Peramivir Trihydrate Clinical Trials

Size	Price	Qty
5mg	USD 170

Clinical Trials

Multiple clinical trials have evaluated intravenous peramivir trihydrate primarily for treating influenza and influenza complicated by renal failure. Spanning Phase 1/2 and Phase 3 studies alongside pharmacokinetic protocols, this research was funded by BioCryst Pharmaceuticals, federal agencies including HHS and NIAID, and academic partners, with recruitment statuses ranging from completed Phase 3 trials to terminated and withdrawn studies. Collectively, these investigations assessed the drug's safety, pharmacokinetics, and antiviral efficacy in diverse groups, including pediatric and elderly cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02635724	Completed	Influenza	BioCryst Pharmaceuticals	2015-12	Phase 3
NCT02369159	Completed	Influenza	BioCryst Pharmaceuticals	2015-03-11	Phase 3
NCT01224795	Terminated	Influenza	BioCryst Pharmaceuticals\|Department of Health and Human Services	2010-10	Phase 3
NCT01146353	Withdrawn	Influenza\|Renal Failure	Midwestern University\|Northwestern University\|BioCryst Pharmaceuticals	2010-02	--
NCT01063933	Withdrawn	Influenza	National Institute of Allergy and Infectious Diseases (NIAID)		Phase 1\|Phase 2

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Peramivir Trihydrate acts as a transition-state analogue that selectively binds to and inhibits viral neuraminidase, thereby blocking the enzymatic cleavage of cell-surface sialic acid residues and preventing the release of newly formed viral progeny from host cells. By suppressing virion dissemination and arresting viral replication, this targeted antiviral mechanism directly underpins its clinical efficacy in reducing viral burden and disease severity in patients with influenza.

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>).