As a novel calcineurin inhibitor with proven efficacy in improving renal outcomes, LUPKYNIS addresses a high unmet medical need. With increasing awareness, supportive guidelines, and potential global expansion, it is well-positioned for steady market growth.
LAS VEGAS, May 8, 2025 /PRNewswire/ -- DelveInsight's "
LUPKYNIS Market Size, Forecast, and Market Insight Report" highlights the details around LUPKYNIS, the first oral lupus nephritis-specific treatment, which has expanded the therapeutic arsenal. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of LUPKYNIS. The report also highlights the historical and forecasted sales from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Aurinia Pharmaceuticals/Otsuka Pharmaceutical's LUPKYNIS (voclosporin) Overview
LUPKYNIS (voclosporin) is an oral immunosuppressant classified as a calcineurin inhibitor (CNI), shown to improve both short- and long-term outcomes in adult patients with active lupus nephritis when used alongside standard immunosuppressive therapies. By targeting calcineurin, LUPKYNIS helps suppress cytokine activity, inhibits interleukin-2 (IL-2) production, and reduces T-cell driven immune responses.
Although the exact mechanism by which voclosporin inhibits calcineurin is not fully understood, it is known that lymphocyte activation increases intracellular calcium, which binds to calcineurin's regulatory site. This activates the calmodulin-binding catalytic subunit, leading to dephosphorylation and activation of the transcription factor NFATc (nuclear factor of activated T-cells, cytoplasmic). The drug's immunosuppressive effect results in decreased lymphocyte proliferation, reduced cytokine production, and lower expression of T-cell activation markers.
The recommended initial dose of LUPKYNIS is 23.7 mg twice daily. It should be used in conjunction with mycophenolate mofetil (MMF) and corticosteroids.
Learn more about LUPKYNIS projected market size for lupus nephritis @
LUPKYNIS Market Potential
Lupus nephritis is a serious and potentially life-threatening complication of systemic lupus erythematosus (SLE), affecting
40–60% of those diagnosed with the disease. It is typically characterized by symptoms such as hematuria (blood in the urine) and proteinuria (protein in the urine). This condition is more prevalent in women, particularly between the ages of 20 and 40. In 2023, the United States recorded the highest number of lupus nephritis cases among the 7MM, with approximately
211K cases, a figure projected to grow by 2034.
Treatment strategies for lupus nephritis depend on the kidney biopsy classification of the disease. Standard therapy often includes corticosteroids in combination with immunosuppressive drugs like cyclophosphamide, mycophenolate mofetil, azathioprine, and calcineurin inhibitors. Rituximab, a monoclonal antibody, is widely used, especially for patients with relapsing or treatment-resistant LN, due to its ability to reduce reliance on steroids.
Currently, there are only two FDA-approved medications for lupus nephritis:
BENLYSTA (belimumab), available as an intravenous or subcutaneous formulation, and
LUPKYNIS (voclosporin), a novel oral calcineurin inhibitor.
Leading pharmaceutical companies such as
Novartis, AstraZeneca, Roche, and Kezar Life Sciences, among others, are actively developing innovative therapies that could redefine the treatment paradigm for lupus nephritis. The treatment landscape is rapidly evolving, shifting away from broad immunosuppression toward more precise, targeted approaches. Recent drug approvals and a strong pipeline of candidates highlight both advancements and the ongoing challenges in creating treatments that are effective, safe, and long-lasting.
Emerging therapies ranging from anti-CD20 antibodies and complement inhibitors to interferon-blocking agents and CAR-T cell therapies hold promise but must address key issues such as safety, sustained efficacy, and accessibility. As our understanding of the disease's underlying mechanisms continues to grow, the future of lupus nephritis treatment is expected to become increasingly personalized, offering renewed hope to patients battling this complex disorder.
