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. 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Approval applications are planned in Europe and Asia going forward.","jir_summary":"### Overview of the Performance\nThis 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.\n\n### Future Outlook and Corporate Strategy\nShionogi & 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.","jir_financial_highlights":"Achievement of primary endpoint: Favorable results (Unknown)","jir_category":"","jir_hashtags":"#ShionogiandCo, #IR, #JapanStocks","jir_key_figures":"Achievement of primary endpoint for Orolofym\nAdverse event incidence rate in Orolofym dosing group: 35.8\uff05\nAdverse event incidence rate in AmBisome treatment group: 63.9\uff05","jir_meta_title":"\u3010Shionogi & Co., Ltd.\u3011Favorable Results in Clinical Trial of New Drug\uff5cJune 2026","jir_meta_description":"Shionogi & Co., Ltd. achieved the primary endpoint in a Phase 3 clinical trial of the new antifungal Orolofym, with good safety profile. Approval applications are planned in Europe and Asia.","jir_og_title":"\u3010Shionogi & Co., Ltd.\u3011Favorable Results in Clinical Trial of New Drug\uff5cJune 2026","jir_og_description":"Shionogi & Co., Ltd.\u2019s new antifungal Orolofym showed favorable results in clinical trials. Significant progress towards approval applications.","jir_og_image_url":"\/assets\/og\/company-general_ir.jpg","jir_chart_data_collection":"[]","ir_related_company":6919,"ir_release_date":"","ir_type":"","ir_is_new":false,"ir_document_url":"","jir_ir_type":"financial_summary","footnotes":""},"sector":[],"importance":[],"class_list":["post-65617","ir_release","type-ir_release","status-publish","hentry"],"yoast_head":"\n