Scleroderma Pipeline Analysis Report 2025
Description
Scleroderma is a rare autoimmune disease characterized by skin thickening and hardening, often affecting internal organs such as the lungs and kidneys. According to the American College of Rheumatology, it accounts for around 8 to 56 new cases per million people annually, with a higher prevalence in females. Scleroderma pipeline analysis by Expert Market Research highlights promising developments in pulmonary arterial scleroderma treatments, including antifibrotic agents and monoclonal antibodies. The growing focus on targeted biologics and immunomodulators is driving innovation in scleroderma therapeutics. Moreover, with increased R&D investments and clinical trials, the scleroderma pipeline is expected to witness significant growth in the coming years.
Report Coverage
The Scleroderma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into scleroderma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for scleroderma. The scleroderma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The scleroderma 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 scleroderma 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 scleroderma.
Scleroderma Pipeline Outlook
Scleroderma is a rare autoimmune disorder that causes the hardening and tightening of the skin and connective tissues due to excess collagen production. It occurs when the immune system mistakenly attacks the body, leading to inflammation and fibrosis that may affect the skin, blood vessels, and internal organs. Scleroderma is classified into localized types (like morphea and linear, affecting skin) and systemic types (limited and diffuse, involving internal organs and skin).
Scleroderma treatment focuses on symptom relief, slowing disease progression, and preventing complications through immunosuppressants, anti-inflammatory drugs, and organ-specific therapies. In February 2024, Certa Therapeutics’ FT011 received fast-track designation from the United States Food and Drug Administration as a potential disease-modifying treatment for systemic sclerosis, showing significant clinical improvement in Phase II studies.
Scleroderma Epidemiology
The global epidemiological profile of scleroderma indicates incidence rates of 8 to 56 new cases per million persons annually, predominantly affecting female patients. A systematic review published in 2019 investigated systemic sclerosis (SSc) epidemiology studies conducted in Europe and the United States. In Europe, prevalence estimates range from 7.2 to 33.9 per 100,000 individuals, while North American rates vary from 13.5 to 44.3 per 100,000. Increasing incidence trends among older individuals highlight the evolving burden of the disease.
Scleroderma – Pipeline Therapeutic Assessment
This section of the report covers the analysis of scleroderma drug candidates based on several segmentations, including:
By Phase
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 II, with 40.74%, covers a major share of the total scleroderma clinical trials, highlighting robust clinical progress and growing therapeutic confidence. Phase I follows at 35.19%, reflecting strong early-stage research. Phase III holds 11.11%, indicating promising late-stage developments. Early Phase I accounts for 7.41%, and Phase IV holds 5.56%, ensuring post-marketing evaluation. This dynamic pipeline positively drives innovation in the scleroderma market.
Scleroderma Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the scleroderma pipeline analysis include small molecules, monoclonal antibodies, biologics, cell therapies, RNA-based therapies, gene therapies, and others. The scleroderma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for scleroderma.
Chimeric antigen receptor (CAR) T cell therapies are emerging as promising immune-based treatments for scleroderma. For example, KYV-101, a fully human anti-CD19 CAR T cell therapy, is under investigation in a phase 1/2 trial for diffuse cutaneous systemic sclerosis. It aims to achieve deep B-cell depletion, potentially resetting the immune system and reducing disease activity.
Scleroderma Clinical Trials – Key Players
The EMR report for the scleroderma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed scleroderma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in scleroderma 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 scleroderma. It includes product description, trial ID, study type, drug class, mode of administration, and the recruitment status of scleroderma drug candidates.
Drug: Divozilimab
Divozilimab is a monoclonal antibody targeting CD20, developed by Biocad CJSC. It is a part of a Phase III trial that is evaluating its efficacy and safety in patients with active systemic scleroderma. The study is enrolling adults meeting ACR/EULAR 2013 criteria. The drug works through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), aiming to reduce immune cell activity and improve skin and lung function.
