Barzolvolimab

The prurigo nodularis treatment landscape has been evolving in recent years, with increasing attention from the pharmaceutical industry due to the chronic and debilitating nature of the condition. There is growing recognition of the need for effective treatments that can break the persistent itch-scratch cycle that exacerbates the disease. Additionally, the launch of emerging therapies such as Povorcitinib, OPZELURA, Rocatinlimab, Barzolvolimab, and others will further fuel the market growth. LAS VEGAS, Sept. 22, 2025 /PRNewswire/ -- DelveInsight's Prurigo Nodularis Market Insights report includes a comprehensive understanding of current treatment practices, prurigo nodularis emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Prurigo Nodularis Market Report According to DelveInsight's analysis, the market size for prurigo nodularis was found to be nearly USD 1 billion in the leading markets in 2024, which is anticipated to grow tremendously owing to the uptake of approved therapies and the emerging pipeline moving towards patients inadequately controlled on topical therapies. In 2024, among all the current therapies for prurigo nodularis, the highest estimated revenue was generated by DUPIXENT, i.e., nearly USD 630 million in the United States. The total diagnosed prevalent cases of prurigo nodularis in the 7MM were ~614,000 in 2024, out of which the highest prevalent cases of this disease were in the United States, with major contribution by patients aged 65 years and old. The US, EU4, and the UK show a higher prevalence of prurigo nodularis in females, which could be attributed to hormonal or genetic factors influencing the development of the condition. Japan, on the other hand, has a significant male predominance, which may indicate regional genetic or lifestyle factors that predispose men to a higher risk of developing the condition. DUPIXENT (dupilumab) became the first FDA-approved treatment for prurigo nodularis in September 2022, with its EU approval expanded in December 2022 for adults with moderate-to-severe cases. Japan's MHLW also approved DUPIXENT in June 2023 for patients unresponsive to conventional treatments. Based on its existing performance and physician acceptance, we anticipate it to generate more than USD 1.2 billion by 2030 in the 7MM. In recent developments for prurigo nodularis treatment, NEMLUVIO (nemolizumab) received US FDA approval in August 2024 for adult patients, with approximately 1,100 healthcare professionals prescribing it since its launch. Prior to this, NEMLUVIO was approved in Japan as the brand name MITCHGA (nemolizumab) in March 2024 for prurigo nodularis in adults and children aged 13 and older, and was launched by Maruho in June 2024. In February 2025, Galderma received marketing authorization for NEMLUVIO from both the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Commission (EC) for the SC treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Leading companies developing emerging therapies for prurigo nodularis include Incyte, Amgen, Kyowa Kirin, and Celldex Therapeutics, which are advancing promising candidates that are expected to enter the prurigo nodularis market in the coming years. The promising prurigo nodularis therapies in the pipeline include Povorcitinib, OPZELURA (ruxolitinib), Rocatinlimab, Barzolvolimab (CDX-0159), and others. Discover which therapies are expected to grab the major prurigo nodularis treatment market share @ Prurigo Nodularis Market Report Key Factors Driving the Prurigo Nodularis Market Rising Prurigo Nodularis Disease Prevalence and Awareness The increasing prevalence of prurigo nodularis, particularly among individuals with underlying skin conditions like atopic dermatitis and eczema, has heightened the demand for effective treatments. The US accounted for approximately 261K diagnosed prevalent cases of prurigo nodularis in 2024. These cases are expected to increase during the forecast period (2025−2034) owing to growing populations, improved diagnostic methods, changes in lifestyle and environmental factors, and advancements in medical technology, allowing for better treatment. Moreover, there is a growing awareness among healthcare professionals and patients about the condition, leading to earlier diagnosis and intervention. Drug Approvals in Prurigo Nodularis Market The approval of DUPIXENT (dupilumab) in 2022 and NEMLUVIO (nemolizumab) in 2024 provides a significant breakthrough for patients with moderate-to-severe prurigo nodularis. These prurigo nodularis therapies offer targeted therapies with proven efficacy. As more treatments are developed and approved, expanding access to biologic therapies like DUPIXENT and NEMLUVIO through improved insurance coverage and cost reduction programs could make these therapies more accessible to a broader range of patients. Emerging Therapies in Prurigo Nodularis Market The emerging prurigo nodularis clinical trial landscape offers a diverse range of therapeutic alternatives, including rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), barzolvolimab (Celldex), and others across various treatment lines. The expected launch of these therapies shall further create a positive impact on the prurigo nodularis market. Prurigo Nodularis Market Analysis The treatment landscape for prurigo nodularis has seen significant advancements in recent years, driven by growing interest from the pharmaceutical sector due to the condition's chronic and distressing nature. Current therapies aim primarily to alleviate itching and