Laninamivir Octanoate Clinical Trials

Size	Price	Qty
5mg	USD 289

Clinical Trials

Several completed Phase I clinical trials evaluated laninamivir octanoate to investigate the safety, tolerability, and pharmacokinetics of single ascending inhaled doses. Sponsored by Biota Scientific Management Pty Ltd in collaboration with Vaxart and U.S. government agencies—including the Department of Health and Human Services and the National Institute of Allergy and Infectious Diseases—these early-phase studies established baseline human pharmacological and pulmonary safety profiles in asthmatic participants and elderly cohorts evaluated for influenza management.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02022761	Completed	Asthma	Biota Scientific Management Pty Ltd\|Department of Health and Human Services\|Vaxart	2013-10	Phase 1
NCT00657111	Completed	Influenza	Biota Scientific Management Pty Ltd\|National Institute of Allergy and Infectious Diseases (NIAID)\|Vaxart	2008-04	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Laninamivir octanoate acts as a prodrug that is converted into laninamivir, which selectively binds to and inhibits viral neuraminidase, thereby preventing the enzymatic cleavage of terminal sialic acid residues on host cell receptors and arresting the release and spread of progeny virions. This robust inhibition of viral replication reduces infectious viral loads and viral-mediated airway pathology, providing therapeutic rationale for its evaluation in clinical trials targeting influenza infections and underlying respiratory conditions such as asthma.

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>).