NULOJIX (belatacept)
Nulojix (belatacept) is a selective T cell costimulation blocker indicated for the prophylaxis of organ rejection in adult kidney transplant recipients. The medication is used in a combination regimen that includes basiliximab induction, mycophenolate mofetil, and corticosteroids. Its use is limited to patients who are Epstein-Barr Virus (EBV) seropositive, and its efficacy has not been established for the transplant of organs other than the kidney.
How NULOJIX Works
Belatacept binds to CD80 and CD86 on antigen-presenting cells, which blocks the CD28-mediated costimulation of T lymphocytes. By preventing this costimulation, the drug inhibits the proliferation of T lymphocytes and the production of inflammatory cytokines like interleukin-2 and interferon-γ. This suppression of T lymphocyte activity, the primary mediator of immunologic rejection, helps prolong graft survival and decrease the production of anti-donor antibodies.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-06-15
- Patent Cliff
- 2018
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
NULOJIX Approval History
What NULOJIX Treats
1 indicationsNULOJIX is approved for 1 conditions since its original approval in 2011. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organ Rejection
NULOJIX Boxed Warning
POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus [see Contraindications (4)...
WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown EBV serostatus [see Contraindications (4) and Warnings and Precautions (5.1) ] . Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources. The physician responsible for maintenance therapy should have complete information requisite for the follow-up of the patient [see Warnings and Precautions (5.2) ] . Increased susceptibility to infection and the possible development of malignancies may result from immunosuppression [see Warnings and Precautions (5.1 , 5.3 , 5.4 , 5.5) ] . Use in liver transplant patients is not recommended due to an increased risk of graft loss and death [see Warnings and Precautions (5.6) ] . WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS See full prescribing information for complete boxed warning. • Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are at a particularly increased risk; therefore, use in EBV seropositive patients only. Do not use NULOJIX in transplant recipients who are EBV seronegative or with unknown serostatus. (4 , 5.1) • Only physicians experienced in immunosuppressive therapy and management of kidney transplant patients should prescribe NULOJIX. (5.2) • Increased
NULOJIX Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
NULOJIX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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 NULOJIX
3 of 16FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
39 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06918990 CarBel | DAIT CTOT-42 | Ph 1 | recruiting | Treatment of Antibody-Mediated Rejection (ABMR) With CarBel |
| NCT05669001 ASCEND | TCD601B203 | Ph 2 | completed | A Study of TCD601 in de Novo Renal Transplant Recipients |
| NCT02310867 | Pro00056079 | Ph 2 | recruiting | Immunomodulation to Optimize Vascularized Composite Allograft Integration for Limb Loss Therapy |
| NCT05017545 ADAPT | DAIT ITN089ST ITN089ST, NIAID CRMS ID#: 38685 | Ph 1, Ph 2 | active not recruiting | Carfilzomib and Belatacept for Desensitization |
| NCT06478017 | DAIT RTB-013 | Ph 2 | recruiting | Belatacept in Heart Transplantation |
| NCT06055608 ADVANTage | DAIT CTOT-41 | Ph 2 | recruiting | Advancing Transplantation Outcomes in Children |
| NCT03504241 TEACH | DAIT ITN062ST UM1AI109565, NIAID CRMS ID#: 20676 | Ph 1 | completed | Tolerance by Engaging Antigen During Cellular Homeostasis |
| NCT06291077 BELAFENDO | 2021/0391/HP | Ph 4 | not yet recruiting | Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO> |
| NCT04877288 | IM103-402 2022-501677-39 | Ph 3 | recruiting | A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications |
| NCT04827979 ATTAIN | DAIT ITN090ST UM1AI109565, NIAID CRMS ID#: 38686 | Ph 1, Ph 2 | active not recruiting | Daratumumab and Belatacept for Desensitization |
| NCT04786067 | STU-2020-1339 CTA202012-0033 | Ph 4 | completed | Use of DNA Testing to Help Transition Kidney Transplant Recipients to Belatacept-only Immunosuppression |
| NCT04477629 | 22-01135 | Ph 2 | recruiting | Belatacept in De Novo Heart Transplantation |
| NCT04955366 | STUDY00001855 | Ph 2 | active not recruiting | Abatacept Conversion in Kidney Transplantation |
| NCT04046549 results posted | VIB4920.P2.S1 | Ph 2 | completed | 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 |
| NCT04066114 results posted | DAIT CTOT-24 NIAID CRMS ID#: 38581 | Ph 1, Ph 2 | completed | Treg Modulation With CD28 and IL-6 Receptor Antagonists |
| NCT02213068 results posted | STU00085274 | Ph 4 | completed | Belatacept 3 Month Post Transplant Conversion Study |
| NCT01953120 results posted | 13-000270 | Ph 4 | completed | Mechanisms of Belatacept Effect on Alloimmunity and Antiviral Response After Kidney Transplantation (BMS IM 103-309) |
| NCT02939365 PROBE | IM103-382 | Ph 4 | withdrawn | Precision Medicine Offers Belatacept Monotherapy |
| NCT03388008 results posted | Bela Lung Pilot | Ph 2 | completed | Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation |
| NCT02327403 results posted | 2015P000154 | Ph 2 | completed | Belatacept Conversion in Proteinuric Kidney Transplant Recipients |
| NCT02314403 results posted | MGH Tolerance Trial | Ph 1 | completed | Renal Allograft Tolerance Through Mixed Chimerism (Belatacept) |
| NCT01729494 results posted | BEST | Ph 4 | completed | Belatacept Early Steroid Withdrawal Trial |
| NCT01790594 results posted | DAIT CTOT-15 U01AI084150, NIAID CRMS ID#: 20117 | Ph 2 | terminated | Optimization of NULOJIX® Usage Towards Minimizing CNI Exposure in Simultaneous Pancreas and Kidney Transplantation |
| NCT02137239 results posted | IM103-177 2013-002090-21 | Ph 2 | completed | Regimen Optimization Study |
| NCT02152345 results posted | AAAL7011 | Ph 4 | completed | Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients |
| NCT01921218 IM103-133 results posted | IRB00060470 IM103-133 | Ph 3 | completed | Belatacept Therapy for the Failing Renal Allograft |
| NCT01820572 results posted | IM103-116 2012-001314-42 | Ph 3 | completed | A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based |
| NCT01856257 results posted | DAIT CTOT-16 | Ph 2 | terminated | Open-Label Phase 2 Trial of a Steroid-Free, CNI-Free, Belatacept-Based Immunosuppressive Regimen |
| NCT02560558 results posted | IRB00082511 | Ph 4 | completed | Bela 8 Week Dosing |
| NCT03375138 | IM103-399 | Ph 1 | completed | A Study Using Healthy Volunteers Comparing Belatacept Which Has Been Manufactured By 2 Different Processes |
| NCT03805178 | Pro00101289 IM103-407 | Ph 2 | withdrawn | Lung Transplant Plasmapheresis/Belatacept/Carfilzomib for Antibody Mediated Rejection and Desensitization |
| NCT02130817 BelatPilot | Should be 2013-0672 IM103-327 | Ph 4 | withdrawn | Belatacept in Kidney Transplantation of Moderately Sensitized Patients |
| NCT01436305 results posted | DAIT CTOT-10 | Ph 2 | terminated | Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation |
| NCT02103855 results posted | BMS 103-337 | Ph 4 | completed | Switch From Calcineurin Inhibitor to Belatacept in Pancreas Transplant Recipients |
| NCT02078193 results posted | IM103-302 | Ph 4 | completed | Efficacy of Belatacept in Reducing DSA |
| NCT01791491 results posted | IM103-144 2011-005257-31 | Ph 2 | completed | Pharmacokinetics, Safety and Tolerability of Single-dose Belatacept in Adolescent Kidney Transplant Recipients |
| NCT00468403 LEEP | DAIT CIT-04 | Ph 2 | completed | LEA29Y (Belatacept) Emory Edmonton Protocol |
| NCT01766050 results posted | IM103-151 | Ph 4 | completed | Study to Evaluate Effect of Belatacept on Pharmacokinetics of Inje Cocktail in Healthy Volunteers |
| NCT00578448 results posted | IM103-047 | Ph 2 | completed | Belatacept Pharmacokinetic Trial in Renal Transplantation |
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.
NULOJIX FDA Label Details
Indications & Usage
FDA Label (PDF)NULOJIX is indicated for the treatment of Organ Rejection.
WARNING: POST-TRANSPLANT LYMPHOPROLIFERATIVE DISORDER, OTHER MALIGNANCIES, AND SERIOUS INFECTIONS Increased risk for developing post-transplant lymphoproliferative disorder (PTLD), predominantly involving the central nervous system (CNS). Recipients without immunity to Epstein-Barr virus (EBV) are a...
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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