Ustekinumab is under clinical development by Johnson & Johnson and currently in Phase III for Pouchitis. According to GlobalData, Phase III drugs for Pouchitis does not have sufficient historical data to build an indication benchmark PTSR for Phase III. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Ustekinumab LoA Report. Buy the report here.

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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, Finlius) 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 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, non-infectious severe uveitis (NISU), 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, Takayasu Arteritis 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, neurovascular care, 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.

This content was updated on 10 June 2024

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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.