CLINICAL TRIALS PROFILE FOR ETHIONAMIDE

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.
NCT02454205 ↗	An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis	Completed	University of Limpopo	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.
NCT02454205 ↗	An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis	Completed	University of Stellenbosch	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.

Clinical Trial Conditions for ETHIONAMIDE

Condition Name

Condition Name for ETHIONAMIDE
Intervention	Trials
Tuberculosis	3
Extensively-drug Resistant Tuberculosis	1
Frontotemporal Dementia	1
HIV Infections	1

Condition MeSH

Condition MeSH for ETHIONAMIDE
Intervention	Trials
Tuberculosis	5
Tuberculosis, Pulmonary	3
Dementia	1
HIV Infections	1

Clinical Trial Locations for ETHIONAMIDE

Trials by Country

Trials by Country for ETHIONAMIDE
Location	Trials
United States	4
South Africa	3

Trials by US State

Trials by US State for ETHIONAMIDE
Location	Trials
Kentucky	1
New York	1
Michigan	1
Illinois	1

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

Clinical Trial Status

Clinical Trial Status for ETHIONAMIDE
Clinical Trial Phase	Trials
Completed	2
Not yet recruiting	2
Terminated	1

Clinical Trial Sponsors for ETHIONAMIDE

Sponsor Name

Sponsor Name for ETHIONAMIDE
Sponsor	Trials
TASK Applied Science	2
Samsung Medical Center	1
National Institute of Allergy and Infectious Diseases (NIAID)	1

Sponsor Type

Sponsor Type for ETHIONAMIDE
Sponsor	Trials
Other	12
NIH	1
INDUSTRY	1

ETHIONAMIDE: Clinical Trials Update, Market Analysis, and 3- to 5-Year Projection

Last updated: May 1, 2026

Ethionamide is an oral, first-line second-generation anti-tuberculosis agent used in drug-susceptible and drug-resistant tuberculosis (DR-TB) regimens. The product is off-patent in most jurisdictions, with commercial activity concentrated in legacy generics and country-level procurement through TB programs. Public clinical development is limited and fragmented, with no single, globally dominant late-stage program driving incremental market growth.

What is the current clinical trials landscape for ethionamide?

Where does ethionamide show up in trials?

Ethionamide is most often evaluated as a component of DR-TB regimens or optimized background therapy rather than as a standalone new molecular entity. Trial activity typically appears in one of three buckets:

• Multi-drug DR-TB regimen studies that test regimen design, dosing schedules, or treatment duration while keeping ethionamide as part of the backbone.
• Platform or observational studies where ethionamide is part of standardized “background” therapy.
• Pharmacokinetic (PK) and exposure-response work aimed at toxicity management and adherence in DR-TB combinations.

Is there a clear late-stage (Phase 3) program driving registration?

No public signal indicates a single Phase 3 program that is:

• registered as a pivotal trial in major global registries,
• on track for regulatory submission,
• and uniquely differentiating ethionamide versus the competitive set of TB combination standards.

As a result, the practical “clinical update” for investment and commercialization is less about a near-term registrational path and more about whether ethionamide remains included in guideline-consistent DR-TB regimens in the countries that drive procurement.

How does the current evidence base affect uptake?

Ethionamide is used because it remains active against Mycobacterium tuberculosis strains where resistance patterns and regimen constraints allow. Clinical selection is driven by:

• baseline susceptibility and resistance history,
• regimen compatibility with companion drugs,
• tolerability and dose-limiting adverse effects (notably gastrointestinal intolerance and hepatotoxicity risk),
• and national formulary and procurement pathways for DR-TB.

That evidence position produces a stable but low-innovation market profile: demand follows TB program needs more than new clinical differentiation.

What does the market look like for ethionamide today?

Commercial structure

The ethionamide market is dominated by:

• generic manufacturers supplying oral ethionamide tablets for TB programs,
• bulk procurement through national tuberculosis programs, donors, and tenders,
• limited brand-driven differentiation, because formulations largely converge on immediate-release oral dosing.

Demand drivers

Demand is primarily driven by:

• global DR-TB case detection and enrollment into treatment
• treatment guideline behavior (whether ethionamide is retained as a backbone option in standardized DR-TB regimens)
• procurement cycles and donor-funded supply chain commitments

Key market constraints

Market upside is capped by:

• the continued shift toward regimens built around newer TB agents in many programs,
• resistance and tolerability issues that can reduce persistence on ethionamide-containing regimens,
• procurement preference for multi-drug fixed-dose combinations where available (reducing the share of single-agent tablet procurement).

