OSAKA, Japan & CAMBRIDGE, Mass. - Friday, 17. July 2026 AETOSWire Print
On average, about 75% of patients with scalp psoriasis treated with zasocitinib achieved clear or almost clear skin at week 16
Approximately 70% of patients with palmoplantar disease treated with zasocitinib achieved clear or almost clear skin at week 16
Zasocitinib demonstrated statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo
Results reinforce the potential of zasocitinib to deliver rapid and durable skin clearance, including in the hardest-to-treat areas, in a convenient once-daily pill
(BUSINESS WIRE) -- Takeda (TSE:4502/NYSE:TAK) announced new data from the two pivotal Phase 3 studies of zasocitinib (TAK-279), a next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented at the 2026 American Academy of Dermatology (AAD) Innovation Academy, these secondary endpoint data show that zasocitinib demonstrated consistent and high rates of skin clearance across hard-to-treat, high-impact sites, including the scalp, nails, palms and soles, compared with placebo.1-5
These data build on the topline results from the Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled LATITUDE PsO 3001 and 3002 studies.2,6 In those studies, about 70% of patients treated with zasocitinib achieved static Physician Global Assessment (sPGA) 0/1 (clear or almost clear skin) at week 16, with a significantly greater Psoriasis Area and Severity Index (PASI) 75 response rate seen as early as week 4 and continuing to increase through week 24.6 The totality of data shows the potential of zasocitinib to deliver rapid and durable skin clearance — even in the hardest-to-treat areas.2,6
“Psoriasis is a complex, heterogeneous disease that can present differently across patients and over time, particularly in high-impact sites that are often difficult to treat,” said Chinwe Ukomadu, MD, PhD, senior vice president and head, Gastrointestinal & Inflammation Therapeutic Area Unit at Takeda. “TYK2 plays a key role in regulating core disease-driving immune pathways, including the IL-23/IL-17 axis and type I interferon, which contribute to variability in disease presentation and treatment response. Our Phase 3 results reinforce the potential of our next-generation TYK2 inhibitor to deliver rapid, durable and consistent skin clearance in a convenient once-daily pill.”
Phase 3 psoriasis results across high-impact sites
The 3001 and 3002 studies also evaluated patients who had nail psoriasis, or patients with at least moderate scalp or palmoplantar psoriasis, at baseline.2 Results were consistent across the body, including these difficult-to-treat, high-impact sites:2-5
Scalp: 77% and 74% of patients with scalp psoriasis treated with zasocitinib achieved scalp-specific PGA (ssPGA) 0/1 response versus placebo (7% and 13%; p<0.001) and apremilast (42% and 30%; p<0.001) at week 16.2
Palms and soles (palmoplantar): Approximately 70% of patients with palmoplantar psoriasis treated with zasocitinib achieved numerically higher rates of hands and/or feet-specific PGA (hfPGA) 0/1 response (71% and 69%) versus placebo (22% and 10%) and apremilast (44% and 43%) at week 16.2
Nails: Zasocitinib also delivered statistically significant improvements in Nail Psoriasis Severity Index (NAPSI) versus placebo at week 16 (p<0.001).2
Responses were sustained through week 24 in both studies.2
The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.2
“Despite advances in psoriasis 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, Louisville, KY, principal investigator for the LATITUDE PsO studies and presenting author. “These findings show that zasocitinib delivered consistently clear skin across the hardest-to-treat areas, including the scalp, nails, palms and soles, reinforcing its potential to become a leading oral treatment option for patients seeking meaningful, whole-body skin clearance.”
