Clinical Trials

The clinical trial landscape for 27-Hydroxycholesterol is currently limited to a clinical trial sponsored by an academic institution, Capital Medical University. Listed with an unassigned phase and holding an active, not recruiting status, this study evaluates key metabolic and physiological factors involving 27-Hydroxycholesterol in patients with Mild Cognitive Impairment. Overall, clinical evaluation of this endogenous oxysterol remains in preliminary exploratory stages, focusing on academic research into neurocognitive impairment rather than commercial drug development.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07486141 ACTIVE_NOT_RECRUITING
Mild Cognitive Impairment
Capital Medical University
 2024-11-01

(data from https://clinicaltrials.gov, updated on 2026-03-20)

Check the 27-Hydroxycholesterol product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

27-Hydroxycholesterol functions as an endogenous selective estrogen receptor modulator and partial agonist of LXRα and LXRβ, binding nuclear receptors to modulate downstream transcriptional activity and lipid metabolism. This receptor engagement alters cellular cholesterol homeostasis and signaling pathways, providing a biological basis for evaluating its regulatory role in Mild Cognitive Impairment.

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>).

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Note: Technical data last updated: Sep 1, 2026.