MSDC-0602K Potassium Clinical Trials

Size	Price	Qty
5mg	USD 219

Clinical Trials

Multiple clinical trials sponsored by Cirius Therapeutics, Inc. have evaluated MSDC-0602K for metabolic and hepatic conditions, including Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH), and Type 2 Diabetes. A completed Phase 2 study assessed the safety, tolerability, and therapeutic efficacy of various dose levels over a 12-month period in patients with NAFLD and NASH. Furthermore, a Phase 3 trial with an unknown recruitment status was initiated to investigate long-term outcomes in patients presenting with NASH accompanied by pre-Type 2 or established Type 2 Diabetes.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03970031	UNKNOWN	Type2 Diabetes; NASH - Nonalcoholic Steatohepatitis; Nonalcoholic Steatohepatitis; Non-Alcoholic Fatty Liver Disease	Cirius Therapeutics, Inc.	2022-06	PHASE3
NCT02784444	COMPLETED	Non-alcoholic Fatty Liver Disease; Non-alcoholic Steatohepatitis; NASH - Nonalcoholic Steatohepatitis	Cirius Therapeutics, Inc.	2016-09-14	PHASE2

(data from https://clinicaltrials.gov, updated on 2021-07-12)

Check the MSDC-0602K Potassium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

MSDC-0602K acts as an insulin sensitizer by selectively modulating the mitochondrial pyruvate carrier (MPC), thereby restricting mitochondrial pyruvate entry and altering downstream hepatic metabolic pathways. This blockade enhances cellular insulin sensitivity and decreases lipid accumulation, mitigating hepatic steatosis and glycemic dysregulation associated with non-alcoholic steatohepatitis and type 2 diabetes.

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>).