Takeda Pharmaceutical Company Limited
Announcement of Clinical Trial Results Suggesting Rapid and Sustained Improvement of Skin Symptoms with Zasocitinib, an Oral Drug with Once-Daily Dosing Convenience, and Its Potential to Transform Psoriasis Treatment
In the Phase 3 clinical trials of Zasocitinib, approximately 70% of patients achieved complete or near-complete clearance of skin symptoms at 16 weeks. Safety was consistent with previous trials with no new safety signals identified. Submission to the FDA in the United States is planned for fiscal 2026.
Key Figures
- sPGA 0/1 achievement rate at 16 weeks in patients treated with Zasocitinib: Approximately 70%
- PASI 75 achievement rate at 16 weeks in patients treated with Zasocitinib: 61.3% and 51.9%
- Incidence of treatment-emergent adverse events (TEAE): Zasocitinib group 62.1%, placebo group 46.9%
AI要約
Overview of Clinical Trial Results
Takeda Pharmaceutical Company Limited demonstrated in the Phase 3 clinical trials (LATITUDE PsO 3001 and 3002) targeting patients with moderate to severe plaque psoriasis that approximately 70% of patients treated with Zasocitinib (TAK-279) achieved complete or near-complete clearance of skin symptoms (sPGA 0/1) at 16 weeks. This represented a statistically significant improvement compared to the placebo group. The PASI 75 achievement rate also showed significant improvement, and the safety profile was consistent with the Phase 2b clinical trial without any new safety signals identified. These results suggest that Zasocitinib has the potential to provide rapid and sustained improvement in skin symptoms.
Future Outlook and Investor Briefing
Takeda plans to submit a new drug application to the U.S. Food and Drug Administration (FDA) and other regulatory authorities in fiscal 2026. An investor briefing on Phase 3 clinical trial data and market opportunities will be held via webcast on March 28 and 29, 2026. These clinical trial results are not expected to have a material impact on the full-year consolidated earnings forecast for the fiscal year ending March 2026 (fiscal 2025).
Takeda Pharmaceutical Company Limited
Company overview · Stock price · Financial data · All IR