Takeda presents additional Phase 3 clinical insights on investigational TYK2 inhibitor zasocitinib (TAK-279) at AAD 2026

Takeda has announced new data, presented at the 2026 American Academy of Dermatology (ADD), from two Phase 3 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). Approximately 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 and a significantly greater PASI 75 response versus placebo was observed as early as week 4. The safety and tolerability profile remained consistent with prior studies.

The Latitude Phase 3 psoriasis studies 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 (PsO).¹

Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these new data show that once-daily oral zasocitinib demonstrated rapid and durable skin clearance.^1,2

Robust efficacy demonstrated at week 16
The Latitude PsO 3001 and 3002 studies demonstrated that more than half of patients treated with zasocitinib achieved clear or almost clear skin at week 16^{. 1,2} Among patients treated with zasocitinib, 71.4% and 69.2% achieved a static Physician Global Assessment (sPGA) score of 0/1 versus placebo (10.7% and 12.6%) and apremilast (32.1% and 29.7%) at week 16 (p<0.001).² Further, 61.3% and 51.9% of patients treated with zasocitinib achieved Psoriasis Area and Severity Index (PASI) 90 versus placebo (5.0% and 4.0%) and apremilast (16.8% and 15.9%) at week 16 (p<0.001).²

Zasocitinib also showed statistically significant improvements in complete skin clearance, an increasingly important treatment goal for patients with plaque psoriasis.^1,2 Among patients treated with zasocitinib, 39.9% and 33.7% of patients achieved an sPGA score of 0 versus placebo (0.7% and 1.4%) and apremilast (8.0% and 6.5%) at week 16 (p<0.001).² In addition, 33.4% and 25.2% of patients treated with zasocitinib achieved a PASI 100 versus placebo (0.7% and 1.1%) and apremilast (2.9% and 4.3%) at week 16 (p<0.001).² Responses for co-primary and key secondary endpoints continued to increase through week 24 in both studies.²

- People living with moderate-to-severe plaque psoriasis often need to manage not only visible symptoms, but also the ongoing impact the disease can have on everyday life. These Phase 3 data provide additional scientific insight into the potential profile of once-daily oral zasocitinib, an investigational medicine currently under clinical development. To date, similar outcomes have largely been reported with injectable therapies, and these findings add to the evolving evidence base for orally administered investigational treatments. At Takeda, we are committed to advancing new medicines that can make a meaningful difference for people living with psoriasis, said Saija Silvola, Nordic Medical Director at Takeda.

Observed clinical responses and safety outcomes
In Latitude PsO 3002, rapidity of response was demonstrated as early as week 4 versus placebo (PASI 75: 16.8% for zasocitinib vs 4.3% for placebo, p<0.001).² Among patients who achieved a PASI 75, PASI 90 or sPGA 0/1 response at week 40 and continued on zasocitinib throughout the study, over 90% maintained their response at week 60.²

Zasocitinib was generally well-tolerated.^1,2 The safety and tolerability profile of zasocitinib in the Phase 3 studies remained consistent with prior studies.^1,2 The most common adverse events for zasocitinib treated patients through week 16 (≥5%) were upper respiratory tract infection (10.1%), nasopharyngitis (6.2%) and acne (6.5%), with no new safety signals identified.²

Treatment-emergent adverse events (TEAEs) through week 16 were 62.1% for zasocitinib, 46.9% for placebo and 50.5% for apremilast.² Serious TEAEs through week 16 were 3.0% for zasocitinib, <1% for placebo and 1.5% for apremilast.²

Takeda is on track to submit a New Drug Application with the United States Food and Drug Administration and other regulatory authorities starting in fiscal year 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.³ 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.^4-6 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.^3,7 Many people living with psoriasis experience intense itching and burning from their psoriasis plaques that disrupt their daily lives.^5,6 Patients also report that their symptoms negatively impact their mental health and quality of life and can lead to social isolation.⁸ Globally, an estimated 64 million people are living with psoriasis and about 80-90% of those have plaque psoriasis.^9,10

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.^11,12It has the potential to be an 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 vitrodata.^11,13 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.^14-16 In addition, Phase 2 studies are ongoing in Crohn’s disease, ulcerative colitis, vitiligo and hidradenitis suppurativa (HS).^17-20 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.^21,22 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.^21,22 Ranked (key) secondary endpoints included comparisons versus placebo (week 16) and apremilast (week 16 and week 24).^21,22

About Tyrosine Kinase 2 (TYK2) Inhibitors

TYK2 is an intracellular enzyme and member of the Janus kinase (JAK) protein family.^13,23,24However, TYK2 is distinct from JAK1, 2 and 3 as it primarily regulates immune responses, whereas JAK1, 2 and 3 regulate broader biological processes. ^13,23,24TYK2 mediates IL-23 plus other immune and inflammatory signaling pathways that are fundamental to psoriasis, psoriatic arthritis and other immune-mediated inflammatory diseases.²⁵ 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. ²⁶

For more information, please contact:

Henry Werner, Head of Communications Nordics and Sweden at Takeda
Henry.Werner@takeda.com

References:

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. J Psoriasis 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/b...
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/stu...
15. Study of Zasocitinib in Adults With Psoriatic Arthritis Who Have Not Taken Biologic Medicines. ClinicalTrials.gov Identifier: NCT06671483. Updated March 9, 2026. Accessed March 2026. https://clinicaltrials.gov/stu....
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. Accessed March 2026. https://clinicaltrials.gov/stu....
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 February 11, 2026. Accessed March 2026. https://clinicaltrials.gov/stu....
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....
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/stu....
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/stu....
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.