Imidazole Ketone Erastin (IKE) Clinical Trials

Size	Price	Qty
2mg	USD 177
5mg	USD 257

Clinical Trials

Multiple clinical trials investigate this compound across diverse areas, including Type 2 diabetes mellitus with renal impairment, general diabetes, hypogonadism in transgenderism, mild and subjective cognitive impairment, and underage vaping. Spanning Phase 1, Phase 3, and non-interventional designs, these completed and actively recruiting studies are supported by pharmaceutical, academic, and corporate sponsors.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05534607	RECRUITING	Mild Cognitive Impairment; Subjective Cognitive Impairment	University of Hawaii	2022-09-15
NCT02861144	COMPLETED	Diabetes	University of Hawaii	2011-02
NCT01555008	Completed	Type 2 Diabetes Mellitus\|Renal Impairment	Lexicon Pharmaceuticals	2012-03	Phase 1
NCT04545450	Completed	Transgenderism\|Hypogonadism	Unita Complessa di Ostetricia e Ginecologia	2008-11-04	Phase 3

(data from https://clinicaltrials.gov, updated on 2024-08-01)

Check the Imidazole Ketone Erastin (IKE) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imidazole ketone erastin (IKE) selectively binds and inhibits the system xc– cystine/glutamate antiporter, thereby blocking cellular cystine uptake and suppressing downstream glutathione biosynthesis. This disruption induces lethal intracellular lipid peroxidation and triggers ferroptosis, providing a targeted mechanism to modulate cell death pathways in disease states such as diabetes, cognitive impairment, and renal disorders investigated in clinical settings.

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>).