Amenamevir Clinical Trials

Size	Price	Qty
1mg	USD 227
5mg	USD 670

Clinical Trials

Multiple clinical trials have evaluated amenamevir (ASP2151) to investigate its safety, pharmacokinetics, and therapeutic efficacy against viral infections. These completed studies comprise Phase 1 evaluations assessing single- and multiple-dose pharmacokinetics, safety profiles, and drug-drug interactions in healthy subjects, as well as Phase 2 trials for herpes zoster and recurrent herpes genitalis. All trials were funded by industry sponsors, including Astellas Pharma Inc., Astellas Pharma Europe Ltd., and Maruho Europe Limited.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02223351	Completed	Healthy	Maruho Europe Limited	2014-09	Phase 1
NCT00487682	Completed	Herpes Zoster	Astellas Pharma Inc	2007-11-13	Phase 2
NCT00486200	Completed	Herpes Genitalis	Astellas Pharma Inc	2007-06-21	Phase 2
NCT02796118	Completed	Healthy Subjects	Astellas Pharma Inc	2006-07	Phase 1
NCT02852876	Completed	Herpes Genitalis\|Herpes Zoster	Astellas Pharma Europe Ltd.\|Astellas Pharma Inc	2005-09	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amenamevir functions as a potent helicase-primase inhibitor that directly targets the viral helicase-primase enzyme complex, thereby blocking double-stranded DNA unwinding and RNA primer synthesis essential for viral replication. By halting viral genomic DNA replication within infected host cells, amenamevir suppresses viral propagation, which provides the biological basis for its therapeutic evaluation in clinical studies for herpes zoster and herpes genitalis.

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>).