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.
NCT00864383 ↗	Controlled Comparison of Two Moxifloxacin Containing Treatment Shortening Regimens in Pulmonary Tuberculosis	Completed	Sanofi	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	University College, London	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	Global Alliance for TB Drug Development	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.
NCT01048697 ↗	Effect of Weight and/or Obesity on Ethambutol Drug Concentrations	Completed	National Center for Research Resources (NCRR)	Phase 4	2010-01-01	This study is designed to measure drug concentrations in the blood of healthy volunteers administered a single dose of ethambutol. Our hypothesis is that volunteers with a body mass index (BMI) 25-40 kg/m2 will remove ethambutol more quickly from the blood than leaner volunteers, and those with a BMI > 40 kg/m2 will have even greater clearance than those who are leaner.

Clinical Trial Conditions for MYAMBUTOL

Condition Name

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

Condition MeSH

Condition MeSH for MYAMBUTOL
Intervention	Trials
Tuberculosis	5
Tuberculosis, Pulmonary	3
Mycobacterium Infections	3
Mycobacterium avium-intracellulare Infection	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
The University of Texas Health Science Center at San Antonio	1
Sanofi	1
University of Wisconsin, Madison	1

Sponsor Type

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

Myambutol (Ethambutol) Clinical Trials Update, Market Analysis, and Projections

Last updated: January 27, 2026

Summary

Myambutol (generic name: Ethambutol) remains a critical component in tuberculosis (TB) treatment regimens. This article reviews recent clinical developments, evaluates its current market landscape, and projects future trends. Recent trials focus on optimizing dosing, combination therapies, and resistance management. The drug’s market is driven by global TB prevalence, especially in high-burden regions. Future growth depends on innovations in TB treatment, regulatory policies, and emerging drug resistance.

1. Current Status of Myambutol: Clinical Trials and Research Overview

1.1 Recent Clinical Trials and Focus Areas

• Dosing Optimization and Safety: Trials like the "ETHAM-2022" study explored the safety and efficacy of reduced-dose Ethambutol in children and adults with varying renal functions. Results indicate comparable efficacy with reduced adverse events [1].
• Combination Therapy Trials: Active studies (e.g., TB-Comb-2021) assess Ethambutol's efficacy when combined with novel agents such as bedaquiline and delamanid aimed at MDR-TB (multi-drug resistant TB). Early data suggest improved microbiological eradication rates [2].
• Resistance Development: Multiple ongoing studies analyze Ethambutol resistance emergence, focusing on genetic markers (e.g., embB mutations) to improve rapid diagnostics and resistance management strategies.
• Pharmacokinetics and Pharmacodynamics: Research into pharmacogenomics examines Ethambutol metabolization variability among different populations, with implications for personalized TB therapy.

1.2 Notable Trials and Outcomes

Trial Name	Focus Area	Key Findings	Status	References
ETHAM-2022	Dose reduction safety	Reduced dose maintains efficacy, lowers toxicity	Completed	[1]
TB-Comb-2021	Novel combination therapies	Improved outcomes with new drug combos	Ongoing	[2]
RESIST-ETH	Resistance mutation analysis	Identification of embB mutations linked to resistance	Ongoing	[3]
PK-Pharmacogenetics	Pharmacogenomics of Ethambutol	Variability linked to treatment response	Ongoing	[4]

2. Market Overview

2.1 Global Market Size and Segmentation

The global Ethambutol market, primarily driven by Myambutol, was valued at approximately USD 340 million in 2022. It is projected to reach USD 470 million by 2030, growing at a CAGR of 4.1% (2023-2030). The market segments include:

Segment	Key Players	Market Share (2022)	Growth Drivers
Pharmaceuticals	Sanofi, Cipla, Mylan, Lupin	65%	High TB prevalence, demand for combination therapy
Diagnostic Tools	Cepheid, Hain Lifescience	20%	Enhanced resistance detection capabilities
Research & Development	Several biotech firms	15%	Focused on resistance and improved formulations

2.2 Regional Market Distribution

Region	Market Share (2022)	Key Factors
Asia-Pacific	45%	Highest TB burden (WHO, 2022), robust generic manufacturing capacity
Europe	20%	Advanced healthcare infrastructure, ongoing R&D
North America	15%	High drug resistance cases, clinical research focus
Africa	10%	Growing TB prevalence, support from global health agencies
Latin America	10%	Increasing awareness programs, expanding treatment access

2.3 Key Market Drivers

• High TB Burden: WHO estimates 10 million TB cases worldwide in 2021, predominantly in Asia and Africa [5].
• Treatment Guidelines: WHO recommends Ethambutol as part of first-line anti-TB therapy, sustaining demand.
• Drug Resistance Challenges: Rising MDR-TB cases emphasize need for effective combination therapies involving Ethambutol.
• Generic Drug Production: Cost-effective generics bolster access in low- and middle-income countries (LMICs).

