Domestic introduction, approval application and marketing of ACCRUFeR®
First written in FY2025. 1 of 2 entries say "Advanced", first in FY2026. Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AdvancedAnnual report
「In June 2025, the company reached an agreement with the PMDA (Pharmaceuticals and Medical Devices Agency) on the domestic development of ferric maltol as a treatment for pulmonary arterial hypertension and the submission of an application for approval. Accordingly, in July 2025, the company submitted the notification for the Phase 2 clinical trial and completed execution of clinical trial agreements with 7 facilities in Japan and placement of the investigational drug.」
The company reports progress on ferric maltol, including ACCRUFeR®, comprising an agreement with the PMDA, submission of the notification for the Phase 2 clinical trial, and completion of agreements and investigational drug placement at 7 facilities in Japan. - FY2025First statedAnnual report
「With respect to ACCRUFeR®, an iron-deficiency treatment for which Shield Therapeutics plc holds the manufacturing and sales rights, the company will conduct research and development, including clinical trials, obtain marketing approval in Japan, manufacture and sell the pharmaceutical in Japan, and distribute the resulting profits. The company will exclusively conduct the application for approval and sales in Japan. During the contract term, it will also pay milestones based on the clinical development stage of ACCRUFeR® and achievement of sales targets, as well as royalties based on sales.」
The note describes a specific project, based on agreements with Neu Pharma and Shield Therapeutics plc, to advance the clinical development, domestic approval application and exclusive sales of ACCRUFeR®, an iron-deficiency treatment.