Discover more about the lupus nephritis market in detail @
Lupus Nephritis Market Report
Emerging Competitors of LUPKYNIS
The developing pipeline for lupus nephritis treatments shows a growing variety of approaches. Multiple candidates, both in early and late stages of development, are underway, including
ianalumab (VAY736) (Novartis),
GAZYVA (obinutuzumab) (Roche),
SAPHNELO (anifrolumab) (AstraZeneca),
FABHALTA (iptacopan) (Novartis),
ULTOMIRIS (ravulizumab) (AstraZeneca), as well as advanced cellular therapies like
CABA-201 (Cabaletta Bio) and
YTB323 (Novartis).
In
March 2025, the FDA accepted a supplemental Biologics License Application based on data from the
Phase III REGENCY trial, where obinutuzumab demonstrated a 46.4% Complete Renal Response (CRR), compared to 33.1% for placebo. Unlike previous anti-CD20 therapies such as rituximab, it provides enhanced B-cell depletion and is the first in its class to show efficacy in a randomized Phase III lupus nephritis trial. If approved, it will become the first CD20-targeted treatment specifically indicated for lupus nephritis, with anticipated sales of
USD 400 million by 2034.
To know more about the number of competing drugs in development, visit @
LUPKYNIS Market Positioning Compared to Other Drugs
Key Milestones of LUPKYNIS
In
September 2024, Japan's Ministry of Health approved it for Lupus Nephritis treatment alongside mycophenolate mofetil.
In
September 2022, the European Commission approved LUPKYNIS for active Class III, IV, or V Lupus Nephritis.
In
January 2021, Aurinia Pharmaceuticals received US FDA approval for LUPKYNIS to treat adult lupus nephritis patients in combination with immunosuppressive therapy.
Discover how LUPKYNIS is shaping the lupus nephritis treatment landscape @
LUPKYNIS Lupus
LUPKYNIS Market Dynamics
LUPKYNIS, developed by Aurinia Pharmaceuticals, is the
first FDA-approved oral therapy specifically indicated for active lupus nephritis, a serious manifestation of systemic lupus erythematosus. Approved in January 2021 in the US, LUPKYNIS entered a
previously underserved market where treatment was largely dependent on off-label use of immunosuppressants like mycophenolate mofetil and corticosteroids. The drug represents a significant advancement in lupus nephritis care, offering both
improved efficacy and a better safety profile compared to existing options, especially in reducing proteinuria and preserving kidney function.
The market dynamics for LUPKYNIS are shaped by several key factors. On the positive side, there is a
strong unmet medical need, a growing prevalence of lupus nephritis, and
increasing physician awareness about early diagnosis and intervention. Moreover, LUPKYNIS benefits from a
relatively high pricing strategy, supported by its novel mechanism and disease-modifying potential. Aurinia has also built a
dedicated commercial infrastructure and patient support programs to drive uptake and adherence.
However, LUPKYNIS faces
competitive and reimbursement challenges. One of the main competitors is
BENLYSTA (belimumab) from GSK, which gained FDA approval for lupus nephritis in December 2020, just a month before LUPKYNIS. Benlysta has the advantage of brand recognition and a longer track record in treating systemic lupus. Additionally, payers have shown some hesitancy in approving LUPKYNIS due to its cost, requiring
extensive prior authorizations and documentation of clinical need. Patient compliance also remains an issue, given the need for frequent monitoring of kidney function and drug levels.
Looking ahead, the market potential for LUPKYNIS will depend on its
ability to expand its label,
demonstrate long-term real-world effectiveness, and
potentially enter international markets. Aurinia is also exploring lifecycle management strategies, including combination therapies and expanded indications.
Partnerships or acquisitions could further boost market access and penetration. Overall, while LUPKYNIS is a pioneering therapy with strong clinical value, its commercial success will be defined by navigating payer landscapes, physician adoption, and sustained differentiation from competing therapies.
Dive deeper to get more insight into LUPKYNIS's strengths & weaknesses relative to competitors @
LUPKYNIS Market Drug Report
Table of Contents
Related Reports
Lupus Nephritis Market
Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 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 lupus nephritis companies, including
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Lupus Nephritis Pipeline
Lupus Nephritis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including
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Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 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
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