Product Description
Baloxavir marboxil is a selective inhibitor of influenza cap-dependent endonuclease. It has shown therapeutic activity in preclinical models of influenza A and B virus infections, including strains resistant to current antiviral agents. (Sourced from: https://www.nejm.org/doi/full/10.1056/NEJMoa1716197)
Mechanisms of Action: Endonuclease Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: None
Company: Hoffmann-La Roche
Company Location:
Company Founding Year: 1896
Additional Commercial Interests: Shionogi
Clinical Description
Countries in Clinic: Australia, Belgium, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Estonia, Finland, France, Germany, Ghana, Greece, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Mexico, Nepal, Netherlands, New Zealand, Pakistan, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count:
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Hoffmann-La Roche presented P3 Influenza, Human results on 2024-09-19 for Baloxavir marboxil
Highest Development Phases
Phase 3: COVID-19|Influenza, Human|Pneumonia
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02735707 |
REMAP-CAP | P3 |
Recruiting |
Pneumonia|COVID-19|Influenza, Human |
2026-02-01 |
2024-11-27 |
||
CTR20253802 |
CTR20253802 | P1 |
Completed |
Influenza, Human |
2025-11-15 |
2025-12-21 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20252936 |
CTR20252936 | P1 |
Completed |
Influenza, Human |
2025-09-08 |
2025-10-12 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT04381936 |
RECOVERY | P3 |
Recruiting |
COVID-19|Pneumonia |
2028-09-30 |
2026-04-23 |
||
NCT06094010 |
Pebblestone | P3 |
Recruiting |
Influenza, Human |
2027-05-11 |
30% |
2026-05-02 |
Patient Enrollment|Primary Endpoints|Treatments |
2023-504672-22-00 |
CV44536 | P3 |
Active, not recruiting |
Influenza, Human |
2027-05-01 |
30% |
2025-05-02 |
Treatments |
NCT06774859 |
YV44465 | P3 |
Completed |
Influenza, Human |
2025-05-08 |
16% |
2025-05-20 |
|
NCT03969212 |
MV40618 | P3 |
Completed |
Influenza, Human |
2024-05-10 |
58% |
2025-08-27 |
|
CTR20253933 |
CTR20253933 | P1 |
Completed |
Influenza, Human |
2026-01-05 |
2026-02-10 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
2018-002154-70 |
Ministone 1 | P3 |
Active, not recruiting |
Influenza, Human |
2021-12-25 |
51% |
2022-03-13 |
Treatments |