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baloxavir marboxil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antivirals | 5301 | 1985606-14-1 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Baloxavir marboxil is a prodrug that is converted by hydrolysis to baloxavir, the active form that exerts anti-influenza virus activity. Baloxavir inhibits the endonuclease activity of the polymerase acidic (PA) protein, an influenza virus-specific enzyme in the viral RNA polymerase complex required for viral gene transcription, resulting in inhibition of influenza virus replication. The 50% inhibitory concentration (IC50) of baloxavir was 1.4 to 3.1 nM (n=4) for influenza A viruses and 4.5 to 8.9 nM (n=3) for influenza B viruses in a PA endonuclease assay. Viruses with reduced susceptibility to baloxavir have amino acid substitutions in the PA protein. It was investigated as a potential treatment during the early stages of the COVID-19 pandemic but in vitro antiviral activity against SARS-CoV-2 was not confirmed.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 40 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.02 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2B,AXL,BRAF,CAMK2D,CDK5,CDK9,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,MAPK7,PDK1,PDK2,PDK4,PIK3CA,PIK3CB,PIK3CG,PRKDC | 19 | |||
| kinase-selectivity-class | AXL | 1 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Jan. 7, 2021 | EMA | ROCHE REGISTRATION GmbH | |
| Oct. 24, 2018 | FDA | GENENTECH INC | |
| Feb. 23, 2018 | PMDA | Shionogi & Co., Ltd. |
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 |
|---|---|---|---|---|---|---|
| No adverse event | 178.90 | 45.63 | 52 | 801 | 67930 | 90559664 |
| Colitis ischaemic | 142.86 | 45.63 | 31 | 822 | 12315 | 90615279 |
| Melaena | 58.69 | 45.63 | 19 | 834 | 34778 | 90592816 |
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 |
|---|---|---|---|---|---|---|
| Colitis ischaemic | 88.46 | 42.55 | 21 | 668 | 7205 | 42613441 |
| No adverse event | 87.13 | 42.55 | 30 | 659 | 38991 | 42581655 |
| Abnormal behaviour | 46.24 | 42.55 | 17 | 672 | 26434 | 42594212 |
| Pneumonia | 43.95 | 42.55 | 43 | 646 | 422106 | 42198540 |
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 |
|---|---|---|---|---|---|---|
| Colitis ischaemic | 209.57 | 46.39 | 48 | 1380 | 17702 | 110570169 |
| No adverse event | 126.21 | 46.39 | 44 | 1384 | 73795 | 110514076 |
| Pneumonia | 66.39 | 46.39 | 68 | 1360 | 876646 | 109711225 |
| Abnormal behaviour | 61.74 | 46.39 | 22 | 1406 | 39017 | 110548854 |
| Anaphylactic reaction | 59.11 | 46.39 | 29 | 1399 | 114271 | 110473600 |
| Loss of consciousness | 51.98 | 46.39 | 32 | 1396 | 196274 | 110391597 |
| Delirium febrile | 46.73 | 46.39 | 6 | 1422 | 65 | 110587806 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | J05AX25 | ANTIINFECTIVES FOR SYSTEMIC USE ANTIVIRALS FOR SYSTEMIC USE DIRECT ACTING ANTIVIRALS Other antivirals |
| MeSH PA | D000890 | Anti-Infective Agents |
| MeSH PA | D000998 | Antiviral Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
Related Drugs by ATC class:
J05AX Other antivirals 15 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Influenza | indication | 6142004 | DOID:8469 |
| Coronavirus infection | off-label use | 186747009 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 2.75 | Basic |
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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | DISCN | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | DISCN | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 40MG | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | RX | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 40MG | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | RX | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 80MG | XOFLUZA | GENENTECH INC | N210854 | March 18, 2021 | RX | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 80MG | XOFLUZA | GENENTECH INC | N210854 | March 18, 2021 | RX | TABLET | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 2MG/ML | XOFLUZA | GENENTECH INC | N214410 | Nov. 23, 2020 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 2MG/ML | XOFLUZA | GENENTECH INC | N214410 | Nov. 23, 2020 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 30MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 30MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 40MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 40MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 10633397 | April 27, 2036 | METHOD FOR TREATING INFLUENZA |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | DISCN | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | DISCN | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
| 40MG | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | RX | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 40MG | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | RX | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
| 80MG | XOFLUZA | GENENTECH INC | N210854 | March 18, 2021 | RX | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 80MG | XOFLUZA | GENENTECH INC | N210854 | March 18, 2021 | RX | TABLET | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
| 2MG/ML | XOFLUZA | GENENTECH INC | N214410 | Nov. 23, 2020 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 2MG/ML | XOFLUZA | GENENTECH INC | N214410 | Nov. 23, 2020 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
| 30MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 30MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
| 40MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR POST-EXPOSURE PROPHYLAXIS OF INFLUENZA |
| 40MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | 11306106 | Aug. 9, 2037 | METHOD FOR TREATING INFLUENZA |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | DISCN | TABLET | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
| 40MG | XOFLUZA | GENENTECH INC | N210854 | Oct. 24, 2018 | RX | TABLET | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
| 80MG | XOFLUZA | GENENTECH INC | N210854 | March 18, 2021 | RX | TABLET | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
| 2MG/ML | XOFLUZA | GENENTECH INC | N214410 | Nov. 23, 2020 | RX | FOR SUSPENSION | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
| 30MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
| 40MG/PACKET | XOFLUZA | GENENTECH INC | N214410 | May 30, 2025 | RX | FOR SUSPENSION | ORAL | Dec. 19, 2027 | ADDITION OF CLINICAL INFORMATION OBTAINED FROM A PEDIATRIC TRIAL TO SECTION 8.4 OF THE LABELING |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Polymerase acidic protein | Enzyme | INHIBITOR | IC50 | 8.85 | DRUG LABEL | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 505CXM6OHG | UNII |
| 4037950 | VANDF |
| C4688747 | UMLSCUI |
| CHEBI:756989 | CHEBI |
| CHEMBL4297503 | ChEMBL_ID |
| 124081896 | PUBCHEM_CID |
| DB13997 | DRUGBANK_ID |
| D11021 | KEGG_DRUG |
| 10491 | INN_ID |
| C000628402 | MESH_SUPPLEMENTAL_RECORD_UI |
| 11748 | IUPHAR_LIGAND_ID |
| 782500006 | SNOMEDCT_US |
| 1985605-59-1 | SECONDARY_CAS_RN |
| 294671 | MMSL |
| 35334 | MMSL |
| d09012 | MMSL |
| 017822 | NDDF |
| 2099995 | RXNORM |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4102 | TABLET, FILM COATED | 20 mg | ORAL | NDA | 31 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50090-4104 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 31 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-583 | GRANULE, FOR SOLUTION | 40 mg | ORAL | NDA | 33 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-599 | GRANULE, FOR SUSPENSION | 30 mg | ORAL | NDA | 33 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-617 | GRANULE, FOR SUSPENSION | 40 mg | ORAL | NDA | 33 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-860 | TABLET, FILM COATED | 40 mg | ORAL | NDA | 33 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50242-877 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 33 sections |
| Xofluza | HUMAN PRESCRIPTION DRUG LABEL | 1 | 85766-058 | TABLET, FILM COATED | 80 mg | ORAL | NDA | 32 sections |