Arbidol HCl Clinical Trials

Size	Price	Qty
10mg	USD 110
100mg	USD 770

Clinical Trials

A Phase 4 clinical trial sponsored by the pharmaceutical manufacturer Pharmstandard evaluates the broad-spectrum antiviral Arbidol HCl for the treatment and prophylaxis of influenza. This post-market safety and efficacy study targeting respiratory influenza infections currently has an unknown recruitment status.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT01651663	Unknown status	Influenza	Pharmstandard	2011-09	Phase 4

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Arbidol HCl specifically targets viral hemagglutinin and membrane phospholipids, thereby blocking pH-dependent fusion of the viral membrane with host endosomal membranes and preventing viral entry into target cells. By halting viral uncoating and subsequent intracellular replication, this entry inhibition mechanism limits viral spread, demonstrating clinical relevance for treating and preventing influenza infections studied in 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>).