Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care
Takeda announced new data from the two pivotal Phase 3studies 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
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
- 71.4% and 69.2% of patients treated with zasocitinib achieved a static Physician Global Assessment (sPGA) score of 0/1 versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%) at week 16 (p<0.001).2
- 61.3% and 51.9% of patients treated with zasocitinib achieved Psoriasis Area and Severity Index (PASI) 90 versus placebo (5.0% and 4.0%) and apremilast (16.8% and 15.9%) at week 16 (p<0.001).2
Zasocitinib also demonstrated statistically significant improvements in complete skin clearance, an increasingly important treatment goal for patients with plaque psoriasis:1,2
- 39.9% and 33.7% of patients treated with zasocitinib achieved an sPGA score of 0 versus placebo (0.7% and 1.4%) and apremilast (8.0% and 6.5%) at week 16 (p<0.001).2
- 33.4% and 25.2% of patients treated with zasocitinib achieved a PASI 100 versus placebo (0.7% and 1.1%) and apremilast (2.9% and 4.3%) at week 16 (p<0.001).2
- Responses for co-primary and key secondary endpoints continued to increase through week 24 in both studies.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:
- Treatment-emergent adverse events (TEAEs) through week 16 were 62.1% for zasocitinib, 46.9% for placebo and 50.5% for apremilast.2
- The most common adverse events for zasocitinib treated patients through week 16 (≥5%) were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%), with no new safety signals identified.2
- Serious TEAEs through week 16 were 3.0% for zasocitinib, <1% for placebo and 1.5% for apremilast.2
“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 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
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