India Pharma Outlook Team | Friday, 19 December 2025
Takeda’s experimental AI?crafted psoriasis pill, zasocitinib, achieved impressive results in two pivotal Phase?3 trials, marking a major milestone in the treatment of plaque psoriasis.
Compared to placebo and active comparators, the once-per-day oral medication was more effective and over half of patients with moderate-to-severe plaque psoriasis achieved clear or nearly clear skin (PASI 90) by week 16. Approximately 30 percent attained 100 percent (PASI100) of clearance on the skin, and the response continued to increase during week 24, which supports its effectiveness.
Plaque psoriasis is an immune-mediated, chronic, skin condition that commonly affects millions of people worldwide. Recent information of Takeda is interesting since zasocitinib, a highly selective oral TYK2 inhibitor, achieved all co-primary and 44 ranked second-endpoints such as superiority over placebo and apremilast on the measures of sPGA 0/1 and PASI 75.
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Favorable safety and tolerability profile of the Phase 3 studies were in line with previous data and highlights its versatility as convenient, oral alternative to injectable biologics and already available oral therapies.
Observers in the industry are assessing the comparisons between this drug and the others available in the established plaque psoriasis market like Sotyktu and Otezla, as well as injectable biologics like Tremfya, Skyrizi, and Cosentyx. Phase 3 success of zasocitinib confirms zasocitinib as a competitive next-generation option that will see increased uptake in patients due to its ability to be taken orally and its strong efficacy.
In fiscal year 2026, Takeda intends to initiate regulatory submissions to the FDA, as well as to other regulatory authorities in the U.S. With the approval, the AI-designed psoriasis pill would potentially be an important commercial property of the company, which can counteract the impact of the patent of the older products on the revenue.
