SIMULECT (basiliximab)
SIMULECT is indicated for the treatment of Organ Rejection.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1998-05-12
- Patent Cliff
- 2005
- Routes
- SINGLE-USE
- Dosage Forms
- VIAL
SIMULECT Approval History
What SIMULECT Treats
1 indicationsSIMULECT is approved for 1 conditions since its original approval in 1998. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
SIMULECT Boxed Warning
WARNING Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources....
WARNING Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.
SIMULECT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to SIMULECT
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
38 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02377193 SATIR | 12 484 03 | Ph 4 | completed | Simulect Versus ATG in Sensitized Renal Transplant Patient |
| NCT04871607 | 20420 NCI-2021-03073, 20420 | Ph 2 | recruiting | Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma |
| NCT01780844 | 7163-CL-0108 | Ph 2 | completed | A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients |
| NCT01526096 | 10-551-B | Ph 1 | completed | Stem Cell Transplantation for Patients With Multiple Myeloma |
| NCT05139004 | 21016 NCI-2021-05555, 21016 | Ph 1 | active not recruiting | 90Y-DOTA-anti-CD25 Basiliximab, Fludarabine, Melphalan, and Total Marrow and Lymphoid Irradiation for the Treatment of High-Risk Acute Leukemia or Myelodysplastic Syndrome |
| NCT01476839 | 08179 NCI-2011-03334, P01CA030206 | Ph 1 | completed | Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma |
| NCT02921789 results posted | 7163-CL-3201 | Ph 2 | completed | Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients |
| NCT00717470 OSAKA | PMR-EC-1210 2007-005376-13 | Ph 4 | completed | A Study in Kidney Transplant Subjects to Investigate the Optimal Suppression of Immunity to Help Prevent Kidney Rejection |
| NCT01011205 DIAMOND | PMR-EC-1106 2008-002231-32, 2010-021075-89 | Ph 3 | completed | Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation |
| NCT00933231 | FKC-014 | Ph 3 | completed | Comparison of Standard Versus Low Dose Advagraf® With or Without Angiotensin-converting Enzyme Inhibitor (ACEi)/Angiotensin Receptor Blocker (ARB) on Histology and Function of Renal Allografts |
| NCT01304836 ADVANCE | PMR-EC-1211 2010-019638-28 | Ph 4 | completed | A Study Looking at Diabetes in Kidney Transplant Recipients Receiving Immunosuppressive Regimen With or Without Steroids |
| NCT06480630 | CD25-2024 | Ph 2 | not yet recruiting | 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 |
| NCT03794492 | 223KT17017 | Ph 4 | completed | Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome |
| NCT02464878 results posted | Islet after Kidney - AAT | Ph 2 | completed | Multicenter Trial of the Effect of AAT on Islet Transplant Engraftment and Durability After Renal Transplant |
| NCT05385432 INSTEAD | DR210298 - INSTEAD | Ph 3 | not yet recruiting | Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies |
| NCT02366728 ELEVATE results posted | Pro00054740 | Ph 2 | completed | DC Migration Study for Newly-Diagnosed GBM |
| NCT02123108 results posted | UCLA: CCHI621AUS17T | Ph 4 | completed | Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation |
| NCT02523768 PIRAT | 0908143 2009-018189-36, A100405-32 | Ph 4 | terminated | Prevention in Recipients With Primary IgA Nephropathy of Recurrence After Kidney Transplantation: ATG-F Versus Basiliximab as Induction Immunosuppressive Treatment |
| NCT01856257 results posted | DAIT CTOT-16 | Ph 2 | terminated | Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen |
| NCT01120028 3C results posted | CTSU3C1 2008-008553-27, ISRCTN88894088 | Ph 2, Ph 3 | completed | Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy |
| NCT03006419 | R-2016-3001-61 | Ph 4 | completed | Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients |
| NCT01842139 | 11-0545 NCI-2011-03588 | Ph 1 | completed | Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission |
| NCT01884571 NIPALS2013 results posted | IRB00064218 NIP-ALS-2013, 2013P000981 | Ph 2 | completed | Immunosuppression in Amyotrophic Lateral Sclerosis (ALS) |
| NCT01436305 results posted | DAIT CTOT-10 | Ph 2 | terminated | Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation |
| NCT01843348 ATHENA results posted | CRAD001ADE44 2011-005238-21 | Ph 3 | completed | 12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients |
| NCT01625377 SIMCER results posted | CRAD001HFR02 2012-000137-39 | Ph 3 | completed | A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients |
| NCT00468403 LEEP | DAIT CIT-04 | Ph 2 | completed | LEA29Y (Belatacept) Emory Edmonton Protocol |
| NCT00975975 results posted | 0908-04; IUCRO-0256 | Ph 2 | completed | Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer |
| NCT02683291 | 16966913.6.0000.5411 | Ph 4 | completed | Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients |
| NCT00543569 results posted | 0485-CL-U201 | Ph 2 | completed | A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients |
| NCT00928811 Simulect | 17718 CHI 621A | Ph 2, Ph 3 | terminated | Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant |
| NCT00965094 results posted | CRAD001AIL03 | Ph 4 | completed | Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients |
| NCT00634920 results posted | CRAD001ASE01 2007-000771-42 | Ph 4 | completed | Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients |
| NCT00790439 | DAIT CIT-01B CIT-01B | Ph 2 | withdrawn | Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant |
| NCT00956293 Senator results posted | CRAD001ADE19 EudraCT-NO. 2008-005109-20, 2008-005109-20 | Ph 4 | terminated | Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program |
| NCT00658320 results posted | CRAD001A1202 | Ph 3 | completed | Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids |
| NCT00555321 results posted | IM103-045 | Ph 2 | terminated | Belatacept in Liver Transplant Recipients |
| NCT00646425 BSX-003 | BSX-003 | Ph 2 | terminated | The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIMULECT FDA Label Details
Indications & Usage
FDA Label (PDF)SIMULECT is indicated for the treatment of Organ Rejection.
WARNING Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients rec...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment