Palonosetron Clinical Trials

Size	Price	Qty
5mg	USD 97
25mg	USD 290

Clinical Trials

Multiple clinical trials evaluate palonosetron across Phase 1 to Phase 3 as well as unassigned protocols. These investigations involve healthy volunteers, terminally ill individuals, and patients with postoperative nausea and vomiting or female genital neoplasms. Sponsored by academic medical centers and commercial entities, the trials exhibit varying recruitment statuses, including completed, terminated, and 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 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Palonosetron functions as a highly potent 5-HT3 receptor antagonist that selectively binds to serotonin 5-HT3 receptors on peripheral vagal nerve terminals and central chemoreceptor trigger zone neurons, thereby inhibiting serotonin-induced depolarization and downstream signaling. By blocking this serotonin-mediated signaling cascade, it prevents activation of the emetic reflex, providing therapeutic efficacy against postoperative nausea and vomiting as well as emesis associated with terminal illness and oncological treatments.

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>).