LM10 Clinical Trials

Size	Price	Qty
10mg	USD 147
200mg	USD 897

Clinical Trials

The clinical trial landscape for this compound currently features a clinical trial focused on acute kidney injury in patients experiencing post-cardiac surgery renal complications. Sponsored by the University of Leicester, this completed observational study operates without an assigned interventional phase to evaluate specific biological markers, namely microvesicles and microRNA. Overall, clinical evaluation remains in an early observational stage led by academic sponsors rather than industry-driven drug development programs.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02315183	Completed	Acute Kidney Injury	University of Leicester	2014-01	--

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

Check the LM10 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

LM10 functions as a selective inhibitor of tryptophan 2,3-dioxygenase (TDO), binding to the enzyme to block the catalytic degradation of L-tryptophan along the kynurenine pathway and preventing the accumulation of immunosuppressive or cytotoxic tryptophan metabolites. This biochemical inhibition restores cellular metabolic balance and immune homeostasis, which is highly relevant to modulating systemic inflammatory responses and tissue injury observed in clinical conditions such as acute kidney injury.

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>).