Prurigo Nodularis Pipeline: Emerging Therapies Set to Reshape the Prurigo Nodularis Treatment Landscape | DelveInsight

The treatment landscape of Prurigo Nodularis (PN), a chronic, intensely pruritic skin disorder, is undergoing a dynamic transformation, fueled by a growing pipeline of novel therapeutics from leading pharma and biotech companies. Notable players such as Menlo Therapeutics, Galderma R&D, and Kiniksa Pharmaceuticals are driving innovation with therapies targeting underlying immune dysregulation, including IL-31 and JAK/STAT pathways, central to PN pathogenesis. These emerging drugs aim to address the high unmet need by reducing itch severity, nodule formation, and disease burden in affected patients.

DelveInsight's "Prurigo Nodularis - Pipeline Insight, 2025" provides a comprehensive analysis of the current clinical development scenario, featuring investigational therapies in various stages-from early preclinical studies to advanced Phase III trials. The report outlines key drug candidates, their mechanisms of action, development status, and potential market entry timelines.

This pipeline assessment offers a 360° view of therapeutic development trends in prurigo nodularis based on drug molecule types, administration routes, and clinical phases. It also sheds light on critical unmet needs, strategic partnerships, regulatory designations, and emerging market disruptors expected to redefine PN treatment standards in the coming years.

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Key Takeaways from the Prurigo Nodularis Pipeline Report
• DelveInsight's prurigo nodularis pipeline analysis depicts a strong space with 5+ active players working to develop 5+ pipeline drugs for prurigo nodularis treatment.
• The leading prurigo nodularis companies include Menlo Therapeutics, Galderma R&D, Kiniksa Pharmaceuticals, Sanofi, Maruho, and others are evaluating their lead assets to improve the prurigo nodularis treatment landscape.
• Key prurigo nodularis pipeline therapies in various stages of development include Maralixibat, Odevixibat, VTX-803, and others.
• In February 2025, Galderma announced that the UK Medicines and Healthcare products Regulatory Agency and Swissmedic approved nemolizumab for treating moderate-to-severe atopic dermatitis and prurigo nodularis.
• In December 2024, Galderma announced that the FDA approved NEMLUVIO® (nemolizumab) for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 and older, in combination with topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI) when topical therapies alone are insufficient. This approval follows the August 2024 FDA approval of Nemluvio for subcutaneous injection for treating adults with prurigo nodularis.

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Prurigo Nodularis Overview
Prurigo Nodularis (PN) is a chronic skin condition characterized by the formation of hard, itchy nodules on the skin. The intense itching, or pruritus, can lead to frequent scratching, often resulting in pain or bleeding. This scratching can exacerbate the condition by causing additional skin lesions to form. The itching is typically aggravated by heat, sweating, or friction from clothing. PN is sometimes associated with other underlying conditions such as eczema (atopic dermatitis), lymphoma, HIV, severe anemia, or kidney disease. The exact cause of PN remains unclear. While scratching is known to trigger the formation of new nodules, the initial cause of the itching is not well understood.

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Prurigo Nodularis Treatment Analysis: Drug Profile
Nemolizumab: Chugai/Galderma
Nemolizumab, developed by Chugai using its proprietary ACT-Ig antibody engineering technology, extends the biological half-life of antibodies in the bloodstream. This drug targets IL-31, a cytokine linked to pruritus in several conditions, including atopic dermatitis and hemodialysis. Nemolizumab works by blocking IL-31 from binding to its receptor, thereby alleviating itching. It is currently in Phase III development.

Nalbuphine ER: Trevi Therapeutics
Trevi Therapeutics is developing Nalbuphine ER, a treatment for conditions with limited treatment options. This drug has a dual mechanism of action: it acts as an antagonist at the mu opioid receptor and an agonist at the kappa opioid receptor. By targeting both the central and peripheral nervous systems, Nalbuphine ER has the potential to improve the quality of life for patients with severe neurologically mediated conditions. It is also in Phase III of development.

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Prurigo Nodularis 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
• Infusion
• Intradermal
• Intramuscular
• Intranasal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical

By Molecule Type
• Gene therapies
• Small molecule
• Vaccines
• Polymers
• Peptides
• Monoclonal antibodies

Scope of the Prurigo Nodularis Pipeline Report
• Coverage: Global
• Key Prurigo Nodularis Companies: Menlo Therapeutics, Galderma R&D, Kiniksa Pharmaceuticals, Sanofi, Maruho, and others.
• Key Prurigo Nodularis Pipeline Therapies: Maralixibat, Odevixibat, VTX-803, and others.

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

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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About DelveInsight
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This release was published on openPR.