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Guselkumab Subcutaneous
Guselkumab is a monoclonal antibody that selectively blocks interleukin-23 (IL-23) signaling to reduce inflammatory immune responses.
Guselkumab is a monoclonal antibody that selectively blocks interleukin-23 (IL-23) signaling to reduce inflammatory immune responses. Used for Moderate to severe plaque psoriasis, Psoriatic arthritis, Crohn's disease.
At a glance
| Generic name | Guselkumab Subcutaneous |
|---|---|
| Also known as | CNTO1959, TREMFYA |
| Sponsor | Janssen Research & Development, LLC |
| Drug class | IL-23 inhibitor (monoclonal antibody) |
| Target | IL-23 (p19 subunit) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Dermatology |
| Phase | Phase 3 |
Mechanism of action
Guselkumab binds to the p19 subunit of IL-23, a key cytokine involved in the differentiation and activation of pathogenic T cells in inflammatory skin and immune-mediated diseases. By inhibiting IL-23 signaling, the drug suppresses the Th17 cell response and downstream inflammatory cascades, reducing skin inflammation and systemic immune activation. This mechanism is particularly effective in psoriasis and other IL-23-driven inflammatory conditions.
Approved indications
- Moderate to severe plaque psoriasis
- Psoriatic arthritis
- Crohn's disease
Common side effects
- Upper respiratory tract infection
- Nasopharyngitis
- Injection site reactions
- Headache
Key clinical trials
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
- A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD) (PHASE4)
- A Study of the Efficacy and Safety of Guselkumab in Participants With Moderately to Severely Active Crohn's Disease (PHASE2, PHASE3)
- A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis (PHASE2)
- Transmural Healing and Disease-Modifying Effect of Guselkumab in Crohn's Disease Patients (PHASE3)
- A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis (PHASE3)
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |