Groowe Groowe BETA / Newsroom
⏱ News is delayed by 15 minutes. Sign in for real-time access. Sign in

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

prnewswire.com
BIIB Biogen is advancing litifilimab in Phase III trials for SLE, with positive funding agreements and accelerated data readouts. However, the drug is still investigational and results are pending. RPRX Royalty Pharma has a funding agreement with Biogen for the development of litifilimab, an investigational SLE therapy. Their involvement is tied to the success of this drug. UCB UCB is collaborating with Biogen on dapirolizumab pegol, an investigational therapy for SLE. The company's involvement is contingent on the drug's development progress. VTRS Viatris has expanded commercialization rights for cenerimod, an investigational SLE therapy, under a revised agreement with Idorsia Pharmaceuticals. Their success is linked to the drug's future market performance. NVS Novartis is developing ianalumab for SLE, with Phase III trials ongoing. Topline results are expected in 2027, and a regulatory submission is planned for 2028, indicating a long development timeline. KZR Kyowa Kirin is mentioned as developing KK-4277, an emerging therapy for SLE. No specific details on its stage or progress are provided, making sentiment assessment difficult. GSK GlaxoSmithKline's BENLYSTA is one of only two FDA-approved therapies for SLE. While established, the article focuses more on emerging treatments, suggesting a stable but not rapidly growing position. AZN AstraZeneca's SAPHNELO is another approved SLE therapy. Similar to GSK, its current market position is noted, but the article emphasizes the potential of new entrants. ABBV AbbVie's RINVOQ (upadacitinib) showed meaningful activity and steroid-sparing benefits in Phase 2 SLE trials, leading to advancement into Phase 3. Positive durability and safety data support a bullish outlook. BMY Bristol Myers Squibb is developing deucravacitinib, an oral small molecule targeting multiple immune pathways in SLE. Its development is part of a broader trend towards oral multi-pathway immune modulation. JNJ Johnson & Johnson's nipocalimab has received Fast Track Designation from the FDA for SLE treatment, indicating significant potential for this investigational therapy.

Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market.

LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life.

The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies.

While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options.

Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ https://www.delveinsight.com/report-store/systemic-lupus-erythematosus-market

The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity.

Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment.

In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions.

As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring.

Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036.

Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market.

Biogen and Royalty Pharma's Litifilimab

CLEC4C protein inhibitors

Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis.

Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program.

Roche's Obinutuzumab (GAZYVA/GAZYVARO)

TSLP inhibitor

Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO.

In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026.

Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size

Novartis' Ianalumab

BAFF-R inhibitor, ADCC-mediated B-cell depletor

Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2).

According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028.

Johnson & Johnson's Nipocalimab (IMAAVY)

FcRn blockade

Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus.

Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs

Idorsia Pharmaceuticals and Viatris' Cenerimod

Sphingosine 1-phosphate receptor modulators

Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE.

In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod.

AbbVie's RINVOQ (upadacitinib)

JAK 1 inhibitor

Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo.

AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported.

The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development.

Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials

Source: Systemic Lupus Erythematosus Market Report

Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others.

Related Reports

Systemic Lupus Erythematosus Clinical Trial Analysis

Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others.

JAK Inhibitors Market

JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others.

FcRn Inhibitors Market

FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others.

TSLP Inhibitors Market

TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others.

About DelveInsight

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. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve.

Contact Us

Shruti Thakur

[email protected]

+14699457679

www.delveinsight.com

SOURCE DelveInsight Business Research, LLP