Psoriasis Clinical Trials Analysis 2025: EMA, PDMA, FDA Approvals, Clinical Trials, Therapies, Medication, NDA Approval, IND, Mechanism of Action, Route of Administration by DelveInsight

Psoriasis Clinical Trials

(Albany, United States) “Psoriasis Pipeline Insight, 2025″ report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Psoriasis Market.

As per DelveInsight’s assessment, globally, Psoriasis pipeline constitutes 80+ key companies continuously working towards developing 80+ Psoriasis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight.

The Psoriasis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details.

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Some of the key takeaways from the Psoriasis Pipeline Report:

• Psoriasis Companies across the globe are diligently working toward developing novel Psoriasis treatment therapies with a considerable amount of success over the years.
• Psoriasis companies working in the treatment market are Fresh Tracks Therapeutics, Inmagene, SFA Therapeutics, Palobiofarma, Sun Pharmaceutical Industries Limited, Biohaven Pharmaceuticals, Inc., Dr. Reddy’s, MetrioPharm, Celltrion, Amgen, Can-Fite Biopharma, and others, are developing therapies for the Psoriasis treatment
• Emerging Psoriasis therapies in the different phases of clinical trials are- FRTX-03, IMG-008, SFA 002, PBF-1650, SCD-044, Rimegepant, PPC-06, MP1032, CT-P43, ABP 654, Piclidenoson, and others are expected to have a significant impact on the Psoriasis market in the coming years.
• In April 2025, Alumis Inc. announced a study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Long-term Safety, Efficacy, and Durability of Response to ESK-001. Patients will enter the long-term extension study following completion of one of the parent studies (ESK-001-016 or ESK-001-017) and will receive open-label ESK-001 twice daily for 24 weeks.
• In December 2024, Celltrion announced today that the U.S. Food and Drug Administration (FDA) has approved STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), for subcutaneous injection or intravenous infusion in adult and pediatric patients with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn’s disease and ulcerative colitis.
• In December 2024, Bristol Myers Squibb (NYSE: BMY) announced that the POETYK PsA-1 and POETYK PsA-2 trials achieved significant secondary endpoints in PsA disease activity at Week 16. The safety profile of Sotyktu through 16 weeks of treatment in both the POETYK PsA-1 and POETYK PsA-2 trials was in line with the previously established safety profile observed in a Phase 2 PsA clinical trial and Phase 3 trials for moderate-to-severe plaque psoriasis.
• In May 2024, InnoCare Pharma announced that it has completed subject enrollment for the Phase II clinical trial of ICP-488, a treatment aimed at individuals with moderate to severe plaque psoriasis. This achievement represents a significant milestone in the drug’s development, as it is a tyrosine kinase 2 (TYK2) JH2 allosteric inhibitor. The randomized, multi-center, double-blind, placebo-controlled trial seeks to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of ICP-488 in adult patients in China.
• In May 2024, Zai Lab administered the first dose to a participant in a Phase II clinical trial of ZL-1102, an investigational therapy for chronic plaque psoriasis (CPP). This randomized, global, double-blind, vehicle-controlled, dose-ranging trial aims to evaluate the efficacy and safety of ZL-1102 as a topical treatment.
• In March 2024, Alumis Inc. announced the presentation of promising clinical data from a Phase II trial of ESK-001, a highly selective allosteric tyrosine kinase 2 (TYK2) inhibitor, for treating patients with moderate-to-severe plaque psoriasis. These findings were shared during a late-breaking session at the American Academy of Dermatology (AAD) Annual Meeting, taking place from March 8-12 in San Diego, California.
• In February 2024, Biocon Biologics announced that it has entered into a settlement and license agreement with Janssen Biotech Inc. and Johnson & Johnson (collectively referred to as Janssen), paving the way for the commercialization of its Bmab 1200, a proposed biosimilar to Stelara, in the United States.

Psoriasis Overview

Psoriasis is a chronic, immune-mediated skin condition characterized by rapid skin cell turnover, leading to thick, red, scaly patches. Psoriasis commonly affects the scalp, elbows, knees, and lower back, though it can appear anywhere on the body. Psoriasis is a non-contagious disease but significantly impacts a patient’s quality of life, often causing physical discomfort and emotional distress.

Psoriasis symptoms vary depending on the type, with plaque psoriasis being the most prevalent form. Psoriasis can also manifest as guttate, inverse, pustular, or erythrodermic types, each with distinct features. Psoriasis triggers include stress, infections, skin injuries, and certain medications. Psoriasis has a strong genetic component, and individuals with a family history are at higher risk.

Psoriasis treatment options range from topical therapies and phototherapy to systemic medications and biologics. Psoriasis biologics have revolutionized care by targeting specific immune pathways. Psoriasis management requires a personalized approach based on disease severity and patient response.

Psoriasis research continues to advance, with ongoing studies exploring new drug targets and treatment strategies. Psoriasis awareness campaigns have helped reduce stigma and increase early diagnosis. Psoriasis remains a lifelong condition, but with proper care and medical support, patients can lead healthier, more comfortable lives despite the challenges of psoriasis.

