Drugs / Ethambutol
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Ethambutol

Small molecule

Developed for
pulmonary tuberculosis · HIV infectious disease · tuberculosis · Mycobacterium avium complex disease · multidrug-resistant tuberculosis · pulmonary non-tuberculous mycobacterial infection · anterior uveitis · meningeal tuberculosis
+7 more · ocular tuberculosis · sarcoidosis · tuberculosis, spinal · drug-resistant tuberculosis · lymph node tuberculosis · pulmonary sarcoidosis · rifampicin-resistant tuberculosis
Investigated by
National Institute of Allergy and Infectious Diseases (NIAID) · European and Developing Countries Clinical Trials Partnership (EDCTP) · Tuberculosis Research Centre, India · University College, London · Beijing Chest Hospital · Centers for Disease Control and Prevention
+135 more · Huashan Hospital · Michael Hoelscher · Radboud University Medical Center · ANRS, Emerging Infectious Diseases · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections · Cystic Fibrosis Foundation · German Federal Ministry of Education and Research · Global Alliance for TB Drug Development · Makerere University · Medical Research Council · Shanghai Pulmonary Hospital, Shanghai, China · The University of Queensland · United States Agency for International Development (USAID) · Abbott · Anderson Clinical Research · Anhui Chest Hospital · Assistance Publique - Hôpitaux de Paris · Aurum Institute · Australian Government Department of Health and Ageing · B. J. Medical College, Pune · Barcelona Institute for Global Health · Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma · Beijing Municipal Science & Technology Commission · Beijing Research Institute for Tuberculosis Control · Biomedical Research and Training Institute, Zimbabwe · Centre Hospitalier Cocody · Centre for Tuberculosis Control of Guangdong Province · Centre for the AIDS Programme of Research in South Africa · Chang Gung Memorial Hospital · Changchun Infectious Disease Hospital · Chengdu Public Health Clinical Center · Chest of Hospital of Xinjiang Uygur Autonomous Region of the PRC · Children's Hospital Foundation · Chongqing Infectious Disease Medical Center · Colorado Clinical & Translational Sciences Institute · E-DA Hospital · Eduardo Mondlane University · Erasmus Medical Center · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · European Union · Faculty of Medicine, University of Indonesia · Far Eastern Memorial Hospital · First Affiliated Hospital of Xinjiang Medical University · Foundation for Innovative New Diagnostics, Switzerland · French National Institute of Health and Medical Research · Gates Medical Research Institute · GlaxoSmithKline · Griffith University · Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control · Harbin Chest Hospital · Heilongjiang Province center for tuberculosis Control and Prevention · Hoechst Marion Roussel · Hospital Universitario 12 de Octubre · Hubei Provincial Center for Disease Control and Prevention · Hunan Institute For Tuberculosis Control · IUATLD, Inc · Infectious Disease Prevention Hospital in Heilongjiang Province · Innovative Medicines Initiative · Innoviva Specialty Therapeutics · Institute of Tropical Medicine, Belgium · International Union Against Tuberculosis and Lung Diseases · Janssen Pharmaceuticals · Jiangsu Province Centers for Disease Control and Prevention · Johns Hopkins University · KTH Royal Institute of Technology · Kaifeng Central Hospital · Kamuzu Central Hospital · Kaohsiung Medical University · Kaohsiung Veterans General Hospital. · LigaChem Biosciences, Inc. · Liverpool School of Tropical Medicine · London School of Hygiene and Tropical Medicine · Malawi-Liverpool-Wellcome Trust Clinical Research Programme · Manhiça Health Research Centre · all 141 on the full record

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) MYAMBUTOL — 1967-11-06 fda.gov ↗

