Nulojix

(Belatacept)

ApprovedProtein / enzyme

Belatacept is used to prevent the body's immune system from rejecting a kidney transplant after someone receives a new kidney from a donor.[2] Nulojix is currently approved and in use across 15 indications[4].[1]

Nulojix is one of 136 small molecule programs targeting Heart Transplant Rejection. It is currently in Approved.

Indications

Total Trials

Active Trials

135

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Heart Transplant RejectionActive, not recruiting

Immune System DiseaseUnknown

Cardiac TransplantRecruiting

Hepatitis BActive, not recruiting

Heart TransplantationRecruiting

Endothelial FunctionNot yet recruiting

Renal TransplantationUnknown status

Renal Transplant RecipientsCompleted

DesensitizationActive, not recruiting

KidneyCompleted

Heart Transplant RejectionPreclinical

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Cardiac TransplantPhase 2

Recruiting

Hepatitis BPreclinical

Active, not recruiting

Heart TransplantationPhase 2

Recruiting

Endothelial FunctionApproved

Not yet recruiting

Renal TransplantationApproved

Unknown status

Renal Transplant RecipientsApproved

Completed

DesensitizationPhase 2

Active, not recruiting

KidneyApproved

Completed

Showing 10 of 15 indications

Competition

Competitive Landscape

55 competitors in Immune System Disease

#DrugCompanyPhaseTrials

Nulojix

Bristol-Myers Squibb

Approved

60 2

Trexall

Medrol

Crestor

Avelox

Neoral

Tecfidera

Otezla

Thalomid

Cellcept

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

Timeline

Expected Milestones

Q4 2026

Recruiting

Treatment

NCT05708534

Q2 2027

Phase 1Recruiting

Kidney Transplant Rejection

NCT06918990

Q1 2028

Phase 2Recruiting

Cardiac Transplant

NCT04180085

Phase 2Recruiting

Heart Transplant

NCT06478017

Phase 1/2Active, not recruiting

Desensitization

NCT05017545

Q2 2028

Phase 2Recruiting

Immunomodulation

NCT02310867

Clinical

Trials by Indication[1]

Kidney Transplant13 trials

Comparison of NODAT in Kidney Transplant Patients Receiving Belatacept Versus Standard Immunosuppression

Unknown status·UUniversity of Arizona·Phase 4·NCT01875224·32 enrolled

A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00402168·173 enrolled

Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309)

Completed·UUniversity of California, Los Angeles·Phase 4·NCT01953120·20 enrolled

Show 10 more trials

A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT01820572·446 enrolled

A Belatacept Compassionate Use Study for Patients With a Kidney Transplant

No longer available· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT00719225

A Study to Evaluate the Safety and Efficacy of Dual Costimulation Blockade With VIB4920 and Belatacept for Prophylaxis of Allograft Rejection in Adults Receiving a Kidney Transplant

Completed· Amgen logo

Amgen·Phase 2·NCT04046549·25 enrolled

Belatacept in Kidney Transplantation of Moderately Sensitized Patients

Withdrawn·UUniversity of Wisconsin, Madison·Phase 4·NCT02130817

Belatacept to Prevent Organ Rejection in Kidney Transplant Patients

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00346151·5 enrolled

Calcineurin Inhibitor-free, Steroid-free Immunosuppressive Regimen in Simultaneous Islet-Kidney Transplantation for Uremic Type 1 Diabetic Patients

Withdrawn·UUniversity of Wisconsin, Madison·N/A·NCT01033500

Belatacept Conversion in Proteinuric Kidney Transplant Recipients

Completed·—·Phase 2·NCT02327403·15 enrolled

A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00455013·93 enrolled

Novel Desensitization Kidney Transplantation

Completed·UUniversity of Chicago·Phase 1/2·NCT05345717·5 enrolled

Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT01791491·16 enrolled

Kidney5 trials

Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT03504241·16 enrolled

Advancing Transplantation Outcomes in Children (CTOT-41)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT06055608·200 enrolled

