Belatacept is under clinical development by Bristol-Myers Squibb and currently in the Phase II in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Belatacept’s likelihood of approval (LoA) and phase transition for Lung Transplant Rejection took place on 28 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Belatacept Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Belatacept overview

Belatacept (Nulojix) is a soluble fusion protein consisting of a modified extracellular domain of human cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) fused to a portion (hinge-CH2-CH3 domains) of the Fc domain of a human immunoglobulin G1 antibody acts as immuno suppressant. Belatacept is produced by recombinant DNA technology in a mammalian cell expression system. It is formulated as injectable powder for concentrate solution, for intravenous route of administration. It is indicated mainly in combination with corticosteroids and a mycophenolic acid (MPA), for prophylaxis of graft rejection in adults receiving a renal transplant. It is also indicated in combination with basiliximab induction, mycophenolate mofetil (MMF) and corticosteroids for the prophylaxis of organ rejection in adult Epstein-Barr Virus (EBV) seropositive patients receiving a kidney transplant.

Belatacept (Nulojix) is also under development for the treatment of heart transplant rejection, lung transplant rejection and switch from calcineurin inhibitor renal transplant rejection.

Bristol-Myers Squibb overview

Bristol-Myers Squibb (BMS) is a specialty biopharmaceutical company that is engaged in discovery, development, licensing and manufacturing, marketing, distribution and sale of medicines and related medical products to patients with serious diseases. Its primary focus is on cancer, cardiovascular, immunology and fibrotic therapeutic projects. The company offers its products across the world to wholesalers, retail pharmacies, hospitals, medical professionals and government entities. BMS provides its products in the US, Europe, and Japan. The company conducts research to focus on the discovery and development of novel medicines that address serious diseases in areas of significant unmet medical need. BMS is headquartered in New York City, New York, the US.

Quick View Belatacept LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Belatacept
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Immunology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.