Trials 54

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05966688 Aug 2023 → Jan 2024 — Spero Therapeutics Completed No outcome recorded
Phase 1 NCT02457208 Jul 2015 → Jan 2018 tuberculosis University of Oxford Completed No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT04044001 Nov 2019 → Mar 2022 pulmonary tuberculosis Michael Hoelscher Completed No outcome recorded
Phase 1/2 NCT02958709 Feb 2017 → Nov 2020 meningeal tuberculosis Johns Hopkins University Completed No outcome recorded
Phase 1/2 NCT01074554 Feb 2010 → Feb 2011 sarcoidosis Vanderbilt University Completed No outcome recorded
Phase 215 trials · 2 met primary · 1 missed
Phase 2 NCT07485010 Apr 2027 → Apr 2031 expected pulmonary non-tuberculous mycobacterial infection The University of Queensland Not yet recruiting No outcome recorded
Phase 2 NCT06748937 Mar 2025 → Mar 2026 overdue pulmonary tuberculosis TASK Applied Science 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 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 NCT02821832 Jun 2017 → Oct 2021 pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT02371681 Feb 2015 → Sep 2017 pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 2 NCT01785186 Apr 2013 → Sep 2014 pulmonary tuberculosis Michael Hoelscher Completed Met primary
Phase 2/34 trials · 1 missed
Phase 2/3 NCT05401071 Jan 2023 → Oct 2024 overdue pulmonary tuberculosis Huashan Hospital Recruiting No outcome recorded
Phase 2/3 NCT04310930 Mar 2020 → Jun 2029 expected pulmonary non-tuberculous mycobacterial infection The University of Queensland 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 NCT03474198 Mar 2018 → Jan 2022 pulmonary tuberculosis University College, London Completed Mixed
Phase 312 trials · 2 met primary · 3 missed
Phase 3 NCT07163143 Nov 2025 → Nov 2028 expected tuberculosis University College, London 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 NCT04738812 Apr 2022 → Nov 2025 HIV infectious disease, immunodeficiency disease, tuberculosis ANRS, Emerging Infectious Diseases Completed No outcome recorded
Phase 3 NCT04117698 Nov 2019 → May 2023 anterior uveitis Assistance Publique - Hôpitaux de Paris Unknown No outcome recorded
Phase 3 NCT02563327 May 2016 → Aug 2021 tuberculosis Centers for Disease Control and Prevention Completed No outcome recorded
Phase 3 NCT02409290 Mar 2016 → May 2022 multidrug-resistant tuberculosis IUATLD, Inc Completed Met primary
Phase 3 NCT01154959 Feb 2010 → Dec 2015 pulmonary tuberculosis Tuberculosis Research Centre, India Completed No outcome recorded
Phase 3 NCT00933790 Sep 2009 → Dec 2016 HIV infectious disease, pulmonary tuberculosis Tuberculosis Research Centre, India Completed Met primary
Phase 3 NCT00864383 Jan 2008 → Oct 2013 pulmonary tuberculosis Global Alliance for TB Drug Development Completed Missed primary
Phase 3 NCT00130247 Apr 2002 → Sep 2008 tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed Missed primary
Phase 412 trials · 3 missed
Phase 4 NCT06153069 Nov 2025 → Nov 2027 expected tuberculosis Huashan Hospital Recruiting No outcome recorded
Phase 4 NCT03830671 Mar 2019 → Jun 2022 multidrug-resistant tuberculosis Beijing Chest Hospital Completed 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 NCT02901288 Aug 2016 → Dec 2018 pulmonary tuberculosis Beijing Chest Hospital Unknown No outcome recorded
Phase 4 NCT02477852 Apr 2015 → Dec 2017 tuberculosis, spinal Beijing Chest Hospital Unknown No outcome recorded
Phase 4 NCT02057796 Sep 2014 → Apr 2018 HIV infectious disease ANRS, Emerging Infectious Diseases Completed Missed primary
Phase 4 NCT02331823 Jun 2013 → Dec 2015 pulmonary tuberculosis Shanghai Pulmonary Hospital, Shanghai, China Unknown No outcome recorded
Phase 4 NCT01782950 Feb 2013 → Mar 2016 tuberculosis Makerere University Unknown No outcome recorded
Phase 4 NCT01380080 Oct 2011 → Jan 2015 HIV infectious disease Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections Completed Missed primary
Phase 4 NCT01048697 Jan → Dec 2010 obesity disorder, tuberculosis Texas Tech University Health Sciences Center Completed No outcome recorded
Phase not applicable6 trials
— NCT03604848 Aug 2018 → Aug 2024 multidrug-resistant tuberculosis Huashan Hospital Unknown No outcome recorded
— NCT02372383 Oct 2014 → Jun 2016 cystic fibrosis University of Colorado, Denver Completed No outcome recorded
— NCT00023374 Aug 2000 → Dec 2006 tuberculosis Centers for Disease Control and Prevention Completed No outcome recorded
— NCT00002331 Jan 1994 → Mar 1995 HIV infectious disease, Mycobacterium avium complex disease Abbott Completed No outcome recorded
— NCT00000950 ? → May 2002 HIV infectious disease, tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
— NCT00000796 ? → Oct 1998 HIV infectious disease, pulmonary tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Comparator or background therapy87 trials
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 NCT01169038 Comparator Jul → Nov 2010 pulmonary sarcoidosis Vanderbilt University Completed No outcome recorded
Phase 1 NCT00004736 Background — HIV infectious disease, tuberculosis National Institute of Allergy and Infectious Diseases (NIAID) Completed No outcome recorded
Phase 1/2 NCT03678688 Comparator Oct 2018 → Feb 2022 pulmonary tuberculosis Otsuka Pharmaceutical Development & Commercialization, Inc. Completed Missed primary
Phase 2 NCT07656012 Background Oct 2026 → Sep 2030 expected tuberculosis University of Wisconsin, Madison Not yet recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 3

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.
2005-11-14 Sequella, Inc. Results Sequella Presentation at the 45th ICAAC Meeting, Washington, DC sequella.com ↗
This study demonstrated that the Sequella anti-TB compound called SQ109 improved outcome and shortened therapy duration when substituted for Ethambutol in combination with Isoniazid and Rifampin in the initial phase of TB treatment.

All press releases naming this drug 3 releases

DateIssuerRelease

Evidence & citations 30 cited values

Every value below carries the sentence it was read from. 144 sources stand behind the page.

FieldValueCited text
Known as Ethambutol “anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS],...” NCT02365623 ↗
135

“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

“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 candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗

“Current guidelines recommend a macrolide-based triple therapy consisting of a macrolide (azithromycin or clarithromycin), ethambutol, and a rifamycin (typically rifabutin).” NCT07585461 ↗

“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

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

“Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained” NCT02153528 ↗

“including rifampicin 10 mg/kg, isoniazid 5 mg/kg, ethambutol 15 - 20 mg/kg, ± pyrazinamide 25 mg/kg and pyridoxine 10-50 mg per day” NCT06446245 ↗

Show 125 more sources

Known as CL 40881 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Dadibutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Dexambutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as E-ethambutol “The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid” NCT03830671 ↗
Known as Ebutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as EMB “Arm 1 participants will receive high-dose rifampicin plus ethambutol (EMB) at standard doses for 8 weeks.” NCT02958709 ↗
5

“regimen of rifampin (RMP), pyrazinamide (PZA) and ethambutol (EMB)” PMID 24903795 ↗ May 2014

“ethambutol (EMB) 20 mg/kg” NCT05383742 ↗

“ethambutol (EMB \[E\])” NCT02371681 ↗

“ethambutol (EMB or E)” NCT02231229 ↗

“ethambutol [EB, EMB]” NCT02365623 ↗

Known as Etambutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Etapiam ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Ethambutol (E) “Ethambutol (E)” NCT07656012 ↗
Known as Ethambutol dihydrochloride ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Ethambutol hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as ETHAMBUTOL HYDROBROMIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as ethambutol hydrochloride “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 ↗
4

“Clarithromycin 500-1000 mg, plus ethambutol hydrochloride (HCl) 15 mg/kg orally once daily or” NCT04553406 ↗

NCT00001047 ↗

NCT00002140 ↗

NCT00002192 ↗

Known as ethambutol tablets “ethambutol tablets” NCT02331823 ↗
Known as Ethambutol=Myambutol “Ethambutol=Myambutol” NCT01074554 ↗
Known as Ethambutoli hydrochloridum ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Etibi ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Myambutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Mycobutol ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Mynah 200 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Mynah 250 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Mynah 300 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as Mynah 365 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗
Known as NSC-757022 ChEMBL registry synonym — accepted as the source's own label CHEMBL44884 ↗