Takeda’s Phase 3 LATITUDE trials showed zasocitinib significantly improved scalp, nail, and palmoplantar psoriasis, supporting FDA submission plans for the oral TYK2 inhibitor
Written By: Fariha Sameen, PharmD
Reviewed By: Pharmacally Editorial Team
Takeda has reported new Phase 3 data showing that its investigational oral TYK2 inhibitor, zasocitinib (TAK-279), achieved high rates of skin clearance in difficult-to-treat forms of moderate-to-severe plaque psoriasis. The findings, presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, demonstrated significant improvements in psoriasis affecting the scalp, nails, palms, and soles, reinforcing the drug’s potential as a once-daily oral treatment.
Phase 3 Data Show Consistent Efficacy Across High-Impact Disease Sites
The new analyses come from the global Phase 3 LATITUDE PsO 3001 (NCT06088043) and LATITUDE PsO 3002 (NCT06108544) studies, which enrolled 693 and 1,108 adults, respectively, with moderate-to-severe plaque psoriasis.
The secondary endpoint analyses showed that approximately 77% and 74% of patients with scalp psoriasis receiving zasocitinib achieved a scalp-specific Physician Global Assessment (ssPGA) score of 0 or 1 at week 16. This compared with 7% and 13% for placebo and 42% and 30% for apremilast, with statistically significant superiority over both comparators (p<0.001).
Among patients with palmoplantar psoriasis, around 71% and 69% achieved a hands and/or feet-specific PGA (hfPGA) score of 0 or 1 by week 16. These response rates exceeded those observed with placebo (22% and 10%) and apremilast (44% and 43%).
Patients with nail involvement also experienced statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) scores versus placebo at week 16 (p<0.001). Clinical responses across all evaluated sites remained durable through week 24.
These findings build on previously reported topline results in which approximately 70% of patients achieved clear or almost clear skin (sPGA 0/1) at week 16, while PASI 75 responses emerged as early as week 4 and continued to improve through week 24.
TYK2 Inhibition Targets Key Psoriasis Pathways
Zasocitinib is a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor. TYK2 regulates inflammatory signaling through the IL-23/IL-17 axis and type I interferon pathways, both of which play central roles in psoriasis pathogenesis.
Unlike broader Janus kinase (JAK) inhibitors, zasocitinib demonstrates more than one-million-fold selectivity for TYK2 over JAK1, JAK2, and JAK3 in laboratory studies. This selectivity may provide effective immune modulation while minimizing effects on pathways involved in hematopoiesis and lipid metabolism.
Psoriasis affects an estimated 64 million people worldwide, with plaque psoriasis accounting for approximately 80% to 90% of cases. Disease affecting the scalp, nails, palms, and soles often causes substantial impairment in daily activities and quality of life while remaining particularly challenging to treat.
Safety Profile Remained Consistent
The overall safety profile through 24 weeks remained consistent with earlier findings.
The most frequently reported adverse events included upper respiratory tract infection, nasopharyngitis, and acne. Investigators reported no new safety signals during the study period.
Investigators Highlight Potential Clinical Impact
Chinwe Ukomadu, MD, PhD, senior vice president and head of Takeda’s Gastrointestinal & Inflammation Therapeutic Area Unit, said the results support the ability of selective TYK2 inhibition to provide rapid and durable skin clearance across the diverse manifestations of psoriasis while offering the convenience of once-daily oral treatment.
Leon Kircik, MD, principal investigator for the LATITUDE PsO studies, noted that psoriasis affecting visible or sensitive body areas continues to place a significant burden on patients despite available therapies. He said the Phase 3 findings demonstrated consistent skin clearance across several of the most difficult-to-treat disease sites.
Regulatory Submission Planned This Fiscal Year
Takeda plans to begin New Drug Application (NDA) submissions for zasocitinib in plaque psoriasis with the U.S. Food and Drug Administration and other regulatory authorities during the current fiscal year.
Beyond psoriasis, the company is evaluating the investigational TYK2 inhibitor in Phase 3 studies for psoriatic arthritis and Phase 2 trials in Crohn’s disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa, expanding its potential role across multiple immune-mediated inflammatory diseases.
Reference
Zasocitinib Shows Consistent Skin Clearance in Phase 3 Psoriasis Studies
About the Writer
Fariha Sameen, PharmD (LinkedIn), is a clinical pharmacy professional with hands-on experience in patient counselling, medication review, therapeutic monitoring, and clinical documentation across multiple departments. She has experience identifying and assessing drug-related problems and supporting medication safety practices. Her interests include pharmacovigilance, ADR reporting, clinical research, and medical writing focused on clear, evidence-based communication.