Shionogi & Co., Ltd.
【Shionogi & Co., Ltd.】Favorable Results in Clinical Trial of New Antifungal Orolofym｜June 2026
Shionogi & Co., Ltd. announced that the Phase 3 global clinical trial of the novel antifungal Orolofym achieved the primary endpoint and demonstrated good safety profile. Approval applications are planned in Europe and Asia going forward.
Key Figures
- Achievement of primary endpoint for Orolofym
- Adverse event incidence rate in Orolofym dosing group: 35.8％
- Adverse event incidence rate in AmBisome treatment group: 63.9％
AI要約
Overview of the Performance
This report details the clinical trial results of the new antifungal Orolofym developed by Shionogi & Co., Ltd. In the global Phase 3 clinical trial (OASIS trial), Orolofym demonstrated non-inferiority to the control group in the primary endpoint of all-cause mortality rate at 42 days post-treatment initiation, with favorable safety results. This indicates the potential of Orolofym as a new treatment option for invasive aspergillosis. Approval applications are planned in Europe and Asia.
Future Outlook and Corporate Strategy
Shionogi & Co., Ltd. is co-developing the drug with F2G Ltd. and has received Orphan Drug designation and QIDP designation from the U.S. FDA and the European Medicines Agency. Based on the recent clinical results, the company plans to proceed with approval applications in Europe and Asia. F2G Ltd. also plans to submit a new drug application in the U.S., aiming to promote innovation in infectious disease treatments and create new therapeutic options.
Shionogi & Co., Ltd.
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