Imeglimin (EMD 387008) Hydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 387

Clinical Trials

Multiple clinical trials across Phase I, II, and IV evaluate the therapeutic utility of Imeglimin for type 2 diabetes mellitus, while assessing pharmacokinetics, bioequivalence, and QT interval variations in healthy subjects and patients with hepatic impairment. Sponsored by institutions including Poxel SA, Mansoura University, Humanis Saglık Anonim Sirketi, and the National Center for Global Health and Medicine, these studies investigate ascending doses, drug interactions, and mitochondrial redox modulation relative to metformin. Across these trials, recruitment statuses span from completed investigations to active and planned non-recruiting studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05366868	ACTIVE_NOT_RECRUITING	Diabetes Mellitus, Type 2	National Center for Global Health and Medicine, Japan	2022-05-26	PHASE4
NCT07436182	NOT_YET_RECRUITING	Mitochondria; Metformin	Mansoura University	2026-03-01	PHASE4
NCT07691177	COMPLETED	Type 2 Diabetes	Humanis Saglık Anonim Sirketi	2026-02-06	PHASE1
NCT07127094	COMPLETED	Bioequivalence Study in Healthy Subjects	Aya Mohammed Abdel Magid Abdel Hamid	2025-03-09	PHASE1
NCT03802786	COMPLETED	Hepatic Impairment	Poxel SA	2018-11-06	PHASE1
NCT03802786	Completed	Hepatic Impairment	Poxel SA	2018-11-06	Phase 1
NCT03646331	COMPLETED	Bioequivalence	Poxel SA	2018-09-03	PHASE1
NCT03646331	Completed	Bioequivalence	Poxel SA	2018-09-03	Phase 1
NCT03618316	COMPLETED	Healthy	Poxel SA	2018-06-19	PHASE1
NCT03618316	Completed	Healthy	Poxel SA	2018-06-19	Phase 1
NCT02924337	COMPLETED	Qt Interval, Variation in	Poxel SA	2016-09	PHASE1
NCT02373150	COMPLETED	Type 2 Diabetes Mellitus	Poxel SA	2015-02	PHASE1
NCT02373150	Completed	Type 2 Diabetes Mellitus	Poxel SA	2015-02	Phase 1
NCT01951235	COMPLETED	Type 2 Diabetes Mellitus	Poxel SA	2013-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-04-09)

Check the Imeglimin (EMD 387008) Hydrochloride product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Imeglimin acts by preserving mitochondrial respiratory function from oxidative stress, thereby enhancing lipid oxidation and restoring cellular energy homeostasis in liver tissue. This suppression of mitochondrial dysfunction improves hepatic and peripheral insulin sensitivity, providing direct clinical relevance for restoring glucose homeostasis in patients with type 2 diabetes mellitus.

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>).