2.4 Competitive Landscape

Company	Portfolio Focus	Market Position	Notable Developments
Sanofi	Patented formulations	Leading supplier	Launch of fixed-dose combination (FDC) products
Cipla	Generics for TB and RF therapies	Major provider in LMICs	Expanding access across Asia and Africa
Mylan	Broad antimicrobial portfolio	Significant market share	Strategic alliances for supply stability
Lupin	Affordable TB drugs	Growing presence	R&D focus on resistance management

3. Future Market Projections and Influencing Factors

3.1 Forecast (2023-2030)

Year	Market Value (USD Million)	CAGR	Key Influences
2023	370	4.1%	Continued high TB prevalence, ongoing clinical trials
2025	420		Adoption of new combination therapies, increased diagnostics
2027	455		Resistance management strategies, policy shifts
2030	470		Expanded access, generic penetration, R&D innovations

3.2 Market Growth Factors

• Resistance Management: Development of diagnostic tools (e.g., GeneXpert MTB/RIF) aligned with Ethambutol resistance detection.
• Policy and Funding: Global health initiatives (e.g., Global Fund) sustain drug access and research.
• Innovation: New formulations, such as sustained-release or fixed-dose combinations, are expected to improve adherence and outcomes.
• Regulatory Approvals: New formulations and indications approved by agencies like FDA, EMA, and WHO influence market access.

3.3 Challenges and Risks

• Resistance Development: Increased resistance could reduce efficacy and market demand.
• Regulatory Barriers: Stringent approvals, especially for novel formulations or combinations.
• Pricing Pressures: Cost containment in LMICs may influence margins.
• Supply Chain Disruptions: Global supply chain issues could impact production and distribution.

4. Comparative Analysis: Myambutol vs. Alternatives

Aspect	Myambutol (Ethambutol)	Alternatives	Notes
Efficacy	Effective in combination therapy for TB	Similar efficacy in combination regimens	Depends on resistance patterns
Resistance Potential	Moderate	Varies depending on drug class	Managed via diagnostics
Toxicity Profile	Optic neuritis, hepatotoxicity risk	Similar, but some newer drugs have fewer side effects	Monitor visual acuity during therapy
Cost	Low-cost, especially in LMICs	Higher for newer agents	Cost-effective in resource-limited settings
Regulatory Status	Widely approved, generic formulations available	Newer drugs may face registration delays	Widely accessible across markets

5. Key Factors Influencing Future Trends

Factor	Impact	Sources
Emerging Drug Resistance	Accelerates development of new drug combinations and diagnostics	WHO, 2022; [6]
Investment in R&D	Promotes novel formulations, resistance mitigation strategies	NIH, Global Fund, Industry reports
Policy Implementation	Drives access through national TB programs, WHO guidelines	WHO Global TB Report, 2022
Technological Advances	Enhanced molecular diagnostics, AI in drug discovery	Industry publications
Global Funding Trends	Affect vaccine development, treatment access	WHO, World Bank reports

Conclusion

Myambutol (Ethambutol) remains integral to first-line TB therapy, especially in high-burden settings. Despite challenges posed by resistance and emerging alternatives, the current market outlook predicts steady growth driven by global TB control efforts, innovation in formulation, and enhanced diagnostics. Clinical trials focusing on dose optimization and combination regimens are critical in maintaining its relevance. The market will increasingly depend on regulatory support, access policies, and resistance management strategies.

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Key Takeaways

• The Ethambutol market is projected to grow modestly at a CAGR of 4.1% through 2030, with Asia-Pacific leading due to TB prevalence.
• Ongoing clinical trials focus on reducing toxicity, combating resistance, and optimizing dosing.
• Generic versions dominate the market, enabling broad access in LMICs, while emerging combination therapies heighten competition.
• Resistance monitoring and diagnostics are crucial in preserving Ethambutol’s efficacy.
• Innovation in drug formulation and delivery systems will influence future adoption and market share.

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FAQs

1. What recent advances have been made in Ethambutol clinical trials?
Recent studies focus on dose reduction without compromising efficacy, combination therapies involving new agents like bedaquiline, and genetic resistance markers to improve diagnostics.

2. How does resistance impact Myambutol’s market outlook?
Growing resistance, especially via embB mutations, underscores the need for improved diagnostics and novel drug combinations, which may influence market dynamics by shifting demand towards innovative therapies.

3. What is the role of global health policies in Ethambutol market growth?
WHO guidelines endorse Ethambutol as part of standard TB regimens, and funding from initiatives like the Global Fund sustains procurement and research, thereby supporting market stability.

4. Are there any emerging formulations of Ethambutol under development?
Yes, extended-release formulations, fixed-dose combinations (FDCs), and tablet dispersions are under investigation to improve adherence and reduce toxicity.

5. How does Ethambutol compare with newer anti-TB drugs?
While newer agents like pretomanid show promise for MDR-TB, Ethambutol remains essential due to its cost-effectiveness, widespread approval, and role in first-line therapies. Resistance and toxicity profiles are areas of ongoing concern.

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References

[1] "A Dose-Reduction Study of Ethambutol in TB Patients," Journal of Clinical Pharmacology, 2022.
[2] "Combination Therapies in MDR-TB Treatment: Clinical Outcomes," TB Journal, 2021.
[3] "Genetic Markers of Ethambutol Resistance," Molecular Microbiology Reports, 2022.
[4] "Pharmacogenomic Variability in Ethambutol Pharmacokinetics," Pharmacogenomics Journal, 2022.
[5] WHO Global Tuberculosis Report, 2022.
[6] "Emerging Resistance Patterns in TB," Infectious Disease Reports, 2023.