ethambutol
Trade name: myambutol
Small moleculeapproved
Approved
Nov 6, 1967
ETHAMBUTOL HYDROCHLORIDE is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus Mycobacterium, including M. tuberculosis. Ethambutol inhibits RNA synthesis and decreases tubercle bacilli replication. Nearly all strains of M. tuberculosis and M. kansasii as well as a number of strains of MAC are sensitive to ethambutol. Ethambutol inhibits arabinosyl transferases which is involved in cell wall biosynthesis. By inhibiting this enzyme, the bacterial cell wall complex production is inhibited. This leads to an increase in cell wall permeability. ETHAMBUTOL HCl is indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. — NCATS
Clinical trial activity
112 trials · 236 clinical orgs · 5 marketing orgs
Phase 1
12
Phase 2
75
Phase 3
36
Phase 4
13
Earliest trial started Jan 1, 1991 (NCT00004689)
Timeline
1960s
- Nov 6, 1967
STI Pharma, LLC — Earliest FDA Approval
- Nov 6, 1967
STI Pharma, LLC — NDA Secondary Org
- Nov 6, 1967
STI Pharma, LLC — NDA Organization
1990s
- Jan 1, 1991
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 3 Sponsor(trial)
- Nov 30, 1999
Akorn, Inc. — Marketing Organization
- Nov 30, 1999
Epic Pharma Llc — Marketing Organization
2000s
- Jan 1, 2000
Earliest Phase 1 Sponsor(trial)
- Nov 26, 2001
Barr Laboratories — Marketing Organization
- Jun 17, 2009
Lupin — Marketing Organization
Indications
Approved for
Studied for
- Acquired Immunodeficiency Syndrome · Phase 4
- Bacterial Infections · Phase 4
- Chemical and Drug Induced Liver Injury · Phase 1
- Extensively Drug-Resistant Tuberculosis · Phase 3
- Healthy Volunteers · Phase 1
- HIV · Phase 3
- HIV Infections · Phase 4
- Lung Diseases · Phase 4
- Mycobacterium avium Complex · Phase 3
- Mycobacterium avium-intracellulare Infection · Phase 4
- Mycobacterium Infections, Nontuberculous · Phase 4
- Mycobacterium tuberculosis · Phase 3
- Obesity · Phase 4
- Respiratory Tract Infections · Phase 4
- Sarcoidosis · Phase 2
- Sarcoidosis, Pulmonary · Phase 1
- Tuberculosis · Phase 4
- Tuberculosis, Lymph Node · Phase 3
- Tuberculosis, Meningeal · Phase 3
- Tuberculosis, Multidrug-Resistant · Phase 3
- Tuberculosis, Pulmonary · Phase 4
- Tuberculosis, Spinal · Phase 4
- Uveitis, Anterior · Phase 3
Mechanism of action
- Arabinosyltransferase AINHIBITOR
embA inhibitor
Approval history
- approvedPriority reviewNov 6, 1967
Chemistry & pharmacology
Loading structure…
SMILES
CC[C@@H](CO)NCCN[C@@H](CC)CO.Cl.Cl- Mol. weight
- 277.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL3140361 ↗
- WikipediaEthambutol ↗
- NCATS8G167061QZ ↗
- ChEMBLCHEMBL44884 ↗
- ChEMBLCHEMBL1628240 ↗
Also known as
- (+)-2,2'-(ethylenediimino)di-1-butanol
- (+)-2,2'-(ethylenediimino)di-1-butanol
- (2s,7s)-2,7-diethyl-3,6-diazaoctane-1,8-diol
- (2s,7s)-2,7-diethyl-3,6-diazaoctane-1,8-diol
- cl-40881
- cl-40881
- diambutol
- emb
- emb
- etambutol
- etambutol
- etambutol
- etambutolo
- etambutolo
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- ethambutol
- (+)-ethambutol
- (+)-ethambutol
- ethambutol dihydrochloride
- ethambutol dihydrochloride
- ethambutol hcl
- ethambutol hcl
- ethambutol hcl
- ethambutol hydrochloride
- ethambutol hydrochloride
- ethambutol hydrochloride
- ethambutol hydrochloride
- ethambutol hydrochloride
- ethambutolum
- ethambutolum
- myambutol
- myambutol
- myambutol
- myambutol
- mynah 200
- mynah 250
- mynah 300
- mynah 365
- (+)-n,n'-bis(1-(hydroxymethyl)propyl)ethylenediamine
- (+)-n,n'-bis(1-(hydroxymethyl)propyl)ethylenediamine
- (+)-s,s-ethambutol
- (+)-s,s-ethambutol
- (s,s)-ethambutol
- (s,s)-ethambutol
- (s,s)-ethambutol
- s,s-ethambutol
- s,s-ethambutol
