According to DelveInsight, the Systemic Lupus Erythematosus (SLE) pipeline involves over 120 major companies actively engaged in developing more than 140 therapeutic options for the treatment of SLE.
Systemic Lupus Erythematosus Overview:
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disorder in which the immune system erroneously attacks healthy tissues, leading to inflammation and damage across multiple organs, including the skin, joints, kidneys, heart, and lungs. This occurs because the immune system cannot distinguish between the body’s own cells and foreign invaders, resulting in persistent inflammation and potentially serious health complications. SLE is highly variable among individuals, making both diagnosis and treatment complex. The condition primarily affects women, particularly those of reproductive age, and is more common in certain ethnic groups—such as African Americans, Hispanics, and Asians—indicating that genetic and hormonal factors play a significant role in susceptibility.
The onset of SLE is influenced by a combination of genetic, environmental, and immune-related factors. Certain genetic variants associated with immune function and inflammatory responses increase the risk of developing the disease. Environmental triggers—including UV exposure, infections, specific medications, and stress—can initiate or exacerbate symptoms in genetically predisposed individuals. Immunologically, SLE is characterized by the presence of autoantibodies, particularly antinuclear antibodies (ANAs) and anti-double-stranded DNA (dsDNA) antibodies, which mistakenly attack the body’s own DNA. These autoantibodies form immune complexes that accumulate in tissues, causing inflammation and contributing to the widespread systemic effects of the disease.
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“Systemic Lupus Erythematosus Pipeline Insight 2025” report by DelveInsight provides a comprehensive analysis of the ongoing clinical development activities and growth prospects across the Systemic Lupus Erythematosus Therapeutics Market.
Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report
DelveInsight’s Systemic Lupus Erythematosus (SLE) pipeline report highlights a dynamic landscape, featuring over 120 active companies developing more than 140 therapeutic candidates for SLE.
Prominent companies such as Biogen, Idorsia Pharmaceuticals, AbbVie, Biosenic, Roche, Eisai, Daiichi Sankyo, Carna Bioscience, Asahi Kasei Pharma, Sanofi, Alpine Immune Sciences, Novartis, Sana Biotechnology, and others are actively evaluating novel therapies to enhance the SLE treatment landscape. Key pipeline candidates in various stages of development include BIIB059, Cenerimod, ABBV 599, Arscimed, Mosunetuzumab, and others.
Notable recent developments include:
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February 2025: The FDA granted Fast Track Designation to Adicet Bio’s ADI-001, an allogeneic gamma delta CAR T-cell therapy for adults with refractory SLE with extrarenal involvement. This designation aims to accelerate development and review of therapies addressing unmet medical needs. Adicet Bio plans to start a Phase 1 clinical trial in lupus nephritis and expand their autoimmune program to additional indications.
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September 2024: Caribou Biosciences received FDA Fast Track Designation for CB-010, an allogeneic anti-CD19 CAR T-cell therapy targeting B cells in treatment-resistant SLE patients, with a Phase 1 trial planned to assess safety and efficacy.
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June 2024: Cabaletta Bio reported encouraging initial results from the first two patients treated with CABA-201 in their Phase 1/2 RESET-Myositis and RESET-SLE trials. This fully human CD19-CAR T-cell therapy aims to deplete CD19-positive B cells and reset the immune system, potentially offering long-term remission without chronic therapy. The treatment was well-tolerated, with no serious adverse events, and demonstrated significant improvements in clinical markers.
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February 2024: The FDA granted Fast Track Designation to Artiva Biotherapeutics’ AlloNK, an experimental natural killer (NK) cell therapy for lupus nephritis in combination with rituximab or obinutuzumab. AlloNK is designed to enhance antibody-dependent cellular cytotoxicity to improve outcomes in patients with limited treatment options.
Systemic Lupus Erythematosus Pipeline Analysis
The report provides insights into:
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The report provides detailed insights into the key companies that are developing therapies in the Systemic Lupus Erythematosus Market.
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The report also evaluates different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Systemic Lupus Erythematosus treatment.
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It analyzes the key companies involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
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It navigates the emerging drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
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Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement, and financing details for future advancement of the Systemic Lupus Erythematosus market.
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Systemic Lupus Erythematosus Emerging Drugs
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BIIB059: Biogen
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Cenerimod: Idorsia Pharmaceuticals
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ABBV 599: AbbVie
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Arscimed: Biosenic
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Mosunetuzumab: Roche
Systemic Lupus Erythematosus Companies
More than 120 leading companies are actively working on developing therapies for Systemic Lupus Erythematosus (SLE). Notably, Biogen and Idorsia Pharmaceuticals have drug candidates that have reached the most advanced stage of clinical testing, currently in Phase III trials.
DelveInsight’s report covers around 140+ products under different phases of clinical development like
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Late stage products (Phase III)
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Mid-stage products (Phase II)
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Early-stage product (Phase I) along with the details of
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Pre-clinical and Discovery stage candidates
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Discontinued & Inactive candidates
Systemic Lupus Erythematosus pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as
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Intravenous
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Subcutaneous
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Oral
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Intramuscular
Systemic Lupus Erythematosus Products have been categorized under various Molecule types such as
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Monoclonal antibody
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Small molecule
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Peptide
Download Sample Pages to Get an in-depth Assessment of the Emerging Systemic Lupus Erythematosus Therapies and Key Companies: Systemic Lupus Erythematosus Clinical Trials and advancements
Systemic Lupus Erythematosus Pipeline Therapeutic Assessment
• Systemic Lupus Erythematosus Assessment by Product Type
• Systemic Lupus Erythematosus By Stage
• Systemic Lupus Erythematosus Assessment by Route of Administration
• Systemic Lupus Erythematosus Assessment by Molecule Type
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Table of Content
1. Report Introduction
2. Executive Summary
3. Systemic Lupus Erythematosus Current Treatment Patterns
4. Systemic Lupus Erythematosus – DelveInsight’s Analytical Perspective
5. Therapeutic Assessment
6. Systemic Lupus Erythematosus Late-Stage Products (Phase-III)
7. Systemic Lupus Erythematosus Mid-Stage Products (Phase-II)
8. Early Stage Products (Phase-I)
9. Pre-clinical Products and Discovery Stage Products
10. Inactive Products
11. Dormant Products
12. Systemic Lupus Erythematosus Discontinued Products
13. Systemic Lupus Erythematosus Product Profiles
14. Systemic Lupus Erythematosus Key Companies
15. Systemic Lupus Erythematosus Key Products
16. Dormant and Discontinued Products
17. Systemic Lupus Erythematosus Unmet Needs
18. Systemic Lupus Erythematosus Future Perspectives
19. Systemic Lupus Erythematosus Analyst Review
20. Appendix
21. Report Methodology
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DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.
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