lanosterol Clinical Trials

Size	Price	Qty
1mg	USD 97
5mg	USD 297

Clinical Trials

Multiple clinical trials evaluate this compound or related metabolic and nutritional formulations for pediatric malnutrition as well as age-related conditions such as frailty, hypertension, and chronic kidney disease. Ranging from Phase 4 studies to unphased protocols, these investigations are supported by industry sponsors like Fresenius Kabi alongside academic institutions, including IRCCS San Raffaele and the Cariplo Foundation. Recruitment across these studies is currently reported as either terminated or of unknown status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03563222	Terminated	Malnutrition Child	Fresenius Kabi	2019-12-18	Phase 4
NCT04630132	Unknown status	Aging\|Frailty\|Hypertension\|CKD	IRCCS San Raffaele\|Cariplo Foundation	2017-03-25	--

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lanosterol acts as a critical biosynthetic substrate that engages sterol pathway enzymes, driving downstream enzymatic conversion steps required for steroidogenesis and cell membrane lipid structural integrity. By maintaining cellular lipid homeostasis and sterol availability, lanosterol-mediated pathways play a vital physiological role in systemic nutrient utilization, which is directly relevant to clinical research in pediatric malnutrition, sarcopenia, frailty, and chronic kidney disease.

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>).