Ergosterol Clinical Trials

Size	Price	Qty
10mg	USD 147

Clinical Trials

A clinical trial evaluated the therapeutic application of ergosterol in pediatric patients affected by child malnutrition. Sponsored by industry sponsor Fresenius Kabi, this Phase 4 interventional study was terminated prior to completion. Consequently, clinical evidence evaluating ergosterol under this protocol remains limited, leaving its formal efficacy and safety profiles in clinical populations unestablished.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03563222	Terminated	Malnutrition Child	Fresenius Kabi	2019-12-18	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a key sterol component of microbial cell membranes and a biological provitamin precursor, Ergosterol maintains lipid bilayer fluidity and undergoes ultraviolet-mediated transformation into ergocalciferol. Disruption of ergosterol synthesis alters membrane integrity to trigger cellular lysis, whereas its metabolic conversion into active vitamin D supports calcium homeostasis and nutrient processing pertinent to pediatric malnutrition.

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>).