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Review
. 2022 Apr;82(5):585-591.
doi: 10.1007/s40265-022-01692-5.

Nirmatrelvir Plus Ritonavir: First Approval

Yvette N Lamb  1
Affiliations
Review

Nirmatrelvir Plus Ritonavir: First Approval

Yvette N Lamb. Drugs. 2022 Apr.

Erratum in

Abstract

Nirmatrelvir plus ritonavir (Paxlovid™; Pfizer) is a co-packaged combination of nirmatrelvir and ritonavir tablets, intended for co-administration and developed for the treatment and post-exposure prophylaxis of coronavirus disease 2019 (COVID-19). Nirmatrelvir is a peptidomimetic inhibitor of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) main protease, while ritonavir is a human immunodeficiency virus type 1 (HIV-1) protease inhibitor and CYP3A inhibitor. Nirmatrelvir plus ritonavir received its first conditional authorization in December 2021 in the United Kingdom, for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at increased risk for progression to severe COVID-19. In January 2022, nirmatrelvir plus ritonavir received authorization in the EU for use in the same indication. Nirmatrelvir plus ritonavir is authorized for emergency use in the USA. This article summarizes the milestones in the development of nirmatrelvir plus ritonavir leading to its first authorizations and approval for the treatment of COVID-19.

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Conflict of interest statement

During the peer review process the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from any comments received were made by the authors on the basis of scientific completeness and accuracy. Yvette Lamb is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All authors contributed to the review and are responsible for the article content.

Figures

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Key milestones in the development of nirmatrelvir plus ritonavir. CHMP Committee for Medicinal Products for Human Use, COVID-19 coronavirus disease 2019, EUA emergency use authorization, SARS-CoV-2 severe acute respiratory syndrome coronavirus 2
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Chemical structure of nirmatrelvir
See this image and copyright information in PMC

References

    1. Pfizer. NCT05047601. A study of a potential oral treatment to prevent COVID-19 in adults who are exposed to household member(s) with a confirmed symptomatic COVID-19 infection. 2022. https://www.clinicaltrials.gov/. Accessed 21 Feb 2022.
    1. Pfizer. NCT05011513. Evaluation of protease inhibition for COVID-19 in standard-risk patients (EPIC-SR). 2022. https://www.clinicaltrials.gov/. Accessed 21 Feb 2022.
    1. Pfizer. NCT04960202. EPIC-HR: study of oral PF-07321332/ritonavir compared with placebo in nonhospitalized high risk adults with COVID-19. 2022. https://www.clinicaltrials.gov/. Accessed 21 Feb 2022.
    1. Fenton C, Lamb YN. COVID-19: state of the vaccination. Drugs Ther Perspect. 2021;37:508–518. doi: 10.1007/s40267-021-00869-4. - DOI - PMC - PubMed
    1. Lamb YN. BNT162b2 mRNA COVID-19 vaccine: first approval. Drugs. 2021;81:495–501. doi: 10.1007/s40265-021-01480-7. - DOI - PMC - PubMed