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Guselkumab is under clinical development by Johnson & Johnson and currently in Phase II for Hidradenitis Suppurativa. According to GlobalData, Phase II drugs for Hidradenitis Suppurativa have a 44% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. 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, active lupus nephritis, generalized pustular psoriasis and erythrodermic psoriasis, familial adenomatous polyposis, skin disease like pityriasis rubra pilaris (PRP), hidradenitis suppurativa, active psoriatic arthritis, polyarticular arthritis, palmoplantar non-pustular psoriasis (first line therapy) and Crohn's disease. It was also under development for the treatment of rheumatoid arthritis and It is in Phase III stage of development for chronic plaque psoriasis in pediatric patients. It is administered through intravenous and subcutaneous routes. It is also under development for moderately to severe active ulcerative colitis. It is developed based on MorphoSys AG antibody technology.

Guselkumab was under development for the treatment of celiac disease.

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 Guselkumab’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 17 November 2023

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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.