zasocitinib (TAK-279) / Takeda, Schrodinger - LARVOL DELTA

Zasocitinib, a Highly Selective Once-Daily TYK2 Inhibitor, Demonstrates Consistent Improvements in Quality of Life and PSSD-Reported Itch and All Other Symptoms in Adults with Moderate-to-Severe Plaque Psoriasis: Results From Two Randomized Phase 3 Trials (LATITUDE-PsO-3001 and 3002) (ACR Convergence 2026) - No abstract available

Clinical • HEOR • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

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) (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Zasocitinib, a highly selective once-daily TYK2 inhibitor, demonstrates consistent improvements in quality of life and PSSD-reported symptoms in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002) (EADV 2026) - No abstract available

Clinical • HEOR • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

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) (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

Zasocitinib, a highly selective, once-daily oral TYK2 inhibitor, was not associated with clinically meaningful laboratory parameter changes for up to 60 weeks in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002) (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

Study design of a phase 2 proof-of-concept randomized, multicentre, double-blind, placebo-controlled trial assessing the efficacy and safety of zasocitinib in moderate-to-severe hidradenitis suppurativa (EADV 2026) - No abstract available

Clinical • P2 data • Dermatology • Hidradenitis Suppurativa • Immunology

Once-daily oral zasocitinib demonstrates robust and consistent efficacy across subgroups of adults with moderate-to-severe plaque psoriasis, including difficult-to-treat populations: an integrated analysis of two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002) (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

Zasocitinib, a highly selective, once-daily oral TYK2 inhibitor, demonstrates superior skin clearance (PASI 100) versus an approved oral TYK2 inhibitor, deucravacitinib, and a consistent safety profile in moderate-to-severe plaque psoriasis: results from a randomized phase 3 intraclass head-to-head trial (LATITUDE Atlas) (EADV 2026) - No abstract available

Clinical • Head-to-Head • Late-breaking abstract • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

Once-daily oral zasocitinib, a highly selective TYK2 inhibitor, demonstrates rapid improvements in skin clearance, quality of life and psoriasis symptoms in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002) (EADV 2026) - No abstract available

Clinical • HEOR • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

Zasocitinib, a highly selective, once-daily oral TYK2 inhibitor, demonstrates durable efficacy for up to 60 weeks in adults with moderate-to-severe plaque psoriasis: results from two randomized phase 3 trials (LATITUDE-PsO-3001 and 3002) (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis • TYK2

The Role of TYK2 Inhibitors in the Pathogenesis and Treatment of Psoriasis. (PubMed, J Clin Aesthet Dermatol) - "TYK2 inhibition represents a significant advancement for the treatment of psoriasis. Continued research will enable optimization of these agents in managing psoriasis and related immune-mediated diseases."

Journal • Review • Dermatology • Immunology • Psoriasis • TYK2

Impact of Selective Tyrosine Kinase 2 Inhibition With Zasocitinib (TAK-279) on Molecular Pathways and Correlated Clinical Response in Patients With Active Psoriatic Arthritis. (PubMed, ACR Open Rheumatol) - P2 | "Reductions in biomarkers related to TYK2 signaling response, inflammation, skin and joint pathogenesis, and cartilage/bone turnover, along with maintenance of bone formation biomarkers at Week 4, occurred following zasocitinib treatment; associations with clinical response (ACR20 and PASI 75) were observed."

Journal • Dermatitis • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment Expectations (Businesswire) - "The NDA filing is supported by a comprehensive data package including the pivotal global Phase 3 LATITUDE PsO 3001 (NCT06088043) and 3002 (NCT06108544) studies, in which all primary and ranked secondary endpoints were met. The submission also included supportive data from LATITUDE PsO 3003 (NCT06550076), an open-label study to evaluate zasocitinib's long-term safety, tolerability and efficacy."

