Golimumab is under clinical development by Johnson & Johnson 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 Golimumab’s likelihood of approval (LoA) and phase transition for Type 1 Diabetes (Juvenile Diabetes) took place on 26 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Golimumab overview

Golimumab (Simponi) is a human monoclonal antibody, acts as immunosuppressant and anti-rheumatic agent. It is formulated as a solution for subcutaneous administration. Simponi in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis, Simponi alone or in combination with methotrexate, is indicated for the treatment of adult  patients with active psoriatic arthritis, for the treatment of adult patients with active ankylosing spondylitis, in adult patients with moderately to severely active ulcerative colitis who have demonstrated corticosteroid dependence or who have had an inadequate response to or  failed to tolerate oral aminosalicylates, oral corticosteroids, azathioprine, or 6-mercaptopurine, for the treatment of adults with severe, active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs (NSAIDs).

Simponi (Golimumab) is under development for the treatment of ulcerative colitis and type 1 diabetes. It was also under development for the treatment of musculoskeletal disorders, sarcoidosis, systemic idiopathic juvenile arthritis, structural damage, asthma, posterior uveitis and anterior uveitis.

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.

Quick View Golimumab LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Golimumab
Administration Pathway
  • Subcutaneous
Therapeutic Areas
  • Gastrointestinal
  • Immunology
  • Metabolic Disorders
  • Musculoskeletal Disorders
  • Ophthalmology
  • Respiratory
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.