Zasocitinib Demonstrates Rapid Onset at Week 4 and Sustained Response Through Week 60 in Phase 3 Psoriasis Trials

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) New data from two pivotal Phase 3 studies of Zasocitinib (TAK-279) were announced today. Zasocitinib (TAK-279) is a next-generation, highly selective oral TYK2 (tyrosine kinase 2) inhibitor for the treatment of adult patients with moderate to severe plaque psoriasis (PsO).¹Data presented in a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting showed that convenient once-daily oral Zasocitinib achieved rapid and sustained clearance of skin lesions, with a safety profile consistent with the Phase 2b study. ^1,2 

Melinda Gooderham, MSc, MD, FRCPC, dermatologist at the SKiN Centre for Dermatology in Peterborough, Ontario, Canada, and lead investigator and author of the Latitude PsO study, stated: "Our goal in treating psoriasis is to achieve complete or near-complete clearance of patients' skin lesions, a goal that has traditionally relied on injectable therapies. The efficacy and safety results from the Phase 3 Latitude PsO study indicate that once-daily oral medication may also offer rapid and sustained clearance of skin lesions, highlighting Zasocitinib's potential to become a leading oral treatment option for plaque psoriasis."

In the Phase 3 randomized, multicenter, double-blind, placebo- and active-controlled Latitude PsO 3001 and 3002 studies, more than half of the patients treated with Zasocitinib achieved complete or near-complete skin clearance by Week 16, a key measure of treatment success:^1.2

• At week 16, 71.4% and 69.2% of patients receiving Zasocitinib achieved static Physician Global Assessment (sPGA) scores of 0/1, compared to 10.7% and 12.6% in the placebo group, and 32.1% and 29.7% in the apremilast group.p<0.001）。²

• At week 16, 61.3% and 51.9% of patients receiving Zasocitinib achieved Psoriasis Area and Severity Index (PASI) 90, compared to 5.0% and 4.0% in the placebo group, and 16.8% and 15.9% in the apremilast group.p<0.001）。²

Zasocitinib also demonstrated statistically significant improvement in complete skin clearance, which is an increasingly important treatment goal for patients with plaque psoriasis:^1,2

• At week 16, 39.9% and 33.7% of patients receiving Zasocitinib achieved an sPGA score of 0; in the placebo group, the rates were 0.7% and 1.4%, and in the apremilast group, they were 8.0% and 6.5% (p<0.001）。²

• At week 16, 33.4% and 25.2% of patients receiving Zasocitinib achieved PASI 100, compared to 0.7% and 1.1% in the placebo group, and 2.9% and 4.3% in the apremilast group (p<0.001）。²

• In two studies, response rates for the co-primary endpoints and ranked secondary endpoints continued to improve up to Week 24.²

In the Latitude PsO 3002 study, the onset of action for Zasocitinib was observed as early as Week 4 compared to placebo (PASI 75: 16.8% in the Zasocitinib group vs. 4.3% in the placebo group, p < 0.001).²Among patients who achieved PASI 75, PASI 90, or sPGA 0/1 response at Week 40 and continued receiving Zasocitinib treatment throughout the study period, over 90% maintained their response at Week 60.²

Zasocitinib was generally well tolerated.^1,2In the Phase 3 study, the safety and tolerability profile of Zasocitinib was consistent with previous study results.^1,2The main results of the two studies include:

• As of Week 16, the incidence rates of treatment-emergent adverse events (TEAEs) in the Zasocitinib, placebo, and apremilast groups were 62.1%, 46.9%, and 50.5%, respectively.²

• As of Week 16, the most common (≥5%) adverse events in patients receiving Zasocitinib were: upper respiratory tract infection (10.1%), nasopharyngitis (6.2%), and acne (6.5%), with no new safety signals identified.²

• As of Week 16, the incidence of serious TEAEs was 3.0% in the Zasocitinib group, <1% in the placebo group, and 1.5% in the apremilast group.²

"Our Phase 3 study results indicate that highly selective TYK2 inhibition has the potential to achieve complete or near-complete skin clearance for many patients with moderate to severe plaque psoriasis," said Dr. Chinwe Ukomadu (MD, PhD), Senior Vice President and Head of Gastroenterology and Inflammation at Takeda Pharmaceutical Company Limited. "These positive data further highlight Zasocitinib’s potential for rapid and sustained skin clearance while maintaining a favorable safety profile consistent with the Phase 2b study. We are working with regulatory authorities to bring an effective, safe, and convenient new oral treatment option to patients as soon as possible."

Takeda Pharmaceutical Company Limited plans to submit new drug marketing authorization applications to the U.S. Food and Drug Administration (FDA) and other regulatory agencies starting from the fiscal year 2026.

The results of the Phase 3 study are not expected to have a significant impact on the full-year consolidated earnings forecast for the fiscal year ending March 31, 2026.

Takeda Pharmaceutical Company Limited to Host Investor Call on March 28 at 6:30 PM (MDT) / 8:30 PM (EDT) / March 29 at 9:30 AM (JST) to Discuss Phase 3 Data and Market Opportunity for Zasocitinib. On-demand replay of the webcast will be available on Takeda’s website following the event.

