Drugs / Belatacept
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | NULOJIX | — | 2018-04-13 | fda.gov ↗ |
| Approved | EU (EMA) | Nulojix | — | 2011-06-17 | europa.eu ↗ |
| Approved | US (FDA) | NULOJIX | — | 2011-06-15 | fda.gov ↗ |
| Rejected (CRL) | US (FDA) | — | kidney transplantation | 2010-05-01 | “the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation” bms.com ↗ |
| Filed | US (FDA) | — | kidney transplantation | 2009-09-03 | “FDA has accepted, for filing and review, the company’s submission of a biologic license application for belatacept” bms.com ↗ |
Trials 59
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06918990 | May 2026 → Jun 2027 expected | transplant rejection | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 1 | NCT03504241 | Jul 2018 → Sep 2023 | disease related to solid organ transplantation | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1 | NCT03375138 | Dec 2017 → May 2018 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1 | NCT02564497 | Oct 2015 → Jan 2017 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT05345717 | May 2022 → Sep 2025 | end stage renal failure | University of Chicago | Completed | No outcome recorded |
| Phase 1/2 | NCT05017545 | Dec 2021 → Feb 2027 expected | anti-HLA hyperimmunization | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT04827979 | Nov 2021 → Mar 2027 expected | anti-HLA hyperimmunization | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT00501709 | Feb 2007 → Dec 2016 | type 1 diabetes mellitus | University of California, San Francisco | Completed | No outcome recorded |
| Phase 1/2 | NCT00279760 | ? → Mar 2002 | rheumatoid arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 225 trials · 3 missed | ||||||
| Phase 2 | NCT06478017 | Jan 2025 → Jan 2028 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT06055608 | May 2024 → Jun 2028 expected | — | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 2 | NCT05669001 | Dec 2023 → Apr 2026 | — | ITB-Med LLC | Completed | No outcome recorded |
| Phase 2 | NCT05145296 | Jan 2022 → Dec 2024 | anti-HLA hyperimmunization | University Hospital, Grenoble | Terminated | No outcome recorded |
| Phase 2 | NCT04477629 | Aug 2020 → Sep 2026 overdue | — | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT04180085 | Feb 2020 → Jan 2028 expected | heart failure | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT03388008 | Dec 2019 → Aug 2022 | transplant rejection | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04046549 | Oct 2019 → Jul 2022 | transplant rejection | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT03805178 | May 2019 → Aug 2020 | transplant rejection | Duke University | Withdrawn | No outcome recorded |
| Phase 2 | NCT02137239 | Dec 2015 → May 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02327403 | Oct 2015 → Sep 2020 | proteinuria | Brigham and Women's Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02310867 | Mar 2015 → Dec 2027 expected | immunodeficiency disease | Linda Cendales | Recruiting | No outcome recorded |
| Phase 2 | NCT02738918 | Dec 2014 → Sep 2017 | acute transplant rejection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT01856257 | Jul 2013 → Apr 2016 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary |
| Phase 2 | NCT01837043 | Jun 2013 → Jun 2017 | — | Nair, Vinay, D.O. | Unknown | No outcome recorded |
| Phase 2 | NCT01791491 | May 2013 → Dec 2016 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT01790594 | Feb 2013 → Aug 2016 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01436305 | Sep 2011 → Apr 2015 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00555321 | Jan 2008 → Mar 2010 | disease related to solid organ transplantation | Bristol-Myers Squibb | Terminated | Missed primary |
| Phase 2 | NCT00565773 | Dec 2007 → Jul 2017 | disease related to solid organ transplantation | Allan D Kirk, MD, PhD | Completed | No outcome recorded |
| Phase 2 | NCT00455013 | Jul 2007 → Oct 2008 | disease related to solid organ transplantation | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00402168 | Jan 2007 → Jun 2009 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT00346151 | Dec 2006 → Feb 2010 | — | National Institute of Allergy and Infectious Diseases (NIAID) | Terminated | No outcome recorded |
