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Tremfya (GUSELKUMAB)
Guselkumab binds to IL-23's p19 subunit, blocking its interaction with the IL-23 receptor and inhibiting proinflammatory cytokine release.
Tremfya (Guselkumab) is a small molecule Interleukin-23 (IL-23) antagonist developed by Janssen Biotech. It is FDA-approved for the treatment of Palmoplantar pustulosis and Plaque psoriasis. As a patented medication, its commercial status is not yet generic. Key safety considerations include its long half-life of 15 to 18 days. Tremfya works by blocking the action of IL-23, a protein involved in inflammation.
At a glance
| Generic name | GUSELKUMAB |
|---|---|
| Sponsor | Johnson & Johnson |
| Drug class | Interleukin-23 Antagonist [EPC] |
| Target | p19 subunit of IL-23 |
| Modality | Monoclonal antibody |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2017 |
| Annual revenue | 3600 |
Mechanism of action
Guselkumab is a human monoclonal antibody that targets the p19 subunit of IL-23. By binding to this subunit, it prevents IL-23 from interacting with its receptor, which reduces the production of proinflammatory cytokines and chemokines involved in inflammation and immune responses.
Approved indications
- Palmoplantar pustulosis
- Plaque psoriasis
Common side effects
- Upper respiratory infections
- Injection site reactions
- Headache
- Arthralgia
- Diarrhea
- Gastroenteritis
- Tinea infections
- Herpes simplex infections
- Migraine
- Candida infections
- Urticaria
- Serious adverse events
Key clinical trials
- A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis With Randomized Withdrawal and Retreatment (PHASE3)
- A Study of Guselkumab in Participants With Moderate to Severe Plaque-type Psoriasis and an Inadequate Response to Ustekinumab (PHASE3)
- A Study Evaluating the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis Including Those Previously Treated With Biologic Anti -Tumor Necrosis Factor (TNF) Alpha Agent(s) (PHASE3)
- A Study of Guselkumab in the Treatment of Participants With Moderate to Severe Plaque-Type Psoriasis (PHASE3)
- A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
- A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
- Dose Reduction of IL17 and IL23 Inhibitors in Psoriasis (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Tremfya CI brief — competitive landscape report
- Tremfya updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI