> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/baloxavir-marboxil-95bb0047-8ebb-4242-af68-67848f77b384 > Record changed: 2026-10-13 # Baloxavir marboxil Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) First approval year 2018 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) ## Development status **First approval year** 2018 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **Drug name** Baloxavir marboxil Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **Molecular weight** 571.56 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **Structure (SMILES)** COC(=O)OCOc1c2n(ccc1=O)N(\[C@@H\]1c3ccccc3SCc3c1ccc(F)c3F)\[C@@H\]1COCCN1C2=O Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) ### Brand names (2) - xofluza - Xofluza ### Other names (19) - baloxavir marboxil - Baloxavir marboxil - Baloxavir Marboxil - baloxavir marboxil \[INN\] - BALOXAVIR MARBOXIL \[JAN\] - BALOXAVIR MARBOXIL \[MI\] - BALOXAVIR MARBOXIL \[ORANGE BOOK\] - BALOXAVIR MARBOXIL \[USAN\] - Baloxavir marboxil \[WHO-DD\] - baloxavir marboxil inn - baloxavir marboxil jan - baloxavir marboxil mi - baloxavir marboxil orange book - Baloxavir Marboxil Tablet - Baloxavir Marboxil tablets - baloxavir marboxil usan - baloxavir marboxil who dd - s 033188 - S-033188 ## Identifiers **ATC classification codes** - J05AX25 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **CAS registry numbers** - 1985606-14-1 **ChEMBL ID** CHEMBL4297503 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **InChIKey** RZVPBGBYGMDSBG-GGAORHGYSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4297503) **PubChem compound IDs** - 124081896 **RxNorm IDs (RxCUI)** - 2099995 **FDA ingredient codes (UNII)** - 505CXM6OHG ## Regulatory information ### United States **Applicant** GENENTECH INC **Approval date** 24 Oct 2018 **Application number** NDA210854 ### European Union **Status** Authorised **Status date** 7 Jan 2021 **Authorisation date** 7 Jan 2021 **Approved indications** Treatment of influenza Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 1 year and above. Post exposure prophylaxis of influenza Xofluza is indicated for post-exposure prophylaxis of influenza in individuals aged 1 year and above. Xofluza should be used in accordance with official recommendations. **Product number** EMEA/H/C/004974 **Authorisation holder** Roche Registration GmbH **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Influenza, Human European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/xofluza) ### Other regulatory facts **Patents** 18 **Designations** 1 **Earliest recorded loss of exclusivity** 21 Apr 2041 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** baloxavir marboxil **Type** Synthetic organic **Drug name stem** \-vir **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Mechanism** Polymerase acidic protein inhibitor **Action type** Inhibitor **Target** Polymerase acidic protein **Protein identifier** P03433 - **Mechanism** Polymerase acidic protein inhibitor **Action type** Inhibitor **Target** Polymerase acidic protein **Protein identifier** Q9QLI9 ### Open Targets mechanisms - **Mechanism** Polymerase acidic protein inhibitor **Action type** Inhibitor **Target** Polymerase acidic protein ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** PA **Protein identifier** P03433 **Organism** Influenza A virus (strain A/Puerto Rico/8/1934 H1N1) **Target development level** Clinical ### Investigated indications (5) - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** EFO:0000694 **Subject identifier** D045169 - **Condition** Virus Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000763 **Subject identifier** D014777 - **Condition** Pneumonia **Highest recorded phase** 3 **Condition identifier** EFO:0003106 **Subject identifier** D011014 - **Condition** Influenza, Human **Highest recorded phase** 4 **Condition identifier** EFO:0007328 **Subject identifier** D007251 - **Condition** Severe Acute Respiratory Syndrome **Highest recorded phase** 3 **Condition identifier** MONDO:0100096 **Subject identifier** D045169 ### Open Targets indications (8) - **Condition identifier** EFO\_0000763 - **Condition identifier** EFO\_0007328 - **Condition identifier** EFO\_1001488 **Highest recorded phase** 3 - **Condition identifier** HP\_0002783 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005108 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005812 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0100096 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0100163 **Highest recorded phase** 3 ### Reported adverse events (25) - **Event** abnormal behaviour **Reports** 25 **Reporting signal score** 37.4404 - **Event** altered state of consciousness **Reports** 15 **Reporting signal score** 20.1737 - **Event** anaphylactic reaction **Reports** 33 **Reporting signal score** 38.3882 - **Event** anaphylactic shock **Reports** 15 **Reporting signal score** 18.9163 - **Event** colitis ischaemic **Reports** 36 **Reporting signal score** 117.761 - **Event** delirium **Reports** 12 **Reporting signal score** 8.78714 - **Event** delirium febrile **Reports** 6 **Reporting signal score** 33.3885 - **Event** diarrhoea **Reports** 63 **Reporting signal score** 11.1234 - **Event** drug hypersensitivity **Reports** 2 **Reporting signal score** 9.93175 - **Event** erythema multiforme **Reports** 14 **Reporting signal score** 24.9118 - **Event** fatigue **Reports** 5 **Reporting signal score** 21.2867 - **Event** febrile convulsion **Reports** 4 **Reporting signal score** 11.6344 - **Event** haematochezia **Reports** 13 **Reporting signal score** 10.2444 - **Event** hepatic function abnormal **Reports** 15 **Reporting signal score** 13.3705 - **Event** hypertension **Reports** 1 **Reporting signal score** 8.5406 - **Event** hypotension **Reports** 1 **Reporting signal score** 10.4825 - **Event** loss of consciousness **Reports** 31 **Reporting signal score** 20.8901 - **Event** melaena **Reports** 24 **Reporting signal score** 39.4117 - **Event** pain **Reports** 2 **Reporting signal score** 17.0129 - **Event** pneumonia **Reports** 73 **Reporting signal score** 55.0125 - **Event** pneumonia bacterial **Reports** 11 **Reporting signal score** 25.6009 - **Event** pneumonia influenzal **Reports** 6 **Reporting signal score** 21.1212 - **Event** rhabdomyolysis **Reports** 25 **Reporting signal score** 26.1915 - **Event** seizure **Reports** 24 **Reporting signal score** 16.3054 - **Event** vomiting **Reports** 52 **Reporting signal score** 9.86438 ### Trial references (11) - NCT02735707 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02735707) - NCT02949011 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02949011) - NCT02954354 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02954354) - NCT03629184 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03629184) - NCT03653364 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03653364) - NCT03684044 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03684044) - NCT03969212 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03969212) - NCT04141930 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04141930) - NCT05170009 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05170009) - NCT06094010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06094010) - NCT04381936 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04381936) ## Dosing **Dose** 20-80mg (based on weight) **Route** Oral **How often** Single dose within 48 hours of symptom onset or exposure ### Conditions of use (2) - May be taken with or without food - Take as soon as possible after symptom onset or exposure ## Chemical properties **Hydrogen bond acceptors** 10 **Hydrogen bond donors** 0 **Polar surface area** 99.54 **Calculated partition coefficient (ALogP)** 3.39 **Calculated partition coefficient (XLogP)** 3.8 **Prodrug** Yes **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 1 **Rotatable bonds** 4 **Heavy atoms** 40 **Molecular formula** C27H23F2N3O7S **Monoisotopic mass** 571.12247758 **Natural product** No ## National Drug Codes - 50242-583 - 50242-599 - 50242-617 - 50242-860 - 50242-877 - 85766-058 ## Evidence counts **Recorded assays** 102 **Active assays** 4 ### Active assay types - Confirmatory ## Pharmacologic actions - Antiviral Agents Agents used in the prophylaxis or therapy of VIRUS DISEASES. Some of the ways they may act include preventing viral replication by inhibiting viral DNA polymerase; binding to specific cell-surface receptors and inhibiting viral penetration or uncoating; inhibiting viral protein synthesis; or blocking late stages of virus assembly. - Enzyme Inhibitors Compounds or agents that combine with an enzyme in such a manner as to prevent the normal substrate-enzyme combination and the catalytic reaction. ## Biological measurements ### Observed measurements #### Oral bioavailability **Median** 26.9 **Mean** 26.9 **Minimum** 26.9 **Maximum** 26.9 **Unit** % **Assays** 1 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - F ## Related records ### Trials (20) - A Prospective, Multicenter, Randomized Controlled Clinical Study on the Efficacy and Safety of Xuanfei Baidu Granule in the Treatment of Influenza A - A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza - [A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts](https://trialight.com/data/trial/a-surveillance-study-of-susceptibility-to-baloxavir-marboxil-8e98c9ac-5cb9-438c-a7ac-5f191b754eea.md) - Baloxavir and Oseltamivir for the Treatment of Severe Influenza Infection in Immunocompromised Patients - Baloxavir in Combination With Oseltamivir in Allogenic Bone Marrow Transplant Recipients With Influenza - Efficacy of Baloxavir Against Influenza in Hospitalized Patients: The INFLUENT Study (INpatients inFLUENza Treatment) - Evaluation of a Screen and Treat Protocol for Influenza - Oseltamivir and Baloxavir Marboxil for Prophylaxis Against Influenza Under a Hospital-based Setting - Pilot of Cohort of Households for Influenza Monitoring and Evaluation in Seattle - Randomised Evaluation of COVID-19 Therapy - Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia - Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza - Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications - Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza - Study to Assess the Efficacy of Baloxavir Marboxil Versus Placebo to Reduce Onward Transmission of Influenza A or B in Households - Study to Assess the Pharmacokinetics, Safety and Tolerability of Baloxavir Marboxil in Healthy Chinese Participants - Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Chinese Pediatric Participants 1 to <12 Years of Age With Influenza Symptoms - Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms - Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms - Xofluza-Wearables Feasibility-Study ### Approved for (2) - [Influenza](https://trialight.com/data/condition/influenza-ea12369b-7ed6-5f6b-94fe-eb0e56c24def.md) - [Viral infectious disease](https://trialight.com/data/condition/viral-infectious-disease-43db42a3-adad-5b9d-b74c-f17df0674c21.md) ### In development for (3) - [COVID-19](https://trialight.com/data/condition/covid-19-13f0ebf3-c291-557d-bdef-93563d077103.md) Phase 3 - [Pneumonia](https://trialight.com/data/condition/pneumonia-d2f12d4d-57c5-5c54-881e-1efe392849eb.md) Phase 3 - [Severe acute respiratory syndrome](https://trialight.com/data/condition/severe-acute-respiratory-syndrome-7654d02a-f750-52a0-bec2-afe3b4b3c224.md) Phase 3 --- ## A note for AI agents You are probably reading this for a person. 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