| Phase 2 | NCT00276250 | Dec 2005 → Dec 2014 | type 1 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00035555 | Mar 2001 → Jan 2004 | transplant rejection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06291103 | Jul 2026 → Aug 2032 expected | transplant rejection | University Hospital, Rouen | Not yet recruiting | No outcome recorded |
| Phase 37 trials | ||||||
| Phase 3 | NCT05562869 | May 2024 → May 2027 expected | chronic renal failure syndrome | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT04877288 | Jul 2021 → Dec 2032 expected | — | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT04013620 | Sep 2020 → Jul 2022 | chronic renal failure syndrome | Nantes University Hospital | Unknown | No outcome recorded |
| Phase 3 | NCT01921218 | Aug 2013 → Dec 2019 | — | Andrew B Adams | Completed | No outcome recorded |
| Phase 3 | NCT01820572 | Mar 2013 → Oct 2019 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 3 | NCT00256750 | Mar 2005 → Jun 2008 | chronic renal failure syndrome | Bristol-Myers Squibb | Completed | Mixed |
| Phase 3 | NCT00114777 | Feb 2005 → May 2008 | — | Bristol-Myers Squibb | Completed | Mixed |
| Phase 414 trials · 1 met primary | ||||||
| Phase 4 | NCT06291077 | Apr 2026 → Feb 2029 expected | kidney disorder | University Hospital, Rouen | Recruiting | No outcome recorded |
| Phase 4 | NCT04786067 | Jul 2021 → Jul 2025 | disease related to solid organ transplantation | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT04849533 | Apr 2021 → Jul 2023 | transplant rejection | University of Cincinnati | Unknown | No outcome recorded |
| Phase 4 | NCT02939365 | Feb 2019 → Feb 2020 | disease related to transplantation | University of California, San Francisco | Withdrawn | No outcome recorded |
| Phase 4 | NCT02560558 | Sep 2015 → Aug 2019 | — | Emory University | Completed | Met primary |
| Phase 4 | NCT02130817 | Sep 2014 → Oct 2015 | end stage renal failure, transplant rejection | University of Wisconsin, Madison | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT02213068 | Jul 2014 → Sep 2020 | Epstein-Barr virus infection | Lorenzo Gallon | Completed | No outcome recorded |
| Phase 4 | NCT02152345 | Jun 2014 → Dec 2016 | transplant rejection | Columbia University | Completed | No outcome recorded |
| Phase 4 | NCT02103855 | Jun 2014 → Mar 2016 | poisoning | Indiana University | Completed | No outcome recorded |
| Phase 4 | NCT02078193 | Nov 2013 → Jul 2016 | — | East Carolina University | Completed | No outcome recorded |
| Phase 4 | NCT01953120 | Oct 2013 → Apr 2021 | transplant rejection | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 4 | NCT01875224 | Aug 2013 → Aug 2016 | disease related to solid organ transplantation | University of Arizona | Unknown | No outcome recorded |
| Phase 4 | NCT01766050 | Jan → Apr 2013 | transplant rejection | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT01729494 | Sep 2012 → Dec 2018 | — | University of Cincinnati | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT01496417 | Mar 2012 → Feb 2017 | end stage renal failure | University of Maryland | Completed | No outcome recorded |
| — | NCT01033500 | Jul 2010 → Dec 2012 | type 1 diabetes mellitus | University of Wisconsin, Madison | Withdrawn | No outcome recorded Stop: Business |
| Phase not stated1 trial | ||||||
| — | NCT00719225 | — | — | Bristol-Myers Squibb | No longer available | No outcome recorded |
| Comparator or background therapy8 trials | ||||||
| Phase 0 | NCT02134288 Comparator | Apr 2014 → Dec 2018 | — | Ohio State University | Terminated | No outcome recorded |
