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.

Clinical Trial Conditions for basiliximab

Condition Name

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

Basiliximab: Clinical Trials Update and Market Projection

Last updated: April 25, 2026

What is basiliximab and where does it sit in the clinical landscape?

Basiliximab (Simulect) is a chimeric monoclonal antibody that targets the IL-2 receptor alpha chain (CD25) to prevent acute organ rejection, used with standard immunosuppression regimens in kidney transplantation. It is an established, marketed biologic with long-standing clinical use in the indication set and no broad, late-stage pipeline momentum that would indicate a near-term “next-generation” substitution at launch for major markets.

From a clinical-trials standpoint, basiliximab’s footprint remains dominated by:

• Post-authorization studies (registries, outcomes follow-up, safety in routine care)
• Comparative or optimization studies that typically evaluate steroid-sparing, regimen timing, or center-specific protocols rather than new MoA expansions

Because basiliximab is not broadly defined by new pivotal trials for a new clinical use right now, the “update” market signal is driven more by label maintenance, real-world utilization patterns, and biosimilar competition than by Phase 3 execution.

What clinical-trials activity should investors track right now?

For active clinical-trials monitoring on basiliximab, the key items that move the market are not drug efficacy readouts but:

1. Safety outcomes in routine practice (infection risk, malignancy signals, immunogenicity in long follow-up windows)
2. Real-world effectiveness (acute rejection rates and treatment rescue usage under contemporary immunosuppression protocols)
3. Protocol refinements (induction dosing patterns, timing relative to surgery, and use with tacrolimus/mycophenolate/steroids)
4. Biosimilar evidence generation (comparability programs and post-marketing risk management plans that support switching)

Actionable interpretation: if trial activity is concentrated in observational studies and protocol validation, clinical supply and pricing power will be decided primarily by competitive access (biosimilar approvals and payer tender dynamics) rather than by a breakthrough efficacy narrative.

What is the global market structure for basiliximab?

Basiliximab’s market is a transplantation induction antibody category with recurring demand tied to:

• Incident kidney transplant volume
• Proportion of patients receiving IL-2 receptor blocker induction
• Local procurement and tender cycles
• Biosimilar penetration and switching behavior

Market demand drivers

• Kidney transplant procedures (primary driver)
• Immunosuppression regimen standardization (basiliximab’s role as an induction backbone in many settings)
• Payer and hospital formularies (moves quickly once a biosimilar is positioned as non-inferior)

Market supply drivers

• Originator versus biosimilar availability
• Regulatory and pharmacovigilance readiness (labeling parity and risk management)
• WAC-to-procurement discounting (tender-driven pricing changes)

Which competitive dynamics matter most (originator vs biosimilars)?

Basiliximab is widely available and faces biosimilar competitive pressure in multiple geographies. That pressure typically compresses pricing and expands access faster than originator-led price protection, especially in hospital tender markets.

Business implication for projections: market growth is usually split into:

• Volume growth from transplant activity and adoption persistence
• Value erosion from biosimilar-driven pricing declines
• Channel reallocation as procurement shifts from originator to lower-cost alternatives

In most mature biologics, investors see that the addressable market rises modestly while revenue per dose declines. Basiliximab behaves like that category: the “growth” is predominantly procedural and adoption-based, not innovation-led.

How do we project basiliximab market size and growth?

A rigorous projection requires a base-year market size and dose-level unit economics by geography. Those hard inputs are not provided in the source set available here. Under strict operating constraints, a complete and accurate numeric forecast cannot be produced without credible baseline figures tied to:

• number of treated kidney transplant patients,
• doses per course (including retreatment rules),
• average net price (by country, net of tenders/discounts),
• mix by originator vs biosimilar and by route/pack.

Accordingly, the only projection that can be delivered as “hard” is a framework that maps expected directionality from structural facts: procedure-linked demand plus pricing compression from biosimilars.

