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.

Clinical Trial Conditions for ethionamide

Condition Name

Condition Name for ethionamide
Intervention	Trials
Tuberculosis	3
Osteomyelitis	1
Rifampicin- and Isoniazid-Susceptible Pulmonary Tuberculosis (TB)	1
Tuberculosis Meningitis	1

Condition MeSH

Condition MeSH for ethionamide
Intervention	Trials
Tuberculosis	5
Tuberculosis, Pulmonary	3
Aphasia, Primary Progressive	1
Tuberculosis, Multidrug-Resistant	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
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for ethionamide

Sponsor Name

Sponsor Name for ethionamide
Sponsor	Trials
TASK Applied Science	2
Innovative Medicines Initiative	1
James Graham Brown Cancer Center	1

Sponsor Type

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

Ethionamide Clinical Trials Update, Market Analysis, and Future Market Projections (2026)

Last updated: July 30, 2026

Ethionamide is a legacy anti-tuberculosis agent used as part of multi-drug regimens for drug-susceptible and drug-resistant tuberculosis (TB). No new late-stage (Phase 3/registration) clinical-readout program is clearly established at the level needed for a reliable, investment-grade “clinical trials update” across geographies and sponsors. Commercial outlook is driven primarily by TB program procurement cycles, resistance patterns, and guideline-driven regimen design rather than by new clinical efficacy breakthroughs.

What is ethionamide and how is it used in TB regimens?

Ethionamide (Eto) is a second-line anti-TB medicine used mainly for drug-resistant TB, including regimens for multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), usually in combination with other active agents.

What conditions does ethionamide treat?

• Multidrug-resistant TB (MDR-TB)
• Extensively drug-resistant TB (XDR-TB)
• Drug-resistant TB regimens in combination protocols

How is ethionamide dosed in practice?

Typical adult use in TB treatment programs follows guideline-based dosing schedules in combination regimens. Ethionamide is generally administered orally; real-world dosing patterns vary by program, regimen, and co-administered agents.

What clinical trial programs exist for ethionamide and what is the latest status?

A reliable, complete “latest clinical trials update” for ethionamide requires a current, cross-referenced trial registry view (ClinicalTrials.gov, EU CTR, and other national registries) tied to specific studies, phases, and readout dates. In the absence of verifiable, itemized trial entries and outcomes within the constraints here, a full status roll-up would risk being incomplete or inaccurate.

Where does ethionamide sit in the TB drug-development pipeline versus newer agents?

Ethionamide competes less with new “same mechanism” candidates and more with modern regimen buildouts for drug-resistant TB that increasingly incorporate newer TB actives and shorter-course strategies. In such environments, ethionamide’s demand is influenced by:

• How often ethionamide is included in guideline-backed regimens for resistant TB cohorts
• Supply reliability and procurement tender allocations by TB programs
• Resistance and tolerability outcomes that determine regimen composition

What is the current market landscape for ethionamide?

Ethionamide market demand is tied to global TB incidence, MDR/RR-TB burden, national TB program treatment volumes, and donor-funded procurement. Unlike many modern specialty drugs, ethionamide’s commercial dynamics are dominated by:

• Government and multilateral purchasing
• Regimen guideline adoption and updates
• Manufacturing capacity for small-molecule TB generics and active pharmaceutical ingredient (API)
• Formulation availability and price competition among generics

Who buys ethionamide?

• National TB programs
• Procurement platforms and donor-funded treatment initiatives
• Government tenders and implementing agencies

What supply-side factors move ethionamide pricing and availability?

• API supply constraints
• Generic manufacturing capacity and yield
• Quality system approvals and batch release timelines
• Contracting and payment cycles tied to TB treatment funding

Ethionamide market share and pricing: what drives competitiveness?

Ethionamide pricing and share typically track:

• Generic entry and number of approved suppliers
• Local tender frameworks (price caps, qualification rules)
• Per-patient regimen use frequency in program-defined MDR/XDR regimens
• Product quality, bioavailability consistency, and regulatory approvals for local markets

How large is the ethionamide market and how is it projected to grow?

A credible forecast requires quantitative baselines (revenue by geography, units by dosage form, and shipment forecasts) derived from licensed datasets or current market research. Within the constraints here, a numeric projection would be speculative.

A decision-grade qualitative projection can be stated at the demand-driver level:

• Demand should remain supported by MDR/RR-TB treatment needs because ethionamide is still used in resistant-TB combinations.
• Growth is likely to be modest rather than exponential given ethionamide’s legacy status and the ongoing shift toward modern regimen combinations that may reduce use in some settings.
• Expansion depends on guideline inclusion persistence and whether programs scale up treatment enrollment for drug-resistant TB faster than newer regimen substitution.

What regulatory and reimbursement factors affect ethionamide adoption?

Regulatory inclusion and access are driven by:

• National medicine registration status and supply continuity
• Formulary inclusion for TB resistant regimens
• Pharmacovigilance and tolerability evidence used by ministries and program committees

Reimbursement in TB programs is typically not commercial insurance-led; it is program procurement and grant/donor financed.

Which geographies have the highest ethionamide demand exposure?

Demand exposure is concentrated in countries with:

• Higher MDR/RR-TB case loads
• Established second-line or all-oral drug-resistant TB regimen usage
• Procurement pipelines that include older second-line oral agents

What generic entry risks exist for ethionamide?

Generic risk is influenced by:

• Availability of multiple generic suppliers (reducing pricing power but improving supply)
• Regulatory file strength in each market and local quality review capacity
• Any remaining product-specific IP constraints in specific jurisdictions

A full patent and exclusivity risk map is not provided here because the required, jurisdiction-specific IP listing and expiration data are not established in the constraints.

How does ethionamide compare with other anti-TB second-line oral agents?

Ethionamide is typically compared within second-line regimen design against other orally administered components used in MDR/XDR regimens. Comparative adoption depends on:

• Regimen efficacy as determined in guideline algorithms
• Tolerability and adverse-event profiles (hepatotoxicity and GI tolerability often affect regimen feasibility in practice)
• Drug-drug interaction constraints within the regimen

Clinical demand outlook: what could expand or reduce ethionamide use?

Expand:

• If MDR/RR-TB treatment scale-up increases absolute treated volumes that include ethionamide
• If regimen guidelines maintain ethionamide as a backbone option for certain resistant profiles

Reduce:

• If newer regimens increasingly displace ethionamide due to improved outcomes, tolerability, or regimen simplicity
• If resistance to ethionamide-specific activation pathways is high enough in some cohorts to reduce its utility

Key takeaways

• Ethionamide remains a used second-line anti-TB agent, mainly in MDR/XDR combination regimens.
• A comprehensive “latest clinical trials update” cannot be reliably produced here without verifiable trial-level registry and readout data.
• Market outlook is driven by TB program procurement volume and regimen guideline composition, not by new drug life-cycle events.
• Near-to-midterm demand is likely to be steady to modest, with displacement risk from modern all-oral regimens.

FAQs

1. Is ethionamide used for drug-susceptible tuberculosis?
2. What adverse events most frequently limit ethionamide dosing in MDR-TB regimens?
3. How do MDR-TB guideline updates influence ethionamide inclusion rates by country?
4. Do all-oral modern MDR-TB regimens reduce ethionamide demand?
5. What drives ethionamide supply continuity for national TB programs?

References

1. World Health Organization (WHO). Global tuberculosis reports and MDR/RR-TB burden summaries.
2. WHO consolidated guidelines on drug-resistant tuberculosis regimen recommendations (latest edition).
3. ClinicalTrials.gov. Ethionamide search results and study listings.