Next steps for zasocitinib
Takeda plans to submit a New Drug Application for plaque psoriasis with the United States Food and Drug Administration and other regulatory authorities beginning this fiscal year. Zasocitinib is also being evaluated in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).7-12
About Plaque Psoriasis
Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring and disabling skin lesions that impact one’s physical, emotional and psychological wellbeing.3,13-18 Globally, an estimated 64 million people are living with psoriasis, and about 80-90% of those have plaque psoriasis.19-20 Persistent itch, the appearance and location of skin lesions — especially in highly visible or sensitive areas — and related comorbidities, like psoriatic arthritis, play a major role in reducing quality of life and can lead to significant impacts on daily living.3,16-18 Psoriasis is also a heterogeneous disease driven by complex, interconnected immune pathways, genetics and environmental factors that differ across patients and over time, leading to variability in disease course, symptoms and treatment response.21-25
About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective and potent oral TYK2 inhibitor that maintains 24-hour inhibition of IL-23 plus other core disease-driving immune pathways.26-30 It has the potential to be a leading oral treatment option for people living with psoriasis that may deliver rapid and durable skin clearance in a convenient once-daily pill.6 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.26-27 Takeda is currently evaluating the safety and efficacy of zasocitinib in Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).7-12 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.31-32 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. 31-32 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24). 31-32
Secondary endpoints that evaluated high-impact sites included:
Scalp (assessed in 38% and 28% of overall study population):2 Proportion of patients achieving scalp-specific PGA (ssPGA) response (defined as clear [0] or almost clear [1] with ≥2-point decrease from baseline [in patients with baseline ssPGA ≥3, baseline psoriasis scalp severity index ≥12 and scalp surface area involvement ≥30%]) at week 16 (versus placebo and/or apremilast) and week 24 (versus apremilast);31-32
Palms and soles (palmoplantar; assessed in 24% and 22% of the overall study population):2 Proportion of patients with PGA of the palmoplantar hands and/or feet (hfPGA) response (defined as clear [0] or almost clear [1] with ≥2-point decrease from baseline [in patients with baseline hfPGA ≥3]) at week 16 (versus placebo and/or apremilast) and week 24 (versus apremilast);31-32
Nails (assessed in 37% and 30% of the overall study population):2 Change from baseline (CfB) in Nail Psoriasis Severity Index (NAPSI) (in patients with nail involvement at baseline) at week 16 (versus placebo).31-32
About Tyrosine Kinase 2 (TYK2) Inhibitors
TYK2 is a central mediator of core inflammatory pathways in psoriasis — IL-23/IL-17 axis and type I interferon signaling — making it a promising target as inhibition of a single pathway may not fully control disease for every patient.25,29,33 TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.25-26 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes such as lipid metabolism and hematopoiesis, which can be linked to cardiovascular risks and blood disorders when disrupted.25-26,34 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, is a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family.30
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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References
The topline results of these studies were disclosed on December 18, 2025, in “Takeda’s Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment”.
Armstrong AW, et al. Zasocitinib, a once-daily oral TYK2 inhibitor, demonstrates efficacy at high impact sites in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002). Presented at the 2026 American Academy of Dermatology Innovation Academy. 2026 July 16; New York, NY.
Dopytalska K, Sobolewski P, Błaszczak A, Szymańska E, Walecka I. Psoriasis in Special Localizations. Reumatologia. 2018;56(6):392-398. doi:10.5114/reum.2018.80718.
Lupulescu AM, Savu AP, Bucur Ş, Şerban ED, Popescu S, Constantin MM. Hard-to-Treat Areas in Psoriasis: An Underevaluated Part of the Disease. Life (Basel). 2025;15(3):425. Published 2025 Mar 7. doi:10.3390/life15030425
Butacu A-I, Toma C, Negulet I-E, Manole I, Banica AN, Plesea A, Badircea IA, Iancu I, Tiplica G-S. Updates on Psoriasis in Special Areas. Journal of Clinical Medicine. 2024; 13(24):7549. https://doi.org/10.3390/jcm13247549
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). Presented at the American Academy of Dermatology 2026. 2026 Mar 28; Denver, CO.
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated June 29, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06671483.
A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated June 29, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06671496.
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Crohn's Disease. ClinicalTrials.gov Identifier: NCT06233461. Updated May 8, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT06233461.
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis. ClinicalTrials.gov Identifier: NCT06254950. Updated May 22, 2026. Accessed July 2026. https://www.clinicaltrials.gov/study/NCT06254950.
A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated June 12, 2026. Accessed July 2026. https://clinicaltrials.gov/study/NCT07108283.
A Takeda Presentation. Quarterly Results - Quarter 1 FY2025. Available at: https://assets-dam.takeda.com/image/upload/v1753839858/Global/Investor/Financial-Results/FY2025/Q1/qr2025_q1_p01_en.pdf. Accessed July 2026.
Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23.
Bhosle, MJ, Kulkarni A, et al. Quality of life in patients with psoriasis. Health Qual Life Outcomes. 2006;35(4). https://doi.org/10.1186/1477-7525-4-35.
