belatacept
belatacept: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.
belatacept evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could belatacept → BMY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (3)
| Company | Phase |
|---|---|
| BRISTOL MYERS SQUIBB CO (BMY) Renal Allograft Recipients | Phase 3 |
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
| BRISTOL MYERS SQUIBB CO (BMY) | Approved |
Clinical Trials (4)
Measuring the Impact of Carfilzomib and Belatacept on Allogeneic Desensitization in Prospective Kidney Transplant Recipients (ITN089ST)
Primary endpoint: Proportion of subjects who do not meet a stopping rule for safety and remain free of all of the following through 26 weeks (Cohort 1) after starting treatment or until receiving a transplant, whichever occurs earlier.
A Mechanistically Driven Therapy to Desensitize >98.0% cPRA Patients: Depletion of Plasma Cells With Anti-CD38 and Prevention of B Cell Activation With Costimulation Blockade (ITN090ST)
Primary endpoint: Proportion of subjects who have not met a subject stopping rule and remain free of all of the safety events listed in the outcome description, through 26 weeks after starting treatment or until receiving a transplant, whichever occurs earlier
A Prospective, Open-label, Multicenter, Randomized Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Renal Allograft Recipients Aged 12 to Less Than 18 Years of Age to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications
Primary endpoint: Proportion of participants who survive with a functional graft with estimated glomerular filtration rate (eGFR) > 30 mL/min/1.73 m2 (updated Schwartz formula) at 24 months post-randomization
Donor-derived Mesenchymal Stromal Cells, Alemtuzumab, Co-stimulation Blockade and Sirolimus for Tolerance Induction in Adult Kidney Allograft Recipients (ITN062ST)
Primary endpoint: Proportion of Participants who Achieve Operational Tolerance
FDA Decisions1 records
Frequently asked questions
Who is developing belatacept?
belatacept is being developed by BRISTOL MYERS SQUIBB CO.
How many clinical trials involve belatacept?
BioSniper tracks 4 clinical trials involving belatacept.
What is belatacept's latest FDA decision?
The most recent tracked FDA decision for belatacept is Approval for 1 INDICATIONS AND USAGE • NULOJIX is a selective T cell costimulation blocker indicated for prophylaxis of organ rejection in adult patients receiving a kidney transplant. (1.1) • Use in combination with basiliximab induction, mycophenolate mofetil, and corticosteroids. (1.1) Limitations of Use : • Use only in patients who are EBV seropositive. (1.2 , 4 , 5.1) • Use has not been established for the prophylaxis of organ rejection in transplanted organs other than the kidney. (1.2 , 5.6) 1.1 Adult, dated June 15, 2011.