Fosaprepitant dimeglumine salt Clinical Trials

Size	Price	Qty
100mg	USD 970

Clinical Trials

Several clinical trials evaluate Fosaprepitant dimeglumine for managing chemotherapy-induced nausea, vomiting, and emesis across various neoplastic conditions, including non-small cell lung cancer and female genital neoplasms. Spanning Phase 2, Phase 3, and non-phased designs, these studies encompass active, completed, and unknown recruitment statuses assessing antiemetic regimens in cancer patients. Research in this landscape is sponsored by a combination of academic medical centers and industry partners.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05755659	Recruiting	Neoplasms	Xijing Hospital	2022-07-15	Not Applicable
NCT02407600	Unknown status	Non-small Cell Lung Cancer\|Vomiting\|Nausea\|Emesis	Ajeet Gajra\|Merck Sharp & Dohme LLC\|State University of New York - Upstate Medical University	2015-04	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 Fosaprepitant dimeglumine salt product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a water-soluble prodrug, fosaprepitant dimeglumine is rapidly converted to aprepitant, which selectively binds to and antagonizes neurokinin-1 (NK1) receptors to block the downstream biochemical signaling of substance P. This receptor blockade suppresses emetic signaling cascades within the central nervous system, thereby mitigating chemotherapy-induced nausea and vomiting in patients undergoing emetogenic cancer 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>).