Every May 10, the global lupus community unites to raise awareness for a disease that often goes unseen, both biologically and socially. The theme of World Lupus Day 2025, “Let’s Make Lupus Visible Together,” highlights the need to shine a light on symptoms, patient experiences and scientific progress.
The Hidden Toll of Lupus Nephritis and Beyond
Lupus is a chronic autoimmune disease in which the immune system attacks healthy tissue, affecting organs from the kidneys and skin to the brain and heart. An estimated 1.5 million people in the US and 5 million worldwide live with lupus, and 90% of cases occur in women aged 15 to 44 years.
A Lupus Foundation of America survey found 53% of US adults know little or nothing about lupus. Many are unaware that it can be life-threatening, often begins in childhood or relies on treatments adapted from cancer and malaria care. Delayed diagnosis remains a major barrier to effective treatment.
Lupus nephritis — kidney inflammation driven by the disease — affects 47% of US patients, yet over 50% lack awareness of warning signs or when to seek testing, with 43% having poor knowledge of lupus nephritis.
Beyond organ damage, fatigue tops the symptom list for more than 80% of patients, while anxiety and depression impact over 85%. Annual costs can exceed $50,000 per person in the US, fueled by misdiagnoses, hospitalizations and lost productivity.
XTALKS WEBINAR: Shaping the Future of Rheumatology Trials: Operational Strategies, Industry Trends and Breakthroughs in Cell and Gene Therapies
Live and On-Demand: Friday, May 30, 2025, at 10am EDT (4pm CEST/EU-Central)
Register for this free webinar to learn about recent cell and gene therapy advances in rheumatology. Attendees will also gain insight into operational strategies to navigate the challenges of conducting rheumatology studies.
Spotlight on New Lupus Drugs in Development (2024 to 2025)
Let’s take a look at some of the innovations and trends that have been taking place across the lupus clinical research landscape.
CAR T-Cell Therapy Advances into Autoimmune Disease Treatment
CAR T-cell therapy is emerging as a potential treatment for severe lupus. In the UK and Germany, patients treated with obecabtagene autoleucel showed signs of remission (though long-term studies are being evaluated), with reduced swelling, improved energy and no ongoing medication. Sponsored by Autolus, the trial will follow participants for 15 years.
In the US, Allogene Therapeutics received FDA investigational new drug (IND) clearance in January 2025 to study ALLO-329, an allogeneic CAR-T therapy for systemic lupus erythematosus (SLE). Adicet Bio also secured Fast Track designation for ADI-100, a gamma delta T-cell therapy targeting extrarenal lupus manifestations.
The Potential of Obinutuzumab for Lupus Nephritis
The Phase III REGENCY trial demonstrated that obinutuzumab, an anti-CD20 antibody, improved kidney response versus standard of care. Although FDA approval is pending, the 2025 ACR guidelines recommend Benlysta (belimumab) and Lupkynis (voclosporin) first-line, positioning obinutuzumab as an option for refractory or complex cases once approved.
KPG-818: An Oral Option for Skin Disease
Kangpu Biopharma’s KPG-818, a small-molecule “molecular glue,” modulates immune signaling to address cutaneous lupus. Now in Phase IIb, it may offer a better-tolerated alternative to systemic immunosuppressants for chronic skin involvement.
Metabolic Modulation with Glucokinase Inhibitors
Conduit Pharmaceuticals and Charles River are exploring glucokinase inhibitors (AZD5658, AZD1656) to rebalance immune regulation via cellular metabolism. Preclinical lupus studies are underway, and a Phase II trial of AZD1656 for lupus nephritis and vasculitis is being planned.
More Lupus Therapies in Development
The lupus treatment landscape is expanding rapidly, with more than a dozen therapies in late-stage trials targeting both systemic and cutaneous manifestations.
The global SLE market was valued at $2.83 billion in 2023 and is projected to reach $6.19 billion by 2034 with a 7.4% compound annual growth rate (CAGR).
With pediatric approvals, oral therapies and cell-based approaches advancing, the field is moving toward earlier, more targeted interventions.
Here are some more early-to-late-stage pipeline highlights in lupus:
- Cenerimod (Idorsia/Viatris): S1P1 receptor modulator in Phase III for systemic lupus.
- Litifilimab (Biogen): BDCA2-targeting antibody in Phase III for SLE.
- Lanalumab (Novartis/MorphoSys): BAFF-R inhibitor entering Phase III.
- Daxdilimab (Amgen): Anti-ILT7 antibody in Phase II for discoid lupus.
- Blinatumomab (Amgen): CD19-directed BiTE molecule in Phase II for SLE.
- Upadacitinib (Rinvoq, AbbVie): A selective JAK1 inhibitor currently in Phase III trials for SLE (specifically the SELECT-SLE and SELECT-DERM studies).
- LK-SC001 (LiveKidney): UC-MSC-based injectable therapy in Phase I/IIa for lupus nephritis, aimed at improving kidney function — now enrolling in the US.
As autoimmune R&D intensifies, these therapies could move the field beyond symptom control toward targeted, durable remission and improved quality of life.
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