Zanamivir Clinical Trials

Size	Price	Qty
2mg	USD 147
10mg	USD 370

Clinical Trials

Multiple clinical trials evaluate the therapeutic utility, safety, and pharmacokinetics of zanamivir, focusing primarily on viral infections—including human influenza, influenza A, respiratory tract infections, and gastric influenza—alongside exploratory indications such as dengue fever and associated arthralgia. Spanning Early Phase 1 through Phase 3 across completed, actively recruiting, terminated, and withdrawn statuses, these investigations are supported by industry sponsors such as GlaxoSmithKline, academic institutions including George Washington University and the University of Oxford, and hospital networks like Hospices Civils de Lyon.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04597437	RECRUITING	Dengue Fever	George Washington University	2024-03-15	PHASE2
NCT05648448	RECRUITING	Influenza; Influenza, Human	University of Oxford	2023-02-22	PHASE2
NCT04494412	COMPLETED	Influenza, Human; Arthralgia	GlaxoSmithKline	2022-11-21	PHASE2
NCT04867707	COMPLETED	Diabetes Mellitus, Type 2	University of Missouri-Columbia	2021-07-14	PHASE2
NCT04597437	Recruiting	Dengue Fever	George Washington University\|Naval Medical Research Center\|Clinica de la Costa\|Global Disease Research	2024-03-15	Early Phase 1
NCT04494412	Recruiting	Influenza Human\|Arthralgia	GlaxoSmithKline	2022-11-21	Phase 2
NCT02377401	COMPLETED	Influenza, Human	GlaxoSmithKline	2015-04-28	PHASE1
NCT02377401	Completed	Influenza Human	GlaxoSmithKline	2015-04-28	Phase 1
NCT01231620	COMPLETED	Influenza, Human	GlaxoSmithKline	2011-01-15	PHASE3
NCT01014988	COMPLETED	Influenza, Human	GlaxoSmithKline	2009-11	PHASE2
NCT01527110	COMPLETED	Influenza, Human	GlaxoSmithKline	2012-01-01	PHASE3
NCT01459081	COMPLETED	Influenza A Virus Infection; Influenza B Virus Infection	Jiangsu Simcere Pharmaceutical Co., Ltd.	2011-10	PHASE3
NCT01527110	Completed	Influenza Human	GlaxoSmithKline	2012-01-01	Phase 3
NCT01353729	COMPLETED	Influenza, Human	GlaxoSmithKline	2011-05-19	PHASE1
NCT01353768	Completed	Infections Respiratory Tract	GlaxoSmithKline	2011-07	--
NCT00980109	COMPLETED	Influenza	University of Oxford	2009-09	PHASE4
NCT00979667	TERMINATED	Upper Respiratory Tract Infection; Influenza	Chinese University of Hong Kong	2009-10	PHASE3
NCT00989404	COMPLETED	Influenza A Virus, H1N1 Subtype	GlaxoSmithKline	2009-10-12	PHASE1
NCT00799760	TERMINATED	Gastric Influenza	Assistance Publique - Hôpitaux de Paris	2008-12	PHASE3
NCT00921726	COMPLETED	Influenza; Virus Diseases	National Institute of Allergy and Infectious Diseases (NIAID)	2009-07	PHASE1
NCT00867139	COMPLETED	Influenza	Fred Hutchinson Cancer Center	2009-03	PHASE1; PHASE2
NCT00830323	TERMINATED	Influenza A Infection	Hospices Civils de Lyon	2009-01	PHASE2
NCT00784784	COMPLETED	Influenza	Mount Sinai Hospital, Canada	2008-11	PHASE3
NCT00540501	WITHDRAWN	Healthy Subjects	GlaxoSmithKline	2007-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-07-29)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Zanamivir selectively binds to and inhibits viral neuraminidase, preventing the cleavage of terminal sialic acid residues on host cell surface glycoconjugates and thereby halting the release and spread of newly synthesized virions from infected host cells. This suppression of viral dissemination effectively limits viral replication within host mucosal tissues, providing the clinical rationale for its evaluation in trials for the prophylaxis and treatment of human influenza A and B viral infections and associated respiratory complications.

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>).