CLINICAL TRIALS PROFILE FOR BENLYSTA

All Clinical Trials for BENLYSTA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01160666 ↗	Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome	Completed	Human Genome Sciences Inc.	Phase 2	2010-03-01	Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
NCT01160666 ↗	Efficacy and Safety of Belimumab in Subjects With Primary Sjögren's Syndrome	Completed	Assistance Publique - Hôpitaux de Paris	Phase 2	2010-03-01	Sjögren's syndrome (SS) is a systemic autoimmune disease characterized by an increase in BAFF (BLyS) levels and a resulting B cell hyperactivity. B cells are involved in the pathogenesis of SS in both systemic and glandular features, and B cell downregulation may lead to a decrease of disease activity. Moreover, pathogenesis of SS is closed to that of Systemic lupus erythematosus, where Belimumab has been proven to be effective.
NCT01532310 ↗	Belimumab (BENLYSTA®) Pregnancy Registry	Recruiting	PPD		2012-07-16	This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
NCT01532310 ↗	Belimumab (BENLYSTA®) Pregnancy Registry	Recruiting	GlaxoSmithKline		2012-07-16	This global Belimumab Pregnancy Registry will collect prospective data on pregnancies and pregnancy outcomes on a voluntary basis in women with systemic lupus erythematosus (SLE) who have received commercially supplied belimumab within the 4 months prior to and/or during pregnancy. The registry will also evaluate outcomes of infants born to mothers who were exposed to belimumab within the 4 months prior to and/or during pregnancy. This registry will add to the current clinical experience with belimumab and will complement reproductive data from animal toxicology studies. It will also assist clinicians in weighing the potential risks against the benefits of treatment for individual patients with SLE. GlaxoSmithKline (GSK) will sponsor the Belimumab Pregnancy Registry in countries where it holds Marketing Authorization.
NCT01670565 ↗	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Completed	Human Genome Sciences Inc.	Phase 2	2012-08-01	This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF.
NCT01670565 ↗	Belimumab for the Treatment of Diffuse Cutaneous Systemic Sclerosis	Completed	Hospital for Special Surgery, New York	Phase 2	2012-08-01	This is a 48 week, phase IIa, single center, randomized, double-blind, placebo-controlled, proof-of-concept pilot study. All participants will first be treated with mycophenolate mofetil (MMF, Cellcept) and titrated up to a dose of 2 grams/day. Following this period, half will be given either a belimumab (Benlysta®) or placebo intravenous infusion to treat early diffuse cutaneous systemic sclerosis. Belimumab/MMF is expected to improve disease activity measured by an improvement in skin thickening and stability of pulmonary function test measurements when compared to patients treated with placebo/MMF.

Clinical Trial Conditions for BENLYSTA

Condition Name

Condition Name for BENLYSTA
Intervention	Trials
Systemic Lupus Erythematosus	2
Systemic Sclerosis	2
Chronic Obstructive Pulmonary Disease	1
Renal Transplant Rejection	1

Condition MeSH

Condition MeSH for BENLYSTA
Intervention	Trials
Sclerosis	2
Scleroderma, Systemic	2
Scleroderma, Diffuse	2
Lupus Erythematosus, Systemic	2

Clinical Trial Locations for BENLYSTA

Trials by Country

Trials by Country for BENLYSTA
Location	Trials
United States	18
France	2
United Kingdom	1
China	1
Belgium	1

Trials by US State

Trials by US State for BENLYSTA
Location	Trials
New York	4
Ohio	2
Missouri	2
Alabama	2
North Carolina	2

Clinical Trial Progress for BENLYSTA

Clinical Trial Phase

Clinical Trial Phase for BENLYSTA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	6

Clinical Trial Status

Clinical Trial Status for BENLYSTA
Clinical Trial Phase	Trials
Completed	6
Recruiting	6
Not yet recruiting	1

Clinical Trial Sponsors for BENLYSTA

Sponsor Name

Sponsor Name for BENLYSTA
Sponsor	Trials
GlaxoSmithKline	9
Assistance Publique - Hôpitaux de Paris	2
Hospital for Special Surgery, New York	2

