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Prurigo Nodularis Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102709
Prurigo nodularis is a chronic inflammatory skin disorder marked by intensely itchy nodules, significantly impacting patients' quality of life. It accounts for approximately 0.19% prevalence in the United States. The growing focus on prurigo nodularis therapeutics is driven by unmet clinical needs, rising awareness, and increasing research investments. Several prurigo nodularis drug candidates are currently in clinical trials, with promising biologics targeting the IL-31 and IL-4/IL-13 pathways. The prurigo nodularis pipeline analysis by the publisher highlights strong market potential, fueled by advancements in dermatological treatments and the development of targeted therapies expected to boost market growth in the coming years.

Report Coverage

The Prurigo Nodularis Pipeline Analysis Report by the publisher gives comprehensive insights into prurigo nodularis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for prurigo nodularis. The prurigo nodularis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The prurigo nodularis 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 prurigo nodularis 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 prurigo nodularis.

Prurigo Nodularis Pipeline Outlook

Prurigo nodularis is a chronic inflammatory skin condition marked by intensely itchy nodules that often develop due to repeated scratching. It is associated with neuroimmune dysregulation, leading to skin thickening and scarring. The disease typically occurs in adults and is often linked to underlying conditions such as atopic dermatitis, liver or kidney disease, or psychological stress.

Prurigo nodularis treatment involves corticosteroids, antihistamines, immunomodulators, and emerging biologic therapies to reduce itch, inflammation, and nodule formation while improving patients’ quality of life. For instance, in August 2024, Galderma’s Nemluvio (nemolizumab) received U.S. FDA approval as the first monoclonal antibody targeting IL-31 signaling for prurigo nodularis, following positive phase III OLYMPIA trial results demonstrating rapid itch and lesion improvement.

Prurigo Nodularis Epidemiology

According to studies, the global annual prevalence of prurigo nodularis ranges from 6.52 to 72 per 100,100 people. In the United States, the estimated prevalence is approximately 0.19%. In the United Kingdom, about 18,000 individuals are affected, while in Japan, the disease impacts an estimated 5.5 million adults. Patients often face a high disease burden with increased risks of psychiatric disorders and systemic illnesses.

Prurigo Nodularis - Pipeline Therapeutic Assessment

This section of the report covers the analysis of prurigo nodularis drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Monoclonal Antibodies
  • Small Molecules
  • Biologics
  • Topical Agents
  • Peptides

By Route of Administration

  • Oral
  • Parenteral
  • Others

Prurigo Nodularis Pipeline Assessment Segmentation by Phases

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 analysis, phase III holds the largest share at 68.75% of the total prurigo nodularis clinical trials, indicating robust clinical advancement in prurigo nodularis drug development. Phase IV follows with 6.25%, while Phase I and Phase II each account for 12.5%.

Prurigo Nodularis Pipeline Assessment Segmentation by Drug Classes

The drug molecule categories covered under the prurigo nodularis pipeline analysis include monoclonal antibodies, small molecules, biologics, topical agents, and peptides. The prurigo nodularis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for prurigo nodularis.

Interleukin inhibitors are gaining prominence in the prurigo nodularis pipeline. For example, nemolizumab, an interleukin-31 receptor alpha antagonist, is in a phase 3 trial. It has shown significant improvement in itch reduction and lesion healing by targeting the neuroimmune pathway. This class of drugs offers a promising approach for treating moderate-to-severe prurigo nodularis.

Prurigo Nodularis Clinical Trials - Key Players

The report for the prurigo nodularis pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed prurigo nodularis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in prurigo nodularis clinical trials:
  • Amgen
  • Incyte Corporation
  • Celldex Therapeutics
  • Keymed Biosciences Co.Ltd.
  • Hengrui Pharmaceutical Co., Ltd.
  • Galderma R&D
  • Sanofi
  • Regeneron Pharmaceuticals
  • AbbVie
  • Trevi Therapeutics
  • Vyne Therapeutics Inc.

Prurigo Nodularis - Emerging Drugs Profile

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 prurigo nodularis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of prurigo nodularis drug candidates.

Drug: Povorcitinib

Povorcitinib is currently being evaluated by Incyte Corporation in a Phase III trial (STOP-PN2) for prurigo nodularis (PN). Povorcitinib is an oral JAK1 inhibitor, showing promise in treating inflammatory skin diseases, including hidradenitis suppurativa and vitiligo. This randomized, double-blind, placebo-controlled study aims to assess the drug’s efficacy in reducing itch and skin lesions.

Drug: SHR-1819 Injection

SHR-1819 is a novel monoclonal antibody developed by Guangdong Hengrui Pharmaceutical Co., Ltd, currently undergoing a Phase II/III trial to assess its efficacy and safety in adult patients with prurigo nodularis. The study is evaluating SHR-1819's ability to block hIL-4Ra, a key target in type 2 inflammatory pathways, aiming to reduce chronic itch and nodular lesions.

Drug: Ruxolitinib Cream

Ruxolitinib cream (Opzelura) is currently being evaluated in a Phase I study sponsored by Incyte Corporation to determine its safety and tolerability under maximal use conditions in adults with prurigo nodularis (PN). This selective JAK1/JAK2 inhibitor, already FDA-approved for vitiligo and atopic dermatitis, is being studied for its potential to address PN’s inflammatory skin lesions.

Reasons To Buy This Report

The Prurigo Nodularis Drug Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for prurigo nodularis. 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 market trends, regulatory environments, and potential growth opportunities within prurigo nodularis pipeline insights.

Key Questions Answered in the Prurigo Nodularis Pipeline Insight Report

  • Which companies/institutions are leading the prurigo nodularis drug development?
  • What is the efficacy and safety profile of prurigo nodularis pipeline drugs?
  • Which company is leading the prurigo nodularis pipeline development activities?
  • What is the current prurigo nodularis commercial assessment?
  • What are the opportunities and challenges present in the prurigo nodularis pipeline landscape?
  • What is the efficacy and safety profile of prurigo nodularis pipeline drugs?
  • Which company is conducting major trials for prurigo nodularis drugs?
  • Which companies/institutions are involved in prurigo nodularis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in prurigo nodularis?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Prurigo Nodularis
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Prurigo Nodularis
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Prurigo Nodularis: Epidemiology Snapshot
5.1 Prurigo Nodularis Incidence by Key Markets
5.2 Prurigo Nodularis - Patients Seeking Treatment in Key Markets
6 Prurigo Nodularis: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Prurigo Nodularis: Key Facts Covered
7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
7.2 Top Countries Contributing to Clinical Trials in Europe
7.3 Top Countries Contributing to Clinical Trials in North America
7.4 Top Countries Contributing to Clinical Trials in Other Regions
8 Prurigo Nodularis, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Prurigo Nodularis Pipeline Drugs
9.1.1 By Company
9.1.2 By Phase
9.1.3 By Indication
9.1.4 By Trial Status
9.1.5 By Funder Type
9.2 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Prurigo Nodularis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
10.1 Comparative Analysis for Late-Stage Drugs
10.1.1 Study Type
10.1.2 Recruitment Status
10.1.3 Company
10.1.4 Funder Type
10.2 Product Level Analysis*
10.2.1 Drug: Upadacitinib
10.2.1.1 Product Description
10.2.1.2 Trial ID
10.2.1.3 Sponsor Name
10.2.1.4 Study Type
10.2.1.5 Drug Class
10.2.1.6 Eligibility Criteria
10.2.1.7 Study Record Dates
10.2.1.7.1 First Submitted
10.2.1.7.2 First Posted
10.2.1.7.3 Last Update Posted
10.2.1.7.4 Last Verified
10.2.1.8 Indication
10.2.1.9 Study Design
10.2.1.10 Recruitment Status
10.2.1.11 Enrollment (Estimated)
10.2.1.12 Location Countries
10.2.1.13 Recent Results
10.2.2 Drug: Povorcitinib
10.2.3 Drug: Rocatinlimab
10.2.4 Drug: Dupilumab
10.2.5 Drug: SHR-1819 Injection
10.2.6 Other Drugs
11 Prurigo Nodularis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
11.1 Comparative Analysis for Mid-Stage Drugs
11.1.1 Study Type
11.1.2 Recruitment Status
11.1.3 Company
11.1.4 Funder Type
11.2 Product Level Analysis*
11.2.1 Biological: Barzolvolimab
11.2.1.1 Product Description
11.2.1.2 Trial ID
11.2.1.3 Sponsor Name
11.2.1.4 Study Type
11.2.1.5 Drug Class
11.2.1.6 Eligibility Criteria
11.2.1.7 Study Record Dates
11.2.1.7.1 First Submitted
11.2.1.7.2 First Posted
11.2.1.7.3 Last Update Posted
11.2.1.7.4 Last Verified
11.2.1.8 Indication
11.2.1.9 Study Design
11.2.1.10 Recruitment Status
11.2.1.11 Enrollment (Estimated)
11.2.1.12 Location Countries
11.2.1.13 Recent Results
11.2.2 Other Drugs
12 Prurigo Nodularis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
12.1 Comparative Analysis for Early-Stage Drugs
12.1.1 Study Type
12.1.2 Recruitment Status
12.1.3 Company
12.1.4 Funder Type
12.2 Product Level Analysis*
12.2.1 Drug: Ruxolitinib Cream
12.2.1.1 Product Description
12.2.1.2 Trial ID
12.2.1.3 Sponsor Name
12.2.1.4 Study Type
12.2.1.5 Drug Class
12.2.1.6 Eligibility Criteria
12.2.1.7 Study Record Dates
12.2.1.7.1 First Submitted
12.2.1.7.2 First Posted
12.2.1.7.3 Last Update Posted
12.2.1.7.4 Last Verified
12.2.1.8 Indication
12.2.1.9 Study Design
12.2.1.10 Recruitment Status
12.2.1.11 Enrollment (Estimated)
12.2.1.12 Location Countries
12.2.2 Other Drugs
13 Prurigo Nodularis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
13.1.1 Study Type
13.1.2 Recruitment Status
13.1.3 Company
13.1.4 Funder Type
13.2 Product Level Analysis*
13.2.1 Drug 1
13.2.1.1 Product Description
13.2.1.2 Trial ID
13.2.1.3 Sponsor Name
13.2.1.4 Study Type
13.2.1.5 Drug Class
13.2.1.6 Eligibility Criteria
13.2.1.7 Study Record Dates
13.2.1.7.1 First Submitted
13.2.1.7.2 First Posted
13.2.1.7.3 Last Update Posted
13.2.1.7.4 Last Verified
13.2.1.8 Indication
13.2.1.9 Study Design
13.2.1.10 Recruitment Status
13.2.1.11 Enrollment (Estimated)
13.2.1.12 Location Countries
13.2.2 Other Drugs
14 Prurigo Nodularis, Key Drug Pipeline Companies
14.1 Amgen
14.1.1 Company Snapshot
14.1.2 Pipeline Product Portfolio
14.1.3 Financial Analysis
14.1.4 Recent News and Developments
14.2 Incyte Corporation
14.2.1 Company Snapshot
14.2.2 Pipeline Product Portfolio
14.2.3 Financial Analysis
14.2.4 Recent News and Developments
14.3 Celldex Therapeutics
14.3.1 Company Snapshot
14.3.2 Pipeline Product Portfolio
14.3.3 Financial Analysis
14.3.4 Recent News and Developments
14.4 Keymed Biosciences Co.Ltd.
14.4.1 Company Snapshot
14.4.2 Pipeline Product Portfolio
14.4.3 Financial Analysis
14.4.4 Recent News and Developments
14.5 Hengrui Pharmaceutical Co., Ltd.
14.5.1 Company Snapshot
14.5.2 Pipeline Product Portfolio
14.5.3 Financial Analysis
14.5.4 Recent News and Developments
14.6 Galderma R&D
14.6.1 Company Snapshot
14.6.2 Pipeline Product Portfolio
14.6.3 Financial Analysis
14.6.4 Recent News and Developments
14.7 Sanofi
14.7.1 Company Snapshot
14.7.2 Pipeline Product Portfolio
14.7.3 Financial Analysis
14.7.4 Recent News and Developments
14.8 Regeneron Pharmaceuticals
14.8.1 Company Snapshot
14.8.2 Pipeline Product Portfolio
14.8.3 Financial Analysis
14.8.4 Recent News and Developments
14.9 AbbVie
14.9.1 Company Snapshot
14.9.2 Pipeline Product Portfolio
14.9.3 Financial Analysis
14.9.4 Recent News and Developments
14.10 Trevi Therapeutics
14.10.1 Company Snapshot
14.10.2 Pipeline Product Portfolio
14.10.3 Financial Analysis
14.10.4 Recent News and Developments
14.11 Vyne Therapeutics Inc.
14.11.1 Company Snapshot
14.11.2 Pipeline Product Portfolio
14.11.3 Financial Analysis
14.11.4 Recent News and Developments
15 Regulatory Framework for Drug Approval, By Region16 Terminated or Suspended Pipeline Products