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nirmatrelvir 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals | 5520 | 2628280-40-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Nirmatrelvir plus ritonavir (Paxlovid) is an antiviral therapeutic developed by Pfizer for the treatment and post-exposure prophylaxis of coronavirus disease 2019 (COVID-19). It received conditional approval by EMA, FDA and PMDA. Nirmatrelvir (PF-07321332) is a peptidomimetic inhibitor of the SARS-CoV-2 main protease (Mpro), also referred to as 3C-like protease (3CLpro) or nsp5 protease. Inhibition of the SARS-CoV-2 Mpro renders the protein incapable of processing polyprotein precursors which leads to the prevention of viral replication. Ritonavir inhibits the CYP3A-mediated metabolism of PF-07321332, thereby providing increased plasma concentrations of PF-07321332.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.60 | g | O |
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | CDK5,EIF2AK3,GRK2,PDK1,PDK2,PDK4 | 6 | |||
| kinase-selectivity-class | PDK1 | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| May 25, 2023 | FDA | Pfizer, Inc. | |
| Jan. 28, 2022 | EMA | Pfizer Europe MA EEIG | |
| Feb. 10, 2022 | PMDA | PFIZER JAPAN INC |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug interaction | 249.28 | 109.32 | 78 | 352 | 276375 | 90351642 |
| Toxicity to various agents | 141.74 | 109.32 | 52 | 378 | 287794 | 90340223 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug interaction | 281.30 | 97.32 | 107 | 412 | 266892 | 42353924 |
| Immunosuppressant drug level increased | 161.52 | 97.32 | 33 | 486 | 7698 | 42613118 |
| Toxicity to various agents | 146.34 | 97.32 | 65 | 454 | 229071 | 42391745 |
| Acute kidney injury | 106.08 | 97.32 | 61 | 458 | 367276 | 42253540 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Drug interaction | 517.92 | 98.70 | 183 | 806 | 500000 | 110088310 |
| Toxicity to various agents | 277.17 | 98.70 | 116 | 873 | 480439 | 110107871 |
| Immunosuppressant drug level increased | 259.75 | 98.70 | 50 | 939 | 11674 | 110576636 |
| Acute kidney injury | 176.63 | 98.70 | 93 | 896 | 635337 | 109952973 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AE30 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Protease inhibitors |
| MeSH PA | D000084762 | Viral Protease Inhibitors |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D011480 | Protease Inhibitors |
| CHEBI has role | CHEBI:147285 | EC 3.4.22.69 (SARS coronavirus main proteinase) inhibitor |
| CHEBI has role | CHEBI:149553 | anticoronaviral agent |
| CHEBI has role | CHEBI:35660 | HIV protease inhibitor |
Related Drugs by ATC class:
J05AE Protease inhibitors 10 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| COVID-19 | indication | 840539006 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 150MG;100MG | PAXLOVID (COPACKAGED) | PFIZER | N217188 | May 25, 2023 | RX | TABLET | ORAL | 11351149 | Aug. 5, 2041 | 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 |
| 150MG;100MG | PAXLOVID (COPACKAGED) | PFIZER | N217188 | May 25, 2023 | RX | TABLET | ORAL | 11541034 | Oct. 31, 2041 | 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 |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 150MG;100MG | PAXLOVID (COPACKAGED) | PFIZER | N217188 | May 25, 2023 | RX | TABLET | ORAL | Jan. 31, 2028 | NEW DOSING RECOMMENDATIONS IN PATIENTS WITH SEVERE RENAL IMPAIRMENT INCLUDINGTHOSE REQUIRING HEMODIALYSIS BASED ON DATA FROM STUDY C4671028 |
| 150MG;100MG | PAXLOVID (COPACKAGED) | PFIZER | N217188 | May 25, 2023 | RX | TABLET | ORAL | May 25, 2028 | NEW CHEMICAL ENTITY |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Cathepsin K | Enzyme | IC50 | 5.92 | CHEMBL | |||||
| Cathepsin S | Enzyme | IC50 | 5.75 | CHEMBL | |||||
| Cathepsin L2 | Enzyme | IC50 | 4.84 | CHEMBL | |||||
| Replicase polyprotein 1ab | Enzyme | INHIBITOR | Ki | 8.51 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Replicase polyprotein 1a | Enzyme | IC50 | 7.70 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| CHEBI:170007 | CHEBI |
| ZGW | PDB_CHEM_ID |
| CHEMBL4802135 | ChEMBL_ID |
| C000718217 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11503 | IUPHAR_LIGAND_ID |
| DB16691 | DRUGBANK_ID |
| 1332141006 | SNOMEDCT_US |
| 1332459000 | SNOMEDCT_US |
| 4041063 | VANDF |
| C5545149 | UMLSCUI |
| D12244 | KEGG_DRUG |
| 12161 | INN_ID |
| 155903259 | PUBCHEM_CID |
| 354383 | MMSL |
| 40180 | MMSL |
| d09839 | MMSL |
| 018919 | NDDF |
| 7R9A5P7H32 | UNII |
| 2587892 | RXNORM |
| C000719967 | MESH_SUPPLEMENTAL_RECORD_UI |
Pharmaceutical products:
None