Baloxavir marboxil
- Generic Name
- Baloxavir marboxil
- Brand Names
- Xofluza
- Drug Type
- Small Molecule
- Chemical Formula
- C27H23F2N3O7S
- CAS Number
- 1985606-14-1
- Unique Ingredient Identifier
- 505CXM6OHG
- Background
Baloxavir marboxil is an antiviral drug used to treat influenza. More specifically, it is a first-in-class cap-dependent endonuclease inhibitor that works to block influenza virus proliferation. It is a prodrug of baloxavir with an improved absorption profile than its active metabolite due to the addition of a phenolic hydroxyl group to its structure. Balox...
- Indication
Baloxavir marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are otherwise healthy adults and pediatric patients five years of age and older, or patients 12 years of age and older who are at high risk ...
- Associated Conditions
- Flu caused by Influenza, Acute, uncomplicated Influenza
- Associated Therapies
- -
Study to Assess Efficacy and Safety of Baloxavir Marboxil In Combination With Standard-of-Care Neuraminidase Inhibitor In Hospitalized Participants With Severe Influenza
- First Posted Date
- 2018-09-25
- Last Posted Date
- 2021-01-06
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 363
- Registration Number
- NCT03684044
- Locations
- 🇯🇵
Naha City Hospital, Naha, Japan
🇯🇵Social Corporation Keigakukai Minamiosaka Hosupital, Osaka, Japan
🇯🇵National Hospital Organaization Shibukawa Medical Center, Shibukawa, Japan
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants From Birth to < 1 Year With Influenza-Like Symptoms
- First Posted Date
- 2018-08-31
- Last Posted Date
- 2024-05-17
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 49
- Registration Number
- NCT03653364
- Locations
- 🇵🇱
IN VIVO Sp. z o.o., Bydgoszcz, Poland
🇺🇸Usf Health, Tampa, Florida, United States
🇺🇸Oak Cliff Research Company, LLC, Dallas, Texas, United States
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
- First Posted Date
- 2018-08-14
- Last Posted Date
- 2020-04-29
- Lead Sponsor
- Hoffmann-La Roche
- Target Recruit Count
- 173
- Registration Number
- NCT03629184
- Locations
- 🇺🇸
The Probe Medical Research, Los Angeles, California, United States
🇺🇸Kentucky Pediatric Research Center, Bardstown, Kentucky, United States
🇺🇸Orange County Research Institute, Ontario, California, United States
A Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Otherwise Healthy Patients With Influenza
- Conditions
- Interventions
- First Posted Date
- 2016-11-03
- Last Posted Date
- 2019-05-08
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 1436
- Registration Number
- NCT02954354
Study of S-033188 (Baloxavir Marboxil) Compared With Placebo or Oseltamivir in Patients With Influenza at High Risk of Influenza Complications
- Conditions
- Interventions
- First Posted Date
- 2016-10-31
- Last Posted Date
- 2019-11-19
- Lead Sponsor
- Shionogi
- Target Recruit Count
- 2184
- Registration Number
- NCT02949011
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
- Conditions
- Interventions
- Other: No systemic corticosteroidOther: No antiviral agent for COVID-19Other: No immune modulation for COVID-19Drug: Standard course macrolideOther: No antiviral agent for influenzaDrug: Local standard venous thromboprophylaxisOther: No immunoglobulinOther: No simvastatinOther: No cysteamineOther: No Immune Modulator for InfluenzaOther: No vitamin COther: No antiplateletProcedure: Clinician-preferred mechanical ventilation strategyOther: No renin-angiotensin system inhibitorOther: No endothelial modulatorDrug: CeftriaxoneDrug: Moxifloxacin or LevofloxacinDrug: Extended course macrolideDrug: Fixed-duration HydrocortisoneDrug: Five-days oseltamivirDrug: Lopinavir / RitonavirBiological: Convalescent plasmaDrug: Angiotensin converting enzyme inhibitorDrug: Nirmatrelvir/ritonavirDrug: Therapeutic dose anticoagulationProcedure: Protocolised mechanical ventilation strategyDrug: Interferon beta-1aDrug: Vitamin CDrug: SimvastatinDrug: AspirinDrug: EritoranDrug: CysteamineDrug: ImatinibDrug: Shock-dependent hydrocortisoneDrug: Ten-days oseltamivirDrug: P2Y12 inhibitorDrug: Angiotensin Receptor BlockersDrug: Conventional low dose thromboprophylaxisBiological: Delayed administration of convalescent plasmaDrug: Piperacillin-tazobactamDrug: HydroxychloroquineDrug: AnakinraDrug: ApremilastDrug: BaricitinibDrug: RemdesivirDrug: Fixed-duration higher dose HydrocortisoneDrug: Hydroxychloroquine + lopinavir/ritonavirDrug: Intermediate dose thromboprophylaxisDrug: Nirmatrelvir/ritonavir + remdesivirDrug: ARB + DMX-200Drug: CeftarolineDrug: Baloxavir MarboxilDrug: TocilizumabDrug: Amoxicillin-clavulanateDrug: Fixed-duration dexamethasoneDrug: Five-days oseltamivir + baloxavir marboxilDrug: Continuation of therapeutic dose anticoagulationDrug: IvermectinDrug: SarilumabDrug: Ten-days oseltamivir + baloxavir marboxil
- First Posted Date
- 2016-04-13
- Last Posted Date
- 2024-07-12
- Lead Sponsor
- UMC Utrecht
- Target Recruit Count
- 20000
- Registration Number
- NCT02735707
- Locations
- 🇨🇦
Toronto Western Hospital, Toronto, Ontario, Canada
🇺🇸University of Illinois Health, Chicago, Illinois, United States
🇦🇺Bankstown-Lidcombe Hospital, Bankstown, New South Wales, Australia
Drug Development Updates
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