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Last Updated: January 11, 2025

CLINICAL TRIALS PROFILE FOR ETHIONAMIDE


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All Clinical Trials for ETHIONAMIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
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.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for ETHIONAMIDE

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2TuberculosisExtensively-drug Resistant TuberculosisFrontotemporal DementiaHIV Infections[disabled in preview]
Condition Name for ETHIONAMIDE
Intervention Trials
Tuberculosis 2
Extensively-drug Resistant Tuberculosis 1
Frontotemporal Dementia 1
HIV Infections 1
[disabled in preview] 0
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Condition MeSH

3211000.511.522.53TuberculosisTuberculosis, PulmonaryDementiaHIV Infections[disabled in preview]
Condition MeSH for ETHIONAMIDE
Intervention Trials
Tuberculosis 3
Tuberculosis, Pulmonary 2
Dementia 1
HIV Infections 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 2
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Trials by US State

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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

25.0%25.0%25.0%25.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 2/Phase 3Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for ETHIONAMIDE
Clinical Trial Phase Trials
Phase 2/Phase 3 1
Phase 2 1
Phase 1 1
[disabled in preview] 1
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Clinical Trial Status

40.0%40.0%20.0%0-0.200.20.40.60.811.21.41.61.822.2CompletedNot yet recruitingTerminated[disabled in preview]
Clinical Trial Status for ETHIONAMIDE
Clinical Trial Phase Trials
Completed 2
Not yet recruiting 2
Terminated 1
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Clinical Trial Sponsors for ETHIONAMIDE

Sponsor Name

trials000001111111Samsung Medical CenterTASK Applied ScienceNational Institute of Allergy and Infectious Diseases (NIAID)[disabled in preview]
Sponsor Name for ETHIONAMIDE
Sponsor Trials
Samsung Medical Center 1
TASK Applied Science 1
National Institute of Allergy and Infectious Diseases (NIAID) 1
[disabled in preview] 1
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Sponsor Type

90.9%9.1%0-101234567891011OtherNIH[disabled in preview]
Sponsor Type for ETHIONAMIDE
Sponsor Trials
Other 10
NIH 1
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ETHIONAMIDE Market Analysis and Financial Projection

Ethionamide in the Fight Against Tuberculosis: Clinical Trials, Market Analysis, and Projections

Introduction to Ethionamide

Ethionamide is a second-line antitubercular drug that has been in use for several decades to treat tuberculosis (TB), particularly in cases where the bacteria are resistant to first-line treatments. Despite its long history, ethionamide continues to be a subject of ongoing research and development to improve its efficacy and reduce its side effects.

Current Clinical Trials and Developments

Alpibectir: A New Approach to Enhance Ethionamide

One of the most promising recent developments involves the use of alpibectir (BVL-GSK098), a novel compound designed to augment the activity of ethionamide and overcome resistance to it. Alpibectir targets the transcription regulator VirS, a mechanism that is distinct from traditional TB drugs and represents a potential paradigm shift in TB treatment[3][4].

  • Phase 1 Clinical Trials: Alpibectir has progressed through nonclinical testing and a first-time-in-human (FTIH) clinical trial. This Phase 1 study, conducted in healthy volunteers, assessed the safety, tolerability, pharmacokinetics, and food effect of alpibectir. The results indicated that alpibectir could significantly reduce the required dose of ethionamide, thereby minimizing dose-dependent side effects and improving patient compliance[3][4].

Ethionamide Resistance and Molecular Determinants

Research into the molecular determinants of ethionamide resistance is crucial for optimizing its use. Studies have shown that resistance to ethionamide can be predicted by analyzing specific genetic loci, such as ethA, fabG1, and inhA. These findings suggest that a significant proportion of TB isolates, even those classified as resistant, may still be susceptible to ethionamide treatment when tested using phenotypic methods[2].

Market Analysis and Projections for TB Drugs

Global Tuberculosis Drugs Market

The global tuberculosis drugs market is expected to experience significant growth over the next few years. Here are some key projections:

  • Market Size: The market is anticipated to grow from USD 1,622.15 million in 2020 to USD 2,095.09 million by the end of 2025[5].
  • Geographical Segmentation: The market is segmented across regions such as the Americas, Asia-Pacific, and Europe, Middle East & Africa. The Asia-Pacific region, which includes countries like India, China, and the Philippines, is expected to be a major contributor to this growth due to the high prevalence of TB in these areas[5].

