DelveInsight’s, “Systemic Lupus Erythematosus Pipeline Insights 2026” 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 May 27, 2026- AstraZeneca conducted a phase 3 Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of IV Anifrolumab in Pediatric Participants 5 to < 18 Years of Age With Moderate to Severe Active Systemic Lupus Erythematosus While on Background Standard of Care Therapy.
• On May 15, 2026- UCB Biopharma SRL announced a study is to evaluate the ability of dapirolizumab pegol (DZP) as an add-on treatment to standard of care (SOC) medication to achieve clinically relevant long term improvement of moderate to severe disease activity.
• On May 14, 2026- Lakefront Biotherapeutics NV initiated a study evaluating the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GLPG3667 administered orally once daily for 48 weeks in approximately 180 adult participants with active Systemic Lupus Erythematosus (SLE).
• On May 14, 2026- Boehringer Ingelheim conducted a phase II study is open to adults with systemic lupus erythematosus (SLE). The purpose of this study is to find out whether a medicine called BI 3000202 helps people with SLE. The study tests different doses of BI 3000202 and aims to find the best dose for people with this condition.
• 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 AbbVie, Beijing InnoCare Pharma Tech Co., Ltd., Alumis Inc., Galapagos NV, Palleon Pharmaceuticals, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Amgen, Johnson & Johnson, Novartis, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO Pharma, Roche, Eisai, Vertex Pharmaceuticals, Kyverna Therapeutics, Miltenyi Biomedicine, AstraZeneca, Century Therapeutics, Daiichi Sankyo Company, Nanjing Immunophage Biotech, Cabaletta Bio, Ascentage Pharma, Excyte Biopharma, Sunshine Guojian Pharmaceutical, Sinocelltech, Otsuka Pharmaceutical, and GRI Bioand 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

According to the American College of Rheumatology, Systemic Lupus Erythematosus (SLE), or lupus, is a chronic autoimmune disease marked by systemic inflammation that can affect multiple organs, including the skin, joints, kidneys, lungs, heart, and brain, with symptoms such as fatigue, fever, and weight loss, and a course characterized by alternating periods of flare-ups and remission. Pathologically, SLE is defined by inflammation, vasculitis, immune complex deposition, and vasculopathy, with lupus nephritis representing a particularly severe complication that involves inflammation of renal microvasculature and contributes significantly to morbidity and mortality.

Systemic Lupus Erythematosus Emerging Drugs Profile

• Obinutuzumab: Roche

GAZYVA/GAZYVARO (obinutuzumab) injection, for IV use, is an engineered monoclonal antibody that targets a protein called CD20 on the surface of the lymphoma and leukemia cells. It binds to Type 2 CD20 antibodies. This allows obinutuzumab to have a much higher induction of antibody-dependent cytotoxicity and a higher direct cytotoxic effect than the classic CD20 antibodies. Upon binding to CD20, it mediates B-cell lysis through the engagement of immune effector cells by directly activating intracellular death signaling pathways and/or activation of the complement cascade. GAZYVA is marketed as GAZYVARO in Europe. Currently, the drug is registered for the treatment of Systemic Lupus Erythematosus.

• BIIB-059: Biogen

BIIB059, discovered and developed exclusively by Biogen, is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) and is being investigated for the potential treatment of SLE. BDCA2 is a receptor that is exclusively expressed on a subset of human immune cells called Plasmacytoid Dendritic Cells (pDCs), and it has been shown to reduce inflammatory cytokine production from pDCs, including type-I IFN (IFN-I). Inflammatory mediators are thought to play a major role in the pathogenesis of lupus. The drug has successfully completed Phase II and is currently in Phase III for SLE.

• Ianalumab: Novartis Pharmaceuticals

Ianalumab is a subcutaneously administered fully human HuCAL antibody that targets BAFF-R and is being investigated by Novartis for the treatment of autoimmune hepatitis, idiopathic pulmonary fibrosis, SLE, and lupus nephritis. It is an anti-BAFF receptor, fully human monoclonal antibody engineered for direct ADCC-mediated B-cell depletion. The drug is currently in Phase III stage of its clinical development for the treatment of SLE.

