RSV604 Clinical Trials

Size	Price	Qty
5mg	USD 97

Clinical Trials

Multiple clinical trials have evaluated RSV604, including a completed Phase I study sponsored by Novartis Pharmaceuticals assessing safety, tolerability, and pharmacokinetics in healthy subjects. Additionally, a completed Phase II trial sponsored by Arrow Therapeutics evaluated the compound's therapeutic safety and efficacy in adult stem cell transplant patients with respiratory syncytial virus infections.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00416442	Completed	Healthy	Novartis Pharmaceuticals\|Novartis	2006-10	Phase 1
NCT00232635	Completed	Respiratory Syncytial Virus Infections	Arrow Therapeutics	2005-09	Phase 2

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

Check the RSV604 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

RSV604 is a novel benzodiazepine derivative that specifically targets the respiratory syncytial virus nucleoprotein, disrupting viral RNA replication and transcription processes. By suppressing viral macromolecular synthesis, RSV604 prevents viral propagation within host epithelial cells, underscoring its therapeutic relevance for treating respiratory syncytial virus infections.

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>).