Salidroside Clinical Trials

Size	Price	Qty
2mg	USD 147
10mg	USD 347

Clinical Trials

A Phase 2 clinical trial is currently evaluating the therapeutic application of salidroside to improve pregnancy outcomes in patients of advanced childbearing age undergoing in vitro fertilization and assisted reproductive technology protocols. Sponsored by an academic medical center, The Second Hospital of Shandong University, the study is currently designated as not yet recruiting. By evaluating these reproductive parameters, the investigation aims to establish the clinical utility and efficacy of salidroside within reproductive medicine.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06990685	NOT_YET_RECRUITING	Salidroside; Randomized Controlled Trial; In Vitro Fertilization; Assisted Reproductive Technology	The Second Hospital of Shandong University	2025-06-01	PHASE2

(data from https://clinicaltrials.gov, updated on 2025-05-25)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Salidroside acts as a prolyl endopeptidase inhibitor that regulates downstream metabolic cascades by activating mTOR signaling and enhancing PINK1/Parkin-mediated mitophagy, thereby preserving cellular survival and reducing apoptosis. This protective cellular action and restoration of metabolic homeostasis support its clinical evaluation for improving pregnancy outcomes and clinical efficacy in patients undergoing in vitro fertilization and assisted reproductive technology.

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>).