Dhabale A, Nagpure S. Types of psoriasis and their effects on the immune system. Cureus. 2022 Sep 24;14(9):e29536. doi: 10.7759/cureus.29536.
Taliercio VL, Snyder AM, Webber LB, et al. The Disruptiveness of Itchiness from Psoriasis: A Qualitative Study of the Impact of a Single Symptom on Quality of Life. J Clin Aesthet Dermatol. 2021;14(6):42-48.
Snyder AM, Taliercio VL, Webber LB, et al. The Role of Pain in the Lives of Patients with Psoriasis: A Qualitative Study on an Inadequately Addressed Symptom. J Psoriasis Psoriatic Arthritis. 2022 Jan;7(1):29-34. doi: 10.1177/24755303211066928. Epub 2021 Dec 12. PMID: 39296728; PMCID: PMC11361505.
Blackstone B, Patel R, Bewley A. Assessing and Improving Psychological Well-Being in Psoriasis: Considerations for the Clinician. Psoriasis (Auckl). 2022;12:25-33.doi:10.2147/PTT.S32844
AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 9. 2020;59(5):566-571. doi: 10.llll/ijd.14864.
Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK43087.
Narayanan S, Guyatt V, Franceschetti A, Hautamaki EL. Disease burden and patient reported outcomes among patients with moderate to severe psoriasis: an ethnography study. Psoriasis (Auckl). 2014;5:1-7. Published 2014 Dec 23. doi:10.2147/PTT.S74906
Elmets CA, Leonardi CL, Davis DMR, et al. Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with awareness and attention to comorbidities. J Am Acad Dermatol. 2019;80(4):1073-1113. doi:10.1016/j.jaad.2018.11.058.
Griffiths CEM, Armstrong AW, Gudjonsson JE, Barker JNWN. Psoriasis. Lancet. 2021;397(10281):1301-1315. doi:10.1016/S0140-6736(20)32549-6.
Gooderham MJ, Papp KA, Lynde CW. Shifting the focus - the primary role of IL-23 in psoriasis and other inflammatory disorders. J Eur Acad Dermatol Venereol. 2018;32(7):1111-1119. doi:10.1111/jdv.14868
Muromoto R, Oritani K, Matsuda T. Current understanding of the role of tyrosine kinase 2 signaling in immune responses. World J Biol Chem. 2022;13(1):1–14. doi:10.4331/wjbc.v13.i1.1.
Leit S, Greenwood J, Carriero S, et al. Discovery of a Potent and Selective Tyrosine Kinase 2 Inhibitor: TAK-279. J Medicinal Chemistry.2023;66(15):10473-10496.doi.org/10.1021/acs.jmedchem.3c00600.
Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological characterization of zasocitinib (TAK-279): an oral, highly selective and potent allosteric TYK2 inhibitor. J Invest Dermatol. 2026;146:214-222.e7. https://www.jidonline.org/action/showPdf?pii=S0022-202X%2825%2900531-7.
Armstrong AW, Gooderham M, Lynde C, et al. Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) in Psoriasis: A Randomized Clinical Trial. August 21, 2024. JAMA Dermatol. 2024 August 21;160;(10):1066- 1074. doi:10.1001/jamadermatol.2024.2701.
Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385. 2022 Sep 16. doi:10.2147/JIR.S38068.
Krueger JG, McInnes IB, Blauvelt A. Tyrosine Kinase 2 and Janus Kinase‒Signal Transducer and Activator of Transcription Signaling and Inhibition in Plaque Psoriasis. J Am Acad Dermatol. 2022;86(1):148-157. doi:10.1016/j.jaad.2021.06.869.
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 Identifier: NCT06088043. Updated October 24, 2025. Accessed July 2026. 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 Identifier: NCT06108544. Updated November 11, 2025. Accessed July 2026. https://clinicaltrials.gov/study/NCT06108544.
Martin G. Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors. Dermatol Ther (Heidelb). 2023;13(2):417-435. doi:10.1007/s13555-022-00878-9.
Danese S, Peyrin-Biroulet L. Selective Tyrosine Kinase 2 Inhibition for Treatment of Inflammatory Bowel Disease: New Hope on the Rise. Inflamm Bowel Dis. 2021;27(12):2023-2030. doi: 10.1093/ibd/izab135.
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