baloxavir marboxil
Trade name: xofluza
Approved
Oct 24, 2018
Baloxavir marboxil, sold under the brand name Xofluza, is an antiviral medication used for the treatment of influenza A and influenza B. It was approved for medical use both in Japan and in the United States in 2018, and is taken by mouth. It can reduce the duration of flu symptoms by about 1-2 days in some people, but can also develop selection of resistant mutants that render it ineffectual; however studies noted this was seen mostly in children that were studied. — Wikipedia
Clinical trial activity
20 trials · 20 clinical orgs · 3 marketing orgs
Earliest trial started Nov 1, 2016 (NCT02954354)
Timeline
Indications
Approved for
Mechanism of action
- Influenza A virusANTAGONIST
Influenza A virus antagonist
- Polymerase acidic proteinINHIBITOR
Polymerase acidic protein inhibitor
- Polymerase acidic proteinINHIBITOR
Polymerase acidic protein inhibitor
Inhibits viral replication. PA is one component of the viral RNA polymerase complex.
Higher activity against Influenza A (IC50 1.4-3.1 nM) versus Influenza B (4.5-8.9 nM). Active in cell culture against subtypes A/H1N1, A/H3N2, A/H7N9 and Type B.
CAP-dependent endonuclease
Approval history
- approvedPriority reviewOct 24, 2018
Chemistry & pharmacology
SMILES
OC1=C2N(C=CC1=O)N([C@@H]3COCCN3C2=O)[C@@H]4C5=CC=CC=C5SCC6=C(F)C(F)=CC=C46- Mol. weight
- 483.487 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- WikipediaBaloxavir marboxil ↗
- NCATS4G86Y4JT3F ↗
- ChEMBLCHEMBL4297503 ↗
- ChEMBLCHEMBL4297215 ↗
Also known as
- baloxavir marboxil
- s-033188
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06762587 | N/A | Jan 5, 2025 | Capital Medical University, Chinese Academy of Medical Sciences, Peking University |
| NCT06653569 | Phase 3 | Dec 1, 2024 | Ente Ospedaliero Cantonale, Swiss National Science Foundation, University of Geneva, University of Zurich |
| NCT06774859 | Phase 3 | Oct 27, 2024 | Roche |
| NCT06507813 | Phase 3 | Jun 28, 2024 | Government of China |
| NCT06205641 | N/A | Jan 31, 2024 | Capital Medical University |
| NCT06161454 | Phase 4 | Dec 14, 2023 | Genentech, University of Pennsylvania |
| NCT06094010 | Phase 3 | Nov 22, 2023 | Roche |
| NCT05648448 | Phase 2 | Dec 22, 2022 | University of Oxford |
| NCT05170009 | Phase 2/Phase 3 (Phase 3) | Apr 22, 2022 | Cornell University, Genentech |
| NCT05012189 | Phase 4 | Aug 6, 2021 | Brown University, Case Western Reserve University, Genentech, Insight Therapeutics, LLC |
| NCT04712539 | Phase 2 | May 1, 2021 | University of Texas at Houston |
| NCT04327791 | Phase 2/Phase 3 (Phase 3) | Apr 3, 2020 | Bassett Healthcare |
| NCT04141930 | Phase 4 | Nov 1, 2019 | University of Washington |
| NCT03969212 | Phase 3 | Jul 6, 2019 | Roche |
| NCT03959332 | N/A | Jun 4, 2019 | Roche, Shionogi |
| NCT03629184 | Phase 3 | Nov 16, 2018 | Roche |
| NCT03653364 | Phase 3 | Oct 27, 2018 | Roche |
| NCT03684044 | Phase 3 | Oct 17, 2018 | Roche |
| NCT02949011 | Phase 3 | Dec 1, 2016 | Shionogi |
| NCT02954354 | Phase 3 | Nov 1, 2016 | Shionogi |
Organizations
Research & Development (20)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 7 | 7 | 2 | 2018 |
| Genentech | For profit | 3 | 0 | 2 | 2021 |
| Shionogi | For profit | 3 | 2 | 2 | 2016 |
| Capital Medical University | Academic/Hospital | 2 | 2 | 1 | 2024 |
| Bassett Healthcare | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Brown University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Case Western Reserve University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Cornell University | Academic/Hospital | 1 | 1 | 1 | 2022 |
| Ente Ospedaliero Cantonale | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Government of China | Government | 1 | 1 | 1 | 2024 |
| Insight Therapeutics, LLC | For profit | 1 | 1 | 1 | 2021 |
| Peking University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Swiss National Science Foundation | Government | 1 | 0 | 1 | 2024 |
| University of Geneva | Academic/Hospital | 1 | 1 | 1 | 2024 |
| University of Oxford | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Pennsylvania | Academic/Hospital | 1 | 1 | 1 | 2023 |
| University of Texas at Houston | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Washington | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Zurich | Academic/Hospital | 1 | 0 | 1 | 2024 |