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

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Takeda | N=21 ➔ 36

Enrollment change • Dermatology • Hidradenitis Suppurativa • Immunology

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=21 | Recruiting | Sponsor: Takeda | N=10 ➔ 21

Enrollment change • Dermatology • Hidradenitis Suppurativa • Immunology

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=1182 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Shifting Role of Oral Therapies in Psoriasis: Unmet Needs and Perspectives on Current and Emerging Therapies, and Evolving Treatment Sequencing Among Dermatologists. (AAD 2026) - " Deucravacitinib gained first-line traction, with dermatologists increasingly delaying biologic initiation...Pipeline interest shifted year-over-year: oral IL-17 and aIL-23R mechanisms remained most valued (>83%), but icotrokinra (oral aIL-23R) emerged as the leading candidate, with aIL-23R awareness surpassing IL-17 agents and >60% of dermatologists favoring icotrokinra for first-line use, while TYK2 inhibitors (envudeucitinib, zasocitinib) were increasingly viewed as later-line options... Dermatologists report an expanding role for oral therapies in PsO. Broader availability of effective oral agents is expected to further delay biologic initiation, representing a paradigm shift in PsO management."

Dermatology • Immunology • 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) (AAD 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology • Immunology • Psoriasis

Early onset of response to zasocitinib (TAK-279), a highly selective and potent TYK2 inhibitor, is correlated with modulation of TYK2 signaling and disease pathway biomarkers in patients with moderate-to-severe plaque psoriasis (AAD 2026) - P2b | "Modulation of these genes was not significantly correlated with improvements from baseline in PASI following biologic treatment targeting IL12/23, IL-17R or TNF (r=0.24, 0.19 and 0.15; p=0.13, 0.12 and 0.43, respectively). Zasocitinib-induced TYK2 and disease pathway biomarker modulation correlated with clinical response as early as Week 4."

Biomarker • Clinical • Dermatology • Immunology • Psoriasis • IL12A • IL23A • TYK2

Phase 2b trial of the selective TYK2 inhibitor zasocitinib (TAK-279) in active psoriatic arthritis: biomarkers associated with pathway modulation, disease activity and clinical responses (EULAR 2026) - No abstract available

Biomarker • Clinical • P2b data • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies • TYK2

A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: Takeda | Trial completion date: Nov 2027 ➔ Mar 2028 | Trial primary completion date: Sep 2027 ➔ Mar 2028

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

Zasocitinib (TAK-279), an investigational oral, allosteric, highly selective and potent TYK2 inhibitor preserves anti-inflammatory IL-10 signalling in vitro (ECCO-IBD 2026) - "This study assessed the effect of zasocitinib, deucravacitinib (TYK2 inhibitor) and upadacitinib (JAK1 inhibitor) treatment on IL-10 signalling. Given the immunosuppressive role of IL-10 in IBD, these observations support the ongoing investigation of zasocitinib as a potential therapeutic for patients. Ongoing clinical trials will further evaluate efficacy and safety of zasocitinib in patients with IMIDs, including IBD."

Preclinical • Inflammatory Bowel Disease • IL10 • IL12A • IL1B • IL23A • IL6 • TNFA • TYK2

TAK-279-HS-2001: A Phase 2 trial to assess efficacy and safety of zasocitinib in moderate to severe hidradenitis suppurativa (clinicaltrialsregister.eu) - P1/2 | N=10 | Not yet recruiting | Sponsor: Takeda Development Center Americas Inc.

New P1/2 trial • Dermatology • Hidradenitis Suppurativa • Immunology

TAK-279-VT-2001: Zasocitinib in Nonsegmental Vitiligo (clinicaltrialsregister.eu) - P1/2 | N=144 | Recruiting | Sponsor: Takeda Development Center Americas Inc.

