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Drug

Belatacept

Established medicine
ClassT-lymphocyte activation antigen CD86 inhibitorResearchOngoing clinical research

Also known as Nulojix.

RxNorm1112973ChEMBLCHEMBL1742990ATCL04AA28UNIIE3B2GI648A
11
Active clinical trials
2
Protein targets
1
Regulatory events
Latest activity
beta

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

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

Clinical trial2026-06-25Results expected Q4 2032 · ClinicalTrials.gov

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

Clinical trial2026-06-09Results expected Q1 2029 · ClinicalTrials.gov

Late Abatacept Conversion in Kidney Transplant Recipients Receiving Belatacept: a Prospective, Randomized Controlled Non-inferiority Trial. IM101-884

Clinical trial2026-06-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-05-26Results expected Q2 2027 · ClinicalTrials.gov

Advancing Transplantation Outcomes in Children (CTOT-41)

Clinical trial2026-05-20Results expected Q2 2028 · ClinicalTrials.gov

A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)

Clinical trial2026-04-10Completed · ClinicalTrials.gov

Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy

Clinical trial2026-04-09Results expected Q4 2027 · ClinicalTrials.gov

Measuring the Impact of Carfilzomib and Belatacept on Allogeneic Desensitization in Prospective Kidney Transplant Recipients (ITN089ST)

Clinical trial2026-04-08Results expected Q1 2027 · ClinicalTrials.gov

Belatacept With Delayed Tacrolimus Withdrawal Versus Standard-of-Care Tacrolimus in Heart Transplant Recipients (RTB-013)

Clinical trial2026-04-07Results expected Q1 2028 · ClinicalTrials.gov

A Mechanistically Driven Therapy to Desensitize >98.0% cPRA Patients: Depletion of Plasma Cells With Anti-CD38 and Prevention of B Cell Activation With Costimulation Blockade (ITN090ST)

Clinical trial2026-01-20Results expected Q1 2027 · ClinicalTrials.gov

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

Clinical trial2026-01-15Results expected Q1 2028 · ClinicalTrials.gov

Approval: Nulojix (EMA)

Regulatory2011-06-17EMA

Profile

Identifiers & mechanism

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

Canonical name
Belatacept
Aliases & brands
Nulojix
RxNorm CUI
1112973
ChEMBL ID
CHEMBL1742990
ATC codes
L04AA28
UNII
E3B2GI648A
Primary mechanism
T-lymphocyte activation antigen CD86 inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

2 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

T-lymphocyte activation antigen CD86
CD86 · P42081
INHIBITORT-lymphocyte activation antigen CD86 inhibitor
T-lymphocyte activation antigen CD80
CD80 · P33681
INHIBITORT-lymphocyte activation antigen CD80 inhibitor

Regulatory timeline

1 event

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
2011-06-17
Latest approval
2011-06-17
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2011-06-17Approval
Approval: Nulojix (EMA)

Indication: Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult&nbsp;recipients of a renal transplant.&nbsp;

Evidence ↗

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

Clinical trials

56 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
56
registered trials across all phases
LATEST COMPLETION 2026
11
Active studies
8
Recruiting
19
Late-stage (III+)
33
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 56
Early Phase 11Phase 15Phase 1 / 25Phase 226Phase 33Phase 414Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

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

RecruitingPH IVUniversity Hospital, Rouenn=442029

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

CompletedPH IVUniversity of Texas Southwestern Medical Centern=252025

A Randomized, Multicenter Study of Belatacept, Everolimus, rATG and Early Steroid Withdrawal Versus Belatacept, Mycophenolate, rATG and Chronic Steroids in Renal Transplantation

Unknown statusPH IVUniversity of Cincinnatin=1202024

Precision Medicine Offers Belatacept Monotherapy (PROBE)

WithdrawnPH IVUniversity of California, San Francisco2022

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

CompletedPH IVUniversity of California, Los Angelesn=202021

Recent completions

Trials that read out recently, adding to the completed evidence base.

A 12-Month, Randomized, Open-Label, Phase IIA Study Evaluating the Safety and Efficacy of Siplizumab in Combination With Belatacept and MPA Compared to Standard of Care Immunosuppression in de Novo Renal Transplant Recipients (ASCEND)

CompletedPH IIITB-Med LLCn=762026

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

CompletedPH INational Institute of Allergy and Infectious Diseases (NIAID)n=82025

Novel Desensitization Protocol With Proteasome Inhibitor and Costimulation Blockade for Highly Sensitized Patients to Allow for Successful Kidney Transplantation. A Pilot Study.

CompletedPH I/IIUniversity of Chicagon=52025

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

CompletedPH IVUniversity of Texas Southwestern Medical Centern=252025

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

CompletedPH I/IINational Institute of Allergy and Infectious Diseases (NIAID)n=242023

A Phase 2a Single-arm, Prospective, Open-label Pilot 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

CompletedPH IIAmgenn=252023
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.