Drugs / Baloxavir Marboxil
Baloxavir Marboxil
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (6) | US (FDA) | XOFLUZA | — | 2019-10-16 – 2025-05-30 | fda.gov ↗ |
| Approved | EU (EMA) | Xofluza | — | 2021-01-07 | europa.eu ↗ |
| Approved | US (FDA) | XOFLUZA | — | 2018-10-24 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04712539 | Oct 2021 → Feb 2028 expected | hematopoietic and lymphoid cell neoplasm, influenza | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT06653569 | Dec 2024 → Apr 2027 expected | influenza | Dre Pauline Vetter | Recruiting | No outcome recorded |
| Phase 3 | NCT06774859 | Oct 2024 → May 2025 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT06094010 | Nov 2023 → May 2027 expected | influenza | Hoffmann-La Roche | Recruiting | No outcome recorded |
| Phase 3 | NCT03969212 | Oct 2019 → May 2024 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03653364 | Jan 2019 → Apr 2023 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03684044 | Jan 2019 → Mar 2020 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT03629184 | Nov 2018 → Apr 2019 | influenza | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 3 | NCT02949011 | Jan 2017 → Apr 2018 | influenza | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT02954354 | Dec 2016 → Apr 2017 | influenza | Shionogi | Completed | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06161454 | Dec 2023 → Apr 2025 | Coronaviridae infectious disease, disease related to transplantation, influenza | Children's Hospital of Philadelphia | Completed | No outcome recorded |
| Phase 4 | NCT04141930 | Nov 2019 → Apr 2020 | influenza | University of Washington | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06762587 | Jan → Apr 2025 overdue | influenza, nosocomial infection | Capital Medical University | Not yet recruiting | No outcome recorded |
| — | NCT03959332 | Jun → Jul 2019 | — | Hoffmann-La Roche | Completed | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05170009 Comparator | Apr 2022 → Jan 2024 | influenza | Weill Medical College of Cornell University | Terminated | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT04381936 Comparator | Mar 2020 → Sep 2028 expected | pneumonia | University of Oxford | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06205641 Comparator | Jan → Jun 2024 | influenza | Capital Medical University | Unknown | No outcome recorded |
Press releases naming this drug 13 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-25 | Roche Global Development | New England Journal of Medicine publishes phase III data showing single-dose Xofluza significantly reduces influenza virus transmission roche.com ↗ |
| 2024-09-19 | Roche Global Development | Positive phase III results show Xofluza significantly reduces the transmission of influenza viruses roche.com ↗ |
| 2023-01-12 | Roche Global Development | Roche announces the European Commission approval of Xofluza for the treatment and prevention of influenza in children aged one year and above roche.com ↗ |
| 2022-08-12 | Roche Global Development | Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older roche.com ↗ |
| 2021-01-11 | Roche Global Development | Roche’s Xofluza approved by the European Commission for the treatment of influenza, the first new influenza antiviral for patients in almost 20 years roche.com ↗ |
| 2020-11-24 | Roche Global Development | Roche announces FDA approval of Xofluza for the prevention of influenza following contact with an infected person roche.com ↗ |
| 2020-11-13 | Roche Global Development | CHMP recommends EU approval of Roche’s Xofluza® (baloxavir marboxil) for the treatment of influenza roche.com ↗ |
| 2019-10-18 | Roche Global Development | Roche announces FDA approval of Xofluza (baloxavir marboxil) for people at high risk of developing influenza-related complications roche.com ↗ |
| 2019-09-02 | Roche Global Development | Positive phase III results show Xofluza reduces risk of developing flu after contact with an infected person by 86% roche.com ↗ |
| 2019-09-02 | Roche Global Development | Roche presents positive phase III study results for one-dose Xofluza in children with flu roche.com ↗ |
| 2018-10-24 | Roche Global Development | Roche announces FDA approval of Xofluza (baloxavir marboxil) for influenza roche.com ↗ |
| 2018-10-04 | Roche Global Development | Positive phase III results for baloxavir marboxil in people at high risk of complications from influenza to be presented at IDWeek 2018 roche.com ↗ |
| 2018-07-17 | Roche Global Development | Phase III CAPSTONE-2 study showed that baloxavir marboxil reduced symptoms in people at high risk of complications from the flu roche.com ↗ |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 21 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | baloxavir marboxil | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04712539 ↗ |
| Known as | baloxavir | “I. To compare the efficacy of baloxavir marboxil (baloxavir) in combination with oseltamivir to oseltamivir monotherapy as measured by changes in influenza viral loads at day 1...” NCT04712539 ↗3“BACKGROUND: Baloxavir marboxil (baloxavir) rapidly reduces influenza virus shedding, which suggests that it may reduce transmission.” PMID 40267424 ↗ Apr 2025 “Baloxavir marboxil (hereafter baloxavir), a selective inhibitor of influenza cap-dependent endonuclease” PMID 32526195 ↗ Jun 2020 “Baloxavir marboxil (baloxavir) is a novel, cap-dependent endonuclease inhibitor” PMID 32516282 ↗ Aug 2020 |
| Known as | Xofluza | “Xofluza® (Baloxavir Marboxil), FDA approved in 2018 for the treatment of acute Influenza, has been shown to have improved outcome characteristics versus Tamiflu® (Oseltamivir),...” NCT06161454 ↗ |
| Action | Inhibit | “a selective inhibitor of influenza cap-dependent endonuclease” PMID 32526195 ↗ Jun 2020 |
| Route | Oral | “Tablets taken orally” NCT02949011 ↗ |