-27	PHASE2
NCT02821832	COMPLETED	Pulmonary Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2017-06-21	PHASE2
NCT01936831	COMPLETED	Tuberculosis	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	2014-08-13	PHASE2
NCT04528277	UNKNOWN	Infertility, Female; Recurrent Implantation Failure; Genital Tuberculoses, Female; Genital Tuberculosis, Latent	Huashan Hospital	2020-09-01	PHASE3
NCT02563327	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2016-01-25	PHASE3
NCT02771249	COMPLETED	HIV Infected Population With Latent Tuberculosis	National Institutes of Health Clinical Center (CC)	2016-06-03	PHASE1
NCT03302299	COMPLETED	Tuberculosis; HIV/AIDS; Alcohol Abuse	University of California, San Francisco	2017-04-07	PHASE4
NCT04504851	UNKNOWN	Pulmonary Tuberculosis	National University Hospital, Singapore	2020-08-12	PHASE2
NCT02454205	COMPLETED	Tuberculosis; Multidrug Resistant Tuberculosis; Extensively-drug Resistant Tuberculosis	University of Cape Town	2015-11-12	PHASE2; PHASE3
NCT04424264	COMPLETED	HIV-1-infection; Tuberculosis	Professor Francois Venter	2019-12-05	PHASE1
NCT02236078	COMPLETED	Tuberculosis; Drug-resistant Tuberculosis; Isoniazid Resistant Tuberculosis (Disorder)	Centers for Disease Control and Prevention	2015-11	PHASE1
NCT02735590	UNKNOWN	Tuberculosis	University of Cape Town	2016-09-20	PHASE2; PHASE3
NCT02980016	COMPLETED	Tuberculosis; HIV	The Aurum Institute NPC	2016-11	PHASE3
NCT02613169	COMPLETED	Tuberculosis	University of Washington	2016-08	PHASE2
NCT03028129	TERMINATED	Tuberculosis, Pulmonary; Antibiotic Prophylaxis	Federal University of Mato Grosso	2017-09-04	PHASE4
NCT03886701	COMPLETED	Latent Tuberculosis; Human Immunodeficiency Virus; Rifamycins Causing Adverse Effects in Therapeutic Use; Drug Interaction Potentiation	Walter K. Kraft	2019-04-22	PHASE1
NCT02651259	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2017-03-13	PHASE1; PHASE2
NCT03278483	COMPLETED	Diabetes Mellitus; Tuberculin (Skin Test) Positive	Instituto Nacional de Salud Publica, Mexico	2019-02-28	PHASE4
NCT02467608	COMPLETED	Pulmonary Tuberculosis	Orient Pharma Co., Ltd.	2012-12-06	PHASE2; PHASE3
NCT03665402	COMPLETED	Tuberculosis; Drug-Induced Liver Injury; Adverse Drug Event	Seoul National University Hospital	2018-05-13
NCT02901288	UNKNOWN	Tuberculosis, Pulmonary	Beijing Chest Hospital	2016-08	PHASE4
NCT02231229	COMPLETED	Tuberculosis	Assistance Publique - Hôpitaux de Paris	2014-07-23	PHASE4
NCT02430259	COMPLETED	Silicosis; Tuberculosis	Huashan Hospital	2015-03	PHASE3
NCT02057796	COMPLETED	HIV-1 Infection	ANRS, Emerging Infectious Diseases	2014-09	PHASE4
NCT02457208	COMPLETED	Tuberculosis	University of Oxford	2015-07-07	PHASE1
NCT02342886	COMPLETED	Tuberculosis, Pulmonary, Drug Sensitive; Tuberculosis, Pulmonary, Multi Drug-resistant	Global Alliance for TB Drug Development	2015-02	PHASE3
NCT02832778	UNKNOWN	HIV	St Stephens Aids Trust	2016-11-21	PHASE1
NCT02477852	UNKNOWN	Tuberculosis, Spinal	Beijing Chest Hospital	2015-04	PHASE4
NCT01404312	COMPLETED	Tuberculosis; HIV Infections	National Institute of Allergy and Infectious Diseases (NIAID)	2012-05-23	PHASE3
NCT03334734	TERMINATED	Tuberculosis	Nearmedic Plus LLC	2016-12-16	PHASE2
NCT01494038	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2014-08-19	PHASE4
NCT00931736	COMPLETED	Latent Tuberculosis Infection	McGill University	2009-08	PHASE3
NCT01601626	TERMINATED	HIV Infection; Tuberculosis	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	2013-07-13	PHASE2
NCT02208427	UNKNOWN	Latent Tuberculosis Infection	National Taiwan University Hospital	2014-08	PHASE3
NCT02279875	COMPLETED	Pulmonary Tuberculosis	Global Alliance for TB Drug Development	2014-11	PHASE2
NCT01782950	UNKNOWN	AIDS With Tuberculosis	Makerere University	2013-02	PHASE4
NCT01825031	COMPLETED	Human Immunodeficiency Virus	Anna Griffiths, MRC	2013-06	PHASE3
NCT02193776	COMPLETED	Tuberculosis	Global Alliance for TB Drug Development	2014-10-23	PHASE2
NCT01223534	COMPLETED	Latent Tuberculosis Infection	Hospital Universitari de Bellvitge	2010-07	PHASE4
