Drugs / Nirmatrelvir
Nirmatrelvir
also known as
PF-07321332 · Nirmatrelvir component of paxlovid · Nirmatrelvir/r · Nirmatrevlir · Paxlovid
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed COVID-19 1 milestone | |||||
| Filed | US (FDA) | PAXLOVID | COVID-19 | 2022-06-30 | “today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of PAXLOVID™” pfizer.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | US (FDA) | PAXLOVID (COPACKAGED) | — | 2023-05-25 | fda.gov ↗ |
| Approved | EU (EMA) | Paxlovid | — | 2022-01-28 | europa.eu ↗ |
Trials 45
| 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| Phase 1 | NCT06397144 | Aug → Dec 2025 | — | Pfizer | Withdrawn | No outcome recorded Stop: Business |
| 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 Stop: Enrollment |
| 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| Phase 1 | NCT05178654 | Feb → Apr 2022 | — | Pfizer | Withdrawn | No outcome recorded |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 · 1 missed | ||||||
| Phase 1/2 | NCT04746183 | Jul 2020 → Mar 2027 expected | COVID-19 | University of Liverpool | Recruiting | Missed primary |
| Phase 210 trials · 1 met primary · 3 missed | ||||||
| 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 | Missed primary |
| 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 | Missed primary |
| 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 | Missed primary |
| Phase 2 | NCT05567952 | Oct 2022 → Sep 2023 | COVID-19 | Pfizer | Completed | Met primary |
| Phase 2 | NCT05438602 | Aug 2022 → Jul 2023 | COVID-19 | Pfizer | Completed | No outcome recorded |
| Phase 2/33 trials · 1 met primary · 2 missed | ||||||
| Phase 2/3 | NCT05047601 | Sep 2021 → Apr 2022 | COVID-19 | Pfizer | Completed | Missed primary |
| Phase 2/3 | NCT05011513 | Aug 2021 → Jul 2022 | COVID-19 | Pfizer | Terminated | Missed primary Stop: Enrollment |
| Phase 2/3 | NCT04960202 | Jul → Dec 2021 | COVID-19 | Pfizer | Completed | Met primary |
| Phase 37 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05614349 | Jan 2023 → Apr 2025 overdue | COVID-19 | Unity Health Toronto | Active not recruiting | Missed primary |
| Phase 3 | NCT05341609 | Apr → May 2022 | COVID-19 | Vigonvita Life Sciences | Completed | Met primary |
| Phase 3 | NCT05261139 | Mar 2022 → Jul 2026 overdue | COVID-19 | Pfizer | Recruiting | No outcome recorded |
| Phase 3 | NCT05321394 | Mar 2022 → Oct 2023 | COVID-19 | Azienda Ospedaliera Universitaria Integrata Verona | Completed | 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 | Mixed |
| 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 applicable2 trials | ||||||
| — | NCT06610643 | Sep 2024 → Sep 2026 overdue | COVID-19, immunodeficiency disease | National Taiwan University Hospital | Not yet recruiting | No outcome recorded |
| — | NCT05813600 | Aug → Dec 2022 | — | Xiangao Jiang | Completed | No outcome recorded |
| Comparator or background therapy9 trials | ||||||
| Phase 1 | NCT05544786 Comparator | Sep → Nov 2022 | — | Pfizer | Completed | No outcome recorded |
| 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 | Mixed |
| 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 | Met primary Stop: Enrollment |
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| 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 |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2023-05-25 | Pfizer | Regulatory Pfizer’s PAXLOVID™ Receives FDA Approval for Adult Patients at High Risk of Progression to Severe COVID-19 pfizer.com ↗ |
| 2023-03-16 | Pfizer | Regulatory FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™ pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness. |
| 2022-12-29 | Shanghai Junshi Bioscience Co., Ltd. | Results 君实生物宣布《新英格兰医学杂志》发表口服抗新冠病毒药物VV116对比PAXLOVID治疗伴有高风险因素的轻/中度COVID-19患者III期临床研究结果 junshipharma.com ↗
在FAS人群中，VV116与PAXLOVID在“至持续临床恢复的时间”达到非劣效（HR=1.17，95%CI：1.02~1.36），且VV116组比PAXLOVID组的中位恢复时间更短（4天 vs. 5天）。 |
| 2022-06-30 | Pfizer | Regulatory Pfizer Announces Submission of New Drug Application to the U.S. FDA for PAXLOVID™ pfizer.com ↗
The submission provides the longer-term follow-up data necessary for acceptance and potential approval. |
| 2022-06-14 | Pfizer | Results Pfizer Reports Additional Data on PAXLOVID™ Supporting Upcoming New Drug Application Submission to U.S. FDA pfizer.com ↗
Pre-specified secondary endpoint resulted in a nominally significant 62% decrease in COVID-19-related medical visits per day across all patients, relative to placebo |
| 2022-01-27 | Pfizer | Regulatory Pfizer Receives CHMP Positive Opinion for Novel COVID-19 Oral Treatment pfizer.com ↗
CHMP recommends PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) for use in adults with COVID-19 |
| 2022-01-18 | Pfizer | Results Pfizer Shares In Vitro Efficacy of Novel COVID-19 Oral Treatment Against Omicron Variant pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today shared results from multiple studies demonstrating that the in vitro efficacy of nirmatrelvir, the active main protease (M pro ) inhibitor of PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets), is maintained against the SARS-CoV-2 variant Omicron. |
| 2021-12-22 | Pfizer | Regulatory Pfizer Receives U.S. FDA Emergency Use Authorization for Novel COVID-19 Oral Antiviral Treatment pfizer.com ↗
PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) is authorized for emergency use in both high-risk adults and high-risk pediatric patients 12 years of age and older weighing at least 40 kg |
| 2021-12-16 | Pfizer | Regulatory EMA Issues Advice for Potential Early Use of Pfizer’s Novel COVID-19 Oral Antiviral Candidate pfizer.com ↗
The CHMP also recommend that PAXLOVID should be administered as soon as possible after diagnosis of COVID-19 and within five days of the start of symptoms. |
| 2021-12-14 | Pfizer | Results Pfizer Announces Additional Phase 2/3 Study Results Confirming Robust Efficacy of Novel COVID-19 Oral Antiviral Treatment Candidate in Reducing Risk of Hospitalization or Death pfizer.com ↗ |
| 2021-11-16 | Pfizer | Regulatory Pfizer Seeks Emergency Use Authorization for Novel COVID-19 Oral Antiviral Candidate pfizer.com ↗
Pfizer Inc. today announced it is seeking Emergency Use Authorization (EUA) of its investigational oral antiviral candidate, PAXLOVID™ (PF-07321332; ritonavir), for the treatment of mild to moderate COVID-19 in patients at increased risk of hospitalizations or death. |
| 2021-11-05 | Pfizer | Results Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study pfizer.com ↗
PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19 |
All press releases naming this drug 21 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 56 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 ↗ “Paxlovid (Nirmatrelvir+ Ritonavir , boosted 3CL-protease inhibitor)” NCT07157007 ↗ “A combination of 5-day remdesivir and 10-day Nirmatrelvir/Ritonavir” NCT06610643 ↗ “Nirmatrelvir 300mg and ritonavir 100mg taken BID (twice a day)” NCT05965726 ↗ |
| 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 |