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Emerging Psoriasis Drugs Under Different Phases of Clinical Development Include:

• FRTX-03: Fresh Tracks Therapeutics
• IMG-008: Inmagene
• SFA 002: SFA Therapeutics
• PBF-1650: Palobiofarma
• SCD-044: Sun Pharmaceutical Industries Limited
• Rimegepant: Biohaven Pharmaceuticals, Inc.
• PPC-06: Dr. Reddy’s
• MP1032: MetrioPharm
• CT-P43: Celltrion
• ABP 654: Amgen
• Piclidenoson: Can-Fite Biopharma

Psoriasis Route of Administration

Psoriasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as

• Oral
• Parenteral
• Intravenous
• Subcutaneous
• Topical

Psoriasis Molecule Type

Psoriasis Products have been categorized under various Molecule types, such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy

Psoriasis Pipeline Therapeutics Assessment

• Psoriasis Assessment by Product Type
• Psoriasis By Stage and Product Type
• Psoriasis Assessment by Route of Administration
• Psoriasis By Stage and Route of Administration
• Psoriasis Assessment by Molecule Type
• Psoriasis by Stage and Molecule Type

DelveInsight’s Psoriasis Report covers around 80+ products under different phases of clinical development like

• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I)
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Further Psoriasis product details are provided in the report. Download the Psoriasis pipeline report to learn more about the emerging Psoriasis therapies

Some of the key companies in the Psoriasis Therapeutics Market include:

Key companies developing therapies for Psoriasis are – AbbVie Inc., Amgen Inc., AstraZenca, Biogen Idec, Boehringer Ingelheim, Celgene Corporation, Dr.Reddy`s Laboratories, Eli Lilly and Company, Forward Pharma, Johnson and Johnson (Janssen Biotech Inc.), Leo Pharma AS, Merck and Co. Inc., Novartis AG, Pfizer Inc., Stiefel Laboratories Inc., Sun pharmaceutical Industries Limited, Takeda Pharmaceutical Company Limited, UCB SA, Valeant Pharmaceuticals, and others.

Psoriasis Pipeline Analysis:

The Psoriasis pipeline report provides insights into

• The report provides detailed insights about companies that are developing therapies for the treatment of Psoriasis with aggregate therapies developed by each company for the same.
• It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Psoriasis Treatment.
• Psoriasis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
• Psoriasis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
• Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Psoriasis market.

The report is built using data and information traced from the researcher’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc.

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Psoriasis Pipeline Market Drivers

Increasing prevalence of Psoriasis across the globe, increasing combinational therapies, an increase witnessed in Biological therapy approvals for Psoriasis are some of the important factors that are fueling the Psoriasis Market.

Psoriasis Pipeline Market Barriers

However, side effects associated with the treatment, high-cost treatment and unfavourable Reimbursement policies and other factors are creating obstacles in the Psoriasis Market growth.

Scope of Psoriasis Pipeline Drug Insight

• Coverage: Global
• Key Psoriasis Companies: Calliditas Therapeutics AB (NASDAQ: CALT), Travere Therapeutics, Inc. (NASDAQ: TVTX), Omeros Corporation (NASDAQ: OMER), Novartis Pharmaceuticals (SWX: NOVN), Chinook Therapeutics, Inc. (NASDAQ: KDNY), Vera Therapeutics, Inc. (NASDAQ: VERA), Otsuka Pharmaceutical (TYO: 4578), Fresh Tracks Therapeutics (NASDAQ: FRTX), Inmagene (Private), SFA Therapeutics (Private), Palobiofarma (Private), Sun Pharmaceutical Industries Limited (NSE: SUNPHARMA), Biohaven Pharmaceuticals, Inc. (NYSE: BHVN), Dr. Reddy’s (NSE: DRREDDY), MetrioPharm (Private), Celltrion (KRX: 068270), Amgen (NASDAQ: AMGN), Can-Fite Biopharma (NYSE American: CANF), and others
• Key Psoriasis Therapies: FRTX-03, IMG-008, SFA 002, PBF-1650, SCD-044, Rimegepant, PPC-06, MP1032, CT-P43, ABP 654, Piclidenoson, and others
• Psoriasis Therapeutic Assessment: Psoriasis current marketed and Psoriasis emerging therapies
• Psoriasis Market Dynamics: Psoriasis market drivers and Psoriasis market barriers

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Table of Contents

1. Psoriasis Report Introduction

2. Psoriasis Executive Summary

3. Psoriasis Overview

4. Psoriasis- Analytical Perspective In-depth Commercial Assessment

5. Psoriasis Pipeline Therapeutics

6. Psoriasis Late Stage Products (Phase II/III)

7. Psoriasis Mid Stage Products (Phase II)

8. Psoriasis Early Stage Products (Phase I)

9. Psoriasis Preclinical Stage Products

10. Psoriasis Therapeutics Assessment

11. Psoriasis Inactive Products

12. Company-University Collaborations (Licensing/Partnering) Analysis

13. Psoriasis Key Companies

14. Psoriasis Key Products

15. Psoriasis Unmet Needs

16 . Psoriasis Market Drivers and Barriers

17. Psoriasis Future Perspectives and Conclusion

18. Psoriasis Analyst Views

19. Appendix

20. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

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