Belatacept

Prevents organ rejection. Sold as Nulojix. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 1 application for Belatacept (sold as Nulojix), first approved Jun 15, 2011, with 1 new use approved and 0 published complete response letters.

First approved: Jun 15, 2011
Applications: 1
New uses approved: 1
Complete response letters: 0
Medicare spending, 2025: $145M
First approved in the EU: Jun 17, 2011

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Nulojix	Part B	$138M	+13%	7,619
Nulojix	Part D	$6.5M	+22%	362

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Prophylaxis of organ rejection in renal allograft recipientsBristol-Myers Squibb Company · designated Feb 20, 2008 · approved Jun 15, 2011

Approvals in the EU (EMA)

First approved in the EU the same month as the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Nulojix, new substanceBristol-Myers Squibb Pharma EEIG · Jun 17, 2011

Clinical Trials

15 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Treatment of Antibody-Mediated Rejection (ABMR) With CarBelKidney Transplant Rejection · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	Recruiting	Apr 9, 2025
Belatacept in Heart TransplantationHeart Transplant · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	Recruiting	Jun 27, 2024
Use of DNA Testing and Gene Expression Profiling to Help Transition Kidney Transplant Recipients to Belatacept-only ImmunosuppressionKidney Transplant Immunosuppression · University of Texas Southwestern Medical Center	Not applicable	Enrolling by invitation	Mar 29, 2024
Comparison of the Effects of Belatacept and Anticalcineurins on Endothelial Function in Renal Transplant Patients - <BELAFENDO>Kidney Diseases · University Hospital, Rouen	Phase 4	Recruiting	Mar 4, 2024
Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R)Kidney Transplant Rejection · University Hospital, Rouen	Phase 2 / Phase 3	Not yet recruiting	Mar 4, 2024
Advancing Transplantation Outcomes in ChildrenKidney Transplant · National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2	Recruiting	Sep 28, 2023
Islet Transplantation With Recipient T-Reg Cells or Deceased Donor Vertebral Bone Marrow TherapyIslet Transplantation · Stanford University	Phase 1	Enrolling by invitation	Aug 3, 2023
Evolution of CMV Antiviral T-cell Immunity Over the Next Six Months Initiation of Treatment With Belatacept.Kidney Transplant Infection · University Hospital, Rouen	—	Active, not recruiting	Feb 1, 2023

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Jun 15, 2011	NulojixBLA 125288 · New molecular entity	Bristol Myers Squibb	8	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA