Product Description
Oseltamivir is a prodrug of oseltamivir carboxylate (Ro 64-0802, GS4071), a potent and selective inhibitor of the neuraminidase glycoprotein essential for replication of influenza A and B viruses. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/11270942/)
Mechanisms of Action: NEU Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Hoffmann-La Roche
Company Location:
Company CEO: Severin Schwan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Belgium, Canada, China, Colombia, Croatia, Czech Republic, Estonia, Finland, France, Germany, Ghana, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Nepal, Netherlands, New Zealand, Pakistan, Portugal, Romania, Saudi Arabia, Serbia, Slovenia, South Africa, Spain, Switzerland, United Kingdom, United States, Vietnam
Active Clinical Trial Count: 7
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: COVID-19|Influenza, Human|Pneumonia|Severe Acute Respiratory Syndrome
Phase 1: Healthy Volunteers
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT02735707 |
REMAP-CAP | P3 |
Recruiting |
Influenza, Human|Pneumonia|COVID-19 |
2026-02-01 |
2024-11-27 |
||
NCT04381936 |
RECOVERY | P3 |
Recruiting |
COVID-19|Severe Acute Respiratory Syndrome |
2026-06-30 |
2024-01-06 |
||
NCT05789342 |
GP681-202202 | P1 |
Completed |
Healthy Volunteers |
2023-09-11 |
23% |
2023-11-15 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
CTR20232328 |
CTR20232328 | P1 |
Completed |
Influenza, Human |
2023-12-05 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20252773 |
CTR20252773 | P3 |
Completed |
Influenza, Human |
2025-11-15 |
2025-12-28 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
CTR20230077 |
CTR20230077 | P1 |
Completed |
Influenza, Human |
2023-09-11 |
2025-04-29 |
Patient Enrollment|Treatments |
|
NCT06057103 |
ZX-7101A-208 | P1 |
Completed |
Healthy Volunteers |
2023-12-05 |
2024-11-05 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |