Ethambutol

Generic Name: Ethambutol

Brand Names: Etibi, Myambutol

Drug Type: Small Molecule

Chemical Formula: C_₁₀H_₂₄N_₂O_₂

CAS Number: 74-55-5

Unique Ingredient Identifier: 8G167061QZ

Background: Ethambutol is a bacteriostatic agent indicated alongside medications such as isoniazid, rifampin, and pyrazinamide in the treatment of pulmonary tuberculosis. Ethambutol was first described in the literature in 1961. It was developed out of a need for therapies active against isoniazid resistant strains of Mycobacterium tuberculosis.

Ethambutol was granted FDA approval on 6 November 1967.

Indication: Ethambutol is indicated in combination with other anti-tuberculosis drugs in the treatment of pulmonary tuberculosis. Ethambutol is commonly used in combination with isoniazid, rifampin, and pyrazinamide.

Associated Conditions: Mycobacterium Avium Intracellulare Complex (MAC), Mycobacterium Infections, Pulmonary Tuberculosis (TB)

Clinical Trials

Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis

Phase 2

Suspended

Conditions: Tuberculous Meningitis

Interventions: Drug: Rifampicin (RIF)
Drug: ethambutol (EMB)
Drug: Isoniazid (INH)
Drug: Linezolid (LZD)
Drug: Rifampicin
Drug: Pyrazinamide (PZA)
Drug: Isoniazid

First Posted Date: 2022-05-20

Last Posted Date: 2025-04-23

Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Target Recruit Count: 330

Registration Number: NCT05383742

Locations: 🇵🇪
Socios en Salud Sucursal Peru CRS (Site ID: 31985), Lima, Peru
🇵🇪
Barranco CRS (Site ID:11301), Lima, Peru
🇵🇭
TB HIV Innovations and Clinical Research Foundation Corp (Site ID: 31981), Cavite, Philippines

and more 15 locations

Four Months Moxifloxacin Containing Daily Regimen Study Among New Pulmonary Tuberculosis Patients

Active, not recruiting

Conditions: Tuberculosis, Pulmonary

Interventions: Drug: Isoniazid
Drug: Rifampicin
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Moxifloxacin

First Posted Date: 2021-09-16

Last Posted Date: 2024-01-05

Lead Sponsor: Tuberculosis Research Centre, India

Target Recruit Count: 550

Registration Number: NCT05047055

Locations: 🇮🇳
National Institute for Research in Tuberculosis, Chennai, Tamilnadu, India

Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)

Phase 2

Active, not recruiting

Conditions: Tuberculosis
Pulmonary Tuberculosis
HIV Coinfection

Interventions: Drug: Isoniazid
Drug: Rifampicin
Drug: Ethambutol
Drug: Pyrazinamide
Drug: Metformin hydrochoride

First Posted Date: 2021-06-18

Last Posted Date: 2025-04-23

Lead Sponsor: University of Massachusetts, Worcester

Target Recruit Count: 112

Registration Number: NCT04930744

Locations: 🇿🇦
Tembisa Clinical Research Centre-The Aurum Institute, Johannesburg, Gauteng, South Africa
🇿🇦
Isango Lethemba TB Research Unit, Port Elizabeth, South Africa

Hypertonic Saline for MAC

Phase 4

Recruiting

Conditions: Nontuberculous Mycobacterial Lung Disease
Nontuberculous Mycobacterium Infection

Interventions: Drug: Hypertonic saline
Drug: Azithromycin
Drug: Ethambutol
Drug: Rifampin

First Posted Date: 2021-06-10

Last Posted Date: 2023-12-19

Lead Sponsor: Oregon Health and Science University

Target Recruit Count: 50

Registration Number: NCT04921943

Locations: 🇺🇸
NYU Langone Health, New York, New York, United States
🇨🇦
University Health Network, Toronto, Ontario, Canada
🇺🇸
Oregon Health & Science University, Portland, Oregon, United States

Study to Evaluate ALIS (Amikacin Liposome Inhalation Suspension) in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Phase 3

Active, not recruiting

Conditions: Mycobacterium Infections, Nontuberculous

Interventions: Drug: ALIS
Drug: Azithromycin
Drug: Ethambutol
Drug: ELC (matching placebo for ALIS)

First Posted Date: 2020-12-21

Last Posted Date: 2025-04-23

Lead Sponsor: Insmed Incorporated

Target Recruit Count: 425

Registration Number: NCT04677569

Locations: 🇬🇧
GBR004, Liverpool, United Kingdom
🇬🇧
GBR007, London, United Kingdom
🇬🇧
GBR010, London, United Kingdom

and more 255 locations

Validation of Patient Reported Outcome Measures in Participants With Nontuberculous Mycobacterial Lung Infection Caused by Mycobacterium Avium Complex

Phase 3

Completed

Conditions: Mycobacterium Infections, Nontuberculous

Interventions: Drug: ALIS
Drug: Azithromycin
Drug: ELC
Drug: Ethambutol

First Posted Date: 2020-12-21

Last Posted Date: 2024-06-28

Lead Sponsor: Insmed Incorporated

Target Recruit Count: 99

Registration Number: NCT04677543

Locations: 🇪🇸
ESP002, Barcelona, Spain
🇪🇸
ESP004, Madrid, Spain
🇪🇸
ESP003, Barcelona, Spain

and more 59 locations

A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Phase 2

Active, not recruiting

Conditions: Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)

Interventions: Drug: Bedaquiline
Drug: Clarithromycin
Drug: Ethambutol
Drug: Rifampicin
Drug: Rifabutin

First Posted Date: 2020-11-16

Last Posted Date: 2025-05-04

Lead Sponsor: Janssen Pharmaceutical K.K.

Target Recruit Count: 129

Registration Number: NCT04630145

Locations: 🇯🇵
Shimonoseki City Hospital, Yamaguchi, Japan
🇯🇵
National Hospital Organization Himeji Medical Center, Himeji, Japan
🇯🇵
Kinki-chuo Chest Medical Center, Sakai, Japan

and more 52 locations

Rosuvastatin Evaluation as a Tuberculosis Treatment Adjunct

Phase 2

Conditions: Pulmonary Tuberculosis

Interventions: Drug: Rifampicin
Drug: Rosuvastatin 10mg
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Ethambutol

First Posted Date: 2020-08-07

Last Posted Date: 2020-08-07

Lead Sponsor: National University Hospital, Singapore

Target Recruit Count: 154

Registration Number: NCT04504851

Locations: 🇺🇬
Joint Clinical Research Centre, Kampala, Uganda
🇻🇳
Vietnam Military Medical University, Hanoi, Vietnam
🇵🇭
Tropical Disease Foundation, Makati City, Philippines

and more 3 locations

Treatment Shortening of Drug-Sensitive Pulmonary Tuberculosis Using High Dose Rifampicin (Hi-DoRi-3)

Phase 3

Not yet recruiting

Conditions: Tuberculosis, Pulmonary

Interventions: Drug: High-dose rifampicin
Drug: Isoniazid
Drug: Pyrazinamide
Drug: Ethambutol
Drug: Rifampicin

First Posted Date: 2020-07-24

Last Posted Date: 2020-07-24

Lead Sponsor: Seoul National University Hospital

Target Recruit Count: 926

Registration Number: NCT04485156

Locations: 🇰🇷
Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine, Seoul, Korea, Republic of

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Phase 2

Recruiting

Conditions: Pulmonary Disease Due to Mycobacteria (Diagnosis)

Interventions: Drug: Amikacin
Drug: Tigecycline
Drug: Imipenem
Drug: Cefoxitin
Drug: Linezolid
Drug: Azithromycin
Drug: co-trimoxazole
Drug: Clarithromycin
Drug: Clofazimine
Drug: Doxycycline
Drug: Moxifloxacin
Drug: Ethambutol
Drug: Bedaquiline
Drug: Rifabutin

First Posted Date: 2020-03-17

Last Posted Date: 2024-12-11

Lead Sponsor: The University of Queensland

Target Recruit Count: 300

Registration Number: NCT04310930

Locations: 🇦🇺
St George Hospital, Kogarah, New South Wales, Australia
🇦🇺
Austin Hospital, Heidelberg, Victoria, Australia
🇦🇺
Royal Melbourne Hospital, Parkville, Victoria, Australia

and more 47 locations

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