Psoriatic Arthritis Clinical Trials Analysis 2025: Expanding Biologics, Small Molecules, and Novel Immunomodulators to Redefine Disease Management | DelveInsight

DelveInsight's "Psoriatic Arthritis - Clinical Trials Analysis, 2025" highlights the dynamic evolution of the therapeutic landscape for psoriatic arthritis (PsA), a chronic immune-mediated inflammatory arthritis affecting joints, skin, and entheses. While TNF inhibitors, IL-17 inhibitors, and IL-23 inhibitors have significantly improved disease control, a large proportion of patients remain undertreated, facing inadequate responses or treatment discontinuations.

The PsA clinical trial environment is accelerating, with selective JAK inhibitors, TYK2 inhibitors, and next-generation IL-17/IL-23 antagonists driving innovation. Oral small molecules are gaining traction due to improved convenience and patient adherence, while dual-pathway inhibitors and novel immune modulators are emerging to address the complex pathophysiology of PsA. Clinical research is also exploring precision-based approaches, including biomarker-driven stratification, to optimize therapy sequencing and tailor treatment choices to individual disease phenotypes.

Several late-stage programs, particularly TYK2 inhibitors and next-generation IL-17 biologics-are advancing rapidly, setting the stage for a paradigm shift in psoriatic arthritis care. The future landscape is expected to move toward more durable responses, improved safety profiles, and combination strategies that can simultaneously target joint, skin, and axial manifestations, reshaping the standard of care for patients worldwide.

Interested in learning more about the current treatment landscape and the key drivers shaping the psoriatic arthritis pipeline? Click here: https://www.delveinsight.com/report-store/psoriatic-arthritis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Psoriatic Arthritis Pipeline Report
• DelveInsight's psoriatic arthritis pipeline analysis depicts a robust space with 20+ active players working to develop 25+ pipeline drugs for psoriatic arthritis treatment.
• The leading psoriatic arthritis companies include Pfizer, selectION Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, Mylan Inc., ACELYRIN Inc., and others are evaluating their lead assets to improve the psoriatic arthritis treatment landscape.
• Key psoriatic arthritis pipeline therapies in various stages of development include PF-06700841, si-544, SHR0302, NDI-034858, HS-10374, BAT2506, MYL-1401A, ABY-035, Bimekizumab, Tildrakizumab, Deucravacitinib, Izokibep, Sotyktu, and others.
• In July 2025, Bristol Myers Squibb announced that the FDA accepted its supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) to treat adults with active psoriatic arthritis. The FDA set a PDUFA goal date of March 6, 2026. This follows similar regulatory progress in China, Japan, and the EU.
• In July 2025, the FDA accepted the Biologics License Application (BLA) for BAT2506, a proposed biosimilar to Simponi® (golimumab), submitted by Accord BioPharma on behalf of Bio-Thera Solutions. BAT2506 targets multiple autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis. The FDA's goal date for review is May 16, 2026, and the application also seeks interchangeable status with Simponi.
• In June 2025, Celltrion announced FDA approval of a new 45mg/0.5mL single-dose vial presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA®, for pediatric patients aged 6-17 years under 60kg with plaque psoriasis or psoriatic arthritis. This expands STEQEYMA's options to match its reference product's dosage forms.
• In May 2025, Teva Pharmaceuticals and Alvotech announced that the FDA has approved SELARSDITM (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab). Starting April 30, 2025, SELARSDI is available in all presentations matching the reference product, for the treatment of adults and pediatric patients with psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis.

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Psoriatic Arthritis Overview
Psoriatic Arthritis (PsA) is a chronic autoimmune inflammatory arthritis that affects some people with psoriasis, a skin condition characterized by red, scaly patches. PsA causes joint pain, stiffness, and swelling, which can affect any part of the body, including the fingers, toes, spine, and sacroiliac joints. The inflammation can lead to joint damage if untreated. The exact cause of PsA is unknown, but it involves genetic, immune, and environmental factors. Diagnosis is based on clinical evaluation, imaging, and ruling out other forms of arthritis. Treatment aims to control symptoms, reduce inflammation, and prevent joint damage using nonsteroidal anti-inflammatory drugs (NSAIDs), disease-modifying antirheumatic drugs (DMARDs), biologics, and lifestyle changes. Early diagnosis and treatment are key to improving long-term outcomes.

Find out more about psoriatic arthritis medication @ https://www.delveinsight.com/report-store/psoriatic-arthritis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Psoriatic Arthritis Treatment Analysis: Drug Profile
Sotyktu: Bristol Myers Squibb
Sotyktu (deucravacitinib) is an oral, selective allosteric inhibitor of tyrosine kinase 2 (TYK2), representing a novel class of small molecules. It uniquely targets the regulatory domain of TYK2 to block signaling pathways involving interleukin (IL)-23, IL-12, and Type 1 interferons (IFN), which are critical in the development of various immune-mediated diseases. By selectively inhibiting TYK2 without affecting JAK1, JAK2, or JAK3 at therapeutic doses, Sotyktu offers targeted immunomodulation. It is currently in Phase III clinical trials for the treatment of psoriatic arthritis.

HS-10374: Hansoh BioMedical R&D Company
HS-10374 is an oral TYK2 inhibitor that blocks the TYK2 protein and its associated signaling pathways, which play a key role in activating immune responses linked to inflammation. This mechanism aims to reduce inflammatory activity in psoriatic arthritis. HS-10374 is presently in Phase II clinical trials for psoriatic arthritis treatment.

Learn more about the novel and emerging psoriatic arthritis pipeline therapies @ https://www.delveinsight.com/report-store/psoriatic-arthritis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Psoriatic Arthritis Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Intramuscular
• Topical.

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Psoriatic Arthritis Pipeline Report
• Coverage: Global
• Key Psoriatic Arthritis Companies: Pfizer, selectION Therapeutics GmbH, Jiangsu HengRui Medicine Co., Ltd., Nimbus Lakshmi, Inc., Hansoh BioMedical R&D Company, Bio-Thera Solutions, Mylan Inc., ACELYRIN Inc., and others.
• Key Psoriatic Arthritis Pipeline Therapies: PF-06700841, si-544, SHR0302, NDI-034858, HS-10374, BAT2506, MYL-1401A, ABY-035, Bimekizumab, Tildrakizumab, Deucravacitinib, Izokibep, Sotyktu, and others.

Dive deep into rich insights for drugs used for psoriatic arthritis treatment; visit @ https://www.delveinsight.com/report-store/psoriatic-arthritis-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Psoriatic Arthritis Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Psoriatic Arthritis Pipeline Therapeutics
6. Psoriatic Arthritis Pipeline: Late-Stage Products (Phase III)
7. Psoriatic Arthritis Pipeline: Late-Stage Products (Phase III)
8. Psoriatic Arthritis Pipeline: Mid-Stage Products (Phase II)
9. Psoriatic Arthritis Pipeline: Early Stage Products (Phase I)
10. Therapeutic Assessment
11. Inactive Products
12. Company-University Collaborations (Licensing/Partnering) Analysis
13. Key Companies
14. Key Products
15. Unmet Needs
16. Market Drivers and Barriers
17. Future Perspectives and Conclusion
18. Analyst Views
19. Appendix

Contact Us:
Jatin Vimal
jvimal@delveinsight.com
+14699457679
Healthcare Consulting
https://www.delveinsight.com/consulting-services

About DelveInsight
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This release was published on openPR.