• Nipocalimab: Johnson & Johnson

Nipocalimab (M281) is a high affinity, fully human, aglycosylated, effectorless IgG1 anti-FcRn monoclonal antibody. In patients with gMG, nipocalimab is expected to improve nerve-to-muscle signals and muscle function, thus alleviating the clinical signs and symptoms of gMG. The drug is currently in phase III stage of development for the treatment of Systemic Lupus Erythematosus.

• SAR441344: Sanofi

Frexalimab (SAR441344) is an anti-CD40L mAb being developed in collaboration with ImmuNext. Frexalimab targets the CD40–CD40L pathway, a key regulator of immune system activation. It is designed to modulate T-cell and B-cell interactions without broadly suppressing the immune system. By inhibiting this pathway, frexalimab aims to reduce inflammation and autoimmune activity. The drug is being explored for the treatment of autoimmune diseases such as systemic lupus erythematosus (SLE). Currently, the drug is in Phase II for the treatment of Systemic Lupus Erythematosus.

• VIS171: Otsuka Pharmaceuticals

VIS171 is a modified interleukin-2 (mIL-2) molecule engineered to selectively activate and expand regulatory T cells (Tregs). It is currently in Phase I clinical development, with trials aimed at evaluating its safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects and those with autoimmune diseases including SLE.

• AB-101: Artiva Biotherapeutics

AB-101, also known as AlloNK, is an innovative therapy currently under investigation for treating lupus nephritis, a severe kidney complication associated with systemic lupus erythematosus (SLE). This therapy utilizes allogeneic natural killer (NK) cells, which are a type of immune cell that can enhance the effectiveness of monoclonal antibody treatments. Currently, the drug is in the Phase I stage of its development for the treatment of Systemic Lupus Erythematosus.

• GRI-0803: GRI Bio

GRI-0803 is an investigational small-molecule therapy developed by GRI Bio for the treatment of Systemic Lupus Erythematosus (SLE), currently in preclinical to early clinical development. It is designed as an oral activator of type 2 natural killer T (NKT) cells, which helps modulate immune responses by suppressing pro-inflammatory pathways, reducing cytokines (such as IL-6 and IL-17), and decreasing autoantibody production. In preclinical lupus models, GRI-0803 has demonstrated inhibition of lupus nephritis, reduction in proteinuria and renal inflammation, and improved survival outcomes. The drug is aimed at targeting upstream immune dysregulation to slow disease progression rather than simply controlling symptoms, positioning it as a potential disease-modifying therapy in SLE. Currently, the drug is in Preclinical Stage of its development for the treatment of 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

AbbVie, Beijing InnoCare Pharma Tech Co., Ltd., Alumis Inc., Galapagos NV, Palleon Pharmaceuticals, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Amgen, Johnson & Johnson, Novartis, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO Pharma, Roche, Eisai, Vertex Pharmaceuticals, Kyverna Therapeutics, Miltenyi Biomedicine, AstraZeneca, Century Therapeutics, Daiichi Sankyo Company, Nanjing Immunophage Biotech, Cabaletta Bio, Ascentage Pharma, Excyte Biopharma, Sunshine Guojian Pharmaceutical, Sinocelltech, Otsuka Pharmaceutical, and GRI Bioand 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

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Table of Contents

1. Introduction
2. Executive Summary
3. Systemic Lupus Erythematosus: Overview
4. Pipeline Therapeutics
5. Therapeutic Assessment
6. Systemic Lupus Erythematosus – DelveInsight’s Analytical Perspective
7. Late Stage Products (Phase III)
8. BIIB059: Biogen
9. Drug profiles in the detailed report…..
10. Mid Stage Products (Phase II)
11. ABBV 599: AbbVie
12. Drug profiles in the detailed report…..
13. Early Stage Products (Phase I)
14. Mosunetuzumab: Roche
15. Drug profiles in the detailed report…..
16. Preclinical and Discovery Stage Products
17. Drug name: Company name
18. Drug profiles in the detailed report…..
19. Inactive Products
20. Systemic Lupus Erythematosus – Collaborations Assessment- Licensing / Partnering / Funding
21. Systemic Lupus Erythematosus – Unmet Needs
22. Systemic Lupus Erythematosus – Market Drivers and Barriers
23. Appendix

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