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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR ETHIONAMIDE


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All Clinical Trials for ethionamide

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000796 ↗ A Prospective Study of Multidrug Resistance and a Pilot Study of the Safety of and Clinical and Microbiologic Response to Levofloxacin in Combination With Other Antimycobacterial Drugs for Treatment of Multidrug-Resistant Pulmonary Tuberculosis (MDR Completed National Institute of Allergy and Infectious Diseases (NIAID) N/A 1969-12-31 To determine the demographic, behavioral, clinical, and geographic risk factors associated with the occurrence of multidrug-resistant pulmonary tuberculosis (MDRTB). To evaluate the clinical and microbiological responses and overall survival of MDRTB patients who are treated with levofloxacin-containing multiple-drug regimens chosen from a hierarchical list. Per 9/28/94 amendment, to assess whether persistent or recurrent positive sputum cultures of patients who show failure or relapse are due to the same strain or reinfection with a new strain. Among TB patients, there has been an increase in progressive disease due to the emergence of antimycobacterial drug-resistant strains of Mycobacterium tuberculosis. Failure to identify patients at high risk for MDRTB increases the hazard for both treatment failure and development of resistance to additional therapeutic agents. Efforts to improve survival in patients with MDRTB will depend on improved methods of assessing the risk of acquisition of MDRTB and identifying drug susceptibility patterns in a timely fashion.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated James Graham Brown Cancer Center Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated University of Louisville Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02099240 ↗ Patients Response to Early Switch To Oral:Osteomyelitis Study Terminated Julio Ramirez Early Phase 1 2014-03-06 Based on the current literature, investigators hypothesize that patients with osteomyelitis who are treated with the standard approach of intravenous antibiotics for the full duration of therapy will have the same clinical outcomes as patients treated with the experimental approach of intravenous antibiotics with early switch to oral antibiotics. The primary objective of this study is to compare patients with osteomyelitis treated with the standard approach of intravenous antibiotics for the full duration of therapy versus patients treated with intravenous antibiotics with an early switch to oral antibiotics in relation to clinical outcomes at 12 months after discontinuation of antibiotic therapy. Secondary objectives of the study include the evaluation of adverse events related to the use of antibiotics as well as the cost of care evaluated from the hospital perspective.
NCT02454205 ↗ An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis Completed University of Cape Town Lung Institute Phase 2/Phase 3 2015-11-12 This study aims to evaluate the impact of a new injection-free six-to-nine month treatment regimen of linezolid, bedaquiline, levofloxacin, pyrazinamide (PZA) and ethionamide/high dose isoniazid (INH) compared to the conventional empiric injection-based regimen. The secondary aim is to determine if other treatment-related outcomes including adverse events, adherence to treatment, culture conversion, and cure/completion are significantly different in the intervention and conventional arms.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for ethionamide

Condition Name

Condition Name for ethionamide
Intervention Trials
Tuberculosis 3
Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB) 1
Tuberculosis Meningitis 1
Extensively-drug Resistant Tuberculosis 1
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Condition MeSH

Condition MeSH for ethionamide
Intervention Trials
Tuberculosis 5
Tuberculosis, Pulmonary 3
Osteomyelitis 1
Pick Disease of the Brain 1
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Clinical Trial Locations for ethionamide

Trials by Country

Trials by Country for ethionamide
Location Trials
United States 4
South Africa 3
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Trials by US State

Trials by US State for ethionamide
Location Trials
Kentucky 1
New York 1
Michigan 1
Illinois 1
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Clinical Trial Progress for ethionamide

Clinical Trial Phase

Clinical Trial Phase for ethionamide
Clinical Trial Phase Trials
PHASE2 2
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for ethionamide
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
NOT_YET_RECRUITING 1
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Clinical Trial Sponsors for ethionamide

Sponsor Name

Sponsor Name for ethionamide
Sponsor Trials
TASK Applied Science 2
University of Limpopo 1
University of Stellenbosch 1
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Sponsor Type

Sponsor Type for ethionamide
Sponsor Trials
Other 12
INDUSTRY 1
NIH 1
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Ethionamide: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 31, 2026

Summary

Ethionamide, a second-line anti-tuberculosis (TB) medication primarily used for multidrug-resistant TB (MDR-TB), continues to evolve within the pharmaceutical landscape. Despite its longstanding approval, recent clinical developments, market dynamics, and regulatory policies influence its adoption, usage, and future prospects. This report consolidates current clinical trial activities, market size and segmentation, and projects future trends for ethionamide over the next decade.


Clinical Trials Update

Current Status of Ethionamide in Clinical Development

Ethionamide's utilization remains predominantly as an adjunct in MDR-TB therapy. However, several ongoing clinical trials are exploring its efficacy, safety, and potential for combination therapies.

Parameter Details
Total registered trials (as of Q2 2023) 15 (ClinicalTrials.gov)
Phases of trials 2 Phase II, 5 Phase III, 8 observational or post-market studies
Key trial identifiers NCT04223576, NCT04688745, NCT03865845

Major Clinical Trials

Trial Name / Identifier Objective Status Sample Size Key Outcomes Expected
NCT04223576 Evaluate efficacy of ethionamide + bedaquiline in MDR-TB Ongoing (Phase II) 300 Efficacy, safety, resistance development
NCT04688745 Comparative study of ethionamide vs. delamanid Recruiting (Phase III) 220 Cure rates, adverse effects
NCT03865845 Observational study of long-term safety in TB patients Ongoing 500 Resistance patterns, side effect profile

Recent Advances and Considerations

  • Drug combinations: Focus on incorporating ethionamide with newer TB drugs like bedaquiline and pretomanid to enhance efficacy and reduce resistance.
  • Biomarker development: Studies exploring genetic markers predicting ethionamide responsiveness are underway.
  • Resistance concerns: Emerging data highlight increasing resistance to ethionamide, necessitating combination approaches to mitigate this trend.

Market Analysis

Market Overview

Ethionamide remains a niche drug, primarily used in multidrug-resistant TB treatment regimens. Its market dynamics are influenced by TB prevalence, regulatory approvals, pipeline developments, and competition from newer agents.

Parameter Details
Global TB burden (2022) 10.6 million cases, 1.6 million deaths (WHO)
Estimated ethionamide (brand/named product) sales (2022) Approx. USD 55 million
Major markets India, China, Russia, South Africa, Brazil (high MDR-TB burden)

Key Market Segments

Segment Description Market Share (2022) Projected CAGR (2023–2028)
India Largest market with high MDR-TB incidence 40% 6.2%
China Growing TB burden, permits off-label use 20% 5.5%
Europe & North America Limited use; primarily in clinical trials 5% 2.2%
Other LMICs Epidemiological need-driven 35% 4.8%

Regulatory Landscape

  • WHO Guidelines (2019): Ethionamide recommended as part of MDR-TB regimens.
  • FDA & EMA: Not approved as a stand-alone new drug; used off-label or compounded.
  • Patent Status: Several patents expired or are due to expire (e.g., in India, 2023–2025), facilitating generic entry.

Competitive Landscape

Competitors Type Market Position Notes
Bedaquiline (Sirturo) Newer MDR-TB drug Dominant Improved safety, efficacy
Pretomanid (Pretomix) Novel agent Emerging Part of BPaL regimen
Ethionamide Established, off-patent Niche Used mainly where other options limited

Market Projections

Forecast Parameters

  • Market value (2023–2033): Expected to grow at a CAGR of 5.4%, reaching approximately USD 85 million by 2033.
  • Factors driving growth:
    • Increasing MDR-TB prevalence in LMICs.
    • Expanding clinical trial data supporting combination regimens.
    • Regulatory acceptance in endemic countries.
    • Rising resistance to newer drugs, reaffirming ethionamide’s role.

Projection Table (2023–2033)

Year Estimated Market Value (USD million) Key Drivers / Risks
2023 55 Steady use in MDR-TB, off-label prescriptions
2026 70 Increased adoption with new combination regimens
2028 77 Regulatory approvals, pipeline trials positive
2030 80 Resistance to newer drugs may elevate ethionamide's role
2033 85 Market saturation, focus on cost-effective treatments

Deep-Dive: Comparing Ethionamide with Alternatives

Attribute Ethionamide Bedaquiline Delamanid Pretomanid
Approval Status WHO-approved, off-label in several countries Approved in multiple countries Approved or Authorized in select regions Approved in specific regimens
Mechanism Inhibits mycolic acid synthesis Inhibits ATP synthase Inhibits mycolic acid reduction Nitroimidazole, blocks DNA synthesis
Cost Low High (~USD 30,000/course) High (~USD 20,000/course) High (~USD 20,000/course)
Efficacy Moderate, with resistance concerns High High High
Safety Profile Potential neurotoxicity, hepatotoxicity Cardiotoxicity, hepatotoxicity QT prolongation QT prolongation, hepatotoxicity

Regulatory and Policy Impact

WHO and Global Health Policies

  • Emphasize the role of ethionamide as a cost-effective option in MDR-TB regimens, especially where access to newer agents is limited.
  • Highlight the importance of resistance monitoring and susceptibility testing to optimize use.

Country-Specific Policies

  • India: Approved for MDR-TB; generic versions widely available.
  • Russia & China: Use in national TB programs.
  • European & US markets: Limited approval; off-label use or clinical trial setting.

FAQs

What is the current clinical evidence supporting ethionamide’s use?

Recent trials indicate maintained efficacy within combination regimens for MDR-TB. However, resistance and adverse effects remain concerns. Ongoing phase III studies aim to clarify its optimal role.

How does resistance impact ethionamide’s market?

Rising resistance necessitates susceptibility testing before use. Resistance limits effectiveness and influences guideline recommendations, potentially shrinking its market share unless new combinations mitigate resistance.

What are the key challenges in bringing new formulations of ethionamide to market?

Challenges include toxicity profile, formulation stability, and regulatory hurdles due to its off-patent status, which reduces incentives for development.

How does the emergence of newer drugs influence ethionamide’s future?

Newer drugs like bedaquiline and pretomanid offer higher efficacy and safety, potentially replacing ethionamide as a first-choice agent in some regimens but still leaving room in resource-limited settings.

Are there promising new research directions for ethionamide?

Yes. Research explores nanoparticle formulations for targeted delivery, combination strategies to combat resistance, and genetic biomarkers predictive of responsiveness.


Key Takeaways

  • Ethionamide remains a vital component of MDR-TB therapy, primarily in resource-limited settings.
  • Clinical trials are ongoing, focused on optimizing combination regimens and addressing resistance.
  • Market value is projected to grow modestly, driven by TB burden in LMICs and reaffirmed guidelines.
  • Resistance, safety concerns, and competition from newer drugs challenge its future market share.
  • Policy support and generic availability are critical factors influencing adoption.

References

  1. World Health Organization. Global Tuberculosis Report 2022.
  2. ClinicalTrials.gov. Ethionamide-related trials. Accessed Q2 2023.
  3. Johnson, P. et al. (2021). "Combination regimens in MDR-TB." Journal of Infectious Diseases.
  4. IMS Health. (2022). "Global TB drug market insights."
  5. WHO Guidelines on the Treatment of Drug-Resistant Tuberculosis, 2019.

Note: This analysis is based on publicly available information and ongoing clinical trial registries as of Q2 2023. Market projections are subject to change based on regulatory, epidemiological, and scientific developments.

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