Drugs / Nirmatrelvir
Nirmatrelvir
also known as
PF-07321332 · Paxlovid · Nirmatrelvir component of paxlovid · Nirmatrelvir/r · Nirmatrevlir
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | PAXLOVID (COPACKAGED) | — | 2023-05-25 | fda.gov ↗ |
| Approved | EU (EMA) | Paxlovid | — | 2022-01-28 | europa.eu ↗ |
Trials 46 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05386433 | Jun → Jul 2022 | COVID-19, uremia | Ruijin Hospital | Unknown | No outcome recorded |
| Phase 118 trials | ||||||
| Phase 1 | NCT06397144 | Aug → Dec 2025 | — | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT05898672 | Jun → Aug 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05441215 | Dec 2022 → Dec 2023 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05487040 | Sep 2022 → Jul 2023 | COVID-19 | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT05525910 | Aug → Nov 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05386472 | Jun 2022 → Mar 2025 | COVID-19 | Pfizer | Terminated | No outcome recorded |
| Phase 1 | NCT05339334 | Mar → Apr 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05263921 | Mar → May 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05263895 | Mar → May 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05178654 | Feb → Apr 2022 | — | Pfizer | Withdrawn | No outcome recorded |
| Phase 1 | NCT05129475 | Nov 2021 → Jan 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05064800 | Sep → Dec 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05032950 | Sep → Dec 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05005312 | Aug → Dec 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04962022 | Jul → Sep 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04962230 | Jul → Oct 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04909853 | Jun → Oct 2021 | impaired renal function disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04756531 | Feb → Sep 2021 | — | Pfizer | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04746183 | Jul 2020 → Mar 2027 expected | COVID-19 | University of Liverpool | Recruiting | No outcome recorded |
| Phase 210 trials | ||||||
| Phase 2 | NCT07597902 | Jun 2026 → Jun 2028 expected | long COVID-19 | Icahn School of Medicine at Mount Sinai | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05965726 | Jul 2023 → Dec 2024 | long COVID-19 | Kanecia Obie Zimmerman | Completed | No outcome recorded |
| Phase 2 | NCT05595369 | Jul 2023 → Aug 2024 | long COVID-19 | Kanecia Obie Zimmerman | Completed | No outcome recorded |
| Phase 2 | NCT05587894 | Apr 2023 → Jun 2026 overdue | COVID-19, immunodeficiency disease | ANRS, Emerging Infectious Diseases | Recruiting | No outcome recorded |
| Phase 2 | NCT07406217 | Apr 2023 → Apr 2026 overdue | COVID-19, immunodeficiency disease | Calmy Alexandra | Recruiting | No outcome recorded |
| Phase 2 | NCT05668091 | Apr 2023 → Apr 2024 | long COVID-19 | Harlan M Krumholz | Completed | No outcome recorded |
| Phase 2 | NCT05545319 | Dec 2022 → Sep 2023 | COVID-19, immunodeficiency disease | Pfizer | Withdrawn | No outcome recorded |
| Phase 2 | NCT05576662 | Nov 2022 → Aug 2023 | long COVID-19 | Stanford University | Completed | No outcome recorded |
| Phase 2 | NCT05567952 | Oct 2022 → Sep 2023 | COVID-19 | Pfizer | Completed | No outcome recorded |
| Phase 2 | NCT05438602 | Aug 2022 → Jul 2023 | COVID-19 | Pfizer | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05047601 | Sep 2021 → Apr 2022 | COVID-19 | Pfizer | Completed | No outcome recorded |
| Phase 2/3 | NCT05011513 | Aug 2021 → Jul 2022 | COVID-19 | Pfizer | Terminated | No outcome recorded |
| Phase 2/3 | NCT04960202 | Jul → Dec 2021 | COVID-19 | Pfizer | Completed | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05614349 | Jan 2023 → Apr 2025 overdue | COVID-19 | Unity Health Toronto | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05341609 | Apr → May 2022 | COVID-19 | Vigonvita Life Sciences | Completed | No outcome recorded |
| Phase 3 | NCT05321394 | Mar 2022 → Oct 2023 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Completed | No outcome recorded |
| Phase 3 | NCT05261139 | Mar 2022 → Jul 2026 overdue | COVID-19 | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05601167 | Feb 2021 → Jun 2022 | COVID-19 | Promomed, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04483960 | Jul 2020 → Jul 2025 | COVID-19 | University of Melbourne | Unknown | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05938140 | Jun 2023 → May 2025 | COVID-19, chronic kidney disease | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05690646 | Jan → Mar 2023 | — | China National Center for Cardiovascular Diseases | Unknown | No outcome recorded |
| Phase 4 | NCT05366192 | May → Jun 2022 | — | RenJi Hospital | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06610643 | Sep 2024 → Sep 2026 expected | COVID-19, immunodeficiency disease | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05813600 | Aug → Dec 2022 | — | Xiangao Jiang | Completed | No outcome recorded |
