Dimethyl pimelimidate dihydrochloride Clinical Trials

Size	Price	Qty
50mg	USD 79
250mg	USD 237

Clinical Trials

Multiple clinical trials evaluate conditions such as multiple sclerosis, type 2 diabetes mellitus, polypathology, and mild neurocognitive disorders in older adults, ranging from observational biomarker research to management outcome evaluations. These studies encompass completed, actively recruiting, and unknown recruitment statuses, though formal trial phases are not specified in the records. The research initiatives are supported by a mix of academic institutions, medical foundations, and commercial sponsors, including Boehringer Ingelheim, the EDMUS Foundation, and Centre Hospitalier Universitaire de Nice.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05622643	Recruiting	Multiple Sclerosis	EDMUS Foundation	2023-01-19	--
NCT04600726	Unknown status	Older Adults With Mild Neurocognitive Disorders\|Older Adults With Non-communicable Diseases\|Healthy Age-matched Older Adults	The Hong Kong Polytechnic University\|Department of Neuroscience Psychology and Behavior. The University of Leicester\|School of Psychology The University of Nottingham\|The Alice Ho Miu Ning Nethersole Hospital	2021-02-01	--
NCT04098575	Completed	Diabetes Mellitus Type 2	Boehringer Ingelheim	2019-09-16	--
NCT02809417	Completed	Polypathology	Centre Hospitalier Universitaire de Nice	2016-01-28	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dimethyl pimelimidate dihydrochloride acts as a homobifunctional amine-reactive crosslinker that covalently binds primary amino groups on proteins, thereby stabilizing macromolecular complexes and inhibiting structural degradation. This crosslinking mechanism preserves intact cellular and protein architectures essential for translational research and diagnostic biomarker analysis across conditions such as multiple sclerosis and 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>).