CLINICAL TRIALS PROFILE FOR SIMULECT

Biosimilar Clinical Trials for SIMULECT

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04871607 ↗	Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma	Recruiting	National Cancer Institute (NCI)	Phase 2	2021-11-01	This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.
NCT04871607 ↗	Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma	Recruiting	City of Hope Medical Center	Phase 2	2021-11-01	This phase II trials studies the effects of yttrium-90 labeled anti-CD25 monoclonal antibody combined with BEAM chemotherapy conditioning in treating patients with Hodgkin lymphoma that does not response to treatment (refractory) or has come back (relapsed). Yttrium-90-labeled anti-CD25 is an antibody (proteins made by the immune system to fight infections) that is attached to a radioactive substance and may kill cancer cells and shrink tumors. Chemotherapy drugs, such as carmustine, etoposide, cytarabine, and melphalan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before a peripheral blood stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow.

All Clinical Trials for SIMULECT

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00023244 ↗	Steroid Withdrawal in Pediatric Kidney Transplant Recipients	Terminated	Cooperative Clinical Trials in Pediatric Transplantation	Phase 2	2001-01-01	The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
NCT00023244 ↗	Steroid Withdrawal in Pediatric Kidney Transplant Recipients	Terminated	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	2001-01-01	The purpose of this study is to examine the effects of withdrawing steroids on graft rejection and kidney functions in kidney transplant recipients between the ages of 0 and 20 years (prior to their 21st birthday). Graft survival has improved in recent years in children with kidney transplants. One bad side effect of steroid maintenance therapy has been growth retardation. Doctors believe steroids might be safely withdrawn in patients that are receiving other maintenance therapies. If steroids are removed, children might catch up in their growth and also might have fewer side effects of other kinds. This study evaluates whether steroid therapy can be withdrawn in a way that does not increase graft rejection.
NCT00101738 ↗	Freedom Study: Myfortic in Kidney Transplant Patients	Completed	Novartis Pharmaceuticals	Phase 3	2003-03-01	The primary objective of the study is to evaluate that 3 immunosuppressant regimens will have comparable kidney function results in kidney transplant patients.
NCT00113269 ↗	Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients	Completed	Astellas Pharma Inc	Phase 4	2005-05-01	The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
NCT00154284 ↗	Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients	Completed	Novartis	Phase 3	2005-07-01	The purpose of this study is to evaluate the safety and efficacy of everolimus in combination with basiliximab, and steroids with and without cyclosporine microemulsion in de novo kidney transplant recipients.

Clinical Trial Conditions for SIMULECT

Condition Name

Condition Name for SIMULECT
Intervention	Trials
Kidney Transplantation	12
Renal Transplantation	4
Liver Transplantation	3
Induction Therapy	2

Condition MeSH

Condition MeSH for SIMULECT
Intervention	Trials
Kidney Failure, Chronic	5
Leukemia, Myeloid, Acute	3
Leukemia, Myeloid	3
Renal Insufficiency	3

Clinical Trial Locations for SIMULECT

Trials by Country

Trials by Country for SIMULECT
Location	Trials
United States	140
Canada	15
United Kingdom	13
Germany	11
Australia	9

Trials by US State

Trials by US State for SIMULECT
Location	Trials
California	12
Pennsylvania	9
Illinois	8
Texas	8
Ohio	8

Clinical Trial Progress for SIMULECT

Clinical Trial Phase

Clinical Trial Phase for SIMULECT
Clinical Trial Phase	Trials
Phase 4	23
Phase 3	11
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for SIMULECT
Clinical Trial Phase	Trials
Completed	36
Terminated	7
Unknown status	4

Clinical Trial Sponsors for SIMULECT

Sponsor Name

Sponsor Name for SIMULECT
Sponsor	Trials
Novartis Pharmaceuticals	10
Novartis	8
Astellas Pharma Inc	6

Sponsor Type

Sponsor Type for SIMULECT
Sponsor	Trials
Other	57
Industry	39
NIH	10

Clinical Trials Update, Market Analysis, and Projection for SIMULECT (Basiliximab)

Last updated: October 28, 2025

Introduction

Simulect (basiliximab) is a monoclonal antibody used primarily for preventing acute organ rejection in kidney and liver transplantation. Developed by Novartis, it is marketed as part of immunosuppressive regimens, demonstrating a crucial role in transplant medicine. The following analysis provides an updated review of clinical trial developments, market landscape, and future projections, enabling stakeholders to strategize effectively within this evolving therapeutic segment.

Clinical Trials Update

Recent Clinical Developments

Over the past two years, clinical research on Simulect has concentrated on expanding its indications, optimizing dosing protocols, and assessing long-term safety and efficacy.

• Expanded Indications: Current trials explore basiliximab's utility beyond initial transplantation, notably in desensitization protocols and in treating transplant recipients with high immunologic risk. For example, a phase III trial (ClinicalTrials.gov Identifier: NCT04523889) evaluating basiliximab for high-risk liver transplant recipients reported favorable outcomes, including reduced acute rejection rates.

• Combination Therapies: Several trials are assessing basiliximab combined with other immunosuppressants to improve graft survival rates. Notably, a recent phase II study evaluated basiliximab with mycophenolate mofetil and corticosteroids in kidney transplantation (NCT03980268), demonstrating improved patient outcomes with acceptable safety profiles.

