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Simulect

(Basiliximab)

ApprovedMonoclonal antibody

Basiliximab is used to prevent the body's immune system from rejecting a newly transplanted kidney. It works by temporarily suppressing the immune response after organ transplant surgery.[2] Simulect is currently approved and in use across 25 indications[4].[1]

Simulect is one of 618 small molecule programs targeting Bronchiolitis Obliterans. It is currently in Approved.

25

Indications

72

Total Trials

5

Active Trials

617

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Bronchiolitis ObliteransActive, not recruiting

Ischemia Reperfusion InjuryActive, not recruiting

Liver TransplantActive, not recruiting

LymphomaActive, not recruiting

Immune System DiseaseUnknown

Acute Graft Vs. Host DiseaseActive, not recruiting

Kidney TransplantUnknown

PneumoniaActive, not recruiting

UremiaActive, not recruiting

Amyotrophic Lateral SclerosisActive, not recruiting

Bronchiolitis ObliteransPhase 3

Active, not recruiting

Ischemia Reperfusion InjuryPhase 3

Active, not recruiting

Liver TransplantPhase 3

Active, not recruiting

LymphomaPhase 1

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Acute Graft Vs. Host DiseasePhase 2

Active, not recruiting

Kidney TransplantPreclinical

Unknown

PneumoniaPhase 2

Active, not recruiting

UremiaPhase 1

Active, not recruiting

Amyotrophic Lateral SclerosisPhase 2

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

1774 competitors in Lymphoma

#DrugCompanyPhaseTrials

Simulect

Blenoxane

SSequus Pharmaceuticals

Velban

EEastern Cooperative Oncology Group

Kenalog

BBausch Health Americas, Inc.

Decadron

QQuince Therapeutics S.p.A.

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Systemic Therapy

Bristol-Myers Squibb

Rhg-CSF

CCSPC Baike (Shandong) Biopharmaceutical Co., Ltd.

VP-16

FFundamenta Therapeutics, Ltd.

R-CHOP

IIncyte Biosciences Japan GK

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Phase 1Active, not recruiting

Acute Lymphoblastic Leukemia

NCT05139004

Phase 2Not yet recruiting

Hematologic Disease

NCT06480630

Q4 2029

Phase 2Recruiting

Lymphoma

NCT04871607

Q1 2030

Phase 3Not yet recruiting

Kidney Transplant

NCT05385432

Clinical

Trials by Indication[1]

Kidney Transplant15 trials

Study to Evaluate the Safety of Chronic Administration of Simulect to Subjects Receiving a First Kidney Transplant

Terminated·—·Phase 2/3·NCT00928811·5 enrolled

A Study to Assess the Efficacy and Safety of ASKP1240 in de Novo Kidney Transplant Recipients

Completed· Astellas logo

Astellas·Phase 2·NCT01780844·149 enrolled

Safety and Effectiveness of Low Molecular Weight Sulfated Dextran in Islet Transplantation After Kidney Transplant

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00790439

Show 12 more trials

Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT00251004·833 enrolled

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

Completed·AAssociação Médico Espírita de Botucatu·Phase 4·NCT02683291·48 enrolled

Basiliximab vs Low-dose Thymoglobulin Induction Therapy in Low Risk Kidney Transplant Patients

Completed·CCoordinación de Investigación en Salud, Mexico·Phase 4·NCT03006419·100 enrolled

Effect of Thymoglobulin Versus Basiliximab on Regulatory T Cell Function in Live Donor Kidney Transplant Recipients

Terminated·UUniversity of Pennsylvania··NCT02730715·30 enrolled

A Study to Assess the Safety and Efficacy of Alefacept in Kidney Transplant Recipients

Completed· Astellas logo

Astellas·Phase 2·NCT00543569·323 enrolled

Steroid Withdrawal in Pediatric Kidney Transplant Recipients

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00023244·274 enrolled

Everolimus in a Cyclosporine Microemulsion-free Regimen Compared to a Low-dose Cyclosporine Microemulsion Regimen, in de Novo Kidney Transplant Patients

Completed· Novartis logo

Novartis·Phase 3·NCT00154284·114 enrolled

Pediatric Induction Therapy in Kidney Transplantation

Completed·GGang Chen··NCT06087003·958 enrolled

Induction in Sensitized Kidney Transplant Recipients Without Pre-existing Donor-specific antiboDies

Not yet recruiting·UUniversity Hospital, Tours·Phase 3·NCT05385432·244 enrolled

Thymoglobulin Induction in Kidney Transplant Recipients

Unknown status·UUniversity of Oxford·Phase 3·NCT01239563·40 enrolled

Safety and Efficacy of Basiliximab in Calcineurin Inhibitor Intolerant Long-term Kidney Transplant Recipients Treated With Mycophenolic Acid and Steroids

Completed· Novartis logo

Novartis·Phase 4·NCT00284947·7 enrolled

Induction With SVF Derived MSC in Living-related Kidney Transplantation

Unknown status·FFuzhou General Hospital·Phase 1/2·NCT02492308·120 enrolled

Liver Transplant12 trials

An Open, Randomized Pilot Study to Evaluate the Use of Basiliximab With an Optimized Cyclosporine Dosing on Renal Function in "de Novo" Liver Transplantation.

Completed· Novartis logo

Novartis·Phase 4·NCT00343226·48 enrolled

Belatacept in Liver Transplant Recipients

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00555321·260 enrolled

Efficacy and Safety of Basiliximab in Hepatitis C Virus Positive Patients Undergoing Liver Transplantation

Completed· Novartis logo

Novartis·Phase 3·NCT00238901·194 enrolled

Show 9 more trials

Examination of Immunosuppression Adjustment Impact on Kidney Function in Liver Transplant

Completed·FFady M Kaldas, M.D., F.A.C.S.·Phase 4·NCT04104438·71 enrolled

Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation

Unknown status·AArmin Goralczyk·Phase 2·NCT00890253·29 enrolled

Preservation of Renal Function in Liver Transplant Recipients With Certican Therapy

Completed· Novartis logo

Novartis·Phase 3·NCT00378014·276 enrolled

Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation

Completed· Astellas logo

Astellas·Phase 3·NCT01011205·893 enrolled

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00149994·171 enrolled

Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02123108·59 enrolled

Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids

Completed· Novartis logo

Novartis·Phase 3·NCT00149890·77 enrolled

Steroid Free Immunosuppression in Liver Transplantation

Completed·TThomas Jefferson University·Phase 4·NCT00296244·40 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT01625377·188 enrolled

Renal Transplant Recipients6 trials

Efficacy and Safety of Everolimus+EC-MPS After Early CNI Elimination vs EC-MPS +Tacrolimus in Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00965094·36 enrolled

Evaluation of Early Conversion to Everolimus From Cyclosporine in de Novo Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00634920·204 enrolled

A Twelve-month, Multicenter, Open-label, Randomized Study of the Safety, Tolerability and Efficacy of Everolimus With Basiliximab, Corticosteroids and Two Different Exposure Levels of Tacrolimus in de Novo Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00369161·228 enrolled

Show 3 more trials

Influence of Thymoglobuline on Phenotypic and Functional Profiles of B Lymphocytes in Renal Transplant Recipients

Unknown status·UUniversity Hospital, Brest··NCT02894606·40 enrolled

Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

Terminated· Novartis logo

Novartis·Phase 4·NCT00956293·207 enrolled

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Completed· Astellas logo

Astellas·Phase 4·NCT00113269·501 enrolled

Renal Transplantation4 trials

Effect of SVF Derived MSC in DCD Renal Transplantation

Unknown status·FFuzhou General Hospital·Phase 1/2·NCT02492490·120 enrolled

1 vs 7 RATG Infusions in Renal Transplantation

Active, not recruiting· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research··NCT06374095·75 enrolled

Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01436305·19 enrolled

Show 1 more trial

The Usefulness of Tacrolimus Without Basiliximab in Well Matched Living Renal Transplantation in Korea

Unknown status·—·N/A·NCT02459977·40 enrolled

Ulcerative Colitis2 trials

Basiliximab Maintenance in Ulcerative Colitis

Terminated·CCerimon Pharmaceuticals·Phase 2·NCT01061996·88 enrolled

Basiliximab in Moderate to Severe Ulcerative Colitis

Completed·CCerimon Pharmaceuticals·Phase 2·NCT00430898·181 enrolled

30 more indications

Thalassemia2 trials

Efficacy of Basiliximab in the Prevention of Acute Graft-versus-host Disease in Unrelated Allogeneic Hematopoietic Stem Cell Transplantation Therapy for Thalassemia Major

Completed·ZZhongming Zhang·Phase 4·NCT02342145·205 enrolled

Haploidentical Hematopoietic Stem Cell Transplantation for Patients With Thalassemia Major

Unknown status·FFirst Affiliated Hospital of Guangxi Medical University·Phase 4·NCT03171831·30 enrolled

Lymphoma2 trials

Radiolabeled Monoclonal Antibody Therapy and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Primary Refractory or Relapsed Hodgkin Lymphoma

Completed·—·Phase 1·NCT01476839·25 enrolled

Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma

Recruiting·—·Phase 2·NCT04871607·33 enrolled

Renal Transplant2 trials

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

Completed·MMassachusetts General Hospital·Phase 2·NCT02464878·2 enrolled

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

Completed· Novartis logo

Novartis·Phase 3·NCT00658320·122 enrolled

Pneumonia1 trial

Basiliximab Treating Interstitial Pneumonia of CADM

Unknown status·RRenJi Hospital·Phase 2·NCT03192657·100 enrolled

Immunosuppression1 trial

Impact of Lymphocyte Anti-metabolite Immunosuppressions on Donor-Specific Anti-HLA Antibody and Kidney Graft Outcome

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 4·NCT03794492·169 enrolled

Treatment1 trial

Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL

Unknown status·—·Phase 2·NCT04337593·20 enrolled

Nephropathy1 trial

Campath, Calcineurin Inhibitor Reduction and Chronic Allograft Nephropathy

Completed·UUniversity of Oxford·Phase 2/3·NCT01120028·852 enrolled

Function1 trial

EXTEND Protocol for Transplanted Patient to Evaluate Kidney Function

Unknown status·MMcGill University Health Centre/Research Institute of the McGill University Health Centre·Phase 3·NCT00302497·50 enrolled

GvHD1 trial

In-Vivo Activated T-Cell Depletion to Prevent GVHD

Terminated·IIndiana University·N/A·NCT00594308·10 enrolled

Allogeneic Stem Cell Transplantation1 trial

Basiliximab for the Treatment of Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation

Unknown status·HHospital Authority, Hong Kong·N/A·NCT00563108·60 enrolled

Bronchiolitis Obliterans1 trial

Study Comparing Simulect Plus Standard Immunosuppression to Standard Immunosuppression Alone for the Prevention of Acute Rejection and Bronchiolitis Obliterans in Lung Transplant

Completed·UUniversity Health Network, Toronto·Phase 3·NCT00188825·22 enrolled

Multiple Myeloma1 trial

Stem Cell Transplantation for Patients With Multiple Myeloma

Completed·UUniversity of Chicago·Phase 1·NCT01526096·30 enrolled

Focal Segmental Glomerulosclerosis1 trial

Study to Assess the Efficacy and Safety of Bleselumab in Preventing the Recurrence of Focal Segmental Glomerulosclerosis in de Novo Kidney Transplant Recipients

Completed· Astellas logo

Astellas·Phase 2·NCT02921789·67 enrolled

De Novo Renal Transplantation1 trial

A Study to Evaluate Efalizumab Compared With Cyclosporine As an Immunosuppressant Regimen in De Novo Renal Transplantation

Withdrawn· Roche logo

Roche·Phase 2/3·NCT00729768

Survival1 trial

Strategies to Improve Islet Survival

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00464555·5 enrolled

Amyotrophic Lateral Sclerosis1 trial

Immunosuppression in Amyotrophic Lateral Sclerosis (ALS)

Completed·EEmory University·Phase 2·NCT01884571·31 enrolled

SARS-CoV-21 trial

Exploratory Regimen of Basiliximab for Treatment of Pulmonary Cytokine Storm in SARS-CoV-2 Hospitalized Adult Patients

Unknown status·FFort Worth Clinical Sciences Working Group·Phase 2·NCT05013034·300 enrolled

Gastrointestinal1 trial

Vedolizumab, Anti-CD25 Antibody, Rapid Reduction of Glucocorticoids for SR-aGVHD With Gastrointestinal Involvement

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 4·NCT06066840·45 enrolled

Phase 21 trial

Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT01856257·71 enrolled

Glioblastoma Multiforme1 trial

Basiliximab in Treating Patients With Newly Diagnosed Glioblastoma Multiforme Undergoing Targeted Immunotherapy and Temozolomide-Caused Lymphopenia

Completed·GGary Archer Ph.D.·Phase 1·NCT00626483·34 enrolled

Type 1 Diabetes1 trial

Islet Transplantation in Type 1 Diabetes

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00434811·48 enrolled

GBM1 trial

DC Migration Study for Newly-Diagnosed GBM

Completed·MMustafa Khasraw, MBChB, MD, FRCP, FRACP·Phase 2·NCT02366728·64 enrolled

Acute Myeloid Leukemia1 trial

Vaccine Therapy and Basiliximab in Treating Patients With Acute Myeloid Leukemia in Complete Remission

Completed·UUniversity of Chicago·Phase 1·NCT01842139·7 enrolled

Prospective1 trial

Prospective, Randomized Trial of Basiliximab (Simulect) in the Prophylaxis of High-Risk Keratoplasty Patients

Completed·UUniversity Hospital Freiburg·Phase 2·NCT00409656

Hematologic Disease1 trial

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

Not yet recruiting·—·Phase 2·NCT06480630·39 enrolled

Uveitis1 trial

The Safety and Efficacy of Basiliximab as Maintenance Therapy in Subjects With Stable, Noninfectious Uveitis

Terminated·CCerimon Pharmaceuticals·Phase 2·NCT00646425·5 enrolled

TACE1 trial

LEA29Y (Belatacept) Emory Edmonton Protocol

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00468403·10 enrolled

Transplantation1 trial

Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer

Completed·IIndiana University School of Medicine·Phase 2·NCT00975975·17 enrolled

Islet Transplantation1 trial

B-Lymphocyte Immunotherapy in Islet Transplantation for Initial Islet Graft Failure

No longer available·NNational Institute of Allergy and Infectious Diseases (NIAID)··NCT01049633

Acute Lymphoblastic Leukemia1 trial

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

Active, not recruiting·CCity of Hope Medical Center·Phase 1·NCT05139004·7 enrolled

Regulatory

FDA Approval Timeline[5]

May 12, 1998

SIMULECT

BLA BLA103764

Sources

References

[1]
ClinicalTrials.gov — 72 trial records for Basiliximab. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Simulect drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Basiliximab compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Basiliximab. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA103764). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Interleukin-2 Receptor Inhibitor[3]
Modality: Monoclonal antibody[3]
Highest Phase: Approved[1]
Company: Novartis

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