TRx0237 (LMTX) mesylate Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 370

Clinical Trials

Multiple clinical trials sponsored exclusively by TauRx Therapeutics Ltd evaluate TRx0237 (LMTX) mesylate for Alzheimer's disease and behavioral variant frontotemporal dementia (bvFTD). Predominantly consisting of Phase 3 studies alongside Phase 2 and unphased protocols, these trials have completed major safety and efficacy evaluations, though certain early-phase efforts were terminated. Expanded treatment access currently remains available.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03446001	COMPLETED	Alzheimer Disease	TauRx Therapeutics Ltd	2017-12-01	PHASE3
NCT01689233	COMPLETED	Alzheimer's Disease	TauRx Therapeutics Ltd	2012-10	PHASE3
NCT01626378	COMPLETED	Behavioral Variant Frontotemporal Dementia (bvFTD)	TauRx Therapeutics Ltd	2013-05	PHASE3
NCT01689246	COMPLETED	Alzheimer's Disease	TauRx Therapeutics Ltd	2013-01	PHASE3
NCT01626391	TERMINATED	Alzheimer's Disease	TauRx Therapeutics Ltd	2012-09	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-09-04)

Check the TRx0237 (LMTX) mesylate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

TRx0237 (LMTX) mesylate acts as a tau protein aggregation inhibitor that binds directly to tau monomers, blocking their self-assembly into toxic oligomers and neurofibrillary tangles to preserve structural neuronal integrity. By mitigating tau-mediated neurotoxicity and pathological protein aggregation, this compound aims to arrest disease progression and attenuate cognitive decline in clinical indications such as Alzheimer's disease and behavioral variant frontotemporal dementia.

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>).