Tolimidone (MLR-1023) Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Tolimidone (MLR-1023) has been evaluated in several clinical trials to investigate its therapeutic efficacy in adults with uncontrolled type 2 diabetes mellitus. Sponsored by industry entities including Melior Pharmaceuticals and Bukwang Pharmaceutical Co. Ltd., these multi-center, double-blind, randomized, placebo-controlled Phase 2 studies encompass completed Phase 2a assessments as well as trials with an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03279263	UNKNOWN	Type 2 Diabetes Mellitus	Melior Pharmaceuticals	2017-09-01	PHASE2
NCT02317796	COMPLETED	Type 2 Diabetes	Melior Pharmaceuticals	2014-12	PHASE2
NCT02317796	Completed	Type 2 Diabetes	Melior Pharmaceuticals\|Bukwang Pharmaceutical Co. Ltd.	2014-12	Phase 2

(data from https://clinicaltrials.gov, updated on 2019-01-09)

Check the Tolimidone (MLR-1023) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tolimidone selectively binds to and activates Lyn kinase while potentiating insulin receptor signaling, thereby enhancing downstream intracellular metabolic cascades. This activation promotes cellular glucose uptake and restores glycemic regulation, providing a mechanistic foundation for improving metabolic control in patients with type 2 diabetes mellitus evaluated in phase 2 clinical trials.

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>).