GS-441524 Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Several clinical trials evaluate GS-441524 and its derivative prodrug formulations for treating COVID-19 across multiple development stages, including Phase 1 through Phase 3 safety, pharmacokinetic, and efficacy investigations. The trial portfolio comprises research funded by commercial sponsors, such as Gilead Sciences and Copycat Sciences LLC, alongside government institutes including the National Institute of Allergy and Infectious Diseases and the National Center for Advancing Translational Sciences. Across these records, recruitment statuses demonstrate a mix of completed pharmacokinetic studies as well as terminated or withdrawn trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT06274853	WITHDRAWN	COVID-19	National Center for Advancing Translational Sciences (NCATS)	2024-06-15	PHASE1
NCT05996744	Terminated	COVID-19	Gilead Sciences	2023-12-26	Phase 2\|Phase 3
NCT05715528	Completed	COVID-19	Gilead Sciences	2023-02-08	Phase 3
NCT05603143	Terminated	COVID-19	Gilead Sciences	2022-11-05	Phase 3
NCT04859244	COMPLETED	COVID-19	Copycat Sciences LLC	2021-01-01	PHASE1
NCT04582266	Completed	COVID-19	National Institute of Allergy and Infectious Diseases (NIAID)\|Gilead Sciences	2021-03-31	--
NCT04859244	Completed	COVID-19	Copycat Sciences LLC	2021-01-01	Phase 1
NCT04539262	Completed	COVID-19	Gilead Sciences	2020-09-14	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2025-02-14)

Check the GS-441524 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a small-molecule nucleoside precursor, GS-441524 undergoes intracellular phosphorylation into an active nucleoside triphosphate metabolite that inhibits viral RNA-dependent RNA polymerase and prematurely terminates viral RNA chain elongation. By suppressing viral genomic replication within infected host cells, this enzymatic inhibition provides the biological mechanism supporting its clinical evaluation for the treatment of COVID-19.

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>).