Belimumab is under clinical development by GSK and currently in Phase II for Graves’ Ophthalmopathy. According to GlobalData, Phase II drugs for Graves’ Ophthalmopathy have a 67% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Belimumab’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Belimumab overview

Belimumab (Benlysta) is a human IgG1 monoclonal antibody specific for soluble human B lymphocyte stimulator protein (BlyS), acts as immunosuppressant agent. It is formulated as Lyophilized powder for solution and solution for intravenous and subcutaneous route of administration. Benlysta is indicated as add-on therapy in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g positive anti-dsDNA and low complement) despite standard therapy, and for the treatment of systemic lupus erythematosus inadequately treated with existing treatments in pediatrics, as an add-on therapy in patients with active, autoantibody-positive systemic lupus erythematosus with a high degree of disease activity in children of five years and older. Benlysta is also indicated for the treatment of adult patients with active lupus nephritis who are receiving standard therapy. Benlysta is indicated for the treatment of children aged 5 to 17 with active lupus nephritis (LN) who are receiving standard therapy.

Belimumab is under development for the treatment of relapsed and refractory chronic lymphocytic leukemia (CLL), persistent or chronic immune thrombocytopenia (ITP), cryoglobulinemia vasculitis (CV), hyperthyroid Graves' disease (GD), relapsing remitting multiple sclerosis and active orbitopathy (GO), diffuse cutaneous systemic sclerosis, and globally (overseas),idiopathic inflammatory myositis, active lupus nephritis, pulmonary emphysema, chronic graft-versus-host disease, lupus nephritis and autoimmune hepatitis.

It was also under development for the treatment of rheumatoid arthritis, Waldenstrom's macroglobulinemia, vasculitis including ANCA associated vasculitis (granulomatosis with polyangiitis (Wegener’s) and microscopic polyangiitis, idiopathic thrombocytopenic purpura,  idiopathic/primary membranous nephropathy, myasthenia gravis, primary Sjögren’s syndrome and prevention of kidney transplant rejection.

GSK overview

GSK is a healthcare company that focuses on developing, manufacturing and commercializing general medicines, specialty medicines and vaccines. It offers drugs for the treatment of diseases such as HIV, respiratory, cancer, immuno-inflammation, anti-viral, central nervous system (CNS), metabolic, cardiovascular, and urogenital, anti-bacterial, dermatology and rare diseases. The company also offers over-the-counter (OTC) products for pain relief, oral health, nutrition, skin health and gastrointestinal diseases. GSK’s vaccine portfolio covers various diseases including hepatitis, diphtheria, tetanus, whooping cough, rotavirus and HPV infections, measles and bacterial meningitis, among others. The company sells its products through wholesalers, pharmacies, hospitals, physicians and other groups worldwide. GSK is headquartered in Brentford, Middlesex, the UK.

For a complete picture of Belimumab’s drug-specific PTSR and LoA scores, buy the report here.

Data Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.