MedPath

PF-07304814

Generic Name
PF-07304814
Drug Type
Small Molecule
Chemical Formula
C24H33N4O9P
Unique Ingredient Identifier
XJ51YOB1SC
Background

PF-07304814 is a small molecule prodrug that targets the 3CL protease (M, which is used by viruses like SARS-CoV-2 to assemble and multiply. Once administered through intravenous infusion, the compound is cleaved into PF-00835231 to exert its anti-viral effects. PF-07304814, developed by Pfizer, was first identified during the SARS outbreak in 2002-2003; it was subsequently shelved as the outbreak was controlled. Now, it is being tested regarding the novel SARS-CoV-2 virus, including studies in conjunction with Remdesivir to treat COVID-19 infection; in vitro data showed synergistic effects on articles published on preprint servers. Phase 1b studies are also exploring the safety and tolerability of PF-07304814 in COVID-19 patients who are hospitalized (NCT04535167).

PF-07304814 for Inpatients With COVID-19 (An ACTIV-3/TICO Treatment Trial)

Phase 3
Terminated
Conditions
COVID-19
Interventions
Drug: Placebo
Biological: Remdesivir
First Posted Date
2023-03-22
Last Posted Date
2024-02-09
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
58
Registration Number
NCT05780541
Locations
πŸ‡ΊπŸ‡Έ

VA San Diego Healthcare System (Site 074-016), 3350 La Jolla Village Drive, San Diego, California, United States

πŸ‡ΊπŸ‡Έ

University of Utah Hospital (Site 211-002), 419 Wakara Way, Suite 207, Salt Lake City, Utah, United States

πŸ‡ΊπŸ‡Έ

Duke University Hospital (Site 301-006), 2301 Erwin Road, Durham, North Carolina, United States

and more 37 locations

Study to Investigate the Mass Balance, Metabolism, and Excretion of [14C]-PF-07304814 in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2021-09-20
Last Posted Date
2022-05-13
Lead Sponsor
Pfizer
Target Recruit Count
5
Registration Number
NCT05050682
Locations
πŸ‡ΊπŸ‡Έ

Labcorp Clinical Research Unit, Madison, Wisconsin, United States

Single Ascending Dose Study of Intravenous Infusion of PF 07304814 in Healthy Adult Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo
First Posted Date
2020-11-13
Last Posted Date
2021-01-06
Lead Sponsor
Pfizer
Target Recruit Count
16
Registration Number
NCT04627532
Locations
πŸ‡ΊπŸ‡Έ

New Haven Clinical Research Unit, New Haven, Connecticut, United States

First-In-Human Study To Evaluate Safety, Tolerability, And Pharmacokinetics Following Single Ascending And Multiple Ascending Doses of PF-07304814 In Hospitalized Participants With COVID-19.

Phase 1
Completed
Conditions
Viral Disease
Interventions
Drug: Placebo
First Posted Date
2020-09-01
Last Posted Date
2023-05-03
Lead Sponsor
Pfizer
Target Recruit Count
26
Registration Number
NCT04535167
Locations
πŸ‡ΊπŸ‡Έ

UC Davis Medical Center, Sacramento, California, United States

πŸ‡ΊπŸ‡Έ

Massachusetts General Hospital Translational and Clinical Research Center, Boston, Massachusetts, United States

πŸ‡§πŸ‡ͺ

University Hospital Brugmann, Brussels, Belgium

and more 10 locations

ACTIV-3: Therapeutics for Inpatients With COVID-19

Phase 3
Completed
Conditions
Covid19
Interventions
Biological: LY3819253
Drug: Placebo
Biological: Remdesivir
Biological: VIR-7831
Biological: BRII-196/BRII-198
Biological: AZD7442
First Posted Date
2020-08-06
Last Posted Date
2023-08-25
Lead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Target Recruit Count
2753
Registration Number
NCT04501978
Locations
πŸ‡ΊπŸ‡Έ

University of Maryland Medical Center (Site 301-019), 22 South Greene Street, Baltimore, Maryland, United States

πŸ‡ΊπŸ‡Έ

Ronald Reagan UCLA Medical Center (Site 203-002), 757 Westwood Plaza, Los Angeles, California, United States

πŸ‡ΊπŸ‡Έ

Lutheran Medical Group (Site 301-010), 7916 W. Jefferson Boulevard, Fort Wayne, Indiana, United States

and more 132 locations
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