DelveInsight’s, “Systemic Lupus Erythematosus Pipeline Insights 2025” report provides comprehensive insights about 120+ companies and 140+ pipeline drugs in Systemic Lupus Erythematosus pipeline landscape. It covers the Systemic Lupus Erythematosus pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Systemic Lupus Erythematosus pipeline therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.
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Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report
- On 28 October 2025, Bristol-Myers Squibb conducted a study is to evaluate the effectiveness and safety of deucravacitinib compared with placebo in an active moderate to severe Systemic Lupus Erythematosus (SLE) population.
- On 23 October 2025, Sanofi conducted a Phase 2, double-blind, 2 arm study evaluating the efficacy and safety of SAR441344 in comparison with placebo in the treatment of participants aged 18 to 70 years with active Systemic Lupus Erythematosus (SLE).
- On 23 October 2025, GlaxoSmithKline conducted a study is to evaluate the pharmacokinetics (PK), safety, and pharmacodynamics (PD) of repeat doses of 200 milligrams per milliliter (mg/mL) belimumab administered via SC injection in pediatric participants 5 to 17 years of age with SLE on a background of standard of care therapy. This bridging PK study is part of an extrapolation strategy to support the use of SC belimumab in pediatric SLE participants, based on the completed adult SLE study with SC belimumab and the pediatric SLE study with intravenous (IV) belimumab.
- On 23 October 2025, AstraZeneca organized a Phase 3 study to evaluate the efficacy and safety of a subcutaneous treatment regimen of anifrolumab versus placebo in participants with moderately to severely active, autoantibody-positive systemic lupus erythematosus (SLE) while receiving standard of care (SOC) treatment. Participants must be taking either 1 or any combination of the following: oral glucocorticoids, antimalarial, and/or immunosuppressants. The study will be performed in adult participants of 18 to 70 years of age.
- DelveInsight’s Systemic Lupus Erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for Systemic Lupus Erythematosus treatment.
- The leading Systemic Lupus Erythematosus Companies such as Biogen, Idorsia Pharmaceuticals, AbbVie, Biosenic, Roche, Eisai, Daiichi Sankyo Company, Carna Bioscience, Asahi Kasei Pharma, Sanofi, Alpine Immune Sciences, Novartis Pharmaceuticals, Sana Biotechnology and others.
- Promising Systemic Lupus Erythematosus Pipeline Therapies such as Obexelimab, Telitacicept, DS-7011a, Belimumab, Sirolimus, Ianalumab, Belimumab (GSK1550188), BMS-986165, JMKX000189, and others.
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Systemic Lupus Erythematosus Overview
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, including the skin, joints, kidneys, heart, and lungs. SLE results from the immune system attacking healthy tissue due to an inability to distinguish between the body’s cells and foreign pathogens. This process triggers widespread inflammation and can lead to significant morbidity, making SLE a highly variable and complex disease to diagnose, treat, and manage. The condition disproportionately affects women, particularly of childbearing age, and is more common in certain ethnic groups, including African Americans, Hispanics, and Asians, which indicates both hormonal and genetic factors may contribute to disease susceptibility.
Systemic Lupus Erythematosus Emerging Drugs Profile
- BIIB059: Biogen
BIIB059, also known as Litifilimab, is a humanized IgG1 monoclonal antibody developed by Biogen, targeting the blood dendritic cell antigen 2 (BDCA2). This antibody is primarily investigated for its therapeutic potential in treating systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), both of which are chronic autoimmune diseases. BIIB059 specifically binds to BDCA2, a receptor found exclusively on plasmacytoid dendritic cells (pDCs). By binding to this receptor, BIIB059 inhibits the production of type-I interferon (IFN-I) and other pro-inflammatory cytokines, which are implicated in the pathogenesis of lupus. This mechanism is crucial as pDCs are known to produce large amounts of IFN-I in response to immune stimuli, contributing to the inflammatory processes seen in lupus patients. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Systemic Lupus Erythematosus.
- Cenerimod: Idorsia Pharmaceuticals
Cenerimod, developed by Idorsia Pharmaceuticals, is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator that is being investigated primarily for the treatment of systemic lupus erythematosus (SLE). This novel oral medication aims to address the unmet medical needs in SLE, a chronic autoimmune disease characterized by significant morbidity and limited treatment options. Currently, the drug is in Phase III stage of its clinical trial for the treatment of Systemic Lupus Erythematosus.
