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Moderate to severe plaque psoriasis is a chronic, immune-mediated inflammatory skin disorder characterized by well-defined, erythematous, scaly plaques that significantly impair physical and psychological well-being. According to the International Psoriasis Council, psoriasis impacts approximately 2-3% of the global population, with higher prevalence in Western regions and peak onset between 35-44 and 65-74 years. Treatment includes biologics, systemic agents, and emerging targeted therapies such as IL-17, IL-23, and TYK2 inhibitors. According to the moderate to severe plaque psoriasis pipeline analysis by Expert Market Research, increasing focus on precision immunotherapy and novel mechanisms is expected to drive substantial pipeline growth in the coming years.
Major companies involved in the moderate to severe plaque psoriasis pipeline analysis include Hansoh BioMedical R&D Company, Oruka Therapeutics, Inc., and others.
Leading drugs currently in the pipeline include HS-20137, TAK-279, ORKA-001, and others.
The robust late-stage biologics targeting IL-17, IL-23, and TYK2 pathways, expanding oral small-molecule options, and increasing biosimilar competition are expected to accelerate innovation, improve long-term remission rates, and enhance treatment accessibility.
The Moderate to Severe Plaque Psoriasis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into moderate to severe plaque psoriasis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for moderate to severe plaque psoriasis. The moderate to severe plaque psoriasis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The moderate to severe plaque psoriasis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with moderate to severe plaque psoriasis treatment guidelines to ensure optimal care practices.
The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to moderate to severe plaque psoriasis.

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Moderate-to-severe plaque psoriasis is a chronic, systemic, immune-mediated skin disorder marked by thick, red, scaly plaques. It develops due to immune system overactivity, which accelerates skin cell turnover and triggers persistent inflammation, significantly impacting physical health, quality of life, and daily activities, often causing discomfort, itching, and social or psychological burdens for affected individuals.
Moderate-to-severe plaque psoriasis treatments include systemic therapies, phototherapy, biologics, and oral small molecules that target immune pathways, reduce inflammation, and improve skin clearance. In September 2022, the United States Food and Drug Administration approved Bristol Myers Squibb’s Sotyktu™ (deucravacitinib), a first-in-class, once-daily oral TYK2 inhibitor. Phase 3 POETYK PSO trials demonstrated superior efficacy, sustained skin clearance, and a favorable safety profile in adults.
The pipeline is expanding in response to the growing global burden of the disease. According to the International Psoriasis Council, psoriasis affects approximately 2-3% of the global population, with higher prevalence in Western countries and bimodal incidence peaks at ages 35–44 and 65–74. As per Sanyam Mehta et al., 2025, plaque psoriasis accounts for 80–90% of all psoriasis cases. The Global Psoriasis Atlas reports a global adult lifetime prevalence of 0.59%, equivalent to approximately 29.5 million adults. Regional prevalence ranges from 0.14% to 3% in adults, and from 0.02% to 0.21% in children. These epidemiological insights support targeted drug development and pipeline prioritization.
This section of the report covers the analysis of moderate to severe plaque psoriasis drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
By Drug Class
The moderate to severe plaque psoriasis pipeline analysis report covers 50+ drug analyses based on drug classes:
By Route of Administration
The pipeline assessment report covers 50+ drug analyses based on the route of administration:
The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase III, with 59%, covers a major share of the total moderate to severe plaque psoriasis clinical trials, driven by advanced efficacy data and larger patient populations. Phase II holds 20%, supported by promising safety and dose-optimization results. Phase IV accounts for 11%, reflecting real-world evidence. Phase I is 8%, guided by initial safety assessments, and early phase I is focused on first-in-human tolerability. These factors collectively strengthen clinical confidence and market potential.
The drug molecule categories covered under the moderate to severe plaque psoriasis pipeline analysis include small molecules, oligonucleotides, and peptides. The moderate to severe plaque psoriasis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for moderate to severe plaque psoriasis. Targeted oral peptide therapies are gaining attention in the pipeline. For instance, Icotrokinra (JNJ-2113) selectively blocks the IL-23 receptor and has demonstrated significant skin clearance and favorable safety in Phase 3 studies. Additionally, other investigational biologics and small molecules targeting IL-23, IL-17, and JAK pathways are being evaluated to improve efficacy and patient convenience.
The EMR report for the moderate to severe plaque psoriasis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed moderate to severe plaque psoriasis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in moderate to severe plaque psoriasis clinical trials:
This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for moderate to severe plaque psoriasis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of moderate to severe plaque psoriasis drug candidates.
HS-20137 Injection is a recombinant humanized IgG1 monoclonal antibody sponsored by Hansoh BioMedical R&D Company for the treatment of moderate-to-severe plaque psoriasis. This Phase 3, randomized, double-blind, placebo-controlled study is evaluating the efficacy and safety of HS-20137 in approximately 720 participants. The drug specifically binds to the p19 subunit of IL-23, blocking its interaction with the IL-23 receptor and inhibiting pro-inflammatory cytokine release. Administered via subcutaneous injection at 200 mg, the study is assessing dosing at Weeks 0, 4, and 8, followed by maintenance every 8 or 12 weeks.
TAK-279 (zasocitinib) is an investigational, next-generation, highly selective oral TYK2 inhibitor sponsored by Takeda and is currently being evaluated in a Phase 3, multicenter, open-label study in participants with moderate-to-severe plaque psoriasis. The objective of this phase is to examine the long-term safety, tolerability, and efficacy of TAK-279 over extended treatment periods. Administered orally, the drug selectively inhibits TYK2-mediated signaling, including IL-23–driven inflammatory pathways, while sparing JAK1/2/3 pathways. The study is enrolling approximately 1,950 participants and is assessing outcomes across up to 217 weeks of treatment and follow-up.
ORKA-001 is a novel, subcutaneously administered, half-life–extended monoclonal antibody targeting IL-23p19 and is sponsored by Oruka Therapeutics, Inc. in an ongoing Phase 2, multicenter, randomized, double-blinded, placebo-controlled proof-of-concept study. The study is evaluating the efficacy, safety, tolerability, and pharmacokinetics of ORKA-001 in adults with moderate-to-severe plaque psoriasis. By selectively inhibiting IL-23p19, the drug suppresses inflammatory pathways central to psoriatic plaque formation. With an extended half-life designed for once- or twice-yearly dosing, ORKA-001 aims to achieve higher systemic exposure and improved rates of complete skin clearance compared to currently approved IL-23 inhibitors.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Moderate to Severe Plaque Psoriasis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for moderate to severe plaque psoriasis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into moderate to severe plaque psoriasis collaborations, regulatory environments, and potential growth opportunities.
Moderate to Severe Plaque Psoriasis Epidemiology Forecast
*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*
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