Biological: Tibulizumab
Tibulizumab, sponsored by Zura Bio Inc., is undergoing Phase II clinical development. The study is assessing the efficacy, safety, and tolerability of Tibulizumab in adults with systemic sclerosis. Tibulizumab is a humanized, tetravalent bispecific antibody targeting IL-17A and BAFF, aiming to reduce inflammation and fibrosis in systemic sclerosis patients.
Biological: CABA-201
CABA-201 is a fully human CD19-CAR T cell therapy sponsored by Cabaletta Bio. The Phase 1/2 study, RESET-SSc, is currently evaluating its safety and efficacy in patients with systemic sclerosis. This investigational drug is being administered as a single dose, combined with cyclophosphamide and fludarabine, aiming to target B cells responsible for autoimmunity and tissue fibrosis.
Key Questions Answered in the Scleroderma Pipeline Insight Report
The Scleroderma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for scleroderma. 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 scleroderma collaborations, regulatory environments, and potential growth opportunities.
Related Reports
Global Scleroderma Therapeutics Market Report and Forecast
Systemic Scleroderma Drug Pipeline Analysis Report
Global Clinical Trials Market
Report Coverage
The Scleroderma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into scleroderma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for scleroderma. The scleroderma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The scleroderma 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 scleroderma 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 scleroderma.
Scleroderma Pipeline Outlook
Scleroderma is a rare autoimmune disorder that causes the hardening and tightening of the skin and connective tissues due to excess collagen production. It occurs when the immune system mistakenly attacks the body, leading to inflammation and fibrosis that may affect the skin, blood vessels, and internal organs. Scleroderma is classified into localized types (like morphea and linear, affecting skin) and systemic types (limited and diffuse, involving internal organs and skin).
Scleroderma treatment focuses on symptom relief, slowing disease progression, and preventing complications through immunosuppressants, anti-inflammatory drugs, and organ-specific therapies. In February 2024, Certa Therapeutics’ FT011 received fast-track designation from the United States Food and Drug Administration as a potential disease-modifying treatment for systemic sclerosis, showing significant clinical improvement in Phase II studies.
Scleroderma Epidemiology
The global epidemiological profile of scleroderma indicates incidence rates of 8 to 56 new cases per million persons annually, predominantly affecting female patients. A systematic review published in 2019 investigated systemic sclerosis (SSc) epidemiology studies conducted in Europe and the United States. In Europe, prevalence estimates range from 7.2 to 33.9 per 100,000 individuals, while North American rates vary from 13.5 to 44.3 per 100,000. Increasing incidence trends among older individuals highlight the evolving burden of the disease.
Scleroderma – Pipeline Therapeutic Assessment
This section of the report covers the analysis of scleroderma 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
- Small Molecules
- Monoclonal Antibodies
- Biologics
- Cell Therapies
- RNA-based Therapies
- Gene Therapies
- Others
- Oral
- Parenteral
- Others
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 II, with 40.74%, covers a major share of the total scleroderma clinical trials, highlighting robust clinical progress and growing therapeutic confidence. Phase I follows at 35.19%, reflecting strong early-stage research. Phase III holds 11.11%, indicating promising late-stage developments. Early Phase I accounts for 7.41%, and Phase IV holds 5.56%, ensuring post-marketing evaluation. This dynamic pipeline positively drives innovation in the scleroderma market.
Scleroderma Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the scleroderma pipeline analysis include small molecules, monoclonal antibodies, biologics, cell therapies, RNA-based therapies, gene therapies, and others. The scleroderma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for scleroderma.
Chimeric antigen receptor (CAR) T cell therapies are emerging as promising immune-based treatments for scleroderma. For example, KYV-101, a fully human anti-CD19 CAR T cell therapy, is under investigation in a phase 1/2 trial for diffuse cutaneous systemic sclerosis. It aims to achieve deep B-cell depletion, potentially resetting the immune system and reducing disease activity.
Scleroderma Clinical Trials – Key Players
The EMR report for the scleroderma pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed scleroderma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in scleroderma clinical trials:
- Novartis Pharmaceuticals
- AstraZeneca
- Biocad
- Paracrine, Inc.
- Boehringer Ingelheim
- Cabaletta Bio
- Zura Bio Inc.