Projection directionality (direction, not numeric size)

• Global demand (doses)
  • Steady to modestly growing with kidney transplant volume trends
  • Resistant to substitution because IL-2 receptor blockade remains a common induction option in routine practice
• Global revenue (value)
  • Likely flat to declining in many markets as biosimilars drive net price compression
  • More stable where tender constraints keep adoption slower or where biosimilar supply is limited
• Near-term growth window
  • Not innovation-led; any “step-change” comes from competitive market entry waves and formulary switching

What investors should model in an internal projection model

Build scenarios on three levers:

1. Treated population share: percentage of kidney transplant patients receiving basiliximab induction versus alternatives (e.g., rATG, other IL-2 blockers where applicable)
2. Dose utilization: induction dosing compliance with label and local protocol variations
3. Net price trend: originator discounting vs biosimilar price erosion

Even without numeric baselines here, this model structure aligns with how transplantation biologics value evolves.

What is the clinical label baseline that drives dosing and utilization?

Basiliximab is indicated for prophylaxis of acute organ rejection in renal transplantation, as induction therapy in combination with other immunosuppressive drugs, with dosing schedules defined in its regulatory labeling. The use pattern is consistent enough that forecasting can be dose-based once transplant patient counts and net pricing are known.

Key clinical update themes that can move market perception

While basiliximab is not currently characterized here by late-stage novelty trials, market-relevant clinical themes still shape buyer confidence and formulary decisions:

1) Safety in contemporary immunosuppression

Focus stays on infection outcomes, delayed graft function context, and malignancy risk surveillance in long-term follow up. These factors influence payer and procurement acceptance, especially where biosimilar switches occur.

2) Immunogenicity and interchangeability confidence

Biosimilar uptake depends on comparability confidence and pharmacovigilance stability. If real-world safety profiles in switching cohorts remain consistent, adoption accelerates.

3) Comparative effectiveness in induction strategies

Any trial evidence indicating reduced acute rejection rates under specific patient subgroups or regimen combinations affects which centers favor basiliximab induction versus alternatives.

What does this mean for R&D and investment strategy?

Given basiliximab’s maturity and reliance on routine-care transplantation pathways, the investment question typically becomes:

• Do you compete on cost and access? (biosimilar entry, manufacturing scale, supply reliability)
• Do you defend on contracting and formulary? (originator or authorized biosimilar partnerships)
• Do you expand into subpopulations? (if label expansions occur, they can move utilization share)

Without evidence of major late-stage clinical breakthroughs in this update context, market upside is tied to competitive penetration and payer behavior more than to new clinical differentiation.

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Key Takeaways

• Basiliximab is an established IL-2 receptor antagonist used for induction in kidney transplantation, with clinical value anchored to routine-care effectiveness and safety rather than near-term innovation.
• Clinical-trials activity that impacts the market typically centers on post-authorization outcomes and protocol optimization, while the largest market shifts come from biosimilar competition and switching.
• Market demand is mainly procedural (kidney transplant volume and induction selection), while market value is primarily pricing-driven due to biosimilar penetration.
• A numeric market projection cannot be stated accurately without base-year unit and pricing inputs; directionally, model logic is stable to modestly rising volume with flat to declining revenue in price-compression markets.

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FAQs

1. Is basiliximab experiencing a major Phase 3 innovation-driven update?
   No broad late-stage breakthrough pattern is indicated here; the clinical footprint is primarily routine-care and post-authorization evidence.

2. What most determines basiliximab revenue trends?
   Net pricing and tender outcomes under biosimilar competition, not new efficacy differentiation.

3. What patient population drives basiliximab utilization?
   Kidney transplant recipients receiving induction immunosuppression with IL-2 receptor blockade.

4. How should biosimilar entry affect market share?
   It typically accelerates switching if pharmacovigilance and contracting support confidence and cost advantages.

5. What is the highest-value KPI for forecasting?
   The treated share of kidney transplant patients on basiliximab induction combined with net price trajectory.

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References

[1] European Medicines Agency. Simulect (basiliximab) product information. EMA. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. Simulect (basiliximab) prescribing information. FDA. https://www.accessdata.fda.gov/
[3] World Health Organization. Biologicals and biosimilars: guidance documents relevant to post-authorization safety monitoring. WHO. https://www.who.int/