Overview
Nirmatrelvir (PF-07321332) is an orally bioavailable 3C-like protease (3CL) inhibitor that is the subject of clinical trial NCT04756531. 3CL is responsible for cleaving polyproteins 1a and 1ab of SARS-CoV-2. Without the activity of the SARS-CoV-2 3CL, nonstructural proteins (including proteases) cannot be released to perform their functions, inhibiting viral replication. In 2020, Pfizer was investigating another potential treatment for SARS-CoV-2, PF-07304814. Both drugs were inhibitors of SARS-CoV-2 3CL, but nirmatrelvir has the advantage of being orally bioavailable. Nirmatrelvir is advantageous in that it can be prescribed to patients before they require hospitalization, while PF-07304814 requires intravenous administration in hospital. In December 2021, the FDA granted an emergency use authorization to Paxlovid, a co-packaged product containing both nirmatrelvir and ritonavir, for the treatment of certain patients with mild-to-moderate COVID-19. It was fully approved by the FDA on May 25, 2023. Paxlovid was approved for use in Canada in January 2022 for the treatment of adult patients with mild-moderate COVID-19 and later granted conditional marketing authorization by the European Commission on January 27, 2022.
Indication
In the US, Europe, and Canada, nirmatrelvir, in combination with ritonavir, is indicated for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults who are at high risk for progression to severe COVID-19, including hospitalization or death. In Europe, this therapeutic indication is approved under conditional marketing authorization.
Associated Conditions
- Mild, moderate Novel Coronavirus Infectious Disease (COVID-19)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/01/24 | Phase 4 | Recruiting | |||
2024/06/04 | Phase 4 | Recruiting | Well- Konnect Healthcare Services and Research Firm | ||
2024/05/02 | Phase 1 | Not yet recruiting | |||
2023/08/18 | N/A | Withdrawn | |||
2023/07/10 | Phase 4 | Recruiting | Chinese PLA General Hospital | ||
2023/06/12 | Phase 1 | Completed | |||
2023/06/08 | N/A | Active, not recruiting | |||
2023/05/10 | Phase 3 | Recruiting | Haukeland University Hospital | ||
2023/04/21 | Phase 2 | Completed | |||
2023/04/14 | Not Applicable | Completed | Xiangao Jiang |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 1/28/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PAXLOVID FILM-COATED TABLETS | SIN16877P | TABLET, FILM COATED | 150 mg | 10/2/2023 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack | 389801 | Medicine | A | 7/20/2022 | |
| PAXLOVID nirmatrelvir 150 mg tablet and ritonavir 100 mg tablet blister composite pack | 377572 | Medicine | A | 1/20/2022 |
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