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Nirmatrelvir and ritonavir stage 1
Nirmatrelvir inhibits the SARS-CoV-2 main protease to prevent viral replication, while ritonavir boosts nirmatrelvir levels by inhibiting its metabolism.
Nirmatrelvir inhibits the SARS-CoV-2 main protease to prevent viral replication, while ritonavir boosts nirmatrelvir levels by inhibiting its metabolism. Used for COVID-19 (treatment of mild to moderate disease in adults at high risk of progression to severe disease).
At a glance
| Generic name | Nirmatrelvir and ritonavir stage 1 |
|---|---|
| Also known as | small dose |
| Sponsor | RenJi Hospital |
| Drug class | Protease inhibitor |
| Target | SARS-CoV-2 3CL protease (main protease) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Nirmatrelvir is a protease inhibitor that binds to and blocks the 3CL protease (main protease) of SARS-CoV-2, preventing the cleavage of viral polyproteins necessary for viral replication. Ritonavir, a CYP3A4 inhibitor, is co-administered as a pharmacokinetic booster to increase nirmatrelvir plasma concentrations and extend its half-life, allowing for lower and more practical dosing.
Approved indications
- COVID-19 (treatment of mild to moderate disease in adults at high risk of progression to severe disease)
Common side effects
- Dysgeusia (taste disturbance)
- Diarrhea
- Nausea
- Headache
- Vomiting
Key clinical trials
- Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (PHASE2)
- AGILE (Early Phase Platform Trial for COVID-19) (PHASE1, PHASE2)
- A Study on 2 Different Combination Tablets of Nirmatrelvir Plus Ritonavir to Compare Them With Marketed Paxlovid in Healthy Participants (PHASE1)
- A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19 (PHASE1)
- 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 (PHASE3)
- EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 (PHASE2, PHASE3)
- Relative Bioavailability Study of 4 Different Formulations of PF-07321332 Relative to the Commercial Tablet Formulation (PHASE1)
- A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID. (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nirmatrelvir and ritonavir stage 1 CI brief — competitive landscape report
- Nirmatrelvir and ritonavir stage 1 updates RSS · CI watch RSS
- RenJi Hospital portfolio CI