Palonosetron HCl Clinical Trials

Size	Price	Qty
10mg	USD 79

Clinical Trials

Palonosetron hydrochloride has been evaluated across several Phase 1, Phase 2, and Phase 3 clinical trials, as well as observational protocols, to manage emetic symptoms in healthy subjects, patients with postoperative nausea and vomiting, terminally ill individuals, and female patients with genital neoplasms. Sponsored by various academic medical centers and pharmaceutical companies—including HK inno.N Corporation, Daegu Catholic University Medical Center, and Helsinn Healthcare SA—these investigations report recruitment statuses ranging from completed to terminated or unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04486157	Completed	Healthy	HK inno.N Corporation	2021-03-18	Phase 1
NCT04466046	Completed	Postoperative Nausea and Vomiting	Daegu Catholic University Medical Center	2019-09-04	--
NCT03148704	Unknown status	Palonosetron	Cttq	2017-03-08	--
NCT00982995	Terminated	Nausea\|Vomiting\|Terminally Ill	University of Michigan Rogel Cancer Center	2010-11	Phase 2
NCT01074697	Completed	Nausea\|Vomiting\|Genital Neoplasms Female	Odense University Hospital\|Helsinn Healthcare SA	2010-04	Phase 3

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palonosetron HCl functions as a selective 5-HT3 receptor antagonist that binds to peripheral and central 5-HT3 receptors, thereby blocking serotonin-mediated ligand-gated ion channel activation and preventing vagal afferent pathway excitation. This inhibition interrupts the emetic reflex arc to suppress signal transmission to the vomiting center, which directly correlates with its clinical application in preventing and treating postoperative nausea and vomiting as well as emetic symptoms in cancer and terminally ill patients.

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>).