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← All drugs Report issue

nirmatrelvir

Trade name: Paxlovid

Small moleculeapprovedFast Track FDA

Approved

May 25, 2023

Clinical trial activity

49 trials · 39 clinical orgs · 1 marketing orgs

Phase 1
21
Phase 2
18
Phase 3
12
Phase 4
6

Earliest trial started Feb 11, 2021 (NCT04756531)

Timeline

2020s

  1. Jan 1, 2021

    Pfizer — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2021

    Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2022

    Pfizer — Earliest Phase 2 Sponsor(trial)

  4. May 25, 2023

    Pfizer — Earliest FDA Approval

  5. May 25, 2023

    Pfizer — NDA Secondary Org

  6. May 25, 2023

    Pfizer — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • paxlovid (copackaged)

    with ritonavir

    Also known as nirmatrelvir and ritonavir, nirmatrelvir, ritonavir

Approval history

  • approvedPriority reviewFast trackMay 25, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)(C)[C@H](NC(=O)C(F)(F)F)C(=O)N1C[C@H]2[C@@H]([C@H]1C(=O)N[C@H](C#N)C[C@@H]1CCNC1=O)C2(C)C
Mol. weight
499.53 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07157007Phase 2Sep 30, 2025Traws Pharma, Inc.
NCT06397144Phase 1Feb 14, 2025Pfizer
NCT06792214Phase 4Jan 3, 2025Kingston Health Sciences Centre, Niagara Health System, Unity Health Toronto, University of Toronto
NCT06441955Phase 4Mar 1, 2024Well- Konnect Healthcare Services and Research Firm
NCT05965726Phase 2Jul 26, 2023Duke University
NCT05938140Phase 4Jun 22, 2023People's Liberation Army of China
NCT05898672Phase 1Jun 9, 2023Pfizer
NCT05852873Phase 3May 12, 2023Norwegian University of Science and Technology, University of Bergen, University of Oslo
NCT05823896Phase 2May 1, 2023Karolinska Institute, Pfizer
NCT05690646Phase 4Jan 28, 2023Chinese Academy of Medical Sciences
NCT05668091Phase 2Jan 23, 2023Pfizer, Yale University
NCT05697055Phase 4Jan 21, 2023Gansu Provincial Hospital, People's Hospital of Rizhao, Shandong first medical University, Shandong Province Qianfoshan Hospital, Shandong Provincial Hospital, Southwest Medical University
NCT05595369Phase 3Jan 17, 2023Duke University
NCT05682586Phase 3Jan 9, 2023Huazhong University of Science and Technology
NCT05614349Phase 3Dec 31, 2022Canadian Institutes of Health Research (CIHR), Health Canada, Unity Health Toronto
NCT05545319Phase 2Dec 13, 2022Pfizer
NCT05441215Phase 1Dec 12, 2022Pfizer
NCT05576662Phase 2Nov 8, 2022Pfizer, Stanford University
NCT05587894Phase 2/Phase 3 (Phase 3)Oct 31, 2022Government of France, University of Geneva
NCT05567952Phase 2Oct 19, 2022Pfizer
Showing 20 of 49 trials
Page 1 / 3

Organizations

Research & Development (39)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
PfizerFor profit292632021
Jiao Tong UniversityAcademic/Hospital3232022
Duke UniversityAcademic/Hospital2222023
Unity Health TorontoAcademic/Hospital2122022
Agenzia Italiana del FarmacoGovernment1012022
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012022
Chinese Academy of Medical SciencesAcademic/Hospital1112023
EVA pharma, EgyptFor profit1012022
Gansu Provincial HospitalAcademic/Hospital1012023
Genuine Research Center, EgyptFor profit1112022
Government of ChinaGovernment1112022
Government of FranceGovernment1112022
Health CanadaAcademic/Hospital1012022
Huazhong University of Science and TechnologyAcademic/Hospital1112023
Karolinska InstituteAcademic/Hospital1112023
Kingston Health Sciences CentreAcademic/Hospital1012025
Moscow State Clinical Hospital №50Academic/Hospital1012021
Niagara Health SystemAcademic/Hospital1012025
Norwegian University of Science and TechnologyAcademic/Hospital1012023
People's Hospital of RizhaoAcademic/Hospital1012023
39 organizations
Page 1 / 2

Marketing (2)

OrganizationOrg typeRelationshipDate
PfizerFor profitNDA2May 25, 2023
PfizerFor profitNDAMay 25, 2023