CLINICAL TRIALS PROFILE FOR BASILIXIMAB

Biosimilar Clinical Trials for basiliximab

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 basiliximab

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.
NCT00106639 ↗	A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients	Completed	Pfizer	Phase 2	2005-05-01	This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the same treatment groups.
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.
NCT00137345 ↗	Study Comparing Sirolimus With Cyclosporine in a Calcineurin Inhibitor (CNI)-Free Regimen in Kidney Transplant Recipients	Terminated	Wyeth is now a wholly owned subsidiary of Pfizer	Phase 3	2005-06-01	The purpose of this study is to determine if one drug is superior to another with regard to safety and the preservation of renal function after a kidney transplant.
NCT00149890 ↗	Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids	Completed	Novartis	Phase 3	2004-03-01	Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of immunosuppressive drugs) given in combination with basiliximab, cyclosporine and steroids in pediatric de novo liver transplant recipients. The treatment is compared to the same treatment regimen including intraoperative steroids with respect to rejection episodes.

Clinical Trial Conditions for basiliximab

Condition Name

Condition Name for basiliximab
Intervention	Trials
KIDNEY TRANSPLANTATION	30
Renal Transplantation	9
Type 1 Diabetes Mellitus	9
Liver Transplantation	9

Condition MeSH

Condition MeSH for basiliximab
Intervention	Trials
Diabetes Mellitus, Type 1	14
Diabetes Mellitus	14
Renal Insufficiency	11
Kidney Failure, Chronic	8

Clinical Trial Locations for basiliximab

Trials by Country

Trials by Country for basiliximab
Location	Trials
United States	251
Canada	25
France	20
Germany	16
China	15

Trials by US State

Trials by US State for basiliximab
Location	Trials
California	22
Illinois	17
Pennsylvania	16
Georgia	14
Florida	14

Clinical Trial Progress for basiliximab

Clinical Trial Phase

Clinical Trial Phase for basiliximab
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	1
Phase 4	44

Clinical Trial Status

Clinical Trial Status for basiliximab
Clinical Trial Phase	Trials
Completed	75
Unknown status	22
Terminated	17

Clinical Trial Sponsors for basiliximab

Sponsor Name

Sponsor Name for basiliximab
Sponsor	Trials
Novartis Pharmaceuticals	22
Novartis	18
National Institute of Allergy and Infectious Diseases (NIAID)	12

Sponsor Type

Sponsor Type for basiliximab
Sponsor	Trials
Other	146
Industry	79
NIH	30

Clinical Trials Update, Market Analysis, and Projection for Basiliximab

Last updated: October 28, 2025

Introduction

Basiliximab, a chimeric monoclonal antibody targeting the IL-2 receptor alpha-chain (CD25), plays a crucial role in immunosuppression therapies, particularly in organ transplantation. Its ability to prevent acute organ rejection has made it a staple in transplant medicine, especially for renal transplant recipients. As the landscape of immunomodulatory therapies evolves, understanding the current clinical trial dynamics, market trajectory, and future growth potential of basiliximab aligns strategic decisions with scientific and market developments.

Clinical Trials Overview

Current Status and Recent Developments

Basiliximab’s clinical evaluation portfolio remains active, predominantly focusing on expanding indications and optimizing dosing regimens. The drug has garnered regulatory approval for prophylaxis of acute rejection in kidney transplantation since its FDA approval in 1998, and European Medicines Agency approval shortly thereafter. Current trials are exploring its utility beyond transplantation, including autoimmune diseases and experimental cancer immunotherapy.

Recent updates indicate several ongoing trials:

• Expanded Use in Solid Organ Transplantation: Trials assessing basiliximab combined with novel immunosuppressants aim to improve graft survival rates. For example, Phase II studies are evaluating its efficacy in cardiac and liver allotransplantation, seeking to establish broader approval.

• Autoimmune Disease Investigations: Preliminary Phase I/II studies examine basiliximab’s role in conditions like multiple sclerosis and psoriasis, leveraging its immunomodulatory effect to attenuate central immune activation.

• Cancer Immunotherapy: Early-stage trials are testing basiliximab's capacity to modulate immune checkpoints in hematologic malignancies, emphasizing its potential to suppress overactive immune responses in oncological settings ([1]).

Safety and Efficacy Data

Consistent with prior evidence, recent trials reaffirm basiliximab’s tolerability and safety profile, with infusion reactions and elevated infection risk being the primary adverse events. Its efficacy in reducing acute rejection episodes remains well-documented, with clinical trials demonstrating significant improvements over traditional therapies alone.

Regulatory and Clinical Guideline Influence

While the drug maintains a stable approval status for renal transplantation, regulatory bodies like EMA and FDA continue to monitor emerging data. The evolving clinical landscape signals potential for label expansion, contingent on positive trial outcomes.

Market Analysis

Current Market Landscape

Basiliximab's market presence is primarily characterized by its role in organ transplantation. Its market share, dominated by its originator, Novartis (branding as Simulect), benefits from longstanding regulatory approval and clinician familiarity.

