Clinical Trials

Ethionamide has been evaluated in a completed, single-center, open-label clinical trial focusing on pulmonary tuberculosis, sponsored by BioVersys AG in collaboration with TASK Applied Science. Although a formal phase was not designated, this exploratory study successfully investigated the pharmacokinetics, systemic exposure, and metabolic behavior of ethionamide and its active metabolite, ethionamide sulfoxide, in patients receiving anti-tuberculosis therapy.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05258877 Completed
Tuberculosis Pulmonary
BioVersys AG|TASK Applied Science
 2022-06-10 --

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Ethionamide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ethionamide functions as a prodrug that undergoes intracellular activation to inhibit mycolic acid biosynthesis in Mycobacterium tuberculosis, thereby disrupting essential cell wall assembly and halting bacterial growth. This structural destabilization ultimately induces bacterial cell death, underlying its therapeutic efficacy in suppressing infection and managing pulmonary tuberculosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.