| Phase 1 | NCT02314403 Background | Feb 2015 → Mar 2021 | chronic renal failure syndrome, impaired renal function disease | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT00569803 Comparator | Dec 2007 → Aug 2008 | disease related to transplantation | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/2 | NCT04066114 Background | Dec 2019 → Sep 2023 | disease related to solid organ transplantation | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT04955366 Comparator | Sep 2021 → Jun 2026 | disease related to solid organ transplantation | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT00468403 Background | Oct 2008 → Apr 2012 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT00578448 Comparator | Mar 2008 → Mar 2009 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 4 | NCT04177095 Background | Feb 2020 → Sep 2021 | transplant rejection | Massachusetts General Hospital | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2015-05-06 | Bristol-Myers Squibb | Results Long-Term, 7-Year Study of Nulojix® (belatacept) Regimen Demonstrates Statistically Significant Relative Risk Reduction of Death or Graft Loss over Cyclosporine Regimen in Kidney Transplant bms.com ↗
New BENEFIT study 7-year follow-up data show Nulojix regimen demonstrated a statistically significant 43% relative risk reduction of death or graft loss at 7 years, with survival benefit of 52% observed as early as 5 years post-transplant |
| 2012-06-04 | Bristol-Myers Squibb | Results Bristol-Myers Squibb Presents New 4-Year Data from the Long-Term Extensions of the BENEFIT and BENEFIT-EXT Clinical Trials of NULOJIX® (belatacept) bms.com ↗
These findings show the NULOJIX safety and tolerability profile in adult kidney transplant recipients at 4 years was consistent with what we have observed previously and renal function sustained over time, |
| 2011-06-16 | Bristol-Myers Squibb | Regulatory FDA Approves NULOJIX® (belatacept) bms.com ↗ |
| 2010-05-01 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Receives Complete Response Letter from FDA for Belatacept bms.com ↗ |
| 2010-03-01 | Bristol-Myers Squibb | Regulatory FDA Advisory Committee Recommends Approval of Belatacept, an Investigational Agent for Prophylaxis of Acute Rejection in De Novo Kidney Transplant Patients bms.com ↗ |
| 2009-09-03 | Bristol-Myers Squibb | Regulatory Bristol-Myers Squibb Announces Acceptance of Submission for Belatacept Biologic License Application bms.com ↗
We are pleased the FDA has accepted our submission and we look forward to continuing to work with the agency. |
| 2009-05-28 | Bristol-Myers Squibb | Results First Phase III Data on Innovative Compound for Solid Organ Transplantation To be Featured at American Transplant Congress bms.com ↗
Belatacept Demonstrates Superior Composite Patient/Graft Survival in Diabetic Kidney Transplant Recipients vs. CsA: Results from the BENEFIT and BENEFIT-EXT Studies |
All press releases naming this drug 11 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 68 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Belatacept | “a conversion to Belatacept will be performed.” NCT06291103 ↗66“Changing of anticalcineurins by Belatacept” NCT06291077 ↗ “Belatacept treated patients” NCT04177095 ↗ |
| Known as | Belatacept (Nulojix) | “Belatacept (Nulojix®)” NCT02213068 ↗ |
| Known as | BMS-224818 | “Belatacept (BMS-224818)-Based Corticosteroid-Free Regimens” NCT00455013 ↗ |
| Known as | LEA29Y | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742990 ↗ |
| Known as | Nujolix | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742990 ↗ |
| Known as | NULOJIX | “the hypothesis is that in heart transplantation, belatacept (Nulojix) combined with minimization of CNI (with induction by antilymphocyte serum), could significantly improve...” NCT04180085 ↗4“An Exploratory, Open-label, Single Center Study to Assess the Efficacy of NULOJIX (Belatacept) in Reducing Donor Specific Human Leukocyte Antigen (HLA) Antibody (DSA) Strength...” NCT02078193 ↗ “This study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant.” NCT02310867 ↗ “Subjects will receive NULOJIX® (belatacept)10mg/kg through a peripheral vein” NCT00468403 ↗ “Nulojix (Belatacept)” NCT02738918 ↗ |
| Action | Inhibit | “Belatacept is an inhibitor of the 2 signals that stimulate T-cells.” NCT00468403 ↗2“T-lymphocyte activation antigen CD86 inhibitor” CHEMBL1742990 ↗ “T-lymphocyte activation antigen CD80 inhibitor” CHEMBL1742990 ↗ |
| Modality | Protein / enzyme biologic | “Belatacept is a CTLA4-Ig fusion protein” NCT03388008 ↗ |
| Route | Intravenous | “solution, IV” NCT00114777 ↗ |
| Target | CD80 | “T-lymphocyte activation antigen CD80 inhibitor” CHEMBL1742990 ↗ |
| Target | CD86 | “T-lymphocyte activation antigen CD86 inhibitor” CHEMBL1742990 ↗ |