- Kyverna Therapeutics
- Argenx SE
- Genentech, Inc.
- Merck Sharp & Dohme LLC
- Cumberland Pharmaceuticals
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 scleroderma. It includes product description, trial ID, study type, drug class, mode of administration, and the recruitment status of scleroderma drug candidates.
Drug: Divozilimab
Divozilimab is a monoclonal antibody targeting CD20, developed by Biocad CJSC. It is a part of a Phase III trial that is evaluating its efficacy and safety in patients with active systemic scleroderma. The study is enrolling adults meeting ACR/EULAR 2013 criteria. The drug works through antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC), aiming to reduce immune cell activity and improve skin and lung function.
Biological: Tibulizumab
Tibulizumab, sponsored by Zura Bio Inc., is undergoing Phase II clinical development. The study is assessing the efficacy, safety, and tolerability of Tibulizumab in adults with systemic sclerosis. Tibulizumab is a humanized, tetravalent bispecific antibody targeting IL-17A and BAFF, aiming to reduce inflammation and fibrosis in systemic sclerosis patients.
Biological: CABA-201
CABA-201 is a fully human CD19-CAR T cell therapy sponsored by Cabaletta Bio. The Phase 1/2 study, RESET-SSc, is currently evaluating its safety and efficacy in patients with systemic sclerosis. This investigational drug is being administered as a single dose, combined with cyclophosphamide and fludarabine, aiming to target B cells responsible for autoimmunity and tissue fibrosis.
Key Questions Answered in the Scleroderma Pipeline Insight Report
- Which companies/institutions are leading the scleroderma drug development?
- What is the efficacy and safety profile of scleroderma pipeline drugs?
- Which company is leading the scleroderma pipeline development activities?
- What is the current scleroderma commercial assessment?
- What are the opportunities and challenges present in the scleroderma pipeline landscape?
- What is the efficacy and safety profile of scleroderma pipeline drugs?
- Which company is conducting major trials for scleroderma drugs?
- Which companies/institutions are involved in scleroderma collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in scleroderma?
The Scleroderma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for scleroderma. 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 scleroderma collaborations, regulatory environments, and potential growth opportunities.
Related Reports
Global Scleroderma Therapeutics Market Report and Forecast
Systemic Scleroderma Drug Pipeline Analysis Report
Global Clinical Trials Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Scleroderma
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Scleroderma
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Scleroderma: Epidemiology Snapshot
- 5.1 Scleroderma Incidence by Key Markets
- 5.2 Scleroderma – Patients Seeking Treatment in Key Markets
- 6 Scleroderma: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Scleroderma: 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 Scleroderma, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Scleroderma 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 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Scleroderma 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: Divozilimab
- 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: MT-0551
- 10.2.3 Drug: KHK4827
- 10.2.4 Other Drugs
- 11 Scleroderma 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 Drug: Avenciguat (BI 685509)
- 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 Biological: Tibulizumab
- 11.2.3 Biological: CABA-201
- 11.2.4 Biological: KYV-101
- 11.2.5 Other Drugs
- 12 Scleroderma 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: RO7303509
- 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 Drug: MK-2225
- 12.2.3 Other Drugs
- 13 Scleroderma 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 Scleroderma, Key Drug Pipeline Companies
- 14.1 Novartis Pharmaceuticals
- 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 AstraZeneca
- 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 Biocad
- 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 Paracrine, Inc.
- 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 Boehringer Ingelheim
- 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 Cabaletta Bio
- 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 Zura Bio Inc.
- 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 Kyverna Therapeutics
- 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 Argenx SE
- 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 Genentech, Inc.
- 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 Merck Sharp & Dohme LLC
- 14.11.1 Company Snapshot
- 14.11.2 Pipeline Product Portfolio
- 14.11.3 Financial Analysis
- 14.11.4 Recent News and Developments
- 14.12 Cumberland Pharmaceuticals
- 14.12.1 Company Snapshot
- 14.12.2 Pipeline Product Portfolio
- 14.12.3 Financial Analysis
- 14.12.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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