Sponsor Type

Sponsor Type for BENLYSTA
Sponsor	Trials
Other	21
Industry	13
NIH	1

Clinical Trials Update, Market Analysis, and Projection for BENLYSTA (belimumab)

Last updated: November 1, 2025

Introduction

Benlysta (belimumab), developed by GSK (GlaxoSmithKline), is a monoclonal antibody approved for the treatment of systemic lupus erythematosus (SLE), a complex autoimmune disease. Since its 2011 approval by the FDA, Benlysta has represented a significant advancement in lupus therapy, offering targeted, biologic treatment options where few existed. This analysis examines recent clinical trial activity, evaluates the drug’s current market landscape, and projects future market dynamics influenced by ongoing research, regulatory developments, and expanding indications.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Since its initial approval, Benlysta has been under continuous clinical investigation, primarily focusing on expanding indications and improving understanding of its long-term safety and efficacy profile. As of 2023, the following key developments have been recorded:

• Expanding Indications:
  Recent trials explore Benlysta's efficacy in other autoimmune conditions, including autoimmune kidney diseases, such as lupus nephritis, and generalized SLE. Notably, the BLISS-LN (Belimumab plus standard therapy in lupus nephritis) Phase III trial, completed in 2020, demonstrated a significant renal response, reinforcing the drug's role in lupus nephritis management. GSK submitted supplemental approval applications based on these data, seeking expanded labeling for kidney disease.

• Combination Therapy Trials:
  Several Phase II and III trials are investigating the efficacy and safety of combining Benlysta with other immunomodulators, aiming to optimize therapeutic responses. For example, trials evaluating its combination with azathioprine, mycophenolate mofetil, and emerging biologics are underway to assess synergistic effects.

• Long-term Safety and Efficacy:
  Ongoing extension studies continue to monitor adverse effects, resistance patterns, and sustained remission in lupus patients. Preliminary data indicate a stable safety profile over extended periods, supporting chronic use.

• Other Autoimmune Diseases:
  Although primarily focused on SLE, early-phase trials are assessing Belimumab’s potential in conditions like dermatomyositis, mixed connective tissue disease, and uveitis, broadening the scope of its therapeutic applications.

Recent Trial Results and Regulatory Movements

• FDA and EMA Submissions:
  Based on BLISS-LN and other pivotal studies, GSK has actively pursued regulatory approval extensions, with some approvals granted in specific territories for lupus nephritis. The FDA approved Benlysta for lupus nephritis in 2020, marking a milestone in expanding its label.

• Real-World Evidence:
  Registries and observational studies post-approval reaffirm Benlysta's efficacy in reducing disease activity, steroid-sparing effects, and improving quality of life for lupus patients. These data reinforce ongoing clinical development strategies.

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Market Analysis

Current Market Landscape

Benlysta remains a niche, yet critical, product within the autoimmune biologics landscape. As of 2023, the drug's global sales are estimated to approach $1.2 billion, reflecting its importance in SLE treatment and growing acceptance.

Market Penetration and Adoption

• Geographical Expansion:
  North America dominates sales, driven by extensive approval and access, with Europe trailing. Clinical acceptance is bolstered by updated guidelines endorsing Benlysta in appropriate patient populations. Entering emerging markets remains a strategic focus due to relatively lower penetration.

• Prescription Dynamics:
  Despite positive clinical perceptions, Prescriber hesitancy persists due to high costs (~$36,000 annually), infusion requirements, and concerns about long-term safety. Nevertheless, patient support programs and evolving reimbursement policies foster increased adoption.

• Competitive Landscape:
  Benlysta's key competitors include anifrolumab (Saphnelo), Rituximab, and belimumab biosimilars. The recent approval of anifrolumab introduces an alternative biologic targeting the interferon pathway, potentially influencing market share dynamics.

Market Challenges

• Pricing and Reimbursement:
  As biologics, Benlysta faces pricing pressures and variable reimbursement scenarios globally, impacting access and sales growth.

• Limited Indication Breadth:
  Its current FDA-approved uses are mainly confined to SLE and lupus nephritis, restricting broader utilization against more prevalent autoimmune conditions such as rheumatoid arthritis or multiple sclerosis.