inflammation. Potent topical corticosteroids are frequently used to calm inflamed skin and ease itching, while tacrolimus ointment offers a non-steroidal alternative with anti-inflammatory benefits. Moisturizers, or emollients, play a vital role in hydrating dry skin and enhancing the effectiveness of other treatments. Non-drowsy antihistamines like fexofenadine can also help control the itch. Phototherapy, including UVA or UVB light therapy, is effective in reducing nodules and itching. Psychological support may help patients cope with stress-related flare-ups. In more severe cases, systemic immunosuppressants such as oral corticosteroids, ciclosporin, methotrexate, or azathioprine are prescribed. A major milestone in treatment was the FDA approval of DUPIXENT, the first medication specifically authorized for prurigo nodularis. DUPIXENT, a monoclonal antibody that blocks IL-4 and IL-13 signaling, helps reduce inflammation and severe itching. Another breakthrough came in August 2024 with the FDA approval of NEMLUVIO, a monoclonal antibody targeting IL-31, offering a new therapeutic option for managing this condition. To know more about prurigo nodularis treatment guidelines, visit @ Prurigo Nodularis Treatment Options Prurigo Nodularis Competitive Landscape Although there are very few approved medications for prurigo nodularis, several drugs are currently under research and development. These include rocatinlimab (Amgen/Kyowa Kirin), povorcitinib and ruxolitinib (Incyte), and barzolvolimab (Celldex), which are being investigated as potential treatments for prurigo nodularis. Povorcitinib is an oral JAK1 inhibitor currently in Phase III clinical trials for prurigo nodularis, with data expected by 2026 and a launch anticipated between 2027–2028. In March 2024, Incyte presented positive late-breaking Phase II data showing that povorcitinib met its primary and secondary endpoints in treating prurigo nodularis. Ruxolitinib, a topical JAK1/2 inhibitor, is also being investigated for prurigo nodularis, with Phase III trial data was presented in March 2025, and a launch is anticipated between 2026–2027. Currently, no oral or topical therapies are approved for prurigo nodularis. While the first study, TRuE-PN1, met its primary endpoint and all key secondary endpoints, the second trial, TRuE-PN2, did not reach statistical significance on its primary endpoint despite the numbers favoring OPZELURA. Rocatinlimab (formerly AMG 451 / KHK4083) is a monoclonal antibody that targets the OX40 receptor to inhibit and reduce pathogenic T-cells, with potential for treating prurigo nodularis. The company launched a Phase III trial for rocatinlimab in July 2024 to assess its efficacy in treating prurigo nodularis. The anticipated launch of these emerging therapies is poised to transform the prurigo nodularis market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the prurigo nodularis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about prurigo nodularis marketed and pipeline drugs @ Prurigo Nodularis Clinical Trials Recent Developments in the Prurigo Nodularis Market In July 2025, Incyte's Q2 2025 report noted that the launch of povorcitinib for the treatment of prurigo nodularis is expected by 2027–2028. In March 2025, Incyte announced the results of Phase III clinical trials (TRuE-PN1 and TRuE-PN2 studies) evaluating ruxolitinib cream 1.5% (OPZELURA) in patients with prurigo nodularis at the 2025 American Academy of Dermatology (AAD) Annual Meeting. According to the Q2 2025 Kyowa Kirin corporate presentation, Phase III completion for rocatinlimab in prurigo nodularis is expected by 2027. What is Prurigo Nodularis? Prurigo nodularis is a long-term skin condition marked by the presence of numerous firm, itchy bumps or nodules that often result from persistent scratching or rubbing. These nodules can vary in size and commonly appear on the arms, legs, back, and chest. The main symptom is severe itching, which leads to repeated scratching, worsening the skin lesions, and causing them to become thickened, scaly, or darkened. In more advanced cases, the nodules may break open or become infected due to continuous irritation and trauma. While the precise cause of prurigo nodularis is not fully understood, it is frequently linked to underlying health issues such as atopic dermatitis, chronic kidney or liver disease, and psychological conditions like anxiety or depression. Diagnosis is mainly clinical, based on the distinct appearance of itchy, raised nodules. Healthcare professionals typically review the patient's medical history, particularly any related conditions, and perform a physical examination to assess the size, number, and distribution of the nodules, which are usually found on the limbs and trunk. Prurigo Nodularis Epidemiology Segmentation The prurigo nodularis epidemiology section provides insights into the historical and current prurigo nodularis patient pool and forecasted trends for the leading markets. The total diagnosed prevalent cases of prurigo nodularis in the US were around 261,900 cases in 2024. According to DelveInsight estimates, in 2024, among the age-specific diagnosed prevalent cases of prurigo nodularis in the US, the highest number of cases were found in the =65 years age group, followed by the 25–44 years age group, while the lowest number of cases was observed in the <15 years age group. The prurigo nodularis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Diagnosed Prurigo Nodularis Prevalence Gender-specific Diagnosed Prurigo Nodularis Prevalence Age-specific Diagnosed Prurigo Nodularis Prevalence Severity-specific Diagnosed Prurigo Nodularis Prevalence Scope of the Prurigo Nodularis Market Report Therapeutic Assessment: Prurigo Nodularis current marketed and emerging therapies Prurigo Nodularis Market Dynamics: Key Market Forecast Assumptions of Emerging Prurigo Nodularis Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Prurigo Nodularis Market Access and Reimbursement Download the report to understand which factors are driving prurigo nodularis market trends @ Prurigo Nodularis Drug Treatment Table of Contents Related Reports JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, among others. 