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Basiliximab (Simulect)
Basiliximab is a chimeric monoclonal antibody that blocks the interleukin-2 (IL-2) receptor on T cells, preventing T cell activation and proliferation.
Basiliximab is a chimeric monoclonal antibody that blocks the interleukin-2 (IL-2) receptor on T cells, preventing T cell activation and proliferation. Used for Acute rejection prophylaxis in renal transplant recipients (in combination with cyclosporine and corticosteroids).
At a glance
| Generic name | Basiliximab (Simulect) |
|---|---|
| Also known as | Simulect, Basiliximab: Simulect |
| Sponsor | Novartis |
| Drug class | IL-2 receptor antagonist (monoclonal antibody) |
| Target | CD25 (IL-2 receptor alpha chain) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Basiliximab binds specifically to the alpha chain (CD25) of the IL-2 receptor on activated T lymphocytes, blocking IL-2-mediated T cell proliferation. This prevents the clonal expansion of T cells that would otherwise drive allograft rejection. By selectively targeting activated T cells during the critical early phase of immune response, it reduces acute rejection without broadly suppressing all immune function.
Approved indications
- Acute rejection prophylaxis in renal transplant recipients (in combination with cyclosporine and corticosteroids)
Common side effects
- Infection
- Hypertension
- Tremor
- Headache
- Constipation
- Diarrhea
- Acne
Key clinical trials
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients (PHASE2)
- Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients (PHASE4)
- Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant (PHASE4)
- Simulect Versus ATG in Sensitized Renal Transplant Patient (PHASE4)
- Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (PHASE2)
- A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients (PHASE2)
- Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR (PHASE4)
- Stem Cell Transplantation for Patients With Multiple Myeloma (PHASE1)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |