Systemic scleroderma, also known as systemic sclerosis, refers to a rare autoimmune disorder that causes abnormal production and accumulation of collagen in the body. Studies show that around 1 in 10,000 people are affected with the disease, with a higher prevalence in women than in men. The increasing number of diagnosed cases is fuelling the demand for innovative systemic scleroderma drugs as well as accelerating pipeline development. Additionally, increased funding from pharmaceutical companies and research organizations is anticipated to expedite the development of new systemic scleroderma drugs that can effectively combat the autoimmune disease.
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 systemic scleroderma.
Since there is no definitive cure, systemic scleroderma therapeutics focuses on symptom management, slowing disease progression, and improving quality of life. Drugs like methotrexate, mycophenolate mofetil, and cyclophosphamide are often taken to suppress immune activity. Antifibrotic agents such as Nintedanib are commonly prescribed for managing lung fibrosis. Additionally, the growing focus on combination therapies that can address multiple disease pathways, along with adherence to systemic scleroderma treatment guidelines, is likely to improve patient outcomes and support pipeline expansion in the coming years.
Systemic scleroderma occurs more commonly in women than in men, with a female-to-male ratio estimated as 5:1. Further, it is observed that patients with African ancestry experience a higher risk of developing systemic scleroderma.
Boehringer Ingelheim is conducting a Phase II placebo-controlled, parallel-group, 48 weeks study aimed at examining the efficacy and safety of systemic scleroderma drug candidate Avenciguat (BI 685509) for the treatment of systemic scleroderma in adults. The interventional study has enrolled about 188 patients and is expected to be completed by November 2025.
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Report Coverage
The Systemic Scleroderma Drug Pipeline Insight Report by the publisher gives comprehensive insights into systemic scleroderma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Systemic Scleroderma. The systemic scleroderma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The systemic 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 systemic 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 systemic scleroderma.
Systemic Scleroderma Drug Pipeline Outlook
Systemic scleroderma is characterized by excessive collagen production and can lead to fibrosis of the skin and internal organs. Although the condition primarily affects connective tissue, it can cause complications in organs such as the lungs, heart, kidneys, and gastrointestinal tract. Vascular abnormalities, such as Raynaud's phenomenon, and immune dysregulation are also observed in patients with systemic scleroderma.Since there is no definitive cure, systemic scleroderma therapeutics focuses on symptom management, slowing disease progression, and improving quality of life. Drugs like methotrexate, mycophenolate mofetil, and cyclophosphamide are often taken to suppress immune activity. Antifibrotic agents such as Nintedanib are commonly prescribed for managing lung fibrosis. Additionally, the growing focus on combination therapies that can address multiple disease pathways, along with adherence to systemic scleroderma treatment guidelines, is likely to improve patient outcomes and support pipeline expansion in the coming years.
Systemic Scleroderma Epidemiology
According to systemic scleroderma epidemiological studies, the prevalence rates range between 38 and 341 cases per million individuals, depending on factors such as geography, ascertainment methods, and case definition. On the other hand, the global incidence rates are reported to vary from 8 to 56 new cases per million people every year.Systemic scleroderma occurs more commonly in women than in men, with a female-to-male ratio estimated as 5:1. Further, it is observed that patients with African ancestry experience a higher risk of developing systemic scleroderma.
Systemic Scleroderma - Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of systemic 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
By Drug Class
- Small Molecules
- Biologic Therapies
- Gene Therapies
- Cell-based Therapies
- Peptides
- Combination Therapies
By Route of Administration
- Oral
- Parenteral
- Others
Systemic Scleroderma - 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 II covers a major share of the total clinical trials, with a substantial number of systemic scleroderma emerging drugs undergoing clinical development.Systemic Scleroderma - Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under systemic scleroderma pipeline analysis include small molecules, biologic therapies, gene therapies, cell-based therapies, peptides, and combination therapies. The systemic scleroderma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for systemic scleroderma.Systemic Scleroderma Clinical Trials Therapeutic Assessment - Competitive Dynamics
The report for the systemic scleroderma drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed systemic scleroderma therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in systemic scleroderma clinical trials:- GlaxoSmithKline
- Biocad
- Boehringer Ingelheim
- Cabaletta Bio
- Kyowa Kirin Co., Ltd.
- Jiangsu Renocell Biotech Company
Systemic Scleroderma - Emerging Drugs Profile
Major drugs currently in the drug pipeline are as follows:
Drug: Divozilimab
Sponsored by Biocad, the objective of this randomized, double-blinded, clinical trial is to investigate the efficacy and safety of divozilimab in systemic scleroderma patients. The study is under Phase III clinical development and has an estimated 152 participants.Drug: Avenciguat (BI 685509
)Boehringer Ingelheim is conducting a Phase II placebo-controlled, parallel-group, 48 weeks study aimed at examining the efficacy and safety of systemic scleroderma drug candidate Avenciguat (BI 685509) for the treatment of systemic scleroderma in adults. The interventional study has enrolled about 188 patients and is expected to be completed by November 2025.
Reasons To Buy This Report
The Systemic Scleroderma Pipeline Insights provides a strategic overview of the latest and future landscape of treatments for systemic 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 market trends, regulatory environments, and potential growth opportunities provided by systemic scleroderma drug report.Key Questions Answered in the Systemic Scleroderma - Pipeline Insight Report
- What is the current landscape of systemic scleroderma pipeline drugs?
- Which companies/institutions are developing systemic scleroderma therapeutic drugs?
- How many phase II drugs are currently present in systemic scleroderma pipeline drugs?
- Which company is leading the systemic scleroderma pipeline development activities?
- What is the current systemic scleroderma commercial assessment?
- What are the opportunities and challenges present in the systemic scleroderma drug pipeline landscape?
- What is the efficacy and safety profile of systemic scleroderma pipeline drugs?
- Which companies/institutions are involved in systemic scleroderma collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What geographies are covered for clinical trials in systemic scleroderma?
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Table of Contents
1 Preface
3 Overview of Systemic Scleroderma
4 Patient Profile: Systemic Scleroderma
5 Systemic Scleroderma: Epidemiology Snapshot
6 Systemic Scleroderma: Market Dynamics
7 Systemic Scleroderma: Key Facts Covered
8 Systemic Scleroderma, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Systemic Scleroderma Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Systemic Scleroderma Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Systemic Scleroderma Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Systemic Scleroderma Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Systemic Scleroderma, Key Drug Pipeline Companies