Market Segmentation by Disease Type and Drug Class

  • Disease Type: The market is segmented into active TB and latent TB. Active TB, which requires immediate treatment, drives a significant portion of the demand for TB drugs[5].
  • Drug Class: The market is further segmented into combination drugs, first-line anti-TB drugs, and second-line anti-TB drugs. Ethionamide falls under the category of second-line anti-TB drugs, which are used when first-line treatments are ineffective or when the bacteria are resistant to first-line drugs[5].

Ethionamide's Role in the Market

Ethionamide, as a second-line drug, plays a critical role in the treatment of drug-resistant TB. Here are some key points regarding its market position:

  • Demand and Supply: The increasing incidence of drug-resistant TB globally is driving the demand for second-line drugs like ethionamide. However, the supply chain and accessibility of these drugs remain challenges, particularly in low- and middle-income countries[5].
  • Competitive Landscape: The market for TB drugs is competitive, with various pharmaceutical companies and research organizations working on new and improved treatments. Ethionamide, enhanced by compounds like alpibectir, is poised to remain a significant player in this landscape[3][4].

Future Directions and Challenges

Improving Efficacy and Safety

  • Combination Therapies: Ongoing clinical trials, such as the one involving TBAJ-876, pretomanid, and linezolid, aim to develop combination regimens that can shorten and improve TB treatment. These regimens may include ethionamide or its enhanced versions to tackle both drug-sensitive and drug-resistant TB[1].
  • Overcoming Resistance: The development of compounds like alpibectir is crucial for overcoming resistance to ethionamide. This approach not only enhances the drug's efficacy but also reduces the required dosage, thereby improving patient compliance and reducing side effects[3][4].

Access and Affordability

  • Global Health Initiatives: Ensuring access to effective TB treatments, including ethionamide and its enhanced versions, is a critical global health challenge. Initiatives by organizations such as the World Health Organization (WHO) and non-profit entities are essential for making these drugs affordable and accessible in resource-poor settings[1][5].

Key Takeaways

  • Clinical Trials: Alpibectir is being tested to enhance the efficacy and safety of ethionamide, with promising results from Phase 1 trials.
  • Market Growth: The global TB drugs market is expected to grow significantly by 2025, driven by the increasing incidence of drug-resistant TB.
  • Ethionamide's Role: Ethionamide remains a vital second-line drug for TB treatment, with ongoing research aimed at improving its efficacy and reducing resistance.
  • Future Directions: Combination therapies and overcoming resistance are key areas of focus for future research and development.

FAQs

What is the current status of alpibectir in clinical trials?

Alpibectir has completed a Phase 1 clinical trial in healthy volunteers, assessing its safety, tolerability, and pharmacokinetics. The results indicate that it can enhance the activity of ethionamide and reduce the required dose.

How does alpibectir overcome resistance to ethionamide?

Alpibectir targets the transcription regulator VirS, a mechanism that overcomes resistance to ethionamide caused by EthA mutations.

What are the market projections for the global TB drugs market?

The global TB 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.

What is the role of ethionamide in the treatment of TB?

Ethionamide is a second-line anti-TB drug used to treat drug-resistant TB. It is particularly useful when first-line treatments are ineffective or when the bacteria are resistant to first-line drugs.

What are the challenges in using ethionamide?

The main challenges include overcoming resistance, reducing side effects, and ensuring access and affordability, especially in low- and middle-income countries.

Sources

  1. TB Alliance Launches Five-Country Phase 2 Clinical Trial Evaluating Next-Generation TB Drug. TB Alliance, 2023.
  2. Molecular Determinants of Ethionamide Resistance in Clinical Isolates of Mycobacterium tuberculosis. MDPI, 2022.
  3. Alpibectir: Early Qualitative and Quantitative Metabolic Profiling from a First-Time-in-Human Clinical Trial. ASPET Journals, 2024.
  4. First-in-human study of alpibectir (BVL-GSK098), a novel potent anti-TB drug. Oxford Academic, 2024.
  5. Tuberculosis Drugs Market Research Report by Disease Type, by Drug Class, Global Forecast to 2025. GlobeNewswire, 2021.

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