Zasocitinib

THURSDAY, April 2, 2026 — Folks with severe plaque psoriasis often have to choose between convenient pills that don’t work very well or highly effective injections that come with the hassle of needles. That trade-off may soon change. New clinical trial data suggests a once-daily pill called zasocitinib may provide the clear skin once only expected from shots. The medicine is in the final stages of study and is not yet approved by the U.S. Food and Drug Administration (FDA). Takeda Pharmaceuticals recently shared results from two late-stage clinical trials involving nearly 1,800 adults with moderate-to-severe plaque psoriasis across 21 countries. The findings — presented at a meeting of the American Academy of Dermatology in Denver last month — showed that about 70% of participants taking the pill reached the goal of having clear or almost clear skin within 16 weeks. Plaque psoriasis makes skin cells grow too fast, forming thick, scaly raised red patches with silvery scales. It causes itching and burning feelings on the skin during flare-ups. The studies compared zasocitinib to a placebo and to apremilast , a widely available pill for psoriasis. About 30% of patients on apremilast saw significant skin improvement, compared to more than double that amount with zasocitinib. Researchers reported that zasocitinib worked with surprising speed. Many patients noticed their skin starting to clear as early as four weeks into the treatment. The results were lasting: Of the patients who had clear skin at the nine-month mark, more than 90% still maintained those results after more than a year of daily use. “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said lead researcher Dr. Melinda Gooderham , a dermatologist in Ontario, Canada. She added that these results show it is possible for a daily pill to deliver rapid, lasting relief. No new or unexpected safety concerns were discovered during the trials. The most common side effects reported were generally mild, such as upper respiratory infections like a common cold. About 6.5% of patients taking the drug also experienced acne, which is a known side effect of this specific class of medication, called TYK2 inhibitors. “Our Phase 3 results demonstrate that highly selective TYK2 inhibition can offer many people with moderate-to-severe plaque psoriasis the potential for clear or nearly clear skin,” said Dr. Chinweike Ukomadu , a senior vice president at Takeda and head of the company’s gastrointestinal and inflammation areas. Takeda plans to submit the drug to the FDA for approval within the next year. Findings from medical conferences are considered preliminary until published in a peer-reviewed journal. Sources Takeda Pharmaceutical Company Limited, news release, March 28, 2026

During this year’s American Academy of Dermatology annual meeting in Denver, companies like Sanofi , Biogen and Tanabe Pharma presented data for their respective candidates. But there were other pharma companies that stood out with results from their previously toplined trials: 📊 Takeda’s Phase 3 plaque psoriasis data: Zasocitinib, which Takeda acquired for $4 billion in its 2022 deal with Nimbus Therapeutics, appears more efficacious than Bristol Myers Squibb’s similar drug Sotyktu (cross-trial caveats notwithstanding). In its two Phase 3 studies, zasocitinib saw 76% and 71% of patients, respectively, achieve skin clearance of at least 75% after 16 weeks. In the two studies Sotyktu used for its plaque psoriasis approval, the Bristol Myers drug helped 58.3% and 53% of patients reach the same level of skin clearance. Both zasocitinib and Sotyktu are oral, once-a-day TYK2 inhibitors. Takeda previously toplined the Phase 3 data in December and says it’s on track to file for FDA approval by March 31, 2027. Also notable were two secondary endpoints looking at 90% and 100% skin clearance after 16 weeks. Takeda said across the two studies, 61.3% and 51.9% of patients saw 90% skin clearance, while 33.4% and 25.2% of patients saw their psoriasis completely clear up. Takeda pitted zasocitinib directly against Amgen’s Otezla and placebo, with zasocitinib reaching statistically significant improvements against both comparator arms. 💊 Alumis also gets a plaque psoriasis win: Aiming to also compete with Sotyktu, Alumis revealed its own full Phase 3 data for an oral TYK2 drug. After 16 weeks, envudeucitinib saw 76.5% and 70.4% of patients, respectively, reach skin clearance of at least 75% . Those figures numerically stack up against Takeda’s reported data for zasocitinib (again, cross-trial caveats notwithstanding) and were statistically superior to placebo and Otezla. Secondary endpoints also fell in similar ranges. In Alumis’ two Phase 3 studies, 59.9% and 53.1% of patients reached skin clearance of 90%, while 29.4% and 27.7% of those who took envudeucitinib achieved full clearance of their psoriasis. Both endpoints were measured after 16 weeks of treatment. Alumis toplined the data in January and plans to file for FDA approval in the second half of 2026. 📊 Roivant touts autoimmune drug ahead of PDUFA: Roivant said the candidate it licensed from Pfizer showed “rapid and statistically significant reductions in itch,” and parallel improvements in skin-related quality of life in a Phase 3 trial for dermatomyositis. Roivant and its subsidiary Priovant announced last year that brepocitinib met its primary endpoint and all nine secondary endpoints. Leerink analysts said this weekend that the additional analyses, including itch reduction, “support our positive outlook on its commercial prospects.” The FDA is expected to make an approval decision in the third quarter of this year. 💊 Incyte unveils JAK1 extension data: Incyte said its drug povorcitinib for hidradenitis suppurativa showed “durable responses” in a 42-week extension period across two Phase 3 studies. Up to 71.4% of patients achieved HiSCR50, a key clinical endpoint that measures the improvement of patients’ skin condition from baseline. Stifel analysts noted that those responses mark a continued improvement from Week 24 data previously reported last year. “We look forward to advancing our regulatory applications in the US and Europe,” Incyte’s president and global head of R&D Pablo Cagnoni said.