FDA approval • FDA filing • Priority review • Plaque Psoriasis

Once-daily Oral Zasocitinib in Moderate-to-Severe Plaque Psoriasis: Results from Two Randomized Phase 3 Trials (ESDR 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Plaque Psoriasis • Psoriasis

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) - P2 | N=268 | Recruiting | Sponsor: Takeda | Trial primary completion date: Sep 2026 ➔ Feb 2027

Trial primary completion date • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

Systemic Treatment of Psoriasis: Current Evidence on Efficacy and Safety. (PubMed, J Dermatol) - "Older conventional systemic agents, such as cyclosporin, acitretin, or methotrexate, remain useful in selected settings, especially when treatment options are limited by cost or availability, when short-term disease control is needed, or when the patient prefers these treatments...Biologics targeting TNF-α or anti-IL-12/23p40 ustekinumab have established the biologic treatment era, and remain clinically relevant, especially for patients having psoriatic arthritis or prioritizing long-term safety...Targeted oral therapies increase options for patients who prefer non-injectable treatment; established or emerging agents include apremilast, deucravacitinib, icotrokinra, zasocitinib, envudeucitinib, and orismilast. Emerging IL-17-directed agents, including sonelokimab and izokibep, may further refine pathway targeting. Selection of treatment should be decided dependently on the completeness of skin clearance achieved, speed and duration of responses, effectiveness on..."

Journal • Review • Candidiasis • Dermatology • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Arthritis • Inflammatory Bowel Disease • Oncology • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • TNFA

A Study of Zasocitinib in Adults With Non-pustular Palmoplantar Psoriasis (clinicaltrials.gov) - P3 | N=40 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Dermatology • Immunology • Psoriasis

Evaluating Zasocitinib as an oral therapy for moderate to severe plaque Psoriasis. (PubMed, Expert Opin Pharmacother) - "Psoriasis varies widely, but treatment is mainly based on whether topicals are enough or stronger therapy is needed. Although better treatment options are still needed, especially for mild disease, new drugs like zasocitinib may have a role, but could face challenges competing with existing highly effective and well-established therapies."

Journal • Review • Dermatology • Immunology • Inflammation • Inflammatory Arthritis • Psoriasis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • IL12A • IL17A • IL23A • TYK2

...Near-Term Launch Preparations and Pipeline Progress on Track (Businesswire) - "Zasocitinib....Takeda is making the necessary investments with a view toward regulatory submissions in 2026 and a commercial launch anticipated in the first half of 2027."

Filing • Launch • Immunology • Plaque Psoriasis

Zasocitinib: Data readout from P2b trial (NCT06233461) for moderate to severe active Crohn’s disease in FY 2026 (Takeda) - Q1 FY2026 Results: Data readout from P2 trial (NCT06254950) for moderate to severe active ulcerative colitis in FY 2026

P2 data • P2b data • Crohn's disease • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of TAK-279 in Adult Participants With Generalized Pustular Psoriasis or Erythrodermic Psoriasis (clinicaltrials.gov) - P3 | N=18 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis • Pustular Psoriasis

Takeda Pharmaceutical (TSE:4502) agreed a multi-year collaboration with the Indonesian Government to develop the country's plasma collection and biopharmaceutical manufacturing ecosystem. (Yahoo Finance) - "The new Indonesia partnership extends its presence in an emerging market healthcare system, while the zasocitinib readout adds another data point in an active immunology pipeline where multiple companies are competing in autoimmune therapies....These developments may be relevant if you track how large pharmaceutical companies allocate capital across regions and therapeutic areas. The combination of local manufacturing projects and late stage immunology assets can affect how a company such as Takeda Pharmaceutical manages growth opportunities, risk, and portfolio mix."

Licensing / partnership • Crohn's disease • Hidradenitis Suppurativa • Immunology • Inflammatory Arthritis • Plaque Psoriasis • Psoriatic Arthritis • Systemic Lupus Erythematosus • Ulcerative Colitis • Vitiligo

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) - P2 | N=268 | Not yet recruiting | Sponsor: Takeda

New P2 trial • Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

Takeda’s Zasocitinib Demonstrates Consistent, High Rates of Skin Clearance Across the Body, Including Hard-to-Treat and High-Impact Sites, in Phase 3 Psoriasis Studies (Takeda Press Release) - "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....The 3001 and 3002 studies also evaluated patients who had nail psoriasis, or patients with at least moderate scalp or palmoplantar psoriasis, at baseline....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."

P3 data • Plaque Psoriasis • Psoriasis