Ethambutol
Ethambutol, Myambutol (ethambutol) is a small molecule pharmaceutical. Ethambutol was first approved as Myambutol on 1982-01-01. It is used to treat mycobacterium infections, nontuberculous mycobacterium infections, and tuberculosis in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
Trade Name
FDA
EMA
Ethambutol, Myambutol (discontinued: Ethambutol, Myambutol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ethambutol hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MYAMBUTOL | STI Pharma | N-016320 RX | 1982-01-01 | 2 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| ethambutol | ANDA | 2009-11-12 |
| ethambutol hydrochloride | ANDA | 2024-09-20 |
| myambutol | New Drug Application | 2012-01-05 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AK: Other drugs for treatment of tuberculosis in atc
— J04AK02: Ethambutol
— J04AM: Combinations of drugs for treatment of tuberculosis
— J04AM03: Ethambutol and isoniazid
— J04AM06: Rifampicin, pyrazinamide, ethambutol and isoniazid
— J04AM07: Rifampicin, ethambutol and isoniazid
HCPCS
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Clinical
Clinical Trials
169 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 11 | 67 | 36 | 16 | 22 | 137 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 5 | 38 | 19 | 5 | 8 | 66 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 10 | 13 | 3 | 5 | 30 |
| Mycobacterium infections | D009164 | — | A31.9 | — | 10 | 11 | 2 | 1 | 21 |
| Infections | D007239 | EFO_0000544 | — | — | 5 | 10 | 1 | 1 | 17 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | 8 | 8 | 2 | 1 | 17 |
| Communicable diseases | D003141 | — | — | — | 4 | 8 | 1 | 1 | 14 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 5 | 5 | 3 | 3 | 14 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | 1 | 4 | 3 | 3 | — | 9 |
| Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | 1 | 4 | 1 | — | 5 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningeal tuberculosis | D014390 | — | A17.0 | 1 | 8 | 2 | — | — | 9 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 2 | 8 | — | — | 9 |
| Meningitis | D008581 | HP_0001287 | G03 | — | 7 | 2 | — | — | 8 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 4 | 2 | — | — | 5 |
| Hiv | D006678 | — | — | — | 2 | 3 | — | — | 5 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | 1 | 1 | — | 1 | 3 |
| Immunologic deficiency syndromes | D007153 | HP_0002721 | D84.9 | — | — | 3 | — | — | 3 |
| Latent tuberculosis | D055985 | — | Z22.7 | 1 | 1 | 1 | — | 1 | 3 |
| Coinfection | D060085 | — | — | — | 1 | 1 | — | — | 2 |
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 1 | 2 | — | — | 2 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoidosis | D012507 | EFO_0000690 | D80-D89 | 2 | 2 | — | — | — | 3 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | 1 | — | — | — | 2 |
| Pharmacokinetics | D010599 | — | — | — | 1 | — | — | — | 1 |
| Pharmacological phenomena | D000069437 | — | — | — | 1 | — | — | — | 1 |
| Meningoencephalitis | D008590 | EFO_0007364 | A69.22 | — | 1 | — | — | — | 1 |
| Central nervous system tuberculosis | D020306 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
| Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | — | — | — | 1 |
| Obstructive lung diseases | D008173 | HP_0006536 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | — | — | — | — | 1 | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | — | — | — | 1 | 1 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | — | — | — | — | 1 | 1 |
| Body weight | D001835 | EFO_0004338 | — | — | — | — | — | 1 | 1 |
| Body weight changes | D001836 | — | — | — | — | — | — | 1 | 1 |
| Motor activity | D009043 | EFO_0003940 | — | — | — | — | — | 1 | 1 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | — | — | — | — | 1 | 1 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | — | — | — | — | 1 | 1 |
| Breast feeding | D001942 | — | — | — | — | — | — | 1 | 1 |
| Granulomatous mastitis | D058890 | — | N61.2 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ethambutol |
| INN | ethambutol |
| Description | Ethambutol is an ethylenediamine derivative that is ethane-1,2-diamine in which one hydrogen attached to each of the nitrogens is sutstituted by a 1-hydroxybutan-2-yl group (S,S-configuration). It is a bacteriostatic antimycobacterial drug, effective against Mycobacterium tuberculosis and some other mycobacteria. It is used (as the dihydrochloride salt) in combination with other antituberculous drugs in the treatment of pulmonary and extrapulmonary tuberculosis; resistant strains of M. tuberculosis are readily produced if ethambutol is used alone. It has a role as an antitubercular agent, an environmental contaminant and a xenobiotic. It is a member of ethanolamines and an ethylenediamine derivative. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC[C@@H](CO)NCCN[C@@H](CC)CO |
Identifiers
| PDB | — |
| CAS-ID | 74-55-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL44884 |
| ChEBI ID | 4877 |
| PubChem CID | 14052 |
| DrugBank | DB00330 |
| UNII ID | 8G167061QZ (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Estimated US medical usage
Ethambutol
Total medical expenditures per year (USD, in millions)
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Trends
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Safety
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Adverse Events
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8,164 adverse events reported
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