Drugs / Isoniazid
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Isoniazid

Small molecule

Developed for
tuberculosis · HIV infectious disease · pulmonary tuberculosis · latent tuberculosis infection · multidrug-resistant tuberculosis · meningeal tuberculosis · anterior uveitis · drug-resistant tuberculosis
+11 more · female genital tuberculosis · infectious disease with sepsis · lymph node tuberculosis · ocular tuberculosis · protein-energy malnutrition · respiratory tract infectious disorder · silicotuberculosis · tuberculosis, spinal · ulcer of lower limbs · X-linked erythropoietic protoporphyria · rifampicin-resistant tuberculosis
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · Johns Hopkins University · Centers for Disease Control and Prevention · Huashan Hospital · National Taiwan University Hospital · University of Cape Town
+245 more · Makerere University · The Aurum Institute NPC · Tuberculosis Research Centre, India · United States Agency for International Development (USAID) · University of Stellenbosch · Beijing Chest Hospital · European and Developing Countries Clinical Trials Partnership (EDCTP) · London School of Hygiene and Tropical Medicine · Medical Research Council · Sanofi · University College, London · University of California, San Francisco · University of Washington · ANRS, Emerging Infectious Diseases · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · All India Institute of Medical Sciences · Aurum Institute · Bill and Melinda Gates Foundation · Centre for the AIDS Programme of Research in South Africa · Chang Gung Memorial Hospital · Chengdu Public Health Clinical Center · Federal University of Mato Grosso · Global Alliance for TB Drug Development · Institute of Tropical Medicine, Belgium · Kaohsiung Veterans General Hospital. · Kenya Medical Research Institute · Merck Sharp & Dohme LLC · Michael Hoelscher · National Institute of Public Health, Mexico · National Institutes of Health Clinical Center (CC) · PENTA Foundation · Radboud University Medical Center · Shanghai Pulmonary Hospital, Shanghai, China · Sociedad Andaluza de Enfermedades Infecciosas · Taipei Veterans General Hospital, Taiwan · US Department of Veterans Affairs · University of Oxford · Wellcome Trust · West China Hospital · Aarhus University Hospital · Affiliated Wenling Hospital of Wenzhou Medical University · All India Institute of Medical Sciences, Bhubaneswar · All India Institute of Medical Sciences, Jodhpur · Anhui Chest Hospital · Asan Medical Center · Asian Medical Center · Assistance Publique - Hôpitaux de Paris · Barcelona Institute for Global Health · Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma · Beijing Ditan Hospital · Beijing Municipal Science & Technology Commission · Beijing Research Institute for Tuberculosis Control · Beijing YouAn Hospital · Bhumibol Adulyadej Hospital · Biomedical Research and Training Institute, Zimbabwe · Boston Medical Center · Boston University · Botswana Ministry of Health · Buddhachinaraj Hospital · Centers for Disease Control, Taiwan · Centre Hospitalier Cocody · Centre for Tuberculosis Control of Guangdong Province · Changchun Infectious Disease Hospital · Chest Hospital of Guangxi Zhuang Autonomous Region · Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC · Chiangrai Prachanukroh Hospital · Chongqing Infectious Disease Medical Center · Chongqing Public Health Medical Center · Chris Hani Baragwanath Academic Hospital · Christian Medical College, Vellore, India · Columbia University · Communicable Disease Program, Brazil · Comprehensive International Program of Research on AIDS · Consortium to Respond Effectively to the AIDS/Tuberculosis Epidemic · all 251 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) NYDRAZID — 1952-09-29 fda.gov ↗