New P1/2 trial • Dermatology • Immunology • Vitiligo

Takeda intends to file a New Drug Application with the FDA…[for] zasocitinib, its investigational TYK2 inhibitor, in moderate-to-severe plaque psoriasis…in 2026 (Businesswire)

FDA filing • Psoriasis

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

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

A Study of Zasocitinib in Adults With Hidradenitis Suppurativa (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Hidradenitis Suppurativa • Immunology

Zasocitinib: Data readout from P2b trial (NCT06233461) for moderate to severe active Crohn's disease in FY 2026 (Takeda) - Q3 FY2025 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

TAK-279-PsO-3003: A Study of TAK-279 in Participants With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=1950 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis (clinicaltrials.gov) - P3 | N=110 | Recruiting | Sponsor: Takeda | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Pediatrics • Psoriasis

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 (Businesswire) - "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...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 and other regulatory authorities starting in fiscal year 2026....Results from the Phase 3 studies have no significant impact on the full-year consolidated forecast for the fiscal year ending March 31, 2026."

Filing • P3 data • Psoriasis

A Study Comparing Zasocitinib (TAK-279) With Deucravacitinib in Adults With Plaque Psoriasis (clinicaltrials.gov) - P3 | N=606 | Active, not recruiting | Sponsor: Takeda | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Continuation Study of Zasocitinib in Adults With Psoriatic Arthritis (clinicaltrials.gov) - P3 | N=1182 | Not yet recruiting | Sponsor: Takeda

New P3 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Leading artificial intelligence-driven drug discovery platforms: 2025 landscape and global outlook. (PubMed, Pharmacol Rev) - "Key developments since 2024 include positive phase IIa results for Insilico Medicine's Traf2- and Nck-interacting kinase inhibitor, ISM001-055, in idiopathic pulmonary fibrosis...In addition, advancement of the Nimbus-originated tyrosine kinase 2 inhibitor, zasocitinib (TAK-279), into phase III clinical trials exemplifies Schrödinger's physics-enabled design strategy reaching late-stage clinical testing...Robotics tightly integrated with AI now enables self-driving laboratories that accelerate design-make-test-learn cycles and improve reproducibility. Together, these advances chart a forward-looking roadmap in which multimodal foundation models, robotics-led platforms, and hybrid physics-AI strategies are poised to accelerate translation, derisk development, and establish trustworthy AI as a cornerstone of modern drug discovery."

Journal • Review • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • TYK2

Molecular, Histological, and Clinical Effects of Selective TYK2 Inhibition with Zasocitinib (TAK-279) in Patients with Moderate-to-Severe Plaque Psoriasis. (PubMed, J Invest Dermatol) - No abstract available

Journal • Dermatology • Immunology • Psoriasis • TYK2

P114 Efficacy and safety of oral Janus kinase, tyrosine kinase 2 and phosphodiesterase 4 inhibitors in the treatment of chronic plaque psoriasis: a network meta-analysis. (PubMed, Br J Dermatol) - "After 16-24 weeks of treatment, tofacitinib and deucravacitinib had the highest efficacy, followed by apremilast, orismilast, upadacitinib and brepocitinib. Zasocitinib, a new highly selective allosteric TYK2 inhibitor, has recently demonstrated promising efficacy in the treatment of psoriasis, with 33% of patients achieving PASI 100 (complete clearance of psoriasis lesions) after just 12 weeks of treatment. In conclusion, oral TYK2 inhibitors have shown efficacy in the treatment of chronic plaque psoriasis comparable with adalimumab, with newer agents demonstrating enhanced effectiveness and surpassing PDE-4 inhibitors in therapeutic outcomes. JAK inhibitors, particularly tofacitinib, exhibit comparable efficacy to some TYK2 and PDE-4 inhibitors."

Clinical • Journal • Retrospective data • Review • Dermatology • Immunology • Psoriasis • TYK2

Zasocitinib-induced modulation of tyrosine kinase 2 signaling biomarkers is associated with treatment response in patients with moderate-to-severe plaque psoriasis (ISDS 2025) - P2b | "Generally, modulation of both pathways together was associated with a greater % CfB in PASI. Overall, modulation of both IL-23 and type I IFN pathways was associated with zasocitinib treatment response."

Biomarker • Clinical • Dermatology • Immunology • Psoriasis • IL12A • IL23A • TYK2

TAK-279-3002: 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) - P3 | N=1108 | Completed | Sponsor: Takeda | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis