Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care
OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE)--Takeda ( TSE:4502/NYSE:TAK) today announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). 1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies. 1,2
“These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasocitinib to become a leading oral treatment option for plaque psoriasis.”
“Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham, MSc, MD, FRCPC, dermatologist, SKiN Centre for Dermatology, Peterborough, Ontario, Canada, principal investigator for the Latitude PsO studies and presenting author. “These efficacy and safety results show it’s possible for a once-daily pill to deliver rapid, lasting skin clearance, highlighting the potential of zasocitinib to become a leading oral treatment option for plaque psoriasis.”
In the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled Latitude PsO 3001 and 3002 studies, more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16, a key measure of treatment success: 1,2
Zasocitinib also demonstrated statistically significant improvements in complete skin clearance, an increasingly important treatment goal for patients with plaque psoriasis: 1,2
In Latitude PsO 3002, rapidity of response was demonstrated as early as week 4 versus placebo (PASI 75: 16.8% for zasocitinib vs 4.3% for placebo, p<0.001). 2 Among patients who achieved a PASI 75, PASI 90 or sPGA 0/1 response at week 40 and continued on zasocitinib throughout the study, over 90% maintained their response at week 60. 2
Zasocitinib was generally well-tolerated. 1,2 The safety and tolerability profile of zasocitinib in the Phase 3 studies remained consistent with prior studies. 1,2 Key findings across the two studies include:
“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 Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “The positive data also underscore zasocitinib’s potential to deliver rapid and durable results with a favorable safety profile consistent with Phase 2b studies. We are working as quickly as possible with regulators to advance a potential new therapeutic option for patients seeking a safe, effective and convenient oral treatment.”
Takeda is on track to submit a New Drug Application with the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 2026.
Results from the Phase 3 studies have no significant impact on the full-year consolidated forecast for the fiscal year ending March 31, 2026.
Takeda Investor Conference Call and Webcast Details
Takeda will host an investor call to discuss the Phase 3 data and market opportunity for zasocitinib on March 28 at 6:30 p.m. MDT / 8:30 p.m. EDT / March 29 at 9:30 a.m. JST. Presentation slides and a virtual meeting registration link will be available here. An on-demand replay of the webcast will be made available on Takeda’s website after the conclusion of the event.
About Plaque Psoriasis
Psoriasis is a chronic immune-mediated inflammatory disease in which the body’s immune system causes inflammation which results in skin cells that multiply too quickly. 3 Plaque psoriasis, the most common form of psoriasis, is characterized by raised, red, gray or purple patches of skin that are itchy, painful and covered by scales. 4-6 Psoriatic plaques can cover any part of the skin surface but are mostly found on the scalp, face, arms and elbows, legs, knees, torso, genitals, nails and in skin folds. 3,7 Many people living with psoriasis experience intense itching and burning from their psoriasis plaques that disrupt their daily lives. 5,6 Patients also report that their symptoms negatively impact their mental health and quality of life and can lead to social isolation. 8 Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis. 9,10
About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways. 11,12 It has the potential to be a leading oral treatment option for people living with immune-mediated inflammatory diseases. Zasocitinib has more than 1-million-fold greater selectivity for TYK2 compared to other JAK enzymes, which could maximize TYK2 inhibition without impacting JAK1, 2 and 3 signaling, based on in vitro data. 11,13 Takeda is currently evaluating the safety and efficacy of zasocitinib in a head-to-head study against deucravacitinib in plaque psoriasis and in Phase 3 studies in psoriatic arthritis. 14-16 In addition, Phase 2 studies are ongoing in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS). 17-20 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.
About the LATITUDE Psoriasis Phase 3 Studies
The Latitude Phase 3 psoriasis studies ( NCT06088043 and NCT06108544) are global, multicenter, randomized, double-blind, placebo- and active comparator-controlled studies to evaluate the efficacy, safety and tolerability of zasocitinib in adult patients with moderate-to-severe plaque psoriasis. 21,22 The studies were conducted in 21 countries and enrolled 693 and 1,108 participants, respectively. The co-primary endpoints were the proportion of zasocitinib-treated patients achieving sPGA 0/1 and PASI 75 response compared to placebo at week 16. 21,22 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24). 21,22
About Tyrosine Kinase 2 (TYK2) Inhibitors
TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family. 13,23,24 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes. 13,23,24 TYK2 mediates IL-23 plus other immune and inflammatory signaling pathways that are fundamental to psoriasis, psoriatic arthritis and other immune-mediated inflammatory diseases. 25 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, may be a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family. 26
About Takeda
Takeda is focused on creating better health for people and a brighter future for the world. We aim to discover and deliver life-transforming treatments in our core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Together with our partners, we aim to improve the patient experience and advance a new frontier of treatment options through our dynamic and diverse pipeline. As a leading values-based, R&D-driven biopharmaceutical company headquartered in Japan, we are guided by our commitment to patients, our people and the planet. Our employees in approximately 80 countries and regions are driven by our purpose and are grounded in the values that have defined us for more than two centuries. For more information, visit www.takeda.com.
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