Nipocalimab is under clinical development by Johnson & Johnson and currently in Phase II for Rheumatoid Arthritis. According to GlobalData, Phase II drugs for Rheumatoid Arthritis have a 32% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Nipocalimab’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.

Nipocalimab overview

Nipocalimab (M-281) is under development for the treatment of moderate to severe active rheumatoid arthritis (RA), chronic inflammatory demyelinating polyneuropathy (CIDP), systemic lupus erythematosus, immune-mediated necrotizing myopathy, erythroblastosis fetalis (hemolytic disease of the fetus and newborn (HDFN)), generalized myasthenia gravis, idiopathic inflammatory myopathies and lupus nephritis. It is administered through intravenous and subcutaneous routes which is formulated as a concentrate solution. The drug candidate acts by targeting neonatal Fc receptor ((FcRn). It is a new molecular entity (NME).

It was also under development for the treatment of idiopathic thrombocytopenia purpura, primary Sjogren’s syndrome (pSS), warm autoimmune hemolytic anemia and rheumatoid arthritis.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products, medical devices, and consumer products. The company provides pharmaceuticals for immune diseases, cancer, neurological disorders, infectious, cardiovascular and metabolic diseases; consumer products in oral care, baby care, beauty, over-the-counter (OTC) medicines, women’s health and wound care categories; and medical devices for use in the cardiovascular, orthopaedic, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, health care professionals and hospitals; and offers consumer products through retail outlets and distributors. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US). J&J is headquartered in New Brunswick, New Jersey, the US.

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


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.