Nirmatrelvir
- Generic Name
- Nirmatrelvir
- Brand Names
- Paxlovid
- Drug Type
- Small Molecule
- Chemical Formula
- C23H32F3N5O4
- CAS Number
- 2628280-40-8
- Unique Ingredient Identifier
- 7R9A5P7H32
- Background
Nirmatrelvir (PF-07321332) is an orally bioavailable 3C-like protease (3CL) inhibitor that is the subject of clinical trial NCT04756531. 3CL is responsible for cleaving polyproteins 1a and 1ab of SARS-CoV-2. Without the activity of the SARS-CoV-2 3CL, nonstructural proteins (including proteases) cannot be released to perform their functions, inhibiting viral...
- Indication
In the US, Europe, and Canada, nirmatrelvir, in combination with ritonavir, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. In Europe, this therapeutic indication is approved under conditional marketing authorization.
- Associated Conditions
- Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)
- Associated Therapies
- -
A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults With Long COVID.
- First Posted Date
- 2022-12-29
- Last Posted Date
- 2024-12-02
- Lead Sponsor
- Harlan M Krumholz
- Target Recruit Count
- 100
- Registration Number
- NCT05668091
- Locations
- 🇺🇸
Yale University, New Haven, Connecticut, United States
Paxlovid for Treatment of Long Covid
- Conditions
- Interventions
- First Posted Date
- 2022-10-12
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- Stanford University
- Target Recruit Count
- 168
- Registration Number
- NCT05576662
- Locations
- 🇺🇸
Stanford University, Stanford, California, United States
A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir
- Conditions
- Interventions
- First Posted Date
- 2022-10-05
- Last Posted Date
- 2024-10-08
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 436
- Registration Number
- NCT05567952
- Locations
- 🇺🇸
University of Massachusetts Chan Medical School, Worcester, Massachusetts, United States
🇺🇸Mercury Street Medical Group, PLLC, Butte, Montana, United States
🇺🇸Global Health Clinical Trials, Miami, Florida, United States
A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19
- First Posted Date
- 2022-09-19
- Last Posted Date
- 2023-03-01
- Lead Sponsor
- Pfizer
- Registration Number
- NCT05545319
- Locations
- 🇧🇬
Multiprofile Hospital for Active Treatment - Sveti Nikolay Chudotvoretz, Lom, Montana, Bulgaria
🇧🇬Specialized Hospital for Active Treatment of Pneumo-Phthisiatric Diseases - Haskovo EOOD, Haskovo, Bulgaria
🇧🇬"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD, Pleven, Bulgaria
A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women
- First Posted Date
- 2022-07-01
- Last Posted Date
- 2024-04-03
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 8
- Registration Number
- NCT05441215
- Locations
- 🇧🇪
Pfizer Clinical Research Unit - Brussels, Brussels, Bruxelles-capitale, Région DE, Belgium
A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System
- Conditions
- Interventions
- First Posted Date
- 2022-06-30
- Last Posted Date
- 2024-01-25
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 157
- Registration Number
- NCT05438602
- Locations
- 🇨🇦
Diex Recherche Sherbrooke Inc., Sherbrooke, Quebec, Canada
🇺🇸Emory University School of Medicine, Atlanta, Georgia, United States
🇧🇷IBPClin - Instituto Brasil de Pesquisa ClÃnica, Rio de Janeiro, Brazil
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19
- First Posted Date
- 2022-05-23
- Last Posted Date
- 2024-10-14
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 49
- Registration Number
- NCT05386472
- Locations
- 🇺🇸
University of Alabama at Birmingham Women & Infant Center, Birmingham, Alabama, United States
🇺🇸University of Alabama at Birmingham/Center for Women's Reproductive Health, Birmingham, Alabama, United States
🇺🇸Abby's Research institute, Phoenix, Arizona, United States
EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease
- First Posted Date
- 2022-03-02
- Last Posted Date
- 2024-11-18
- Lead Sponsor
- Pfizer
- Target Recruit Count
- 160
- Registration Number
- NCT05261139
- Locations
- 🇺🇸
University of Alabama at Birmingham - School of Medicine, Birmingham, Alabama, United States
🇺🇸Phoenix Children's Hospital, Phoenix, Arizona, United States
🇺🇸Arkansas Children's Hospital, Little Rock, Arkansas, United States
Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV)
- Conditions
- Interventions
- Drug: Nirmatrelvir/ritonavir (e.g. PAXLOVIDâ„¢)Drug: NitazoxanideDrug: Molnupiravir and nirmatrelvir/ritonavir (e.g. PAXLOVIDâ„¢)Drug: HydroxychloroquineOther: No treatmentDrug: Monoclonal antibodiesDrug: FluoxetineDrug: MolnupiravirDrug: SotrovimabDrug: EnsitrelvirDrug: FavipiravirDrug: IvermectinDrug: RemdesivirDrug: Atilotrelvir/ritonavirDrug: MetforminDrug: Nirmatrelvir/ritonavirDrug: Nirmatrelvir
- First Posted Date
- 2021-09-13
- Last Posted Date
- 2024-10-28
- Lead Sponsor
- University of Oxford
- Target Recruit Count
- 3800
- Registration Number
- NCT05041907
- Locations
- 🇳🇵
Sukraraj Tropical & Infectious Disease Hospital, Kathmandu, Nepal
🇧🇷Universidade Federal de Minas Gerais, Minas Gerais, Brazil
🇱🇦Laos-Oxford-Mahosot Wellcome Trust Research Unit, Vientiane, Lao People's Democratic Republic
Drug Development Updates
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