Trials 120 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 111 trials
Phase 1 NCT07069582 Apr → Oct 2026 expected tuberculosis McGill University Health Centre/Research Institute of the McGill University Health Centre Not yet recruiting No outcome recorded
Phase 1 NCT07708779 Dec 2025 → Jul 2026 overdue tuberculosis University Medical Center Groningen Recruiting No outcome recorded
Phase 1 NCT05413551 Mar 2023 → Apr 2025 isoniazid toxicity, tuberculosis Stanford University Completed No outcome recorded
Phase 1 NCT03886701 Apr → May 2019 HIV infectious disease, isoniazid toxicity, latent tuberculosis infection Walter K. Kraft Completed No outcome recorded
Phase 1 NCT03510468 Jun 2018 → Nov 2022 — National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 1 NCT02771249 Jun 2016 → Aug 2021 latent tuberculosis infection National Institutes of Health Clinical Center (CC) Completed No outcome recorded
Phase 1 NCT02236078 Nov 2015 → Sep 2020 drug-resistant tuberculosis Centers for Disease Control and Prevention Completed No outcome recorded
Phase 1 NCT02457208 Jul 2015 → Jan 2018 tuberculosis University of Oxford Completed No outcome recorded
Phase 1 NCT01119521 Oct 2010 → Jul 2013 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1 NCT00816426 Dec 2008 → Aug 2014 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/26 trials
Phase 1/2 NCT05122026 Jan 2024 → Oct 2025 overdue pregnancy disorder, tuberculosis The Aurum Institute NPC Active not recruiting No outcome recorded
Phase 1/2 NCT05122767 May 2023 → Jul 2025 overdue HIV infectious disease, tuberculosis The Aurum Institute NPC Active not recruiting No outcome recorded
Phase 1/2 NCT04044001 Nov 2019 → Mar 2022 pulmonary tuberculosis Michael Hoelscher Completed No outcome recorded
Phase 1/2 NCT03730181 Oct 2019 → Dec 2024 latent tuberculosis infection Centers for Disease Control and Prevention Completed No outcome recorded
Phase 1/2 NCT03435146 Jan 2018 → Dec 2022 HIV infectious disease, respiratory tract infectious disorder The Aurum Institute NPC Completed No outcome recorded
Phase 1/2 NCT02651259 Mar 2017 → Apr 2019 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 214 trials · 1 met primary · 2 missed
Phase 2 NCT07129629 Aug 2025 → Dec 2026 expected pulmonary tuberculosis Shanghai Pulmonary Hospital, Shanghai, China Not yet recruiting No outcome recorded
Phase 2 NCT05383742 Dec 2023 → Apr 2028 expected meningeal tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Recruiting No outcome recorded
Phase 2 NCT06041919 Sep 2023 → Jul 2024 pulmonary tuberculosis Thirty Respiratory Limited Terminated No outcome recorded
Phase 2 NCT05971602 Jul 2023 → Feb 2025 pulmonary tuberculosis Gates Medical Research Institute Terminated No outcome recorded
Phase 2 NCT05807399 Apr 2023 → Oct 2027 expected pulmonary tuberculosis Michael Hoelscher Recruiting No outcome recorded
Phase 2 NCT05124678 Dec 2021 → Mar 2022 tuberculosis Makerere University Unknown No outcome recorded
Phase 2 NCT04311502 Nov 2021 → Jun 2024 HIV infectious disease, tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Terminated Missed primary Stop: Enrollment
Phase 2 NCT05005637 Aug 2021 → Oct 2024 ocular tuberculosis Faculty of Medicine, University of Indonesia Completed Met primary
Phase 2 NCT04272242 Feb → Dec 2021 HIV infectious disease, latent tuberculosis infection National Institute of Allergy and Infectious Diseases (NIAID) Terminated No outcome recorded
Phase 2 NCT02821832 Jun 2017 → Oct 2021 pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2/38 trials · 1 met primary · 2 missed
Phase 2/3 NCT06568484 May 2026 → Jul 2027 expected latent tuberculosis infection Johns Hopkins University Recruiting No outcome recorded
Phase 2/3 NCT05401071 Jan 2023 → Oct 2024 overdue pulmonary tuberculosis Huashan Hospital Recruiting No outcome recorded
Phase 2/3 NCT03915366 Mar 2020 → Jan 2025 HIV infectious disease, cytomegalovirus infection, pneumonia, tuberculosis Hospital Universitario 12 de Octubre Completed Missed primary
Phase 2/3 NCT02735590 Sep 2016 → Dec 2019 tuberculosis University of Cape Town Unknown Mixed
Phase 2/3 NCT02454205 Nov 2015 → Dec 2020 extensively drug-resistant tuberculosis, multidrug-resistant tuberculosis University of Cape Town Completed Met primary
Phase 2/3 NCT00080119 Feb 2004 → May 2009 HIV infectious disease, Pneumocystis infectious disease, tuberculosis International Maternal Pediatric Adolescent AIDS Clinical Trials Group Terminated Missed primary
Phase 2/3 NCT00513396 Jan 2004 → Dec 2006 multidrug-resistant tuberculosis GSVM Medical College Completed No outcome recorded
Phase 2/3 NCT00023348 Jul 1999 → Nov 2002 HIV infectious disease, tuberculosis Centers for Disease Control and Prevention Completed No outcome recorded
Phase 335 trials · 6 met primary · 5 missed
Phase 3 NCT07332325 Oct 2026 → Mar 2029 expected infectious disease with sepsis, tuberculosis University of Virginia Not yet recruiting No outcome recorded
Phase 3 NCT07163143 Nov 2025 → Nov 2028 expected tuberculosis University College, London Not yet recruiting No outcome recorded
Phase 3 NCT06253715 Jan 2025 → Sep 2027 expected lymph node tuberculosis, pulmonary tuberculosis Johns Hopkins University Recruiting No outcome recorded
Phase 3 NCT06191692 Nov 2024 → Dec 2025 latent tuberculosis infection Freundeskreis Für Internationale Tuberkulosehilfe e.V Withdrawn No outcome recorded
Phase 3 NCT05330884 Jul 2024 → Jun 2027 tuberculosis Tuberculosis Research Centre, India Suspended No outcome recorded
Phase 3 NCT05994742 Jul 2024 → Aug 2026 overdue HIV infectious disease, protein-energy malnutrition Queen Mary University of London Active not recruiting No outcome recorded
Phase 3 NCT05917340 Mar 2024 → Sep 2027 expected meningeal tuberculosis Indian Council of Medical Research Not yet recruiting No outcome recorded
Phase 3 NCT06727864 Jan 2024 → Dec 2027 expected pulmonary tuberculosis Kaohsiung Veterans General Hospital. Recruiting No outcome recorded
Phase 3 NCT05454345 Oct 2022 → Jun 2025 pulmonary tuberculosis First Affiliated Hospital of Zhejiang University Unknown No outcome recorded
Phase 3 NCT04600167 Jun 2022 → Dec 2025 diabetes mellitus, tuberculosis Dr. Nyanda Elias Ntinginya Unknown No outcome recorded
Phase 427 trials · 2 met primary · 5 missed
Phase 4 NCT06153069 Nov 2025 → Nov 2027 expected tuberculosis Huashan Hospital Recruiting No outcome recorded
Phase 4 NCT05118490 Jul 2023 → Jul 2025 overdue AIDS-related disorder, tuberculosis The Aurum Institute NPC Active not recruiting No outcome recorded
Phase 4 NCT05411744 Jul 2022 → Jan 2026 overdue end stage renal failure, latent tuberculosis infection Rutgers, The State University of New Jersey Active not recruiting No outcome recorded
Phase 4 NCT04703075 Mar 2022 → Jun 2024 tuberculosis Johns Hopkins University Completed Missed primary
Phase 4 NCT04830462 Apr 2021 → May 2023 latent tuberculosis infection, type 2 diabetes mellitus Herlev and Gentofte Hospital Completed No outcome recorded
Phase 4 NCT03266991 Oct 2017 → Feb 2023 — Aarhus University Hospital Terminated No outcome recorded Stop: Enrollment
Phase 4 NCT03028129 Sep 2017 → Aug 2019 pulmonary tuberculosis Federal University of Mato Grosso Terminated No outcome recorded
Phase 4 NCT03237182 Jun 2017 → Dec 2022 multidrug-resistant tuberculosis Centre for the AIDS Programme of Research in South Africa Terminated No outcome recorded
Phase 4 NCT03302299 Apr 2017 → Apr 2021 HIV infectious disease, alcohol abuse, tuberculosis University of California, San Francisco Completed No outcome recorded
Phase 4 NCT02901288 Aug 2016 → Dec 2018 pulmonary tuberculosis Beijing Chest Hospital Unknown No outcome recorded
Phase not applicable19 trials · 1 met primary · 1 missed
— NCT07608172 May 2026 → Jun 2028 expected pulmonary tuberculosis Shanghai Public Health Clinical Center Not yet recruiting No outcome recorded
— NCT07086820 Oct 2025 → May 2028 expected latent tuberculosis infection Pontificia Universidad Catolica de Chile Recruiting No outcome recorded
— NCT06512831 Jun 2023 → Feb 2024 isoniazid toxicity, tuberculosis West China Hospital Completed No outcome recorded
— NCT05249699 Apr 2022 → Jul 2023 disease related to solid organ transplantation, isoniazid toxicity, tuberculosis West China Hospital Unknown No outcome recorded
— NCT03787940 Mar 2019 → Dec 2021 meningeal tuberculosis Beijing Chest Hospital Unknown No outcome recorded
— NCT03900858 Dec 2018 → Jan 2022 silicotuberculosis Huashan Hospital Unknown No outcome recorded
— NCT03665402 May → Dec 2018 drug-induced liver injury, tuberculosis Seoul National University Hospital Completed No outcome recorded
— NCT03089983 Aug 2017 → Apr 2024 HIV infectious disease, hepatitis, opiate dependence, tuberculosis Yale University Completed Missed primary
— NCT01926379 Jul 2013 → Feb 2016 HIV infectious disease, tuberculosis Columbia University Completed No outcome recorded
— NCT01550705 Mar 2012 → Dec 2015 X-linked erythropoietic protoporphyria University of Utah Terminated No outcome recorded
Comparator or background therapy103 trials
Phase 0 NCT02099240 Comparator Mar 2014 → Nov 2018 osteomyelitis University of Louisville Terminated No outcome recorded Stop: Enrollment
Phase 1 NCT07058090 Comparator Jul → Dec 2025 overdue drug-induced liver injury, tuberculosis Liaquat National Hospital & Medical College Not yet recruiting No outcome recorded
Phase 1 NCT05592223 Comparator Dec 2022 → Aug 2023 tuberculosis Fred Hutchinson Cancer Center Completed No outcome recorded
Phase 1 NCT04424264 Background Dec 2019 → Oct 2020 HIV infectious disease, tuberculosis Professor Francois Venter Completed No outcome recorded
Phase 1 NCT02832778 Background Nov 2016 → Jan 2018 HIV infectious disease St Stephens Aids Trust Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-11-19 Global Alliance for TB Drug Development Results Phase 2 Clinical Trial Results Show Potential to Shorten TB Treatment Time tballiance.org ↗
The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential to shorten treatment time for active TB.
2014-09-07 Global Alliance for TB Drug Development Results Results of Phase 3 Clinical Trial of New Tuberculosis Drug Regimen Published in New England Journal of Medicine tballiance.org ↗
The study found that, while the experimental regimens initially killed more TB bacteria than the standard regimen, patients receiving those shortened regimens were more likely to relapse than those taking the standard treatment.

All press releases naming this drug 2 releases

DateIssuerRelease

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 227 sources stand behind the page.

FieldValueCited text
Known as Isoniazid “empiric initiation of the enhanced spectrum antimicrobial therapy regimen (rifampin, isoniazid, linezolid, and levofloxacin) for 14 days plus standard care which includes...” NCT07332325 ↗
223

“INTERVENTIONS: Patients were randomized to receive daily treatment with 4 drugs (rifampicin, isoniazid, pyrazinamide, ethambutol) given as an FDC (n = 798 patients) or...” PMID 21486974 ↗ Apr 2011

“This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O), 0.4g of pyrazinamide (C5H5N3O), and 0.275g of ethambutol...” NCT06224036 ↗

“Increased doses of rifampicin (R) to 35±5 mg/kg daily and isoniazid (H) 10±2 mg/kg daily together with standard-dose of pyrazinamide (Z) 20-30 mg/kg daily + ethambutol (E)...” NCT04738812 ↗

“FDC intensive phase containing 150 mg of rifampicin, 75 mg of isoniazid not 300mg, 400 mg of pyrazinamide, and 275 mg of ethambutol, while FDC continuation phase containing...” NCT05005637 ↗

“The standard six-month regimen is eight weeks of daily treatment with isoniazid, rifampin, ethambutol, and pyrazinamide followed by sixteen weeks of isoniazid and rifampin.” NCT03561753 ↗

“This study aimed to quantify the influence of food on the pharmacokinetics of isoniazid, rifampicin, ethambutol and pyrazinamide in TB patients starting anti-TB treatment.” PMID 26661397 ↗ Dec 2015

