Rilematovir Clinical Trials

Size	Price	Qty
5mg	USD 79
25mg	USD 237

Clinical Trials

Multiple clinical trials sponsored by Janssen Research & Development LLC have evaluated the therapeutic and pharmacokinetic profiles of rilematovir across Phase I, Phase II, and Phase III investigations. These studies encompassed healthy adults, subjects with hepatic impairment, and pediatric or adult patients with respiratory syncytial virus and respiratory tract infections. Although a Phase I pharmacokinetic interaction trial in healthy adults was completed, additional Phase I, Phase II, and Phase III evaluations assessing efficacy and safety in hepatic impairment, pediatric respiratory illness, and adult viral infections were terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05155007	Completed	Healthy	Janssen Research & Development LLC	2021-12-10	Phase 1
NCT04978337	Terminated	Respiratory Syncytial Virus	Janssen Research & Development LLC	2021-11-17	Phase 2
NCT04583280	Terminated	Respiratory Tract Infections	Janssen Research & Development LLC	2021-09-06	Phase 3
NCT04332523	Terminated	Hepatic Impairment	Janssen Research & Development LLC	2020-08-17	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Rilematovir selectively binds to the respiratory syncytial virus fusion protein, blocking viral envelope fusion with host membranes and preventing viral entry into host bronchial epithelial cells. By halting viral entry and replication, this mechanistic inhibition directly targeted respiratory syncytial virus and pediatric respiratory tract infections evaluated across Phase 2 and Phase 3 clinical trials.

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>).