Regulatory T Cell Modulation in Kidney Transplantation With Biologic Blockade of Dual Effector Pathways, CD28 and IL-6 (CTOT-24)

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Preclinical·NCT04066114·24 enrolled

Show 2 more trials

Optimization of NULOJIX® (Belatacept) Usage as a Means of Avoiding CNI and Steroids in Renal Transplantation (CTOT-10)

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

Use of Donor Derived-cell Free DNA (AlloSure) to Facilitate Belatacept Monotherapy in Kidney Transplant Patients

Completed·UUniversity of Texas Southwestern Medical Center·Approved·NCT04786067·25 enrolled

Renal Transplantation4 trials

Belatacept Pharmacokinetic Trial in Renal Transplantation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00578448·14 enrolled

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

Unknown status·UUniversity of Cincinnati·Phase 4·NCT04849533·120 enrolled

Belatacept in Renal Transplantation With Intermediate Risk Maryland Aggregate Pathology Index (MAPI) Scores

Completed·—·N/A·NCT01496417·20 enrolled

Show 1 more trial

Randomized, Open Label, Multicenter Study of Belatacept-based Early Steroid Withdrawal Regimen With Alemtuzumab or rATG Induction Compared to Tacrolimus-based Early Steroid Withdrawal Regimen With rATG Induction in Renal Transplantation

Completed·UUniversity of Cincinnati·Approved·NCT01729494·316 enrolled

Renal Transplant Recipients4 trials

Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function

Unknown status·NNair, Vinay, D.O.·Phase 2·NCT01837043·90 enrolled

Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Completed·—·Phase 4·NCT02152345·57 enrolled

Belatacept for Renal Transplant Recipients With Delayed Graft Function

Terminated·OOhio State University·Phase 1·NCT02134288·8 enrolled

Show 1 more trial

A Study of TCD601 in de Novo Renal Transplant Recipients

Active, not recruiting·IITB-Med LLC·Phase 2·NCT05669001·76 enrolled

TACE3 trials

LEA29Y (Belatacept) Emory Edmonton Protocol

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

A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT03375138·84 enrolled

Belatacept 3 Month Post Transplant Conversion Study

Completed·LLorenzo Gallon·Phase 4·NCT02213068·28 enrolled

25 more indications

Tics2 trials

Subcutaneous Pharmacokinetics of Belatacept

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00569803·153 enrolled

Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 4·NCT01766050·45 enrolled

Tolerance2 trials

Belatacept Post Depletional Repopulation to Facilitate Tolerance

Completed·—·Phase 2·NCT00565773·40 enrolled

Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)

Completed·MMassachusetts General Hospital·Phase 1·NCT02314403·2 enrolled

Desensitization2 trials

Carfilzomib and Belatacept for Desensitization

Active, not recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT05017545·21 enrolled

Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization

Withdrawn·—·Phase 2·NCT03805178

Allograft2 trials

Belatacept Therapy for the Failing Renal Allograft

Completed·AAndrew B Adams·Phase 3·NCT01921218·13 enrolled

Steroid and Tacrolimus Avoidance Using NULOJIX® (Belatacept) in Renal Transplantation (CTOT-16)

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

Kidney Transplant Rejection2 trials

Targeting the B Cell Response to Treat Antibody-Mediated Rejection With Carfilzomib and Belatacept (CarBel)

Recruiting·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT06918990·25 enrolled

Impact of the Microbiota on the Likelihood of Renal Graft Rejection

Active, not recruiting·IInstitut National de la Santé Et de la Recherche Médicale, France··NCT04736381·70 enrolled

Hepatitis B1 trial

Viral Immunity in Solid Organ Transplant Recipients: Monitoring Of The Response To Hepatitis B Booster Vaccination

