Ustekinumab is under clinical development by Johnson & Johnson and currently in Phase III for Type 1 Diabetes (Juvenile Diabetes). According to GlobalData, Phase III drugs for Type 1 Diabetes (Juvenile Diabetes) have a 62% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Ustekinumab’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.

Ustekinumab overview

Ustekinumab (Stelara) is a human monoclonal antibody used as immunosuppressant. It is produced by a recombinant DNA technology. It is formulated as a injectable solution for injection, powder for solution and solution for injection in pre-filled syringe for subcutaneous and intravenous route and injectable concentrate solution for subcutaneous route of administration. It is indicated for the treatment of adult patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy, for the treatment of adult  patients (18 years or  older) with active psoriatic arthritis (PsA), alone or in combination with methotrexate. Stelara is also indicated for the treatment of moderate to severe plaque psoriasis in adolescent patients from the age of 12 years to 17 years, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies, for the treatment of moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant to treatment with one or more TNF blockers, and for the treatment of adult patients with moderately to severely active ulcerative colitis. Stelara is also indicated for the treatment of pediatric patients aged 6 to 11 years with moderate to severe plaque psoriasis. Stelara is also indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies. Ustekinumab is under development for the treatment of active juvenile psoriatic arthritis, ichthyosis, pouchitis and Crohn's disease in pediatrics, ulcerative colitis in pediatrics, Takayasu Arteritis and type 1 diabetes mellitus. It is based on UltiMAb technology. The drug candidate acts by targeting interleukin 12 subunit beta and interleukin 23 subunit alpha. It was also under development for the treatment of sarcoidosis, active radiographic or non-radiographic axial spondyloarthritis, primary biliary cirrhosis (PBC), rheumatoid arthritis, hidradenitis suppurativa, severe atopic dermatitis, and relapsing-remitting multiple sclerosis. It was under development for systemic lupus erythematosus, active polymyositis and dermatomyositis.

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 Ustekinumab’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.