Ensitrelvir fumarate Clinical Trials

Size	Price	Qty
5mg	USD 470
25mg	USD 1,270

Clinical Trials

Multiple clinical trials across Phase 1, Phase 2, and Phase 3 are evaluating ensitrelvir fumarate (S-217622) for primary SARS-CoV-2 infection, symptomatic COVID-19, and post-acute sequelae such as Long COVID. These studies also encompass clinical pharmacology assessments of safety, pharmacokinetics in populations with renal or hepatic impairment, and drug-drug interactions in healthy female participants. Sponsored by commercial entities such as Shionogi, academic institutions like the University of Oxford, and independent investigators, these trials currently span completed, recruiting, and active but not recruiting statuses.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05041907	RECRUITING	COVID-19	University of Oxford	2021-09-30	PHASE2
NCT06775730	COMPLETED	Healthy Adult Female Participants	Shionogi	2024-12-30	PHASE1
NCT06161688	ACTIVE_NOT_RECRUITING	Long COVID; Post Acute Sequelae of COVID-19; Post-Acute COVID-19	Timothy Henrich	2024-04-09	PHASE2
NCT05897541	Recruiting	SARS-CoV-2 Infection	Shionogi\|Shionogi Inc.	2023-06-09	Phase 3
NCT05409911	Completed	Hepatic Impairment	Shionogi\|Shionogi Inc.	2022-09-13	Phase 1
NCT05363215	Completed	Renal Impairment	Shionogi\|Shionogi Inc.	2022-08-10	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-02-19)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ensitrelvir fumarate acts as an orally active, non-covalent, non-peptidic inhibitor that selectively binds to the SARS-CoV-2 3CL protease with an IC50 of 13 nM, thereby blocking viral polyprotein processing and halting viral replication within host cells. By suppressing intracellular viral propagation, this compound mitigates tissue damage and viral persistence, directly addressing clinical manifestations of acute SARS-CoV-2 infection, COVID-19, and post-acute sequelae such as Long COVID.

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>).