Takeda Pharmaceutical Company Limited
Innovative Phase 3 Clinical Trial Data Demonstrates Zasositinib, Administered Once Daily Orally for Plaque Psoriasis, Improves Skin Lesions and Opens a New Era in Treatment
Zasositinib (TAK-279) achieved primary endpoints in a Phase 3 clinical trial targeting patients with moderate to severe plaque psoriasis, with over half achieving PASI90 and approximately 30% achieving PASI100 at week 16.
Key Figures
- Product/Service Name: Zasositinib (TAK-279)
- Launch/Start Date: Fiscal year 2026 onwards (new drug application planned)
- Target Market: Plaque psoriasis market and immune-mediated inflammatory disease area
- Development Stage: Phase 3 clinical trials completed, approval application preparation underway
AI要約
Overview of the Product/Service
Zasositinib (TAK-279) is a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor for plaque psoriasis. In two pivotal Phase 3, randomized, multicenter, double-blind, placebo- and active-controlled clinical trials (LATITUDE Psoriasis Phase 3 trials) involving adult patients with moderate to severe disease, the primary efficacy endpoints at week 16 — Physician's Global Assessment (sPGA) 0/1 and PASI75 — were met. All 44 secondary endpoints, including PASI90 and PASI100, were also achieved. The drug demonstrated generally good tolerability, with a safety profile consistent with previous clinical trials. New drug applications are planned to be submitted to the FDA and other regulatory authorities in fiscal year 2026.
Market Impact and Outlook
Zasositinib has the potential to become a leading oral treatment option for plaque psoriasis patients by providing complete clearance of skin lesions with once-daily oral dosing, combining safety, high efficacy, and rapid onset of action. Ongoing clinical trials include head-to-head studies against competitor deucravacitinib, as well as trials in indications such as psoriatic arthritis, Crohn's disease, and ulcerative colitis, which are expected to drive significant future revenue contributions. This positions Zasositinib as a strategic product strengthening Takeda's pipeline and redefining medical care.
