CLINICAL TRIALS PROFILE FOR MYAMBUTOL

All Clinical Trials for Myambutol

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002343 ↗	A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS	Completed	Pharmacia	Phase 4	1969-12-31	To optimize Mycobacterium avium Complex (MAC) prophylaxis in AIDS patients by measuring serum rifabutin levels and adjusting the dose accordingly. To combine rifabutin with ethambutol to examine the effect of combination therapy in preventing or delaying the incidence of MAC bacteremia in this patient population.
NCT00864383 ↗	Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis	Completed	Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma	Phase 3	2008-01-01	REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.
NCT00864383 ↗	Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis	Completed	European and Developing Countries Clinical Trials Partnership (EDCTP)	Phase 3	2008-01-01	REMoxTB is a study for the "Rapid Evaluation of Moxifloxacin in the treatment of sputum smear positive tuberculosis". REMoxTB aims to find and evaluate new drugs and regimens that shorten the duration of tuberculosis therapy. The purpose of REMoxTB is to evaluate the efficacy, safety and acceptability of two moxifloxacin-containing treatment combinations to determine whether substituting ethambutol with moxifloxacin in one combination, and/or substituting isoniazid with moxifloxacin in another combination, makes it possible to reduce the duration of treatment for TB.

Clinical Trial Conditions for Myambutol

Condition Name

Condition Name for Myambutol
Intervention	Trials
Pulmonary Tuberculosis	3
Tuberculosis	2
Mycobacterium Avium-Intracellulare Infection	1

Condition MeSH

Condition MeSH for Myambutol
Intervention	Trials
Tuberculosis	5
Mycobacterium avium-intracellulare Infection	3
Tuberculosis, Pulmonary	3

Clinical Trial Locations for Myambutol

Trials by Country

Trials by Country for Myambutol
Location	Trials
United States	45
France	8
India	5
South Africa	5
New Zealand	4

Trials by US State

Trials by US State for Myambutol
Location	Trials
Colorado	3
Texas	3
California	3
South Carolina	2
Pennsylvania	2

Clinical Trial Progress for Myambutol

Clinical Trial Phase

Clinical Trial Phase for Myambutol
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Myambutol
Clinical Trial Phase	Trials
Completed	5
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for Myambutol

Sponsor Name

Sponsor Name for Myambutol
Sponsor	Trials
Singapore Immunology Network	1
Johns Hopkins University	1
European and Developing Countries Clinical Trials Partnership (EDCTP)	1

Sponsor Type

Sponsor Type for Myambutol
Sponsor	Trials
Other	52
Industry	4
NIH	2

MYAMBUTOL: Clinical Trials, Market Analysis, and Projections

Introduction to MYAMBUTOL

MYAMBUTOL, also known as ethambutol, is a crucial antituberculosis agent used in the treatment and prophylaxis of pulmonary tuberculosis. It was first described in the literature in 1961 and gained FDA approval on November 6, 1967[2].

Clinical Use and Indications

Ethambutol is indicated for use in combination with other anti-tuberculosis drugs to treat pulmonary tuberculosis. It is commonly used alongside isoniazid, rifampin, and pyrazinamide. The drug should not be used as the sole antituberculous agent but rather as part of a multi-drug regimen to prevent the emergence of drug-resistant strains of Mycobacterium tuberculosis[1][2].

Mechanism of Action

Ethambutol acts as a bacteriostatic agent by inhibiting the arabinosyltransferases (embA, embB, and embC) in Mycobacterium tuberculosis. This inhibition prevents the formation of cell wall components such as arabinogalactan and lipoarabinomannan, which are essential for cell division and interaction with host cells[2].

Dosage and Administration

The dosage of MYAMBUTOL varies depending on whether the patient is undergoing initial treatment or retreatment. For patients who have not received previous antituberculous therapy, the recommended dose is 15 mg/kg (7 mg/lb) of body weight, administered once every 24 hours. For those who have received previous therapy, the dose is 25 mg/kg (11 mg/lb) of body weight[1].

Clinical Trials and Research

While there are no recent clinical trials specifically focused on MYAMBUTOL alone, the drug is often included in broader studies on tuberculosis treatment regimens. For example, clinical trials on new tuberculosis vaccines and treatments may include ethambutol as part of the standard treatment arm to compare efficacy and safety[4].