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07303699 | Phase 2 | Jan 3, 2026 | Obafemi Awolowo University, Open Philanthropy Project |
| NCT07163143 | Phase 3 | Nov 30, 2025 | Aurum Institute, Foundation for Innovative New Diagnostics, Switzerland, KTH Royal Institute of Technology, University of London, Wits Health Consortium (Pty) Ltd |
| NCT07073638 | Phase 2 | Oct 6, 2025 | 30 Technology |
| NCT07129629 | Phase 2 | Aug 20, 2025 | Fudan University, Huazhong University of Science and Technology |
| NCT07058090 | Phase 1 | Jul 31, 2025 | Liaquat University of Medical & Health Sciences |
| NCT07076225 | Phase 3 | Jul 25, 2025 | Capital Medical University, Fudan University, Huazhong University of Science and Technology, Shenzhen Third People's Hospital, Sichuan University, Tsinghua University |
| NCT07213765 | Phase 4 | Jul 24, 2025 | Anhui Medical University, Capital Medical University, Guangzhou Chest Hospital., Huazhong University of Science and Technology, Jiangxi Chest Hospital, MicuRx, Peking University |
| NCT07084402 | Phase 4 | Jul 24, 2025 | Capital Medical University, MicuRx, Peking University |
| NCT06905522 | Phase 3 | Apr 15, 2025 | Shenyang Tenth People's Hospital, Shenzhen Third People's Hospital, Zhejiang University |
| NCT06917495 | Phase 2 | Apr 5, 2025 | Shandong University |
| NCT06253715 | Phase 3 | Nov 27, 2024 | Johns Hopkins University, United States Agency for International Development |
| NCT06192160 | Phase 2 | Oct 15, 2024 | National Institute of Allergy and Infectious Diseases (NIAID), TB Alliance, University of California, Berkeley, Vanderbilt University |
| NCT05917340 | Phase 3 | Mar 31, 2024 | All India Institute of Medical Sciences, Christian Medical College, Vellore, India, Indian Council of Medical Research, Jawaharlal Institute of Postgraduate Medical Education and Research, Madras Medical College, National Institute for Research in Tuberculosis, Chennai, India |
| NCT06114628 | Phase 2 | Dec 8, 2023 | German Center for Infection Research, GlaxoSmithKline, Government of France, Janssen Pharmaceutica NV, KNCV Tuberculosis Foundation, Otsuka, Radboud University, Research Center Borstel, TASK Applied Science, TB Alliance, Tuberculosis Network European Trialsgroup, University of California, San Francisco, University of Cambridge, University of Hamburg, University of Liverpool, University of London, University of Milan, University of Oxford, University of Porto, University of St Andrews, Uppsala University, Vita-Salute University of Milano. Italy |
| NCT06081361 | Phase 3 | Nov 1, 2023 | Capital Medical University |
| NCT06058299 | Phase 2 | Oct 31, 2023 | Global Alliance for TB Drug Development, TB Alliance |
| NCT06224036 | Phase 2 | Oct 31, 2023 | Capital Medical University, Huazhong University of Science and Technology, Sichuan University |
| NCT06041919 | Phase 2 | Sep 27, 2023 | 30 Technology |
| NCT05966688 | Phase 1 | Aug 4, 2023 | Spero Therapeutics |
| NCT05686356 | Phase 2/Phase 3 (Phase 3) | Jul 28, 2023 | Aurum Institute, Global Alliance for TB Drug Development, Government of Mozambique, Katholieke Universiteit Leuven, Ludwig Maximilians University, National Institute for Medical Research, Tanzania, Sequella, Inc., Stellenbosch University, Wits Health Consortium (Pty) Ltd |
Showing 20 of 112 trials
Page 1 / 6
Organizations
Research & Development (236)
236 organizations
Page 1 / 12
Marketing (6)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Akorn, Inc. | For profit | MKTG | Nov 30, 1999 |
| Barr Laboratories | For profit | MKTG | Nov 26, 2001 |
| Epic Pharma Llc | For profit | MKTG | Nov 30, 1999 |
| Lupin | For profit | MKTG | Jun 17, 2009 |
| STI Pharma, LLC | For profit | NDA2 | Nov 6, 1967 |
| STI Pharma, LLC | For profit | NDA | Nov 6, 1967 |