| — | NCT05532852 | Jul 2022 → Jun 2023 | pneumonia | Ruijin Hospital | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05544786 Comparator | Sep → Nov 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07157007 Comparator | Sep 2025 → Feb 2026 overdue | COVID-19 | Traws Pharma, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05823896 Comparator | May 2023 → Nov 2024 | COVID-19, long COVID-19, post-infectious syndrome, postural orthostatic tachycardia syndrome | Karolinska Institutet | Completed | No outcome recorded |
| Phase 2 | NCT05041907 Comparator | Sep 2021 → Jan 2027 expected | COVID-19 | University of Oxford | Recruiting | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT05852873 Comparator | May 2023 → Sep 2025 overdue | COVID-19, post-COVID-19 disorder | Haukeland University Hospital | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05271929 Background | Apr 2022 → Jan 2024 | COVID-19 | German Red Cross Blood Transfusion Service Baden-Württemberg-Hessen | Terminated | No outcome recorded |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06441955 Comparator | Mar 2024 → Sep 2030 expected | long COVID-19 | Well- Konnect Healthcare Services and Research Firm | Recruiting | No outcome recorded |
| Phase 4 | NCT05697055 Comparator | Jan → May 2023 | COVID-19 | Shandong Provincial Hospital | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05642910 Comparator | Oct 2022 → Jan 2023 | COVID-19 | Southeast University, China | Unknown | No outcome recorded |
Press releases naming this drug 6 releases
| Date | Issuer | Release |
|---|---|---|
| 2023-10-13 | Pfizer | Pfizer Amends U.S. Government Paxlovid Supply Agreement and Updates Full-Year 2023 Guidance pfizer.com ↗ |
| 2023-05-25 | Pfizer | Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19 pfizer.com ↗ |
| 2023-03-16 | Pfizer | FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™ pfizer.com ↗ |
| 2022-09-22 | Pfizer | Pfizer to Supply Global Fund Up to 6 Million PAXLOVID™ Treatment Courses for Low-and-Middle-Income Countries pfizer.com ↗ |
| 2022-06-30 | Pfizer | Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID™ pfizer.com ↗ |
| 2022-06-14 | Pfizer | Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA pfizer.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 58 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | nirmatrelvir | “Participants were randomly assigned to receive usual care plus nirmatrelvir (300 mg)-ritonavir (100 mg) twice a day for 5 days or to receive usual care alone.” PMID 42019019 ↗ Apr 202638“The purpose of this study is to learn about the bioequivalence of nirmatrelvir plus ritonavir after taking 2 different combination tablet forms by mouth.” NCT06397144 ↗ “Nirmatrelvir/r is a combination of two molecules: nirmatrelvir which is a protease inhibitor (against 3CL) and ritonavir which has a booster role.” NCT07406217 ↗ “Nirmatrelvir (PF-07321332), the first orally bioavailable, severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) Mpro inhibitor” PMID 35388471 ↗ May 2022 “Nirmatrelvir (PF-07321332) has demonstrated antiviral activity and an acceptable safety profile in clinical studies.” PMID 42090083 ↗ May 2026 “one (100mg ritonavir tablet and two 150mg nirmatrelvir tablets) taken orally in the morning and evening” NCT07597902 ↗ “Paxlovid® (300mg nirmatrelvir + ritonavir 100mg) twice a day (BD) for 5 days.” NCT04746183 ↗ “Day 1\~5: 300 mg of Nirmatrelvir and 100 mg of ritonavir, Q12H X 5 days” NCT05341609 ↗ “A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir” NCT06610643 ↗ “Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)” NCT07157007 ↗ “Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day)” NCT05965726 ↗ “Paxlovid contains two medicines: nirmatrelvir and ritonavir.” NCT05386433 ↗ “Paxlovid (nirmatrelvir 300mg, ritonavir 100mg) bid x 25 days” NCT05595369 ↗ “300 mg nirmatrelvir and 100 mg ritonavir twice daily” PMID 40383127 ↗ May 2025 |
| Known as | Nirmatrelvir component of paxlovid | ChEMBL registry synonym — accepted as the source's own label CHEMBL4802135 ↗ |
| Known as | Nirmatrelvir/r | “Nirmatrelvir/r (marketed by Pfizer under the brand name Paxlovid®) is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at...” NCT05587894 ↗ |
| Known as | Nirmatrevlir | “Nirmatrevlir / Ritonavir (Paxlovid)” NCT05271929 ↗ |
| Known as | Paxlovid | “Nirmatrelvir/r (marketed by Pfizer under the brand name Paxlovid®) is indicated for the treatment of COVID-19 in adults who do not require supplemental oxygen and who are at...” NCT05587894 ↗ |
| Known as | PF-07321332 | “A PHASE 1, RANDOMIZED, FIXED SEQUENCE, MULTIPLE-DOSE, OPEN-LABEL STUDY TO ESTIMATE THE EFFECT OF NIRMATRELVIR (PF-07321332)/RITONAVIR ON ROSUVASTATIN PHARMACOKINETICS IN...” NCT05898672 ↗18“Nirmatrelvir (PF-07321332) has demonstrated antiviral activity and an acceptable safety profile in clinical studies.” PMID 42090083 ↗ May 2026 “Nirmatrelvir \[PF-07321332\] is a SARS-CoV-2 main protease (Mpro) inhibitor” NCT05386433 ↗ “Nirmatrelvir (PF-07321332) /RITONAVIR ORAL POWDER” NCT05544786 ↗ “PF-07321332 (nirmatrelvir)/ritonavir” NCT05487040 ↗ |
| Action | Inhibit | “Nirmatrelvir (PF-07321332), the first orally bioavailable, severe acute respiratory syndrome-coronavirus 2 (SARS-CoV-2) Mpro inhibitor” PMID 35388471 ↗ May 2022 |
| Modality | Small molecule | “A. Small molecule drugs: currently nitazoxanide, nirmatrelvir/ritonavir, hydroxychloroquine, atilotrelvir/ritonavir and metformin.” NCT05041907 ↗ |
| Route | Oral | “oral antivirals” PMID 40383127 ↗ May 2025 |