Clinical Trials

Lufotrelvir (PF-07304814) has been evaluated in several completed clinical trials, all sponsored by Pfizer. Centered on early-stage clinical development, these investigations consist exclusively of Phase 1 and Phase 1b studies targeting healthy adult participants as well as patients with viral disease. Across these completed protocols, researchers assessed safety, dose escalation, pharmacokinetics, mass balance, and excretion profiles.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05050682 Completed
Healthy
Pfizer
 2021-10-07 Phase 1
NCT04627532 Completed
Healthy
Pfizer
 2020-10-23 Phase 1
NCT04535167 Completed
Viral Disease
Pfizer
 2020-09-09 Phase 1

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

Check the Lufotrelvir (PF-07304814) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Lufotrelvir (PF-07304814) is a phosphate prodrug converted into active PF-00835231, which selectively binds to and inhibits the SARS-CoV-2 3CL protease with a Ki of 174 nM, thereby preventing essential viral polyprotein cleavage. By suppressing this enzymatic processing, the compound halts intracellular assembly of infectious virions, providing the mechanistic basis for its clinical evaluation in viral disease.

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>).

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Note: Technical data last updated: Sep 1, 2026.