Guselkumab is under clinical development by Johnson & Johnson and currently in Phase III for Crohn’s Disease (Regional Enteritis). According to GlobalData, Phase III drugs for Crohn’s Disease (Regional Enteritis) have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Guselkumab’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.

Guselkumab overview

Guselkumab (CNTO-1959, Tremfya, Tremfya One-Press) is a human immunoglobulin G1 lambda (IgG1λ) monoclonal antibody developed using HuCAL (Human Combinatorial Antibody Library) technology. It is formulated as the solution for subcutaneous route of administration. Tremfya is indicated for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy, and also indicated for the treatment of patients with palmoplantar pustulosis who are not responding or are refractory to existing treatments in adults. It is indicated for the treatment of adult patients with active psoriatic arthritis.

Guselkumab is under development for the treatment of erosive oral lichen planus, systemic sclerosis (SSc), giant cell arteritis, pediatric psoriasis and erythrodermic psoriasis, skin inflammation (pityriasis rubra pilaris (PRP)), pediatric juvenile psoriatic arthritis, structural damage psoriatic arthritis, ulcerative colitis and Crohn's disease. It is administered through intravenous and subcutaneous routes. It is developed based on MorphoSys AG antibody technology.

It was also under development for the treatment of rheumatoid arthritis, active lupus nephritis, celiac disease, familial adenomatous polyposis and hidradenitis suppurativa.

Johnson & Johnson overview

Johnson & Johnson (J&J) researches, develops, manufactures, and sells pharmaceutical products and medical devices. The company conducts business through its operating companies. It provides pharmaceuticals for immune disorders, cancer, neurological disorders, infectious, cardiovascular, and metabolic diseases; and medical devices for use in cardiovascular, orthopaedic, neurovascular care, general surgery and vision care fields. J&J distributes pharmaceutical and medical products to retailers, wholesalers, healthcare professionals and hospitals. The company offers its products in the US; Europe; Asia-Pacific and Africa; and Western Hemisphere (excluding the US) and Latin America. J&J is headquartered in New Brunswick, New Jersey, the US.

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

This content was updated on 10 June 2024

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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.