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HAMPTON, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival. The data were presented in an oral e-poster presentation (EPS02.09) at the EADV Congress 2025 by Martin Metz, M.D., Professor, Department of Dermatology and Allergy, Head of Translation Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin and the lead investigator of the study. “These data reinforce that mast cells are important drivers of CSU and that barzolvolimab, with its novel mechanism of action, has significant potential to be a meaningful treatment for all patients with CSU, regardless of underlying disease endotype,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex. “This is especially important for patients with low IgE levels, who typically have more severe disease and are less likely to respond to IgE targeted therapies, including omalizumab.” Key data highlights: Barzolvolimab demonstrated rapid and sustained efficacy in patients with CSU with both low (<40) and normal/high (>40) IgE levels. Similar improvement in weekly urticaria activity scores (UAS7; mean change from baseline) were observed across both IgE low and IgE normal/high subgroups at Weeks 12 and 52. Similar rates of well-controlled disease (UAS7<6) and complete disease control (both UAS7=0) were also observed across both IgE normal/high and IgE low subgroups at Weeks 12 and 52. Similar rates of well-controlled disease (UCT7>12) and complete disease control (UCT7=16) were also observed across both IgE normal/high and IgE low subgroups at Weeks 12 and 52. Data reinforce that mast cells are important drivers of CSU regardless of the underlying endotype and are consistent with the novel mechanism of action of barzolvolimab. Barzolvolimab is a promising therapy for all patients with moderate to severe CSU, regardless of underlying endotype. The Company previously announced that this Phase 2 study of barzolvolimab in patients with moderate to severe CSU refractory to antihistamines, including patients with biologic-refractory disease, met its primary endpoint—a significant improvement in UAS7 compared to placebo at 12 weeks—across all dose groups tested. Barzolvolimab also demonstrated rapid, profound complete response rates (UAS7=0; no itch/no hives) in up to 51% of patients at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. Seven months after completion of dosing, patients continued to experience profound clinical benefit, with up to 41% of patients reporting a complete response at 76 weeks and 48% of patients reporting that their disease no longer impacted their quality of life. Barzolvolimab demonstrated a well tolerated safety profile throughout the study. The Company is currently enrolling patients in a global Phase 3 Program for barzolvolimab in CSU, consisting of two Phase 3 trials (EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. About Barzolvolimab Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), two forms of chronic inducible urticaria (CIndU) – cold urticaria (ColdU) and symptomatic dermographism (SD), prurigo nodularis (PN) and atopic dermatitis (AD), with additional indications planned for the future. About the Phase 2 CSU Study The randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CSU who remained symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 208 patients were randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment period. After 16 weeks, patients then entered a 36-week active treatment period, in which patients receiving placebo or the 75 mg dose were randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks; patients already randomized to the 150 mg and 300 mg treatment arms remained on the same regimen as during the placebo-controlled treatment period. After 52 weeks, patients entered a follow-up period for an additional 24 weeks. Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels. For additional information on this trial (NCT05368285), please visit www.clinicaltrials.gov. About the Phase 3 Program Celldex is currently conducting a global Phase 3 Program for barzolvolimab in CSU, consisting of two Phase 3 trials (EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. Enrollment is underway. About Chronic Spontaneous Urticaria (CSU) CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin (release of histamines, leukotrienes, chemokines) results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. Current therapies provide symptomatic relief only in some patients. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit www.celldex.com. Forward Looking Statement This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company Contact Sarah Cavanaugh Senior Vice President, Corporate Affairs & Administration (508) 864-8337 scavanaugh@celldex.com Patrick Till Meru Advisors (484) 788-8560 ptill@meruadvisors.com Source: Celldex Therapeutics, Inc.