“SOC plus 6 months of tuberculosis treatment (isoniazid, rifampicin, pyrazinamide, and ethambutol for 2 months, plus isoniazid and rifampicin for 4 subsequent months)” PMID 42468541 ↗ Jul 2026

“provision of tuberculin skin tests, and use of isoniazid preventive therapy in Brazilian HIV clinics significantly reduced incident tuberculosis and death” PMID 23954450 ↗ Aug 2013

“RIFATER © (Isoniazid + Rifampicin + Pyrazinamide) + Ethambutol (13.5-20 mg / kg / day) for 2 months then RIFINAH © (Isoniazid + Rifampicin) for 4 months” NCT04117698 ↗

“using regimens containing isoniazid (INH \[H\]), rifampin (RIF \[R\]), pyrazinamide (PZA \[Z\]), moxifloxacin (MXF \[M\]), and ethambutol (EMB \[E\]).” NCT02371681 ↗

Show 213 more sources

Known as Generic name: Isoniazid. “Generic name: Isoniazid.” NCT01761201 ↗
Known as INH “This study is a phase I, single-center, open label, randomized controlled clinical trial assessing the effect of pre-clearance of latent Mycobacterium tuberculosis (MTB) by...” NCT01119521 ↗
38

“To evaluate and compare the safety and effectiveness of a one-year course of isoniazid (INH) versus a two-month course of rifampin plus pyrazinamide for the prevention of...” NCT00000638 ↗

“Standard of care involves Isoniazid Prevention Therapy (IPT) - the administration of Isoniazid (INH) to individuals with latent infection with M. tuberculosis in order to...” NCT01926379 ↗

“Patients will be screened to confirm TBM diagnosis, will receive 8 weeks of study treatment, and then will receive isoniazid (INH)/rifampicin for an additional 40 weeks, to...” NCT02958709 ↗

“Many people living with human immunodeficiency virus (PLWH) require TB treatment with isoniazid (INH) and rifampicin (RIF), which affect cytochrome P450 and antiretroviral exposure.” PMID 30084943 ↗ Jan 2019

“Isoniazid (INH) is a first-line antituberculous medication discovered in 1952 and used in the prevention (alone) and treatment (in combination) of tuberculosis.” NCT00816426 ↗

“Randomized controlled trial (RCT) of isoniazid (INH) vs. no INH to prevent Mycobacterium tuberculosis infection in HIV-exposed uninfected (HEU) infants.” NCT02613169 ↗

“compared with an isoniazid (INH) control arm in patients with newly-diagnosed sputum smear-positive pulmonary tuberculosis (TB).” NCT00396084 ↗

“To evaluate the safety and effectiveness of a 6-month course of isoniazid ( INH ) in the prevention of clinical tuberculosis.” NCT00000959 ↗

“Isoniazid prophylaxis:300 mg of INH once a day before breakfast for six months, starting one month after study inclusion” NCT00495651 ↗

“The Arkansas colorimetric method monitors adherence to isoniazid (INH) by the detection of INH metabolites in urine.” PMID 24903787 ↗ May 2014

Show 28 more sources

Known as Isoniazid (H) “Isoniazid (H)” NCT07656012 ↗
Known as Isoniazid I INH “Isoniazid I INH” NCT03900858 ↗
Known as isoniazid tablets “isoniazid tablets” NCT02331823 ↗
Known as isonicotinic acid hydrazine “This study is a phase I, single-center, open label, randomized controlled clinical trial assessing the effect of pre-clearance of latent Mycobacterium tuberculosis (MTB) by...” NCT01119521 ↗
Known as Rifinah “Isoniazid (Rifinah)” NCT00728546 ↗
Known as RIMIFON “of Isoniazid (RIMIFON®)” NCT05534750 ↗
Action Inhibit “Its primary action is to inhibit the synthesis of long-chain mycolic acids” NCT02409290 ↗
Modality Small molecule “This product is a compound preparation, consisting of 0.15g of rifampicin (C43H58N4O12), 0.075g of isoniazid (C6H7N3O)” NCT06224036 ↗
Route Oral “self-administer oral isoniazid” NCT00004740 ↗