• Market Size (2022): The global immunosuppressant market was valued at approximately USD 10 billion in 2022, with basiliximab accounting for a significant fraction—estimated around USD 600-800 million—given its specific indication in renal transplantation ([2]).

• Competitive Landscape: The drug faces competition predominantly from alternative biologics such as thymoglobulin, belatacept, and newer agents like costimulation blockers. The shift towards personalized immunosuppressive regimens influences market dynamics.

• Geographical Distribution: North America remains the largest market, driven by high transplantation rates and advanced healthcare infrastructure, followed by Europe and Asia-Pacific. Emerging markets present growth opportunities due to increasing transplant procedures and healthcare investments.

Pricing and Reimbursement Dynamics

Pricing strategies reflect the drug's status as a specialty biologic, with premiums justified by its efficacy. Reimbursement policies, especially in major markets, favor biologics for transplant prophylaxis, although cost considerations impact adoption rates.

Market Trends and Drivers

• Growing Transplant Volumes: The global increase in organ transplants, propelled by improved surgical techniques and donor management, boosts basiliximab demand.
• Regulatory Expansion Potential: Positive clinical trial outcomes could lead to label extensions, expanding its market scope.
• Competitive Innovation: Development of biosimilars and biospecific alternatives could influence pricing and market share, pressuring incumbent biologics like basiliximab.

Market Challenges

• Generic and Biosimilar Entry: The expiration of patents or emergence of biosimilars could compress margins.
• Therapeutic Alternatives: Increasing use of treatments such as belatacept, which targets similar pathways, may shift prescribing patterns.
• Regulatory Hurdles: Approval for new indications entails substantial investment and time, potentially delaying market expansion.

Market Projection

Forecasting (2023-2030)

Based on current clinical development momentum, transplant epidemiology, and healthcare infrastructure trends, the basiliximab market is poised for steady growth:

• Compound Annual Growth Rate (CAGR): Estimated at 4-6%, driven primarily by emerging markets and broader transplant indications.
• Market Volume (2030 projection): Predicted to reach USD 1.2 - 1.5 billion, extrapolating from current figures and forecasted transplant procedure increases ([2], [3]).

Influencing Factors

• Regulatory approvals for new indications could substantially elevate market size.
• Biosimilar development and adoption may exert downward pressure on prices but expand access.
• Advancements in personalized immunosuppression could optimize therapy protocols, impacting utilization rates.

Risks and Uncertainties

• Unsuccessful trial outcomes or regulatory delays could diminish growth prospects.
• Competitive pressures from biosimilars and alternative immunosuppressants pose significant threats.
• Variations in transplant rates due to policy changes or organ donation rates also influence market expansion.

Conclusion

Basiliximab's clinical and market outlook remains cautiously optimistic. Its established role in preventing acute transplant rejection provides a strong foundation, but future growth hinges on successful expansion into new therapeutic areas, regulatory approvals, and competitive positioning amidst biosimilar proliferation.

Key Takeaways

• Robust Clinical Evidence: Basiliximab continues to demonstrate efficacy and safety in renal transplantation, with ongoing trials exploring broader immunosuppressive applications.
• Market Potential: The drug sustains a significant share within the global transplant immunosuppression market, with growth driven by increasing transplant rates and potential label extensions.
• Competitive Dynamics: Biosimilar entry and alternative therapies may challenge market share; strategic positioning and innovation are vital.
• Regulatory Pathways: Expanding indications hinge on positive clinical data; regulatory agencies remain attentive to emerging evidence.
• Long-term Outlook: The global transplant landscape's growth, coupled with evolving immunomodulatory therapies, positions basiliximab favorably, contingent on successful clinical and commercial strategies.

FAQs

1. What are the main current indications for basiliximab?
   Basiliximab is primarily indicated for prophylaxis of acute rejection in kidney transplantation, often administered alongside other immunosuppressants like corticosteroids and calcineurin inhibitors.

2. Are there ongoing trials for basiliximab in autoimmune diseases?
   Yes. Certain early-phase trials are investigating its potential in autoimmune conditions such as multiple sclerosis and psoriasis, although these are not yet approved indications.

3. How might biosimilar development affect basiliximab’s market share?
   The emergence of biosimilars could lower prices and increase accessibility but may also intensify competition, prompting incumbent manufacturers to innovate further or seek regulatory label expansions.

4. What future therapeutic areas could expand basiliximab’s use?
   Potential expansion includes broader organ transplantation indications, autoimmune diseases, and possibly certain hematologic malignancies where immune modulation is necessary.

5. What are the key risks facing basiliximab’s market growth?
   Risks include clinical trial failures, regulatory delays, biosimilar competition, and shifts in transplant volume and policies.

---

References

[1] ClinicalTrials.gov. Basiliximab studies. [Online]. Available: https://clinicaltrials.gov

[2] Grand View Research. Global Immunosuppressants Market Size, Share & Trends Analysis Report. 2022.

[3] IQVIA. Transplantation Market Report, 2022.