Unknown status·UUniversity Hospital, Grenoble··NCT06307808·66 enrolled

Monotherapy1 trial

Precision Medicine Offers Belatacept Monotherapy

Withdrawn·UUniversity of California, San Francisco·Phase 4·NCT02939365

Efficacy1 trial

Efficacy of Belatacept in Reducing DSA

Completed·—·Phase 4·NCT02078193·3 enrolled

Post-Transplant Lymphoproliferative Disorder1 trial

Belatacept and Risk of Post-transplant Lymphoproliferative Disorder in US Renal Transplant Recipients

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb··NCT01656343·775 enrolled

Rheumatoid Arthritis1 trial

Phase I/II Multiple-Dose LEA29Y vs CTLAG4Ig vs Placebo in Rheumatoid Arthritis

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1/2·NCT00279760·210 enrolled

Safety and Efficacy1 trial

Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00035555·230 enrolled

Transplant Recipient1 trial

Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients

Completed·IIndiana University·Phase 4·NCT02103855·6 enrolled

Endothelial Function1 trial

Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>

Not yet recruiting·UUniversity Hospital, Rouen·Phase 4·NCT06291077·44 enrolled

Immunomodulation1 trial

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Recruiting·LLinda Cendales·Phase 2·NCT02310867·50 enrolled

Cardiac Transplant1 trial

Pilot Study: Interest of Belatacept as a Non-nephrotoxic Immunosuppressive Treatment in Cardiac Transplant Patients at Risk of Chronic Renal Failure (BELACOEUR)

Recruiting·NNantes University Hospital·Phase 2·NCT04180085·25 enrolled

Lung Transplantation1 trial

Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation

Completed·WWashington University School of Medicine·Phase 2·NCT03388008·27 enrolled

Treatment1 trial

Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.

Recruiting·UUniversity Hospital, Rouen··NCT05708534·28 enrolled

Heart Transplantation1 trial

Belatacept in De Novo Heart Transplantation

Recruiting·NNYU Langone Health·Phase 2·NCT04477629·12 enrolled

Islet Transplantation1 trial

Islet Transplantation Using Abatacept

Completed·EEmory University·Phase 2·NCT00276250·5 enrolled

Completed·EEmory University·Phase 2·NCT04955366·87 enrolled

Renal Allograft Recipients1 trial

A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT04877288·102 enrolled

Unspecified2 trials

Regimen Optimization Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02137239·58 enrolled

Bela 8 Week Dosing

Completed·EEmory University·Phase 4·NCT02560558·166 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 15, 2011

NULOJIX

BLA BLA125288

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Belatacept. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nulojix drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Belatacept compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Belatacept. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (BLA BLA125288). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Bristol-Myers Squibb company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: T-Lymphocyte Activation Antigen CD80 Inhibitor; T-Lymphocyte Activation Antigen CD86 Inhibitor[3]
Modality: Protein / enzyme[3]
Highest Phase: Approved[1]
Company: Bristol-Myers Squibb

Nulojix

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q2 2027

Q1 2028

Q2 2028

Trials by Indication[1]

Kidney Transplant13 trials

Kidney5 trials

Renal Transplantation4 trials

Renal Transplant Recipients4 trials

TACE3 trials

Tics2 trials

Tolerance2 trials

Desensitization2 trials

Allograft2 trials

Kidney Transplant Rejection2 trials

Hepatitis B1 trial

Monotherapy1 trial

Efficacy1 trial

Post-Transplant Lymphoproliferative Disorder1 trial

Rheumatoid Arthritis1 trial

Safety and Efficacy1 trial

Transplant Recipient1 trial

Endothelial Function1 trial

Immunomodulation1 trial

Cardiac Transplant1 trial

Lung Transplantation1 trial

Treatment1 trial

Heart Transplantation1 trial

Islet Transplantation1 trial

Highly Sensitized Prospective Kidney Transplant Recipients1 trial

Heart Transplant1 trial

Simultaneous Kidney and Pancreas Transplantation1 trial

Renal Transplant Recipient1 trial

Renal Allograft Recipients1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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