• Manufacturing and Access:
  Infusion-based administration necessitates healthcare infrastructure, which can limit use in outpatient or resource-limited settings.

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Market Projections

Growth Drivers

• Expansion of Indications:
  The ongoing trials for lupus nephritis and possibly other autoimmune conditions will likely lead to U.S. and European approvals, broadening market potential.

• Companion Diagnostic Development:
  Efforts to identify biomarkers predictive of response could enhance prescriber confidence, improve patient selection, and increase adoption.

• Competitive Innovation:
  Next-generation biologics and biosimilars may introduce price competition but also stimulate innovation and reimbursement incentives for Benlysta's sustained use.

• Global Market Penetration:
  Emerging markets, especially in Asia-Pacific, represent significant growth opportunities, driven by increasing prevalence of autoimmune diseases and expanding healthcare access.

Projected Revenue Outlook

Analysts estimate that with broader approvals and increased clinical uptake, Benlysta's global sales could reach $2.4 billion by 2028, driven by:

• Expanded indication approvals, particularly in lupus nephritis and broad SLE populations.
• Greater penetration in emerging markets, fueled by strategic partnerships and localized manufacturing.
• Advances in personalized medicine, optimizing patient selection and treatment outcomes.

While competition remains intense, GSK’s continued investment in clinical research, supportive regulatory strategies, and patient access initiatives position Benlysta favorably within the autoimmune biologic space.

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Conclusion

Benlysta’s clinical trial landscape reflects a strategic shift toward broader indications and combination therapies, supported by promising trial outcomes. Market-wise, the drug maintains a niche but vital position in SLE and lupus nephritis treatment, with growth potential driven by global expansion, regulatory approvals, and evolving clinical practices. Future success hinges on addressing reimbursement challenges, ongoing clinical validation, and evolving competitive pressures.

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Key Takeaways

• Clinical Program Expansion:
  Current trials target lupus nephritis and other autoimmune diseases; positive results could unlock new approval opportunities, expanding market potential.

• Market Growth Prospects:
  With potential indication extensions and increased global access, Benlysta’s sales could more than double by 2028, reaching approximately $2.4 billion.

• Competitive Environment:
  New biologics and biosimilars pose competitive pressures, but GSK’s strategic clinical and regulatory approaches sustain Benlysta's relevance.

• Pricing and Access Strategies:
  Emphasizing value-based pricing, patient support programs, and local manufacturing are critical to optimizing adoption.

• Regulatory and Reimbursement Dynamics:
  Close monitoring of regulatory filings and reimbursement policies will be crucial for capitalizing on clinical advancements.

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FAQs

1. What is the current approved indication for Benlysta?
Benlysta is FDA and EMA approved for treating active systemic lupus erythematosus (SLE) in adults and pediatric patients aged 5 years and older, as well as for lupus nephritis in specific populations.

2. Are there ongoing efforts to expand Benlysta’s indications?
Yes. Trials are investigating its efficacy in lupus nephritis, other autoimmune diseases, and as part of combination therapies, with some seeking regulatory approval for these expanded uses.

3. How does Benlysta compare to other biologics in the lupus market?
Benlysta benefits from robust safety data, targeted mechanism via BAFF inhibition, and an established clinical profile. However, newer agents like anifrolumab offer alternative pathways and may influence future market shares.

4. What are the primary challenges limiting Benlysta’s market growth?
High cost, infusion requirements, limited indications, and competitive biologics constrain broader adoption. Reimbursement hurdles and healthcare infrastructure also impact access.

5. What is the outlook for Benlysta in emerging markets?
Significant growth potential exists due to rising autoimmune disease prevalence, increasing healthcare access, and strategic market expansion initiatives by GSK, likely driving substantial future revenue contributions.

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Sources:

1. GSK. Benlysta (belimumab) prescribing information.
2. U.S. FDA. Benlysta approval announcements.
3. Company filings and investor presentations.
4. Market research reports (2023).
5. Published clinical trial data (BLISS series and BLISS-LN study).