Drug

Basiliximab

Established medicine

ClassInterleukin-2 receptor inhibitorResearchOngoing clinical research

Also known as Basiliximab (Murine), Simulect.

RxNorm196102 ChEMBLCHEMBL1201439 ATCL04AC02UNII9927MT646M

Active clinical trials

Protein targets

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase I Study of Escalating Doses of 90Y-DOTA-Anti-CD25 Monoclonal Antibody Added to the Conditioning Regimen of Fludarabine, Melphalan, and Organ Sparing Total Marrow and Lymphoid Irradiation (TMLI) as Conditioning for Allogeneic Hematopoietic Cell Transplantation in Patients With High-Risk Acute Leukemia or Myelodysplastic Syndrome

Clinical trial2026-07-06Results expected Q2 2027 · ClinicalTrials.gov

Effectiveness and Safety of a Single-Center Clinical Study on a CD25 Monoclonal Antibody-Containing GVHD Prophylaxis Scheme to Reduce the Incidence of Severe Acute GVHD After Umbilical Cord Blood Transplantation for Malignant Hematologic Diseases

Clinical trial2026-06-30Primary completion · ClinicalTrials.gov

Induction in Sensitized Kidney Transplant Recipients Without Preexisting Donor-specific antiboDies: a Randomized Multicentre Trial Between a Lymphocyte Depleting and Basiliximab.

Clinical trial2026-06-18Results expected Q4 2030 · ClinicalTrials.gov

A Study in Adults on Pre LT Dialysis With Basiliximab, Delayed Tacrolimus (TAC), Mycophenolate (MMF), Steroids (Grp 1) vs. Basiliximab, Delayed TAC, MMF, Steroids, With Everolimus 30d Post LT(Grp 2), vs. TAC, MMF, Steroids (Grp 3).

Clinical trial2025-12-16Results posted · ClinicalTrials.gov

A Phase 2 Trial of Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy (aTac-BEAM) Conditioning for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

Clinical trial2025-12-04Results expected Q4 2029 · ClinicalTrials.gov

Vedolizumab, Anti-CD25 Antibody Combined With Rapid Reduction of Glucocorticoids as Treatment of Grade 3-4 Steroid-resistant Acute Graft-versus-host Disease With Lower Gastrointestinal Involvement

Clinical trial2025-07-31Primary completion · ClinicalTrials.gov

A Phase 2a, Randomized, Open-Label, Active Control, Multi-Center Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

Clinical trial2024-12-04Results posted · ClinicalTrials.gov

Pilot Study T Cell Depletion in the Setting of Autologous Stem Cell Transplantation for Patients With Multiple Myeloma

Clinical trial2024-08-28Completed · ClinicalTrials.gov

Phase I Study of Yttrium-90 Labeled Anti-CD25 (a-Tac) Monoclonal Antibody Plus BEAM for Autologous Hematopoietic Cell Transplantation (AHCT) in Patients With Primary Refractory or Relapsed Hodgkin Lymphoma, the "a-Tac BEAM Regimen"

Clinical trial2024-05-31Completed · ClinicalTrials.gov

Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant

Clinical trial2023-12-22Results posted · ClinicalTrials.gov

Drug Safety Update: Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation

Regulatory2014-12-11MHRA

Approval: Simulect (EMA)

Regulatory1998-10-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Basiliximab

Aliases & brands

Basiliximab (Murine)Simulect

RxNorm CUI

196102

ChEMBL ID

CHEMBL1201439

ATC codes

L04AC02

UNII

9927MT646M

Primary mechanism

Interleukin-2 receptor inhibitor

Regulatory jurisdictions

emamhra

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Interleukin-2 receptor subunit alpha

IL2RA · P01589

INHIBITORInterleukin-2 receptor inhibitor

Cytokine receptor common subunit gamma

IL2RG · P31785

INHIBITORInterleukin-2 receptor inhibitor

Interleukin-2 receptor subunit beta

IL2RB · P14784

INHIBITORInterleukin-2 receptor inhibitor

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

1998-10-09

Latest approval

1998-10-09

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 1 event

1998-10-09Approval

Approval: Simulect (EMA)

Indication: Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used… Show full indication

Simulect is indicated for the prophylaxis of acute organ rejection in de-novo allogeneic renal transplantation in adult and paediatric patients (1-17 years). It is to be used concomitantly with ciclosporin for microemulsion- and corticosteroid-based immunosuppression, in patients with panel reactive antibodies less than 80%, or in a triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Basiliximab: indicated for renal transplantation only; efficacy and safety not shown in heart transplantation

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).