Systemic Lupus Erythematosus Pipeline

DelveInsight’s, “Systemic Lupus Erythematosus (SLE) - Pipeline Insight, 2025” report provides comprehensive insights about 120+ companies and 140+ pipeline drugs in Systemic Lupus Erythematosus (SLE) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

 

Geography Covered

• Global coverage

 

Systemic Lupus Erythematosus (SLE): Understanding

Systemic Lupus Erythematosus (SLE): Overview

Systemic Lupus Erythematosus (SLE or lupus) is a chronic autoimmune disease characterized by systemic inflammation that can affect multiple organs, including the skin, joints, kidneys, lungs, heart, and brain. Common symptoms include fatigue, fever, weight loss, joint pain, muscle weakness, and malaise, with disease activity fluctuating between flares and periods of remission. Lupus nephritis, resulting from inflammation of kidney blood vessels, is a major cause of morbidity and mortality. SLE predominantly affects women of reproductive age, though onset after 40 years is increasingly recognized, particularly in Europeans. Disease progression involves immune dysregulation, including polyclonal B-cell activation, abnormal memory B-cell subsets, and T-cell defects, contributing to organ infiltration and tissue damage. Cytokines such as BLyS, IL-6, IL-17, IL-18, type I interferons, and TNFα play key roles in inflammation and represent potential therapeutic targets, highlighting ongoing advances in understanding and managing this complex disease.

Systemic Lupus Erythematosus (SLE) is an autoimmune disease in which the immune system attacks healthy tissues, likely arising from a combination of genetic susceptibility and environmental triggers. Potential triggers include sunlight, infections, and certain medications such as procainamide, hydralazine, minocycline, phenytoin, and isoniazid, which can induce drug-related lupus that often resolves upon discontinuation. Genetic factors play a significant role: first-degree relatives and identical twins of affected individuals have a substantially higher risk of developing the disease. Women, particularly between ages 15 and 44, are more frequently affected, and SLE is more prevalent and often more severe in people of color, including African Americans, Hispanics/Latinos, Asian Americans, Native Americans, Native Hawaiians, and Pacific Islanders. Family history further increases risk, though most children of affected mothers do not develop the disease.

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with highly variable manifestations, ranging from mild to severe, characterized by periods of flares and remissions. Common symptoms include fatigue, fever, joint pain or swelling, skin rashes, mouth sores, hair loss, and, in some cases, involvement of the heart, lungs, kidneys, blood, or nervous system. Childhood-onset SLE more frequently presents with malar rash, mucocutaneous ulcers, renal issues such as proteinuria and urinary casts, seizures, thrombocytopenia, hemolytic anemia, fever, and lymphadenopathy, whereas adults more commonly exhibit Raynaud’s phenomenon, pleuritis, and sicca. The classic triad of fever, joint pain, and rash in women of childbearing age often signals the need to investigate SLE.

Systemic Lupus Erythematosus (SLE) is a chronic, multifactorial autoimmune disease in which genetic, environmental, and hormonal factors trigger immune dysregulation, loss of self-tolerance, and autoantibody production, leading to systemic inflammation and organ damage. Genetic susceptibility involves multiple loci, including TREX1, DNASE1L3, ATG5, IRF5/7, STAT4, and TLRs, affecting apoptosis, nucleic acid sensing, and type I interferon responses. Aberrant T- and B-cell signaling—characterized by hyperactive B cells, defective T-cell cytokine production, and altered gene regulation—drives inflammation and autoantibody formation, while innate immune dysfunction, including defective neutrophils, monocytes, and dendritic cells, contributes to impaired clearance of apoptotic debris and excessive cytokine production. Cytokines such as IL-6, IL-17, IL-21, IL-23, and type I interferons perpetuate inflammation and autoimmunity. Despite advances, biologics have shown limited efficacy due to disease heterogeneity, highlighting the need for early diagnosis using emerging biomarkers like NGAL, MCP-1, TWEAK, IL-6, IL-17, and type I/II interferons, which may guide timely intervention and improve patient outcomes.

Systemic Lupus Erythematosus (SLE) is a multisystem inflammatory disease with highly variable presentations, affecting the skin, joints, kidneys, lungs, CNS, and hematopoietic system, making diagnosis challenging and often delayed. Diagnosis relies on a combination of clinical features such as fatigue, fever, rash, and joint pain and laboratory criteria, including ANA, anti-dsDNA, complement levels, and specific autoantibodies (e.g., anti-Sm, anti-RNP, anti-SSA/SSB). Differential diagnosis is crucial to exclude conditions with overlapping symptoms, such as rheumatoid arthritis, Sjögren’s syndrome, infectious diseases, and other connective tissue disorders. The 2012 SLICC criteria enhance sensitivity by combining clinical and immunologic findings, while the ACR criteria remain the diagnostic standard. Comprehensive evaluation may include blood tests, urinalysis, imaging, and tissue biopsies, with assessment of APLAs, liver and renal function, and other biomarkers to guide diagnosis, monitor disease activity, and inform treatment decisions.

SLE has no cure, and treatment aims to control symptoms, prevent flares, and protect organs. Mild disease is managed with NSAIDs and antimalarials, while glucocorticoids and immunosuppressants (methotrexate, azathioprine, cyclophosphamide, mycophenolate) are used for moderate to severe organ involvement. Biologics like belimumab and rituximab target B-cell activity. Therapy is tailored to organ systems, with ongoing monitoring for toxicity, flares, and steroid-related side effects, combined with lifestyle measures and patient education.

 

"Systemic Lupus Erythematosus (SLE)- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Systemic Lupus Erythematosus (SLE) pipeline landscape is provided which includes the disease overview and Systemic Lupus Erythematosus (SLE) treatment guidelines. The assessment part of the report embraces, in depth Systemic Lupus Erythematosus (SLE) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Systemic Lupus Erythematosus (SLE) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

 

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Systemic Lupus Erythematosus (SLE) R&D. The therapies under development are focused on novel approaches to treat/improve Systemic Lupus Erythematosus (SLE).

 

Systemic Lupus Erythematosus (SLE) Emerging Drugs Chapters

This segment of the Systemic Lupus Erythematosus (SLE) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

 

Systemic Lupus Erythematosus (SLE) Emerging Drugs

• BIIB059: Biogen

BIIB059, exclusively discovered and developed by Biogen, is a humanized IgG1 monoclonal antibody targeting blood dendritic cell antigen 2 (BDCA2). It is under investigation for the treatment of SLE. BDCA2 is selectively expressed on plasmacytoid dendritic cells (pDCs) and its activation has been shown to suppress inflammatory cytokine production, including type I interferons, which are key contributors to lupus pathogenesis. Currently, the drug is in Phase III stage of its development for the treatment of Systemic Lupus Erythematosus.

 

• Cenerimod: Viatris Inc.

Cenerimod is an experimental medication designed as a highly selective modulator of the S1P1 receptor, administered orally once daily. It targets the underlying mechanisms of systemic lupus erythematosus (SLE) by modulating immune responses, specifically affecting lymphocyte activity, inflammation, and antigen transport. Offering a potentially innovative treatment option for SLE, a condition with limited therapies and a substantial burden on patients Cenerimod works by lowering levels of circulating and infiltrating lymphocytes, reducing both systemic and localized inflammation, and decreasing the presence of autoantibodies and the movement of auto-antigens to lymph nodes. This results in reduced T-cell activation and less secretion of proinflammatory cytokines, ultimately improving disease outcomes. Currently, the drug is in Phase III stage of its development for the treatment of Systemic lupus Erythematosus.

 

• MIL62: Beijing Mabworks Biotech Co., Ltd.

MIL62, developed by Beijing Mabworks Biotech, is a third-generation monoclonal antibody targeting CD20, designed to boost antibody-dependent cellular cytotoxicity (ADCC). It focuses on B cells to help regulate autoimmune responses in diseases such as systemic lupus erythematosus (SLE). With enhanced effectiveness compared to earlier CD20-targeted treatments, MIL62 presents a promising new approach for managing B cell-mediated disorders. The drug is currently in Phase II/III stage of its development for the treatment of Systemic Lupus Erythematosus.

 

• Obexelimab: Zenas Biopharma

Obexelimab is a promising first-in-class bifunctional antibody that binds to CD19 through its variable region and engages the FcγRIIb receptor using Xencor's XmAb® Immune Inhibitor Fc Domain. This receptor plays a key role in suppressing B-cell activity, a crucial part of the immune system. Early clinical studies by Xencor have shown that Obexelimab can effectively suppress B-cell function without destroying the cells, demonstrating encouraging therapeutic potential in patients with various autoimmune disorders. Currently, the drug is in Phase II stage of its clinical development for the treatment of SLE.

 

• ABBV 599: AbbVie

ABBV-599 is a combination therapy being developed for the treatment of systemic lupus erythematosus (SLE), consisting of ABBV-105, a Bruton’s tyrosine kinase (BTK) inhibitor, and ABT-494 (upadacitinib), a selective JAK1 inhibitor. Upadacitinib is an oral medication approved by the FDA in August 2019 for treating moderate to severe rheumatoid arthritis, active psoriatic arthritis, ankylosing spondylitis, severe atopic dermatitis, and ulcerative colitis, particularly in patients who have not responded well to other treatments. It was also approved by the European Commission in December 2019 and is marketed under the brand name RINVOQ. ABBV-105 is an irreversible BTK inhibitor with high kinome selectivity, showing strong activity in assays involving B-cell receptors, Fc receptors, and TLR-9 signaling pathways. Currently, the drug is in Phase II stage of its clinical development for the treatment of SLE.

 

• E6742: Eisai

E6742 is a potent and selective inhibitor of TLR7/8, developed by Eisai’s former Andover Research Laboratories in the U.S. Recent studies have identified TLR7/8, part of the Toll-like receptor (TLR) family, as being involved in the development of systemic lupus erythematosus (SLE), indicating that targeting these receptors could offer a new way to manage the disease. In preclinical studies, E6742 effectively and specifically reduced cytokine production triggered by TLR7/8 activation. Furthermore, in mouse models with SLE-like symptoms, E6742 demonstrated significant improvements in disease-related pathology. Currently, the drug is in Phase I/II stage of its clinical development for the treatment of SLE.

 

• VIS171: Otsuka Pharmaceutical

VIS171 is an engineered form of interleukin-2 (mIL-2) designed to specifically stimulate and promote the expansion of regulatory T cells (Tregs), which are essential for maintaining immune system balance and preventing autoimmune reactions. The drug is currently in Phase I clinical trials, where it is being assessed for its safety, tolerability, pharmacokinetic and pharmacodynamic properties, as well as its potential to trigger an immune response (immunogenicity). These early-stage studies involve both healthy participants and individuals with autoimmune conditions such as systemic lupus erythematosus (SLE).

 Further product details are provided in the report……..

 

Systemic Lupus Erythematosus (SLE): Therapeutic Assessment

This segment of the report provides insights about the different Systemic Lupus Erythematosus (SLE) drugs segregated based on following parameters that define the scope of the report, such as:

 

Major  Players in Systemic Lupus Erythematosus (SLE)

• There are approx. 120+ key companies which are developing the therapies for Systemic Lupus Erythematosus (SLE). The companies which have their Systemic Lupus Erythematosus (SLE) drug candidates in the most advanced stage, i.e. Phase III include, Biogen.

 

Phases

DelveInsight’s report covers around 140+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

 

Route of Administration

Systemic Lupus Erythematosus (SLE) 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

 

Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

 

Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

 

Systemic Lupus Erythematosus (SLE): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Systemic Lupus Erythematosus (SLE) therapeutic drugs key players involved in developing key drugs.

 

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Systemic Lupus Erythematosus (SLE) drugs.

 

Systemic Lupus Erythematosus (SLE) Report Insights

• Systemic Lupus Erythematosus (SLE) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

 

Systemic Lupus Erythematosus (SLE) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

 

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Systemic Lupus Erythematosus (SLE) drugs?
• How many Systemic Lupus Erythematosus (SLE) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Systemic Lupus Erythematosus (SLE)?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Systemic Lupus Erythematosus (SLE) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Systemic Lupus Erythematosus (SLE) and their status?
• What are the key designations that have been granted to the emerging drugs?