- Phase 3 studies of zasocitinib met all primary and secondary endpoints in moderate-to-severe plaque psoriasis.
- Over 50% of participants achieved PASI 90, and 30% achieved PASI 100 by week 16.
- Zasocitinib's safety profile was consistent with previous studies, with common adverse events like upper respiratory infections.
- Takeda plans to submit a New Drug Application in fiscal year 2026.
Study Results
Pivotal Phase 3 studies of the oral drug zasocitinib demonstrated success in treating moderate-to-severe plaque psoriasis. The trials met all primary and secondary endpoints, with more than half of participants achieving clear or almost clear skin (PASI 90) and about 30% achieving completely clear skin (PASI 100) by week 16.
Safety Profile
Zasocitinib was generally well-tolerated, with a safety profile consistent with previous clinical studies. Common adverse events included upper respiratory tract infections, nasopharyngitis, and acne, with no new safety signals identified.
Future Plans
Takeda intends to present these results at upcoming medical congresses and plans to submit a New Drug Application to the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 2026.
Ongoing Research
Zasocitinib is also being evaluated in a head-to-head study against deucravacitinib for plaque psoriasis, as well as in Phase 3 studies for psoriatic arthritis and Phase 2 studies for Crohn’s disease and ulcerative colitis.
