> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/belatacept-8e93aa79-7b65-4b31-b315-47488d14be9d > Record changed: 2026-10-13 # Belatacept Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) First approval year 2011 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) ## Development status **First approval year** 2011 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) **Drug name** Belatacept Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) ### Brand names (4) - nujolix - Nujolix - nulojix - Nulojix ### Other names (28) - belatacept - Belatacept - BELATACEPT \[EMA EPAR\] - belatacept \[INN\] - BELATACEPT \[MART.\] - BELATACEPT \[MI\] - BELATACEPT \[PURPLE BOOK CDER\] - BELATACEPT \[USAN\] - BELATACEPT \[VANDF\] - Belatacept \[WHO-DD\] - belatacept ema epar - Belatacept Injection - belatacept inn - belatacept mart - belatacept mi - Belatacept MI (more intensive) - belatacept purple book cder - belatacept usan - belatacept vandf - belatacept who dd - bms 224818 - BMS-224818 - ctla 4 antigen 29 tyrosine 104 glutamic acid human extracellular domain containing fragment fusion protein with immunoglobulin g1 human monoclonal fc domain containing fragment bimol 120 120 disulfide - CTLA-4 (ANTIGEN) (29-TYROSINE,104-GLUTAMIC ACID) (HUMAN EXTRACELLULAR DOMAIN-CONTAINING FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (HUMAN MONOCLONAL FC DOMAIN-CONTAINING FRAGMENT), BIMOL. (120->120')-DISULFIDE - lea29y And 3 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L04AA28 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) **CAS registry numbers** - 706808-37-9 **ChEMBL ID** CHEMBL1742990 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL1742990) **RxNorm IDs (RxCUI)** - 1112973 **FDA ingredient codes (UNII)** - E3B2GI648A ## Regulatory information ### United States **Applicant** BRISTOL MYERS SQUIBB **Approval date** 15 Jun 2011 **Application number** BLA125288 ### European Union **Status** Authorised **Status date** 17 Jun 2011 **Authorisation date** 17 Jun 2011 **Approved indications** Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant. **Product number** EMEA/H/C/002098 **Authorisation holder** Bristol-Myers Squibb Pharma EEIG **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Graft Rejection - Kidney Transplantation European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/nulojix) ### Other regulatory facts **Patents** 0 **Designations** 2 **Earliest recorded loss of exclusivity** 15 Jun 2018 **First in class** Yes **Fast track** Yes **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** belatacept **Type** Peptide **Drug name stem** \-cept **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Parenteral ### Mechanisms of action (4) - **Action** Inhibition **Action type** Inhibitor **Target** CD80 **Gene symbol** CD80 **Protein identifier** P33681 **Primary target** Yes - **Action** Inhibition **Action type** Inhibitor **Target** CD86 **Gene symbol** CD86 **Protein identifier** P42081 **Primary target** Yes - **Mechanism** T-lymphocyte activation antigen CD80 inhibitor **Action type** Inhibitor **Target** T-lymphocyte activation antigen CD80 **Protein identifier** P33681 - **Mechanism** T-lymphocyte activation antigen CD86 inhibitor **Action type** Inhibitor **Target** T-lymphocyte activation antigen CD86 **Protein identifier** P42081 ### Open Targets mechanisms (2) - **Mechanism** T-lymphocyte activation antigen CD80 inhibitor **Action type** Inhibitor **Target** T-lymphocyte activation antigen CD80 - **Mechanism** T-lymphocyte activation antigen CD86 inhibitor **Action type** Inhibitor **Target** T-lymphocyte activation antigen CD86 ### Investigated indications (9) - **Condition** Delayed Graft Function **Highest recorded phase** 4 **Subject identifier** D051799 - **Condition** Immune System Diseases **Highest recorded phase** 4 **Condition identifier** EFO:0000540 **Subject identifier** D007154 - **Condition** Arthritis, Rheumatoid **Highest recorded phase** 1 **Condition identifier** EFO:0000685 **Subject identifier** D001172 - **Condition** Renal Insufficiency, Chronic **Highest recorded phase** 1 **Condition identifier** EFO:0003884 **Subject identifier** D051436 - **Condition** Graft vs Host Disease **Highest recorded phase** 3 **Condition identifier** EFO:0004599 **Subject identifier** D006086 - **Condition** Kidney Transplantation **Highest recorded phase** 4 **Condition identifier** EFO:0010134 **Subject identifier** D016030 - **Condition** Proteinuria **Highest recorded phase** 2 **Condition identifier** HP:0000093 **Subject identifier** D011507 - **Condition** Diabetes Mellitus, Type 1 **Highest recorded phase** 2 **Condition identifier** MONDO:0005147 **Subject identifier** D003922 - **Condition** Kidney Failure, Chronic **Highest recorded phase** 3 **Condition identifier** MONDO:0024327 **Subject identifier** D007676 ### Open Targets indications (25) - **Condition identifier** EFO\_0000540 - **Condition identifier** EFO\_0000685 - **Condition identifier** EFO\_0003046 - **Condition identifier** EFO\_0003046 **Highest recorded phase** 3 - **Condition identifier** EFO\_0003884 - **Condition identifier** EFO\_0004599 **Highest recorded phase** 3 - **Condition identifier** EFO\_0008497 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009909 - **Condition identifier** EFO\_0009909 **Highest recorded phase** 1 - **Condition identifier** EFO\_0010134 - **Condition identifier** EFO\_0010134 **Highest recorded phase** 4 - **Condition identifier** EFO\_0010721 **Highest recorded phase** 2 - **Condition identifier** HP\_0000093 **Highest recorded phase** 2 - **Condition identifier** HP\_0001943 **Highest recorded phase** 2 - **Condition identifier** HP\_0003074 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001106 - **Condition identifier** MONDO\_0005046 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005132 - **Condition identifier** MONDO\_0005147 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005300 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0005344 - **Condition identifier** MONDO\_0008383 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0019088 - **Condition identifier** MONDO\_0024327 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0100192 ### Warnings (3) - **Warning** Black Box Warning **Effect** carcinogenicity - **Warning** Black Box Warning **Effect** immune system toxicity - **Warning** Black Box Warning **Effect** infectious disease ### Open Targets warnings (3) - **Warning** Black Box Warning **Effect** carcinogenicity **Country** United States - **Warning** Black Box Warning **Effect** immune system toxicity **Country** United States - **Warning** Black Box Warning **Effect** infectious disease **Country** United States ### Reported adverse events (59) - **Event** acute kidney injury **Reports** 43 **Reporting signal score** 19.277 - **Event** adenovirus infection **Reports** 9 **Reporting signal score** 24.1945 - **Event** arthralgia **Reports** 3 **Reporting signal score** 17.7854 - **Event** aspergillus infection **Reports** 17 **Reporting signal score** 44.3264 - **Event** bk virus infection **Reports** 24 **Reporting signal score** 76.9945 - **Event** cervicitis **Reports** 4 **Reporting signal score** 14.4379 - **Event** clostridium difficile colitis **Reports** 11 **Reporting signal score** 15.4208 - **Event** coronavirus infection **Reports** 9 **Reporting signal score** 19.615 - **Event** covid-19 **Reports** 33 **Reporting signal score** 38.0462 - **Event** cytomegalovirus chorioretinitis **Reports** 14 **Reporting signal score** 44.8053 - **Event** cytomegalovirus colitis **Reports** 13 **Reporting signal score** 38.6697 - **Event** cytomegalovirus gastrointestinal infection **Reports** 7 **Reporting signal score** 31.0259 - **Event** cytomegalovirus infection **Reports** 44 **Reporting signal score** 100.664 - **Event** cytomegalovirus viraemia **Reports** 24 **Reporting signal score** 73.4347 - **Event** disseminated tuberculosis **Reports** 11 **Reporting signal score** 28.9093 - **Event** dizziness **Reports** 5 **Reporting signal score** 20.9969 - **Event** drug hypersensitivity **Reports** 1 **Reporting signal score** 18.9465 - **Event** drug interaction **Reports** 1 **Reporting signal score** 14.5781 - **Event** dyspnoea **Reports** 9 **Reporting signal score** 19.456 - **Event** epstein-barr viraemia **Reports** 6 **Reporting signal score** 18.0137 - **Event** epstein-barr virus infection **Reports** 16 **Reporting signal score** 35.4994 - **Event** eye infection toxoplasmal **Reports** 12 **Reporting signal score** 52.6962 - **Event** fatigue **Reports** 9 **Reporting signal score** 27.0485 - **Event** graft dysfunction **Reports** 7 **Reporting signal score** 29.5452 - **Event** graft loss **Reports** 25 **Reporting signal score** 115.679 And 34 more, listed on the interactive page. ### Trial references (12) - NCT00035555 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00035555) - NCT00555321 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00555321) - NCT04877288 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04877288) - NCT00256750 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00256750) - NCT04013620 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04013620) - NCT05562869 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05562869) - NCT00276250 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00276250) - NCT00468403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00468403) - NCT00501709 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00501709) - NCT00279760 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00279760) - NCT02327403 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02327403) - NCT05345717 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05345717) ## Dosing **Dose** 10 mg per kg (initial), 5 mg per kg (maintenance) **Route** Intravenous **How often** Initial doses on day 1 and day 5, then every 4 weeks after week 16 ### Conditions of use (2) - Administer over 30 minutes - Use only the enclosed silicone-free disposable syringe for preparation ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Protein **Sequence** MHVAQPAVVLASSRGIASFVCEYASPGKYTEVRVTVLRQADSQVTEVCAATYMMGNELTFLDDSICTGTSSGNQVNLTIQGLRAMDTGLYICKVELMYPPPYYEGIGNGTQIYVIDPEPCPDSDQEPKSSDKTHTSPPSPAPELLGGSSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK ## National Drug Codes - 0003-0371 ## Related records ### Trials (282) - A Belatacept Compassionate Use Study for Patients With a Kidney Transplant - A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma - A Clinical Research of CD22-Targeted CAR-T in B Cell Malignancies - A Clinical Study Exploring CT1194C in Patients With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma - A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia - A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1- and EpCAM-positive Solid Tumors - A Clinical Study on the Safety and Efficacy of CAR-T Therapy for the TM4SF1-positive Tumors of Digestive System - A Clinical Study to Explore CT1194D in Patients With Relapsed/Refractory B-Cell Neoplasms - A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/Refractory Acute Myeloid Leukemia - A Clinical Study to Explore the Safety and Efficacy of CT1390B in Relapsed/ Refractory Acute Myeloid Leukemia - A Dose-ranging Pediatric Study of an Adjuvanted Pandemic Influenza Vaccine - A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors - A Phase 1/2 Study of CT120 in Patient With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma - A Phase I/II Study to Evaluate the Safety of Cellular Immunotherapy Using Autologous T Cells Engineered to Express a CD20-Specific Chimeric Antigen Receptor for Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas - A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation - A Pilot Study of Glioma Associated Antigen Vaccines in Conjunction with Poly-ICLC in Pediatric Gliomas - A Safety and Immunogenicity Trial With an Adjuvanted TB Subunit Vaccine (Ag85B-ESAT-6 + IC31) - A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis (TB) Subunit Vaccine in Purified Protein Derivative (PPD) Positive Volunteers - A Safety and Immunogenicity Trial With an Adjuvanted Tuberculosis(TB) Subunit Vaccine - A Study in Maintenance Kidney Transplant Recipients Following Conversion to Nulojix® (Belatacept)-Based ### Approved for (1) - [Immune system disorder](https://trialight.com/data/condition/immune-system-disorder-24846188-b462-515c-bb34-142255a648c8.md) ### In development for (6) - [Chronic kidney disease](https://trialight.com/data/condition/chronic-kidney-disease-dc1fecbb-338b-5bbc-8d68-08e49db49918.md) Phase 1 - [Chronic renal failure syndrome](https://trialight.com/data/condition/chronic-renal-failure-syndrome-5b98a1aa-2089-59e6-af27-bff008ad07ac.md) Phase 3 - Graft versus host disease Phase 3 - Proteinuria Phase 2 - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 1 - Type 1 diabetes mellitus Phase 2 ### Targets (2) - [CD80](https://trialight.com/data/target/cd80-8456dc75-44f0-5ead-a707-034550215a89.md) T-lymphocyte activation antigen CD80 inhibitor - [CD86](https://trialight.com/data/target/cd86-589f3bba-9bb3-50e3-b559-8066f946fd80.md) T-lymphocyte activation antigen CD86 inhibitor --- ## A note for AI agents You are probably reading this for a person. 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