NCT01926379	COMPLETED	HIV; Tuberculosis	Columbia University	2013-07
NCT01589497	COMPLETED	Tuberculosis	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	2015-06-30	PHASE2
NCT01154959	COMPLETED	Pulmonary Tuberculosis	Tuberculosis Research Centre, India	2010-02	PHASE3
NCT01550705	TERMINATED	Erythropoietic Protoporphyria (EPP); X Linked Erythropoietic Protoporphyria	University of Utah	2012-03
NCT02331823	UNKNOWN	Reinfection Pulmonary Tuberculosis	Shanghai Pulmonary Hospital, Shanghai, China	2013-06	PHASE4
NCT02076685	UNKNOWN	Hepatotoxicity	National Taiwan University Hospital	2007-11
NCT00728546	UNKNOWN	Tuberculosis; Hepatotoxicity	National Taiwan University Hospital	2008-06	PHASE4
NCT01838200	TERMINATED	Metastatic Melanoma	Ludwig Institute for Cancer Research	2014-03	PHASE1
NCT02554318	COMPLETED	Pulmonary Tuberculosis; Body Weight Changes; Motor Activity	University of Giessen	2013-11
NCT01380080	COMPLETED	HIV Infection	Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	2011-10	PHASE4
NCT00495651	COMPLETED	HIV Infections; Tuberculosis	French National Agency for Research on AIDS and Viral Hepatitis	2008-03	PHASE3
NCT00170209	COMPLETED	Latent Tuberculosis Infection	McGill University	2011-08	PHASE3
NCT01582711	COMPLETED	Latent Tuberculosis Infection	Centers for Disease Control and Prevention	2012-09	PHASE3
NCT01785186	COMPLETED	Tuberculosis, Pulmonary	Michael Hoelscher	2013-04	PHASE2
NCT00816426	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2008-12-29	PHASE1
NCT02121314	COMPLETED	Tuberculosis	University Medical Center Groningen	2013-07	PHASE2
NCT01761201	TERMINATED	Latent Tuberculosis Infection; Infection in Solid Organ Transplant Recipients	Fundación Pública Andaluza para la gestión de la Investigación en Sevilla	2012-01	PHASE3
NCT01516203	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2012-12-05	PHASE2
NCT01398618	UNKNOWN	Latent Tuberculosis Infection	National Taiwan University Hospital	2011-05	PHASE3
NCT01395654	UNKNOWN	Hepatitis; Tuberculosis, Pulmonary	National Taiwan University Hospital	2011-07	PHASE4
NCT00864383	COMPLETED	Pulmonary Tuberculosis	Global Alliance for TB Drug Development	2008-01	PHASE3
NCT01119521	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2010-10	PHASE1
NCT01087190	COMPLETED	Kidney Transplant Recipient	Asan Medical Center	2010-06
NCT00728507	TERMINATED	Tuberculosis	Johns Hopkins University	2009-11	PHASE2
NCT01245036	COMPLETED	Sarcoidosis; Tuberculosis	Post Graduate Institute of Medical Education and Research, Chandigarh	2009-01
NCT03498534	WITHDRAWN	Latent Tuberculosis; Diabetes Mellitus	Instituto Nacional de Salud Publica, Mexico	2012-09	PHASE4
NCT00850915	COMPLETED	Tuberculosis	KNCV Tuberculosis Foundation	2009-04	PHASE4
NCT02014272	COMPLETED	Healthy Volunteers	Pfizer	2012-09	PHASE1
NCT01875952	UNKNOWN	Human Immunodeficiency Virus (HIV); Tuberculosis (TB); Latent Tuberculosis Infection (LTI)	Instituto Nacional de Salud Publica, Mexico	2010-05	PHASE4
NCT00571753	TERMINATED	Pulmonary Tuberculosis	University of Cologne	2008-06	PHASE3
NCT00330304	COMPLETED	Tuberculosis	University of Cape Town	2003-01	PHASE3
NCT00463086	COMPLETED	Tuberculosis; Latent Tuberculosis Infection; HIV Infections	University of Cape Town	2007-11
NCT01399788	COMPLETED	Healthy Volunteers	Pfizer	2011-07	PHASE1
NCT01311505	COMPLETED	Tuberculosis	Pfizer	2011-04	PHASE1
NCT01136161	COMPLETED	Latent Tuberculosis Infection; Tuberculosis	Archivel Farma S.L.	2010-06	PHASE2
NCT00495326	COMPLETED	Tuberculosis; Aids; Hiv Infections	French National Agency for Research on AIDS and Viral Hepatitis	2007-12	PHASE2; PHASE3
NCT00767975	COMPLETED	Tuberculosis	National Taiwan University Hospital	2008-01	PHASE3
NCT00023452	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2001-06	PHASE3
NCT00164281	COMPLETED	Tuberculosis; HIV Infections	Centers for Disease Control and Prevention	2004-11	PHASE4
NCT00080119	TERMINATED	HIV Infection; Tuberculosis; Pneumocystis Jiroveci Pneumonia	International Maternal Pediatric Adolescent AIDS Clinical Trials Group	2004-02	PHASE2; PHASE3
