Takeda’s Oral TYK2 Inhibitor Zasocitinib Delivers Strong Phase 3 Results in Plaque Psoriasis

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Takeda reports detailed Phase 3 data showing Zasocitinib delivers rapid, high levels of skin clearance and durable responses through week 60 in plaque psoriasis

Written By: Nikita Jha, PharmD

Reviewed By: Pharmacally Editorial Team

Takeda Pharmaceutical Company has presented detailed results from its pivotal Phase 3 LATITUDE PsO program evaluating zasocitinib (TAK-279), an investigational oral TYK2 inhibitor, in adults with moderate-to-severe Plaque Psoriasis. The data, shared at the American Academy of Dermatology Annual Meeting 2026, expand on previously reported topline findings and provide a comprehensive view of efficacy, speed of response, durability, and safety.

Takeda had previously reported topline results from these Phase 3 studies in December 2025.

In the two global, randomized, double-blind studies Latitude PsO 3001 ( NCT06088043) and 3002 (NCT06108544) zasocitinib demonstrated robust efficacy across all key endpoints at week 16. More than two-thirds of patients achieved clear or almost clear skin (sPGA 0/1), with response rates of 71.4% and 69.2%, compared with around 11–13% for placebo and approximately 30% for the active comparator apremilast. Similarly, PASI 90 responses, reflecting near-complete skin clearance, were achieved by 61.3% and 51.9% of patients receiving zasocitinib, far exceeding placebo (4–5%) and apremilast (16%).

The updated dataset provides deeper insight into complete skin clearance, an increasingly important treatment goal. Up to 39.9% of patients achieved an sPGA score of 0, while PASI 100 responses reached as high as 33.4%, both significantly higher than placebo and apremilast. These findings suggest that once-daily oral zasocitinib may approach efficacy levels typically associated with injectable biologics.

The AAD 2026 presentation also clarifies the speed of response. Clinically meaningful improvements were observed as early as week 4, with PASI 75 responses of 16.8% compared to 4.3% with placebo. In addition, responses continued to improve through week 24, indicating a progressive treatment effect over time.

One of the most notable additions beyond the earlier topline release is long-term durability. Among patients who achieved PASI 75, PASI 90, or sPGA 0/1 responses at week 40 and continued therapy, more than 90% maintained their response through week 60. This sustained efficacy supports the potential of zasocitinib as a long-term treatment option.

Safety findings were consistent with previous studies, with no new signals identified. Treatment-emergent adverse events were reported in 62.1% of patients receiving zasocitinib, compared with 46.9% for placebo and 50.5% for apremilast. Serious adverse events remained low at 3.0%. The most common events included upper respiratory tract infections, nasopharyngitis, and acne, aligning with earlier Phase 2b observations.

Zasocitinib is a next-generation, highly selective TYK2 inhibitor designed to target IL-23–driven inflammatory pathways while minimizing effects on other JAK enzymes. This high selectivity may help balance efficacy with safety, a key consideration in the evolving TYK2 inhibitor class.

Takeda plans to begin regulatory submissions, including a New Drug Application in the United States, starting in fiscal year 2026. In parallel, the company is continuing to evaluate zasocitinib across multiple immune-mediated diseases, including psoriatic arthritis and inflammatory bowel disease.

Overall, the expanded Phase 3 dataset reinforces zasocitinib’s profile as a potentially leading oral therapy in plaque psoriasis combining rapid onset, high levels of skin clearance, durable response, and a manageable safety profile in a once-daily pill.

References

A Study About How Well TAK-279 Works and Its Safety in Participants with Moderate-to-severe Plaque Psoriasis During 52 Weeks of Treatment, ClinicalTrials.gov ID NCT06088043, https://clinicaltrials.gov/study/NCT06088043

A Study About How Well TAK-279 Works and Its Safety in Participants With Moderate-to-severe Plaque Psoriasis During 60 Weeks of Treatment With a Withdrawal and Retreatment Period, ClinicalTrials.gov ID NCT06108544, https://clinicaltrials.gov/study/NCT06108544

Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care, 28 March 2026, Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in Phase 3 Trials

About the Writer

Nikita Jha BPharm is a pharmacy graduate with expertise in clinical research, pharmacovigilance, and medical writing. In her words, she is passionate about translating complex scientific data into clear, accurate healthcare communications that advance drug safety and patient care.


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