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 Français

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Takeda Canada Inc.

Dec 22, 2025, 08:00 ET

  • Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psoriasis
  • More than half of study participants treated with zasocitinib achieved clear or almost clear skin (PASI 90), and on average about 30 percent achieved completely clear skin (PASI 100) by week 16
  • Zasocitinib was generally well-tolerated with a safety profile consistent with previous clinical studies

TORONTO, Dec. 22, 2025 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75, at week 16, with a significantly greater PASI 75 response rate seen as early as week 4 and continuing to increase through week 24. The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a convenient once-daily pill to deliver complete skin clearance for patients with PsO.

"People living with psoriasis continue to seek safe, effective and fast-acting oral therapies. These landmark results support zasocitinib's promise to become a leading oral treatment option that can deliver clear skin for patients with plaque psoriasis," said Christophe Weber, president and chief executive officer at Takeda. "This marks the third positive Phase 3 readout from our overarching pipeline this year. Each of these programs – zasocitinib, oveporexton and rusfertide – has potential to transform patient lives, redefine medical practice and deliver significant revenue growth in the future."

Zasocitinib was generally well-tolerated. The safety and tolerability profile of zasocitinib in the Phase 3 studies remained consistent with prior studies, including the Phase 2b plaque psoriasis study. The most common adverse events through week 24 were upper respiratory tract infection, nasopharyngitis and acne, with no new safety signals identified.

"It is incredibly rewarding and exciting to see our Phase 2 results validated in Phase 3, with more than half of patients treated with zasocitinib achieving clear or almost clear skin (PASI 90) and about 30 percent achieving completely clear skin (PASI 100) at week 16, with response rates continuing to increase through week 24," said Andy Plump, M.D., Ph.D., president of R&D at Takeda. "These findings help demonstrate that highly selective inhibition of TYK2, a key mediator of IL-23 and other signaling pathways fundamental to psoriasis, may provide patients with significant reductions in their disease burden, including for many, the possibility of complete skin clearance."

Takeda intends to present the results at upcoming medical congresses and plans to submit a New Drug Application with the United States Food and Drug Administration, as well as analogous filings to Health Canada and other regulatory authorities, starting in fiscal year 2026.

Zasocitinib is also being evaluated in a head-to-head study against deucravacitinib in plaque psoriasis, Phase 3 studies in psoriatic arthritis and Phase 2 studies in Crohn's disease and ulcerative colitis, among other indications.1-6 Results from the Phase 3 studies have no significant impact on the full-year consolidated forecast for the fiscal year ending March 31, 2026.

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.7 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.8-10 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.7,11 Many people living with psoriasis experience intense itching and burning from their psoriasis plaques that disrupt their daily lives.9,10 Patients also report that their symptoms negatively impact their mental health and quality of life and can lead to social isolation.12 Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis.13,14

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.15,16 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.15,17 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. In addition, Phase 2 studies are ongoing in Crohn's disease, ulcerative colitis and vitiligo, and being initiated in hidradenitis suppurativa (HS).1-6 Zasocitinib is an investigational compound that has not been approved for use by any regulatory authority.

The safety and effectiveness of zasocitinib are still under investigation and marketing authorization has not been granted by any regulatory authority at this time. In the absence of marketing authorization in Canada, Takeda does not currently recommend the use of the zasocitinib outside of a clinical study authorized by Health Canada.

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.18,19 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 16.18,19 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).18,19 

About Tyrosine Kinase 2 (TYK2) Inhibitors

TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.17,20,21 However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes. 17,20,21 TYK2 mediates IL-23 plus other immune and inflammatory signaling pathways that are fundamental to psoriasis, psoriatic arthritis and other immune-mediated inflammatory diseases.22 Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, 2 and 3, may be a promising therapeutic approach to target immune-mediated inflammation while potentially avoiding risks associated with inhibition of other members of the JAK family. 23

About Takeda Canada Inc.

Takeda Canada Inc. is the Canadian organization of Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to discovering and delivering life-transforming treatments, guided by our commitment to patients, our people and the planet. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Genetics and Hematology, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries and regions. For more information, visit: https://www.takeda.com/en-ca/.

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References:

  1. A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis. ClinicalTrials.gov Identified: NCT06973291. Updated December 17, 2025. Accessed December 2025.https://clinicaltrials.gov/study/NCT06973291.
  2. Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated December5, 2025. Accessed December 2025. https://clinicaltrials.gov/study/NCT06671483?cond=Psoriatic%20Arthritis&term=tak-279&rank=2
  3. A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated December5, 2025. Accessed December 2025. https://clinicaltrials.gov/study/NCT06671496?cond=Psoriatic%20Arthritis&term=tak-%20279&rank=1.
  4. https://clinicaltrials.gov/study/NCT06973291A 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 December 17, 2025. Accessed: December 2025. https://clinicaltrials.gov/study/NCT06233461.
  5. 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 November 21, 2025. Accessed: December 2025. https://www.clinicaltrials.gov/study/NCT06254950.
  6. 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 December 2025.
  7. 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.
  8. Gkini MA, Nakamura M, Alexis AF, et al. Psoriasis in People With Skin of Color: An Evidence-Based Update. Int J Dermatol. 2025;64(4):667-677. doi:10.1111/ijd.17651
  9. 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.
  10. 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;7(1):29-34. doi:10.1177/24755303211066928.
  11. 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.
  12. 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.S328447.
  13. AIQassimi S, AIBrashdi S, Galadari H, Hashim MJ. Global Burden of Psoriasis - Comparison of Regional and Global Epidemiology, 1990 to 2017. Int J Dermatol. 2020;59(5):566-571. doi: 10.llll/ijd.14864.
  14. Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025.https://www.ncbi.nlm.nih.gov/books/NBK430879/
  15. Mehrotra S, Sano Y, Halkowycz P, et al. Pharmacological Characterization of Zasocitinib (TAK-279): An Oral, Highly Selective and Potent Allosteric TYK2 Inhibitor. May 26, 2025. J Invest Dermatol. 2025 May 27:S0022-202X(25)00531-7. doi:10.1016/j.jid.2025.05.014. Online ahead of print.
  16. Shang L, et al. TYK2 in immune responses and treatment of psoriasis. J Inflamm Res. 2022;15:5373-5385.
  17. 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.
  18. 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 December 2025. https://clinicaltrials.gov/study/NCT06088043.
  19. 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 December 2025. https://clinicaltrials.gov/study/NCT06108544.
  20. 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.
  21. 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.
  22. Rusiñol L, Puig L. Tyk2 Targeting in Immune-Mediated Inflammatory Diseases. Int J Mol Sci. 2023;24(4):3391. Published 2023 Feb 8. doi:10.3390/ijms24043391.
  23. 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.

SOURCE Takeda Canada Inc.

Media Contact: Kristen King, [email protected], 905-876-6402; C-ANPROM/INT/TAK-279/0330 | December 2025; NPRMCDA/CA/Zas/0001 | December 2025

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Takeda Canada Inc.