NCT00057122	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2002-09	PHASE3
NCT00130325	COMPLETED	Tuberculosis	Medical Research Council Unit, The Gambia	2004-10
NCT00128206	COMPLETED	Tuberculosis	University of California, San Francisco	2004-11	PHASE3
NCT02043314	COMPLETED	Tuberculosis	Oswaldo Cruz Foundation	2008-10	PHASE1
NCT00130247	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2002-04-08	PHASE3
NCT04802928	WITHDRAWN	Arterial Leg Ulcer	Pharma 2100	2008-04	PHASE2
NCT00351702	COMPLETED	Human Immunodeficiency Virus; Tuberculosis	Tuberculosis Research Centre, India	2001-02	PHASE3
NCT00164450	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2005-09
NCT00293228	COMPLETED	Tuberculosis	Instituto Nacional de Salud Publica, Mexico	2007-02	PHASE4
NCT00396084	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2004-02-10	PHASE1; PHASE2
NCT00376012	UNKNOWN	Tuberculosis; Human Immunodeficiency Virus Infections	Tuberculosis Research Centre, India	2001-02	PHASE3
NCT00164463	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2004-07	PHASE2
NCT00144417	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2006-02	PHASE2
NCT00023374	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2000-08
NCT00306319	COMPLETED	Tuberculosis	Radboud University Medical Center	2006-01	PHASE2
NCT00023413	COMPLETED	HIV Infections; Tuberculosis	Centers for Disease Control and Prevention	1999-11	PHASE2
NCT00000950	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00140309	COMPLETED	Tuberculosis, Pulmonary	Centers for Disease Control and Prevention	2003-07	PHASE2
NCT00023335	COMPLETED	Pulmonary Tuberculosis	Centers for Disease Control and Prevention	1995-04	PHASE3
NCT00000959	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00000636	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00317330	COMPLETED	Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)	2004-12	PHASE3
NCT00402454	COMPLETED	HIV Infections	Sociedad Andaluza de Enfermedades Infecciosas	1994-01	PHASE4
NCT00397709	TERMINATED	Tuberculosis	Hospital Virgen de la Luz	1996-03	PHASE4
NCT00000796	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00298870	COMPLETED	Pulmonary Tuberculosis	Osaka University	2005-06	PHASE4
NCT00023348	COMPLETED	HIV Infections; Tuberculosis	Centers for Disease Control and Prevention	1999-07	PHASE2; PHASE3
NCT00004740	UNKNOWN	Tuberculosis	National Institute on Drug Abuse (NIDA)	1995-02
NCT00004736	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1
NCT00000638	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)
NCT00023387	COMPLETED	Tuberculosis	Centers for Disease Control and Prevention	2000-03
NCT00018083	UNKNOWN	Tuberculosis; HIV Infections	National Center for Research Resources (NCRR)
NCT00001033	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE3
NCT00402610	COMPLETED	HIV Infections; Tuberculosis	Sociedad Andaluza de Enfermedades Infecciosas	1994-01	PHASE4
NCT00513396	COMPLETED	Tuberculosis, Multidrug-Resistant	GSVM Medical College	2004-01	PHASE2; PHASE3
NCT00322907	TERMINATED	Clinical Malaria	Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland	2000-04	PHASE2
NCT00000778	COMPLETED	HIV Infections; Tuberculosis	National Institute of Allergy and Infectious Diseases (NIAID)		PHASE1

(data from https://clinicaltrials.gov, updated on 2025-03-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Isoniazid is a prodrug activated by mycobacterial KatG catalase-peroxidase to form a covalent adduct with NAD, which acts as a tight-binding competitive inhibitor of the enoyl reductase InhA and blocks downstream mycolic acid synthesis essential for bacterial cell wall integrity. This inhibition exerts bactericidal activity against actively growing Mycobacterium tuberculosis, directly accounting for its clinical efficacy in managing pulmonary tuberculosis and preventing latent tuberculosis in high-risk populations.

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>).