MSDC-0160 Clinical Trials

Size	Price	Qty
10mg	USD 242

Clinical Trials

A completed Phase 2 clinical trial, sponsored by the industry sponsor Metabolic Solutions Development Company, evaluated the therapeutic application of MSDC-0160 in patients with Alzheimer's disease. This randomized, double-blind, placebo-controlled feasibility study assessed the effects of MSDC-0160 on regional brain glucose utilization, cognitive performance, and related functional parameters. Overall, these findings highlight the structured clinical evaluation of MSDC-0160 as a novel, mitochondrial-targeted therapeutic candidate for neurodegenerative disorders.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01374438	Completed	Alzheimer''s Disease	Metabolic Solutions Development Company	2011-07	Phase 2

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

Check the MSDC-0160 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MSDC-0160 selectively modulates the mitochondrial target of thiazolidinediones (mTOT) complex, thereby regulating mitochondrial pyruvate entry and optimizing downstream bioenergetic pathways. This metabolic regulation improves cellular energy balance and insulin sensitivity, providing therapeutic potential for metabolic and neurodegenerative conditions such as diabetes and Alzheimer's disease.

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>).