Safety and Side Effects

Ethambutol is known to have several side effects, the most notable being optic neuritis, which can lead to decreased visual acuity. Regular monitoring of visual acuity is recommended, and the drug should be discontinued if significant changes are observed[1].

Market Analysis

Global Tuberculosis Drugs Market

The global tuberculosis drugs market is projected to grow significantly from 2020 to 2025. According to market research, the global market is expected to increase from USD 1,622.15 million in 2020 to USD 2,095.09 million by the end of 2025[5].

Market Segmentation

The tuberculosis drugs market is segmented based on disease type (active TB and latent TB) and drug class (combination drugs, first-line anti-TB drugs, and second-line anti-TB drugs). Ethambutol falls under the category of first-line anti-TB drugs, along with isoniazid, pyrazinamide, and rifampin[5].

Geographic Distribution

The market is also analyzed geographically, with regions including the Americas, Asia-Pacific, and Europe, Middle East & Africa. The Asia-Pacific region, which includes countries like India, China, and Indonesia, is a significant market due to the high prevalence of tuberculosis in these areas[5].

Market Projections

Growth Drivers

The growth of the tuberculosis drugs market is driven by several factors, including the increasing incidence of tuberculosis, especially in developing countries, and the emergence of drug-resistant strains. The COVID-19 pandemic has also highlighted the need for robust healthcare systems and effective treatments for infectious diseases like tuberculosis[5].

Challenges

Despite the growth projections, the market faces challenges such as the high cost of drug development and the need for continuous innovation to combat drug resistance. Additionally, the market performance of antimicrobial drugs, including those for tuberculosis, can be influenced by factors like regulatory approvals, clinical benefit scores, and market competition[3].

Key Takeaways

• Clinical Use: MYAMBUTOL is used in combination with other drugs to treat pulmonary tuberculosis.
• Mechanism of Action: It inhibits arabinosyltransferases, preventing cell wall formation in Mycobacterium tuberculosis.
• Market Growth: The global tuberculosis drugs market is expected to grow from USD 1,622.15 million in 2020 to USD 2,095.09 million by 2025.
• Market Segmentation: Ethambutol is classified under first-line anti-TB drugs.
• Geographic Focus: The Asia-Pacific region is a significant market due to the high prevalence of tuberculosis.

FAQs

What is the primary use of MYAMBUTOL?

MYAMBUTOL, or ethambutol, is primarily used in the treatment of pulmonary tuberculosis, typically in combination with other anti-tuberculosis drugs.

How does ethambutol work?

Ethambutol works by inhibiting the arabinosyltransferases in Mycobacterium tuberculosis, preventing the formation of essential cell wall components.

What are the common side effects of ethambutol?

Common side effects include optic neuritis leading to decreased visual acuity, necessitating regular monitoring.

What is the projected growth of the tuberculosis drugs market?

The global tuberculosis drugs market is expected to grow from USD 1,622.15 million in 2020 to USD 2,095.09 million by the end of 2025.

Which regions are significant in the tuberculosis drugs market?

The Asia-Pacific region, including countries like India and China, is a significant market due to the high prevalence of tuberculosis.

Why is ethambutol not used as a sole antituberculous agent?

Ethambutol is not used alone to prevent the emergence of drug-resistant strains of Mycobacterium tuberculosis.

Sources

1. FDA Label for MYAMBUTOL: https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16320slr060_myambutol_lbl.pdf
2. DrugBank - Ethambutol: https://go.drugbank.com/drugs/DB00330
3. ASPE - Antimicrobial Drugs Market Returns Analysis: https://aspe.hhs.gov/sites/default/files/documents/b0962d8b3a6a3a825216485a4a988c76/antimicrobial-drugs-market-returns-analysis.pdf
4. ClinicalTrials.gov - VPM1002: https://clinicaltrials.gov/ct2/show/NCT04351685
5. GlobeNewswire - Tuberculosis Drugs Market Research Report: https://www.globenewswire.com/news-release/2021/04/28/2218339/0/en/Tuberculosis-Drugs-Market-Research-Report-by-Disease-Type-by-Drug-Class-Global-Forecast-to-2025-Cumulative-Impact-of-COVID-19.html

Last updated: 2025-01-03