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Severe psoriasis contributes significantly to the global psoriasis burden, with approximately 42.98 million prevalent cases worldwide in 2021, nearly doubling since 1990. Overall psoriasis affects 2-3% of the global population, with higher prevalence in adults and in high-socio-demographic regions. The severe psoriasis pipeline analysis by Expert Market Research highlights an active landscape of emerging therapies, including monoclonal antibodies, small-molecule inhibitors, and novel cell-based candidates, aimed at improving efficacy, safety, and long-term disease management.
Major companies involved in the severe psoriasis pipeline analysis include Huabo Biopharm Co., Ltd., Haisco Pharmaceutical Group Co., Ltd., and others.
Leading drugs currently in the pipeline include ORKA-001, HSK47388, and others.
Rapid expansion of IL-23–specific and next-generation TYK2 inhibitor pipelines is uniquely driving severe psoriasis development. Increasing demand for durable skin clearance with less frequent dosing, combined with biomarker-driven patient stratification. Competitive differentiation among biologics and oral agents, is accelerating innovation and investment in highly targeted, mechanism-specific psoriasis therapies.
The Severe Psoriasis Pipeline Analysis Report by Expert Market Research gives comprehensive insights into severe psoriasis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for severe psoriasis. The severe psoriasis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The severe 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 severe 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 severe psoriasis.

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The severe psoriasis pipeline outlook reflects a shift beyond conventional management approaches, which typically include systemic biologics targeting IL-17, IL-23, and TNF pathways, alongside emerging oral small-molecule inhibitors. Despite these options, unmet needs remain for durable efficacy, safety, and novel mechanisms. Pipeline activity is increasingly focused on innovative disease-modifying strategies.
Severe psoriasis treatment continues to evolve as regulatory progress underscores ongoing innovation in this space. In January 2026, FibroBiologics filed a Phase 1/2 IND with the U.S. FDA for CYPS317, an investigational allogeneic fibroblast spheroid therapy for moderate-to-severe psoriasis. Supported by encouraging preclinical data, the candidate represents a novel, cell-based approach aimed at modulating inflammatory pathways and advancing treatment options beyond established biologic and oral therapies.
Severe psoriasis epidemiology reflects a significant global disease burden, with overall psoriasis affecting an estimated 43 million people worldwide based on physician/dermatologist-diagnosed cases, and up to 102 million when self-reported cases are included. Prevalence varies widely by region and genetic background, from under 1 % in some areas to several percentage points in high-income regions, with adults more commonly affected than children. Strengthening global surveillance initiatives is expected to generate more comprehensive and reliable prevalence insights in the coming years.
This section of the report covers the analysis of severe 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 severe 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 covers a major share of the total severe psoriasis clinical trials. Phase III accounts for the largest share at 52.1%, followed by phase II at 28.8%, phase IV at 11.0%, phase I at 8.2%, while early-phase programs represent 0.0%.
The drug molecule categories covered under the severe psoriasis pipeline analysis include monoclonal antibodies, small-molecule inhibitors, and fusion proteins. The severe psoriasis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for severe psoriasis. In December 2025, Takeda announced positive Phase 3 results for its oral TYK2 inhibitor zasocitinib in moderate-to-severe plaque psoriasis. The once-daily therapy met all primary and secondary endpoints, with more than half of patients achieving near-clear or clear skin, reinforcing its potential as a leading oral treatment option.
The EMR report for the severe psoriasis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed severe psoriasis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in severe 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 severe psoriasis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of severe psoriasis drug candidates.
CMAB015 is a monoclonal antibody belonging to the biologics class, developed to selectively modulate key inflammatory pathways involved in immune-mediated diseases. The candidate is designed to neutralize a specific cytokine target, thereby reducing downstream inflammatory signaling and immune cell activation that drive chronic disease progression. In clinical development, CMAB015 aims to offer targeted efficacy with an improved safety profile compared with broader immunosuppressive therapies. This drug is being sponsored by a China-based biopharmaceutical company, Taizhou Mabtech Pharmaceutical Co.,Ltd. with growing expertise in antibody engineering and biologic drug development.
IBI112 is a novel biologic therapy classified as a monoclonal antibody, engineered to inhibit a defined immune signaling pathway implicated in inflammatory and autoimmune disorders. By selectively blocking its molecular target, IBI112 aims to suppress pathogenic immune responses while preserving normal immune function. This mechanism supports its potential use in chronic inflammatory conditions requiring long-term control. The drug is being developed by Innovent Biologics, a leading Chinese biotechnology company recognized for its robust immunology pipeline and strong clinical development capabilities across global markets.
HS-20137 is a targeted small-molecule or biologic candidate (depending on formulation) under investigation for its immunomodulatory effects in inflammatory diseases. It is designed to interfere with specific intracellular or cytokine-driven pathways that contribute to sustained inflammation and tissue damage. By offering a more selective mechanism of action, HS-20137 seeks to improve efficacy while limiting systemic side effects. The candidate is being developed by Haisco Pharmaceutical Group, a China-based company expanding its focus beyond generics into innovative and specialty therapeutics.
*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*
The Severe Psoriasis Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for severe 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 severe psoriasis collaborations, regulatory environments, and potential growth opportunities.
*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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