belatacept
Trade name: nujolix
Recombinant proteinapprovedOrphan Drug FDA
Approved
Jun 15, 2011
Belatacept, sold under the brand name Nulojix, is a fusion protein composed of the Fc fragment of a human IgG1 immunoglobulin linked to the extracellular domain of CTLA-4, which is a molecule crucial in the regulation of T cell costimulation, selectively blocking the process of T-cell activation. It is intended to provide extended graft and transplant survival while limiting the toxicity generated by standard immune suppressing regimens, such as calcineurin inhibitors. It differs from abatacept (Orencia) by only two amino acids. — Wikipedia
Clinical trial activity
68 trials · 39 clinical orgs · 1 marketing orgs
Phase 1
12
Phase 2
43
Phase 3
8
Phase 4
14
Earliest trial started Mar 1, 2001 (NCT00035555)
Timeline
2000s
- Jan 1, 2001
Bristol-Myers Squibb — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
Earliest Phase 1 Sponsor(trial)
- Jan 1, 2005
Bristol-Myers Squibb — Earliest Phase 3 Sponsor(trial)
- Feb 20, 2008
Orphan Drug Designation
2010s
- Jun 15, 2011
Bristol-Myers Squibb — Earliest FDA Approval
- Jun 15, 2011
Bristol-Myers Squibb — Marketing Organization
- Jun 15, 2011
Bristol-Myers Squibb — NDA Organization
Indications
Approved for
Studied for
- Abdominal Wall · Phase 2
- Allografts · Phase 3
- Arthritis, Rheumatoid · Phase 2
- Delayed Graft Function · Phase 2
- Diabetes Mellitus · Phase 4
- Diabetes Mellitus, Type 1 · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Fistula · Phase 2
- Graft Rejection · Phase 4
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 2
- Heart Transplantation · Phase 2
- Hernia, Abdominal · Phase 2
- Herpesvirus 4, Human · Phase 4
- Immunosuppression Therapy · Phase 2
- Kidney Diseases · Phase 4
- Kidney Failure, Chronic · Phase 4
- Kidney Transplantation · Phase 4
- Liver Transplantation · Phase 2
- Lung Transplantation · Phase 2
- Organ Transplantation · Phase 2
- Proteinuria · Phase 2
- Renal Insufficiency · Phase 1
- Renal Insufficiency, Chronic · Phase 1/Phase 2
- Risk Factors · Phase 2
- Transplantation · Phase 4
Mechanism of action
- T-lymphocyte activation antigen CD80INHIBITOR
CD80 inhibitor
- T-lymphocyte activation antigen CD86INHIBITOR
CD86 inhibitor
- Cytotoxic T-lymphocyte protein 4INHIBITOR
CTLA4 inhibitor
Approval history
- approvedJun 15, 2011
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warningFirst in class
Sources
- WikipediaBelatacept ↗
- NCATSE3B2GI648A ↗
- ChEMBLCHEMBL1742990 ↗
Also known as
- belatacept
- belatacept
- belatacept
- belatacept
- belatacept
- belatacept
- belatacept
- belatacept
- belatacept
- bms 224818
- bms-224818
- bms-224818
- lea29y
- nujolix
- nulojix
- nulojix
- nulojix
- nulojix
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06918990 | Phase 2 | Oct 10, 2025 | Duke University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT06291077 | Phase 4 | Jan 1, 2025 | Rouen Normandy University |
| NCT06291103 | Phase 2/Phase 3 (Phase 3) | Jan 1, 2025 | Rouen Normandy University |
| NCT06478017 | Phase 2 | Nov 18, 2024 | Cedars-Sinai Medical Center, Emory University, Harvard University, National Institute of Allergy and Infectious Diseases (NIAID), New York University |
| NCT06055608 | Phase 2 | Nov 1, 2023 | Duke University, National Institute of Allergy and Infectious Diseases (NIAID) |
| NCT05669001 | Phase 2 | Apr 30, 2023 | ITB-Med LLC |
| NCT05562869 | Phase 3 | Nov 1, 2022 | University of Nantes |
| NCT05345717 | Phase 1/Phase 2 (Phase 2) | May 1, 2022 | University of Chicago |
| NCT04786067 | Phase 4 | Dec 1, 2021 | CareDx, The University of Texas, Dallas |
| NCT05145296 | N/A | Dec 1, 2021 | Bristol-Myers Squibb, University of Grenoble |
| NCT04827979 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2021 | Bristol-Myers Squibb, Immune Tolerance Network, National Institute of Allergy and Infectious Diseases (NIAID), PPD, Rho, Inc., University of California, San Francisco |
| NCT05017545 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2021 | Bristol-Myers Squibb, Duke University, Immune Tolerance Network, National Institute of Allergy and Infectious Diseases (NIAID), PPD, Rho, Inc. |
| NCT04955366 | Phase 2 | Sep 22, 2021 | Emory University |
| NCT04877288 | Phase 3 | May 7, 2021 | Bristol-Myers Squibb |
| NCT04849533 | Phase 4 | Apr 9, 2021 | University of Cincinnati |
| NCT04477629 | Phase 2 | Aug 6, 2020 | Bristol-Myers Squibb, New York University |
| NCT04180085 | Phase 2 | Jan 1, 2020 | University of Nantes |
| NCT04066114 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2019 | Bristol-Myers Squibb, Clinical Trials in Organ Transplantation, National Institute of Allergy and Infectious Diseases (NIAID), University of California, San Francisco |
| NCT04038970 | Phase 2 | Sep 15, 2019 | Alphamab Co., Ltd. |
| NCT04046549 | Phase 2 | Aug 30, 2019 | Viela Bio |
Showing 20 of 68 trials
Page 1 / 4
Organizations
Research & Development (39)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Bristol-Myers Squibb | For profit | 36 | 17 | 5 | 2001 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 12 | 12 | 2 | 2006 |
| Emory University | Academic/Hospital | 11 | 5 | 3 | 2005 |
| Duke University | Academic/Hospital | 7 | 3 | 2 | 2015 |
| University of California, San Francisco | Academic/Hospital | 5 | 2 | 2 | 2004 |
| Clinical Trials in Organ Transplantation | Government | 4 | 0 | 1 | 2011 |
| Immune Tolerance Network | Academic/Hospital | 4 | 0 | 2 | 2006 |
| Harvard University | Academic/Hospital | 3 | 2 | 2 | 2015 |
| University of Nantes | Academic/Hospital | 3 | 3 | 2 | 2019 |
| Juvenile Diabetes Research Foundation | Academic/Hospital | 2 | 0 | 1 | 2004 |
| New York University | Academic/Hospital | 2 | 1 | 1 | 2020 |
| PPD | For profit | 2 | 0 | 1 | 2021 |
| Rho, Inc. | For profit | 2 | 0 | 1 | 2021 |
| Rouen Normandy University | Academic/Hospital | 2 | 2 | 2 | 2025 |
| University of Cincinnati | Academic/Hospital | 2 | 2 | 1 | 2012 |
| University of Wisconsin | Academic/Hospital | 2 | 2 | 2 | 2010 |
| Alphamab Co., Ltd. | For profit | 1 | 1 | 1 | 2019 |
| CareDx | Academic/Hospital | 1 | 0 | 1 | 2021 |
| Cedars-Sinai Medical Center | Academic/Hospital | 1 | 0 | 1 | 2024 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2014 |
39 organizations
Page 1 / 2
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Bristol-Myers Squibb | For profit | MKTG | Jun 15, 2011 |
| Bristol-Myers Squibb | For profit | NDA | Jun 15, 2011 |