Clinical Trials

Multiple clinical trials sponsored by the biopharmaceutical company Telik evaluated ezatiostat in Phase 1 and Phase 2 studies targeting myelodysplastic syndrome, severe chronic neutropenia, and non-small cell lung cancer. These investigations utilized dose-ranging and comparative efficacy protocols to evaluate therapeutic response. While early Phase 1 and Phase 2 studies were completed, several clinical trials in later Phase 2 stages were ultimately terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT00909584 TERMINATED
Severe Chronic Neutropenia
Telik
 2009-04 PHASE2
NCT01422486 TERMINATED
Myelodysplastic Syndrome (MDS)
Telik
 2011-10 PHASE2
NCT01459159 TERMINATED
Myelodysplastic Syndrome (MDS)
Telik
 2011-10 PHASE2
NCT01062152 COMPLETED
Myelodysplastic Syndrome
Telik
 2009-11 PHASE1
NCT01459159 Terminated
Myelodysplastic Syndrome (MDS)
Telik
 2011-10 Phase 2
NCT01422486 Terminated
Myelodysplastic Syndrome (MDS)
Telik
 2011-10 Phase 2
NCT00700206 COMPLETED
Myelodysplastic Syndrome (MDS)
Telik
 2008-05 PHASE2
NCT00701870 TERMINATED
Non-small Cell Lung Cancer
Telik
 2008-10 PHASE2
NCT00280631 COMPLETED
Myelodysplastic Syndrome (MDS)
Telik
 2006-02 PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2013-11-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ezatiostat acts as a peptidomimetic glutathione analog that selectively inhibits glutathione S-transferase P1-1 (GSTP1-1), relieving GSTP1-1-mediated suppression to activate c-Jun NH2-terminal kinase (JNK1) and ERK pathways and induce apoptosis. This pro-apoptotic pathway activation and restoration of normal hematopoiesis underpin its clinical investigation for therapeutic application in myelodysplastic syndrome, severe chronic neutropenia, and non-small cell lung cancer.

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>).

Jump to

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