- Once-daily oral Zasocitinib demonstrated statistically superior efficacy versus deucravacitinib across all primary and key secondary endpoints in a plaque psoriasis study.
- At Week 16, over 35% of patients treated with Zasocitinib achieved complete skin clearance (PASI 100)—a response rate more than 2.5 times that of deucravacitinib.
- Safety profile consistent with prior studies, with no new safety signals identified.
Osaka, Japan, and Cambridge, Massachusetts, USAJune 12, 2026 /PRNewswire/ — Takeda (TSE:4502/NYSE:TAK) announced positive topline results from a Phase 3, randomized, multicenter, double-blind study comparing Zasocitinib (TAK-279) with deucravacitinib in adult patients with moderate-to-severe plaque psoriasis (PsO). Zasocitinib is an investigational, next-generation, highly selective, potent oral tyrosine kinase 2 (TYK2) inhibitor.
In the LATITUDE Atlas (TAK-279-PsO-3004) head-to-head study, Zasocitinib demonstrated statistically superior efficacy versus deucravacitinib on the primary endpoint—Psoriasis Area and Severity Index (PASI) 100 response rate at Week 16. The study also showed statistically superior efficacy for Zasocitinib versus deucravacitinib across all key secondary endpoints, including PASI 90 response and static Physician Global Assessment (sPGA) 0 at Week 16. Zasocitinib was generally well tolerated, with a safety and tolerability profile consistent with prior studies, and no new safety signals were identified.
Insights from the Zasocitinib Head-to-Head Study
“In this head-to-head study, Zasocitinib clearly demonstrated superior efficacy in skin clearance compared with deucravacitinib, highlighting a clinically meaningful difference within the oral treatment class,” said Dr. Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health and lead investigator of the LATITUDE Atlas study. “As expectations for oral therapies continue to rise, these results support the potential of Zasocitinib to reshape patient and physician expectations for oral treatment options in plaque psoriasis.”
“These head-to-head results build on the robust efficacy observed in prior Phase 3 programs, with over 35% of patients treated with Zasocitinib achieving complete skin clearance (PASI 100) at Week 16—a response rate more than 2.5 times that of deucravacitinib—and with separation from deucravacitinib as early as Week 8,” said Dr. Chinwe Ukomadu, Senior Vice President and Head of the Gastroenterology and Inflammation Therapeutic Area at Takeda. “Taken together, these results further reinforce the potential of Zasocitinib to deliver rapid and durable skin clearance through a convenient once-daily oral regimen, and demonstrate the potential of highly selective, potent TYK2 inhibition to offer a transformative treatment option for patients with plaque psoriasis.”
Next Steps for the Zasocitinib Psoriasis Head-to-Head Study and Development Program
Following the recent presentation of landmark Phase 3 LATITUDE PsO results (studies 3001 and 3002) at the American Academy of Dermatology Annual Meeting, Takeda plans to present detailed data from this head-to-head study at upcoming medical congresses. The company is on track to submit a New Drug Application for plaque psoriasis to the U.S. Food and Drug Administration and other regulatory authorities starting this fiscal year.
About Plaque Psoriasis
Psoriasis is a chronic, systemic immune-mediated inflammatory disease characterized by itchy, painful, disfiguring, and disabling skin lesions that can affect patients’ physical, emotional, and mental well-being.[1]-[7] Approximately 64 million people worldwide have psoriasis, with about 80-90% having plaque psoriasis.[8]-[9] Persistent itching, the appearance and location of lesions—especially on visible or sensitive areas—and associated comorbidities such as psoriatic arthritis can significantly reduce quality of life and have a major impact on daily activities.[4]-[7] Psoriasis is also a heterogeneous disease driven by complex, interconnected immune pathways, genetic factors, and environmental triggers that vary among patients and over the course of the disease, leading to differences in disease progression, symptoms, and treatment response.[10]-[14]
About Zasocitinib (TAK-279)
Zasocitinib is an investigational, next-generation, highly selective, potent oral TYK2 inhibitor that provides sustained 24-hour inhibition of IL-23 and other core immune pathways driving disease progression.[15]-[19] It has the potential to become an important oral treatment option for patients with psoriasis, potentially delivering rapid and durable skin clearance through a convenient once-daily oral regimen.[20] Based on in vitro data, Zasocitinib is more than one million-fold selective for TYK2 over other JAK family members, a property that may maximize TYK2 inhibition without disrupting JAK1, JAK2, and JAK3 signaling pathways.[15]-[16] Takeda is currently evaluating Zasocitinib in Phase 3 studies for safety and efficacy in psoriatic arthritis, and in Phase 2 studies for Crohn’s disease, ulcerative colitis, vitiligo, and hidradenitis suppurativa (HS).[21]-[27] Zasocitinib is an investigational compound and has not been approved for use by any regulatory authority.
About the LATITUDE Atlas Study
About Tyrosine Kinase 2 (TYK2) Inhibitors
TYK2 is a key mediator of core inflammatory pathways in psoriasis, involved in the IL-23/IL-17 axis and type I interferon signaling. Given that inhibition of a single pathway may not adequately control disease in all patients, TYK2 is considered a promising therapeutic target.[14],[18],[29] TYK2 is an intracellular enzyme belonging to the Janus kinase (JAK) protein family.[14]-[15] However, unlike JAK1, JAK2, and JAK3, which regulate broader biological processes such as lipid metabolism and hematopoiesis—disruption of which may be associated with cardiovascular risk and blood disorders—TYK2 primarily modulates immune responses.[14]-[15],[30] Highly selective allosteric inhibition of TYK2, with minimal inhibition of JAK1, JAK2, and JAK3, represents a promising therapeutic strategy to target immune-mediated inflammation while potentially avoiding the risks associated with inhibiting other JAK family members.[19]
About Takeda
Takeda is driven by its mission to create better health for people and a brighter future for the world. We focus on key therapeutic areas including gastroenterology and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience, and vaccines, striving to develop and deliver breakthrough innovative therapies for patients. Our goal is to build a dynamic and diverse pipeline in partnership with collaborators, continuously improve patient experiences, and expand exploration of cutting-edge treatment options. Headquartered in Japan, Takeda is a values-based, R&D-driven global biopharmaceutical company committed to fulfilling its promises to patients, employees, and the planet. Our employees across more than 80 countries and regions share the same mission, upholding values formed over more than two centuries.
For more information, please visit: https://www.takeda.com.
Approval Number: C-ANPROM/CN/TAK-279/0028
Approval Date: June 2026
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Disclaimer
- This material is intended solely to introduce the company’s business and operational activities, etc., and is not intended to promote or advertise any company product and/or service, nor should it be construed as providing any advice or recommendations regarding the selection of any drug, medical device, or treatment regimen.
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- The Zasocitinib (TAK-279) drug mentioned in this document has not yet been approved in China.
References
- Langley RGB, Krueger GG, Griffiths CEM. Psoriasis: epidemiology, clinical features, and quality of life. Ann Rheum Dis. 2005;64(Suppl 2):ii18–23.
- 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.
- Mehta S, Sathe NC. Plaque Psoriasis. In: StatPearls. Treasure Island (FL): StatPearls Publishing; September 14, 2025. https://www.ncbi.nlm.nih.gov/books/NBK43087.
- 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.
- 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 June 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 6, 2026. Accessed June 2026. https://www.clinicaltrials.gov/study/NCT06254950.