Tropisetron Clinical Trials

Size	Price	Qty
25mg	USD 97

Clinical Trials

A clinical trial sponsored by Beijing Chao Yang Hospital evaluates the therapeutic efficacy and safety of Tropisetron for preventing postoperative cognitive dysfunction and postoperative delirium. Designed as a late-stage Phase IV, randomized, double-blind, placebo-controlled study, its current recruitment status is documented as unknown. Overall, this research reflects interest in utilizing Tropisetron to attenuate perioperative neurocognitive impairments following surgical procedures.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04195204	Unknown status	Postoperative Cognitive Dysfunction\|Postoperative Delirium	Beijing Chao Yang Hospital	2020-11-01	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Tropisetron functions as a 5-HT3 receptor antagonist with an IC50 of 70.1 nM and acts as an α7-nicotinic acetylcholine receptor agonist, thereby inhibiting serotonin-mediated ion channel gating while enhancing cholinergic signaling pathways. This dual action modulates central neurotransmitter release and suppresses neuroinflammatory cascades, providing a rational mechanistic basis for mitigating postoperative cognitive dysfunction and postoperative delirium.

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>).