Rolapitant Clinical Trials

Size	Price	Qty
5mg	USD 147
100mg	USD 970

Clinical Trials

A completed Phase 2 clinical trial sponsored by an academic institution, Duke University, evaluated an oral combination regimen of rolapitant and ondansetron for cancer patients with chemo-radiation induced nausea and vomiting. The study assessed efficacy, treatment compliance, and overall patient satisfaction to determine the drug's utility in mitigating treatment-induced emetic side effects associated with oncology therapies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02991456	Completed	Chemo-radiation Induced Nausea and Vomiting	Duke University	2017-10-09	Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rolapitant acts as a high-affinity, selective, and competitive antagonist of the human substance P/neurokinin-1 receptor, potently inhibiting substance P-mediated signaling cascades within central and peripheral emetic centers. By suppressing neurogenic emetic signals and downstream signaling pathways, rolapitant inhibits emetic responses and reduces the incidence of chemo-radiation induced nausea and vomiting.

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>).