- ABBV 599: AbbVie
ABBV-599, developed by AbbVie, is a novel fixed-dose combination therapy that combines two well-known agents: elsubrutinib, a Bruton’s tyrosine kinase (BTK) inhibitor, and upadacitinib, a Janus kinase (JAK) inhibitor. This combination is primarily being investigated for the treatment of autoimmune diseases, particularly systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). Currently, the drug is in the Phase II stage of development to treat Systemic Lupus Erythematosus.
- Arscimed: Biosenic
Arscimed, developed by BioSenic, is an innovative drug utilizing arsenic trioxide to target autoimmune diseases at the source of the immune cascade. This therapy is particularly focused on conditions such as chronic graft-versus-host disease (cGVHD), systemic lupus erythematosus (SLE), and systemic sclerosis. Currently, the drug is in the Phase II stage of development to treat Systemic Lupus Erythematosus.
- Mosunetuzumab: Roche
Mosunetuzumab, a bispecific antibody developed by Roche, is currently being evaluated for its potential use in treating systemic lupus erythematosus (SLE), a chronic autoimmune disease. This investigational therapy targets both CD20 on B cells and CD3 on T cells, aiming to enhance immune response against autoantibody-producing B cells. Currently, the drug is in the Phase I stage of development to treat Systemic Lupus Erythematosus.
The Systemic Lupus Erythematosus Pipeline Report Provides Insights into
- The report provides detailed insights about companies that are developing therapies for the treatment of Systemic Lupus Erythematosus with aggregate therapies developed by each company for the same.
- It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Systemic Lupus Erythematosus Treatment.
- Systemic Lupus Erythematosus Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
- Systemic Lupus Erythematosus 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.
- 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 Companies
Biogen, Idorsia Pharmaceuticals, AbbVie, Biosenic, Roche, Eisai, Daiichi Sankyo Company, Carna Bioscience, Asahi Kasei Pharma, Sanofi, Alpine Immune Sciences, Novartis Pharmaceuticals, Sana Biotechnology and others.
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
- Oral
- Intravenous
- Subcutaneous
- Parenteral
- Topical
Systemic Lupus Erythematosus Products have been categorized under various Molecule types such as
- Recombinant fusion proteins
- Small molecule
- Monoclonal antibody
- Peptide
- Polymer
- Gene therapy
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Scope of the Systemic Lupus Erythematosus Pipeline Report
- Coverage- Global
- Systemic Lupus Erythematosus Companies- Biogen, Idorsia Pharmaceuticals, AbbVie, Biosenic, Roche, Eisai, Daiichi Sankyo Company, Carna Bioscience, Asahi Kasei Pharma, Sanofi, Alpine Immune Sciences, Novartis Pharmaceuticals, Sana Biotechnology and others.
- Systemic Lupus Erythematosus Pipeline Therapies- Obexelimab, Telitacicept, DS-7011a, Belimumab, Sirolimus, Ianalumab, Belimumab (GSK1550188), BMS-986165, JMKX000189, and others.
- Systemic Lupus Erythematosus Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
- Systemic Lupus Erythematosus Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III
Find out in DelveInsight’s exclusive Systemic Lupus Erythematosus Pipeline Report—access it now! @ Systemic Lupus Erythematosus Emerging Drugs and Major Companies
Table of Contents
- Introduction
- Executive Summary
- Systemic Lupus Erythematosus: Overview
- Pipeline Therapeutics
- Therapeutic Assessment
- Systemic Lupus Erythematosus – DelveInsight’s Analytical Perspective
- Late Stage Products (Phase III)
- BIIB059: Biogen
- Drug profiles in the detailed report…..
- Mid Stage Products (Phase II)
- ABBV 599: AbbVie
- Drug profiles in the detailed report…..
- Early Stage Products (Phase I)
- Mosunetuzumab: Roche
- Drug profiles in the detailed report…..
- Preclinical and Discovery Stage Products
- Drug name: Company name
- Drug profiles in the detailed report…..
- Inactive Products
- Systemic Lupus Erythematosus – Collaborations Assessment- Licensing / Partnering / Funding
- Systemic Lupus Erythematosus – Unmet Needs
- Systemic Lupus Erythematosus – Market Drivers and Barriers
- Appendix
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