LM11A-31 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 297

Clinical Trials

Several clinical trials evaluate the therapeutic profile of LM11A-31 for neurodegenerative disorders, focusing on mild to moderate Alzheimer's disease and progressive supranuclear palsy using Phase 1 and Phase 2 designs. A completed Phase 1/2 study sponsored by PharmatrophiX Inc. evaluated the safety and tolerability of LM11A-31 in Alzheimer's disease. Further Phase 2 platform trials sponsored by Adam Boxer target progressive supranuclear palsy, with recruitment statuses reported as recruiting and enrolling by invitation.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07173803	RECRUITING	Progressive Supranuclear Palsy(PSP)	Adam Boxer	2026-07-29	PHASE2
NCT07264283	ENROLLING_BY_INVITATION	PSP - Progressive Supranuclear Palsy	Adam Boxer	2026-07-29	PHASE2
NCT03069014	COMPLETED	Mild to Moderate Alzheimer's Disease	PharmatrophiX Inc.	2017-02-15	PHASE1; PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-21)

Check the LM11A-31 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LM11A-31 selectively binds to the p75 neurotrophin receptor (p75NTR) as a small-molecule ligand, modulating receptor conformation to block pro-apoptotic signaling cascades and degenerative downstream kinase pathways. By preventing neurotrophin-mediated cell death and reversing cholinergic neurite dystrophy, this targeted mechanism provides therapeutic potential for neurodegenerative conditions evaluated in clinical trials, including Alzheimer's disease and progressive supranuclear palsy.

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>).