Pricing and margin profile

Given off-patent status and competitive generic supply, ethionamide pricing typically exhibits:

• tender-driven pricing
• compressed margins versus on-patent TB products
• inventory and compliance requirements that raise operating cost more than unit manufacturing costs

Competitive set

In practice, ethionamide competes as a component within DR-TB regimens with other second-line oral TB agents that can substitute in background therapy based on susceptibility and regimen design. The competitive landscape is procurement- and resistance-pattern dependent rather than label- or indication-exclusive.

What is the 3- to 5-year market projection for ethionamide?

Projection framework

Because ethionamide’s future is governed more by TB program procurement than by new drug approvals, the projection should be framed around:

• growth in DR-TB treatment enrollment,
• retention of ethionamide in guideline-consistent regimens,
• and the ability of generic suppliers to sustain tender supply.

Base case: stable-to-low growth

The most likely profile is stable demand with modest growth, driven by ongoing DR-TB burden management. The market does not show a strong vector for step-change growth without:

• a new pivotal trial that expands indication scope,
• or a major guideline shift that sharply increases ethionamide’s regimen share.

Upside scenario: stronger regimen retention in DR-TB backbones

Potential upside comes from:

• programs continuing to rely on older core second-line drugs when newer agents face access, cost, or resistance constraints,
• improved regimen design that keeps ethionamide in more patients.

Upside remains bounded by generic saturation and tender pricing.

Downside scenario: regimen migration toward newer standardized combinations

Downside comes from:

• continued migration toward newer agents in DR-TB standards,
• supply chain disruptions or quality failures in generic portfolios,
• and guideline or policy revisions that reduce ethionamide’s role.

Clinical and commercial timeline view

Near term (0 to 12 months)

• Ethionamide demand tracks DR-TB procurement cycles.
• Clinical activity remains mostly regimen and PK-focused, not a decisive registrational driver.
• Market pricing remains tender-led and competitive.

Mid term (12 to 36 months)

• Continued enrollment-driven purchasing in TB programs.
• Any incremental clinical signal would be incremental, not transformative.
• Generic supply and QA capacity determine continuity of supply.

Longer term (36 to 60 months)

• Growth stays tied to DR-TB treatment coverage.
• Regimen composition trends determine whether ethionamide maintains its share of oral backbone therapy.

Actionable implications for R&D and investment

R&D

• Future value is in improving regimen performance and tolerability rather than attempting a new single-agent differentiation.
• Practical R&D targets align with PK, dosing, and safety mitigation in DR-TB regimens.

Commercial

• Winning is mostly procurement execution: regulatory dossiers, consistent QA, lead time reliability, and tender pricing discipline.
• Market share is less sensitive to marketing and more sensitive to tender qualification and supply certainty.

Key Takeaways

• Ethionamide’s clinical profile is predominantly embedded in DR-TB multi-drug regimen use rather than a standalone late-stage development story.
• The market is primarily generic and tender-driven, with commercial outcomes tied to DR-TB enrollment and regimen guideline retention.
• The base-case outlook for 3 to 5 years is stable-to-modest growth, with upside limited by regimen share ceiling and downside tied to migration toward newer standardized regimens.

FAQs

1) Does ethionamide have a current Phase 3 registrational pathway?

Publicly visible global evidence does not show a single dominant pivotal Phase 3 program that would be expected to drive major label expansion.

2) What primarily drives ethionamide sales?

National and donor procurement tied to DR-TB treatment enrollment and regimen design.

3) What are the biggest risks to ethionamide demand?

Guideline or regimen shifts that reduce its use, plus tolerability and resistance-pattern constraints that lower persistence in treated patients.

4) Where does value accrue for generic suppliers?

Tender qualification, reliable supply, and low-cost compliance while maintaining quality consistency.

5) What would create a major upside case?

A guideline-driven increase in ethionamide’s regimen share or a new evidence package that expands or strengthens its standardized use.

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References

[1] World Health Organization (WHO). Consolidated guidelines on tuberculosis: Module 4: Treatment - Drug-resistant tuberculosis treatment (latest edition). WHO.
[2] ClinicalTrials.gov. Ethionamide (study results and recruiting status). National Library of Medicine. https://clinicaltrials.gov/
[3] WHO Global Tuberculosis Programme. Drug-resistant tuberculosis (DR-TB) data and guidance materials. World Health Organization. https://www.who.int/teams/global-tuberculosis-programme/