Zasocitinib: High Rates of Clearance for Scalp, Nail, Palmoplantar PsO

Zasocitinib (TAK-279; Takeda), an investigational once-daily oral tyrosine kinase 2 (TYK2) inhibitor, demonstrated consistent and high rates of skin clearance across the scalp, nails, palms, and soles in secondary endpoint analyses from the Phase 3 LATITUDE PsO 3001 and 3002 studies in adults with moderate-to-severe plaque psoriasis (PsO), Takeda announced July 16, 2026.¹ The data were presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy in New York and build on primary endpoint results from the same trials reported earlier this year.²

In the co-primary endpoint analyses presented at AAD Annual Meeting in March 2026, approximately 70% of zasocitinib-treated patients achieved static Physician Global Assessment (sPGA) 0/1 — clear or almost clear skin — at week 16, with PASI 75 responses emerging as early as week 4 and continuing to increase through week 24.² The new data extend those findings to hard-to-treat, high-impact sites that carry significant quality-of-life burden and are often undertreated.

High Rates of Scalp, Palmoplantar, and Nail Clearance

Scalp PsO was assessed in a subgroup representing 38% and 28% of the overall study populations in 3001 and 3002, respectively. Among those patients, 77% (3001) and 74% (3002) treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response at week 16, compared with 7% and 13% in the placebo arms and 42% and 30% in the apremilast arms (P <.001 vs both comparators in both studies).¹ Response criteria required a baseline ssPGA ≥3, scalp psoriasis severity index ≥12, and scalp surface area involvement ≥30%.

Palmoplantar disease was evaluated in subgroups representing 24% and 22% of each trial's overall population. Zasocitinib produced hands and/or feet-specific PGA (hfPGA) 0/1 response rates of 71% (3001) and 69% (3002) at week 16, compared with 22% and 10% for placebo and 44% and 43% for apremilast. Takeda did not disclose specific P values for this endpoint.¹

For nail PsO — assessed in patients with nail involvement at baseline, representing 37% and 30% of the overall populations — zasocitinib produced statistically significant improvements in Nail PsO Severity Index (NAPSI) versus placebo at week 16 (P <.001). Responses across all 3 anatomical sites were sustained through week 24 in both studies.¹

The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis, and acne. No new safety signals were identified.¹

"Despite advances in PsO care, many patients continue to experience persistent symptoms, especially in highly visible or sensitive areas like the scalp — impacting about half of patients with psoriasis — which can disproportionately affect daily life," said Leon Kircik, MD, founder and medical director of Skin Sciences and Physicians Skin Care in Louisville, Kentucky, who served as principal investigator for the LATITUDE PsO studies. "These findings show that zasocitinib delivered consistently clear skin across the hardest-to-treat areas, including the scalp, nails, palms and soles."¹

LATITUDE Data to Support NDA Submission

Zasocitinib is designed to inhibit TYK2 with more than 1-million-fold selectivity over JAK1, 2, and 3 based on in vitro data, targeting the IL-23/IL-17 axis and type I interferon signaling that drive psoriatic inflammation while sparing broader JAK-family signaling associated with cardiovascular and hematologic risk.¹ These site-specific secondary analyses follow topline data from the head-to-head LATITUDE Atlas trial in which zasocitinib produced PASI 100 response rates more than 2.5 times higher than deucravacitinib at week 16.³

Takeda plans to submit a New Drug Application to the FDA for plaque PsO during the current fiscal year. Zasocitinib is additionally being evaluated in Phase 3 studies in psoriatic arthritis (NCT06671483, NCT06671496) and Phase 2 studies in Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa. The drug has not been approved by any regulatory authority.¹

References

1. Takeda Pharmaceutical Company Limited. Takeda's zasocitinib demonstrates consistent, high rates of skin clearance across the body, including hard-to-treat and high-impact sites, in Phase 3 psoriasis studies. Press release. July 16, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-phase-3-psoriasis-skin-clearance/

2. Gooderham M, et al. Once-daily oral zasocitinib demonstrates rapid and reproducible skin clearance with a consistent safety profile in moderate-to-severe plaque psoriasis: results from two randomized Phase 3 trials (LATITUDE-PsO-3001 and 3002). Late-breaking abstract presented at: American Academy of Dermatology Annual Meeting; March 28, 2026; Denver, CO.

3. Takeda Pharmaceutical Company Limited. Takeda's zasocitinib significantly outperforms deucravacitinib in head-to-head Phase 3 psoriasis study. Press release. June 11, 2026. https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-outperforms-deucravacitinib-study/