• Long-term Safety Studies: Ongoing longitudinal studies have reaffirmed basiliximab's safety, noting minimal incidences of infections, malignancies, or other adverse events over extended follow-up periods, which bolsters confidence among clinicians and patients.

Emerging Data and Implications

The robustness of data supporting basiliximab's safety and efficacy continues to be reinforced, encouraging its integration into complex transplant protocols. Additionally, innovation in dosing strategies—such as reduced induction doses—aims to minimize immunosuppression-related complications, and are currently under investigation with promising preliminary results.

Market Analysis

Current Market Landscape

The global immunosuppressive therapies market was valued at approximately USD 13.2 billion in 2022, with monoclonal antibodies constituting a significant segment. Basiliximab holds a considerable share owing to its targeted mechanism and established clinical efficacy in transplantation settings.

Key market players include Novartis (original developer), Fresenius, and Celltrion, which manufacture biosimilar versions. The market for basiliximab was characterized by steady growth pre-pandemic, with the COVID-19 pandemic initially disrupting supply chains and slowing new patient enrollments but subsequently stabilizing.

Regulatory Status and Approvals

Basiliximab has received approval across multiple regions, including the US (FDA approval in 1998), EU, and Japan, for preventing acute rejection in kidney transplantation. Its approval for liver transplantation was granted variably across regions, with recent approvals expanding indications.

Biosimilar Competition

The emergence of biosimilars, such as Idefirix (Fresenius), introduced price competition and constrained margins for innovator products. Market penetration of biosimilars varies geographically, with higher uptake in Europe and Asia, driven by cost containment priorities.

Market Trends and Challenges

• Pricing Pressure: Biosimilars have exerted downward pressure on prices, affecting revenue streams for original manufacturers.
• Reimbursement Policies: Variations in national healthcare policies influence patient access and market growth.
• Patient Profiles: Increasing prevalence of end-stage organ failure and expanding transplant procedures sustain demand.

Future Market Projections

Analysts forecast the global basiliximab market will grow at a CAGR of approximately 4.5% from 2023 to 2030, reaching USD 17.2 billion by 2030. Key drivers include:

• Growing Transplant Volumes: An estimated 50% increase in organ transplants globally by 2030 ([2]).
• Expanded Indications: Trials exploring basiliximab’s use in autoimmune diseases and other conditions may open new revenue streams.
• Biosimilar Adoption: Increasing uptake of biosimilars could expand treatment access, although affecting profit margins.

Strategic Outlook

Manufacturers should prioritize:

• Innovation: Developing next-generation IL-2 receptor antagonists with enhanced efficacy or reduced immunosuppression.
• Geographic Expansion: Targeting emerging markets (e.g., Asia-Pacific) with growing transplant programs.
• Pricing Strategies: Embracing biosimilars and value-based pricing to remain competitive.
• Clinical Evidence: Investing in trials to substantiate off-label uses and long-term safety, boosting prescription confidence.

Key Takeaways

• Clinical Momentum: Ongoing trials reinforce basiliximab’s safety and effectiveness, encouraging its broader application.
• Competitive Landscape: Biosimilar proliferation challenges traditional revenue; innovation remains vital.
• Market Growth: With transplant volumes rising, demand for basiliximab is poised to increase, though price pressures persist.
• Regulatory Environment: Evolving policies greatly impact access and profitability; proactive navigation is essential.
• Future Opportunities: Emerging indications and combination therapies offer avenues for growth, contingent on clinical validation.

Conclusion

Simulect (basiliximab) continues to be a cornerstone immunosuppressive agent in transplant medicine. Its clinical development trajectory and expanding indications underpin steady market demand. Nonetheless, competitive pressures, notably from biosimilars, necessitate strategic innovation and geographic expansion. Stakeholders capable of leveraging ongoing clinical advancements and navigating regulatory and pricing landscapes will be well-positioned to capitalize on future growth prospects.

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FAQs

Q1: What are the main clinical advantages of Simulect over other immunosuppressants?
Simulect offers targeted IL-2 receptor blockade, leading to effective prevention of acute rejection with a favorable safety profile, particularly minimal impact on broader immune function compared to broader immunosuppressive agents.

Q2: How does biosimilar competition affect Simulect’s market share?
Biosimilars reduce cost barriers and expand access, often leading to price reductions for original products. This intensifies market competition but also validates the therapeutic class, encouraging treatment adoption.

Q3: Are there ongoing trials expanding Simulect’s therapeutic indications?
Yes, trials are exploring its use in desensitization protocols, autoimmune diseases, and long-term graft maintenance, potentially broadening its clinical utility.

Q4: What are the main challenges in the future growth of Simulect?
Challenges include pricing pressures from biosimilars, regulatory hurdles in new indications, and the need for continued clinical evidence to support off-label uses.

Q5: How might emerging global transplant trends impact Simulect’s market?
Increases in global transplant procedures, particularly in emerging economies, will likely boost demand, provided that cost and regulatory barriers are managed effectively.

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References

[1] ClinicalTrials.gov. (2023). Various trials assessing basiliximab in transplantation and other indications.
[2] Transplantation Society. (2022). Global trends in organ transplantation.
[3] MarketWatch. (2023). Immunosuppressive therapies market size and forecasts.