Presentation slides and virtual meeting registration link:

https://www.takeda.com/investors/events/

Psoriasis is a chronic immune-mediated inflammatory disease, and its pathogenesis involves the immune system triggering an inflammatory response, leading to the over-rapid proliferation of skin cells.³Plaque psoriasis is the most common type, characterized by raised red, gray, or purple lesions covered with silvery-white scales, which may be accompanied by itching and pain.^4-6Commonly affected areas include the scalp, face, arms and elbows, legs, knees, trunk, external genitalia, nail plates, and skin folds.^3,7Many patients experience intense itching and a burning sensation, severely affecting their daily lives.^5,6The disease can also lead to psychological burden and decreased quality of life, resulting in social isolation.⁸There are approximately 64 million psoriasis patients globally, with 80–90% having plaque psoriasis.^9,10

Zasocitinib is a next-generation, highly selective, oral TYK2 inhibitor in development that can continuously suppress IL-23 and other core immune pathways driving disease progression within 24 hours.^{11, 12}It has the potential to become the leading oral treatment option for patients with immune-mediated inflammatory diseases. According to in vitro study data, Zasocitinib is more than a million times more selective for TYK2 than for other JAK enzymes, a characteristic that means it can maximize TYK2 inhibition without affecting the signaling pathways of JAK1, JAK2, and JAK3.^{11, 13}Takeda is currently conducting a head-to-head study of Zasocitinib versus Deucravacitinib in plaque psoriasis and advancing its Phase 3 clinical trial in psoriatic arthritis.^14-16In addition, phase 2 studies of this drug are ongoing in the fields of Crohn's disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa (HS).^17-20Zasocitinib is still in the research stage and has not yet received marketing approval from any regulatory authority.

The Phase 3 Latitude Psoriasis Studies (NCT06088043 and NCT06108544) are global, multicenter, randomized, double-blind, placebo-controlled and active comparator clinical trials designed to evaluate the efficacy, safety, and tolerability of Zasocitinib in adult patients with moderate to severe plaque psoriasis.^21,22Two studies were conducted in 21 countries, enrolling 693 and 1,108 participants, respectively. The co-primary endpoints of the studies were the response rates of patients receiving Zasocitinib who achieved sPGA 0/1 and PASI 75 at week 16 compared to placebo.^21,22The ranked (key) secondary endpoints include comparisons with placebo at Week 16, and comparisons with apremilast at Weeks 16 and 24.^21,22 

TYK2 is an intracellular enzyme and a member of the Janus kinase (JAK) protein family.^13,23,24, but unlike JAK1, JAK2, and JAK3, TYK2 primarily regulates immune responses, whereas JAK1, 2, and 3 are involved in a broader range of biological processes.^13,23,24TYK2 mediates IL-23 and other immune and inflammatory signaling pathways that are crucial for psoriasis, psoriatic arthritis, and various immune-mediated inflammatory diseases.²⁵By highly selective allosteric inhibition of TYK2 and minimizing the impact on JAK1, JAK2, and JAK3, it may become a promising therapeutic strategy for immune-mediated inflammatory diseases, while potentially reducing the risks associated with inhibiting other JAK family members.²⁶

Takeda Pharmaceutical Company Limited is committed to "creating a healthy life for humanity and building a better future for the world." We focus on key therapeutic areas such as gastroenterology and inflammatory diseases, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines, striving to develop and deliver groundbreaking innovative treatments for patients. Our goal is to collaborate with partners to build a dynamic and diversified product pipeline, continuously improve patient experiences, and expand the exploration of cutting-edge treatment solutions.

Headquartered in Japan, Takeda Pharmaceutical Company Limited is a global, values-based, R&D-driven biopharmaceutical company. We are committed to fulfilling our promises to patients, employees, and the planet. Our employees across more than 80 countries and regions share the same mission and uphold the values that have been formed over two centuries.

Statement

1. This material is only for introducing the company's business and operational activities, and is not intended to promote any company products and/or services. It should not be interpreted as providing any opinions or suggestions regarding the selection of any drugs, medical devices, or treatment plans.

2. If you wish to learn any information about a company's products, diseases, and/or diagnosis and treatment, etc., please be sure to consult a healthcare professional.

3. The drug Zasocitinib (TAK-279) mentioned in this article has not yet been approved in China.

ReferenceData：

1.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”.

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). Presented at American Academy of Dermatology 2026. 2026 Mar 28; Denver, CO.  

3.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.

4.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

5.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.

6.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. JPsoriasis Psoriatic Arthritis. 2022;7(1):29-34. doi:10.1177/24755303211066928

7.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.

8.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.

9.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.

10.Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025.https://www.ncbi.nlm.nih.gov/books/NBK430879/

11.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.

12.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.S380686

13.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.

14.A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis. ClinicalTrials.gov Identified: NCT06973291. Updated December 17, 2025. Accessed March 2026.  https://clinicaltrials.gov/study/NCT06973291.

15.Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated March 9, 2026. Accessed December 2025. https://clinicaltrials.gov/study/NCT06671483.

16.A Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have or Have Not Been Treated With Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671496. Updated March 9, 2026. AccessedMarch 2026. https://clinicaltrials.gov/study/NCT06671496.

17.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 December 17, 2025. Accessed: March 2026. https://clinicaltrials.gov/study/NCT06233461.

18.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 March 13, 2026. Accessed: March 2026. https://www.clinicaltrials.gov/study/NCT06254950.

19.A Study of Zasocitinib in Adults With Nonsegmental Vitiligo. ClinicalTrials.gov Identifier: NCT07108283. Updated March 13, 2026. Accessed March 2026. https://clinicaltrials.gov/study/NCT07108283.

20.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 March 2026.

21.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 March 2026. https://clinicaltrials.gov/study/NCT06088043.

22.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 March 2026. https://clinicaltrials.gov/study/NCT06108544.

23.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.

24.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.

25.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.

26.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.