Guselkumab: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Guselkumab appears in the FDA drug-label database. Marketed as TREMFYA.
- Drug class
- Interleukin-23 Antagonist (FDA established pharmacologic class)
- Mechanism of action
- Interleukin-23 Antagonists (as stated on the FDA label)
FDA-approved use
TREMFYA is an interleukin-23 antagonist indicated for the treatment of: adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. ( 1.1 ) adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. ( 1.2 ) adults with moderately to severely active ulcerative colitis. ( 1.3 ) adults with moderately to severely active Crohn's disease. ( 1.4 ) 1.1 Plaque Psoriasis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with moderate-to-severe plaque psoriasis and who are candidates for systemic therapy or phototherapy. 1.2 Psoriatic Arthritis TREMFYA is indicated for the treatment of adults and pediatric patients 6 years of age and older who also weigh at least 40 kg with active psoriatic arthritis. 1.3 Ulcerative Colitis TREMFYA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis. 1.4 Crohn's Disease TREMFYA is indicated for the treatment of adult patients with moderately to sever…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Temperature Abuse — Cardinal Health Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2021-03-09 |
Phase breakdown
Conditions being studied
Recruiting trials involving Guselkumab
- A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
- A Study of Guselkumab Administered Subcutaneously in Treatment of Indian Participants With Psoriatic Arthritis (PsA)
- A Study of Guselkumab Versus Risankizumab in Participants With Moderately to Severely Active Crohn's Disease
- A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
- A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
- A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
- A Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
- A Study to Evaluate Comparative Efficacy and Safety of Guselkumab in High-dose and Extended-interval Versus Standard-dose in Chinese Participants of Moderate-to-severe Plaque Psoriasis
- Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis
- Elucidating Shared Mechanisms Contributing to NAFLD and PsA Disease Severity With Guselkumab Therapy
- Guselkumab vs Golimumab in PsA TNF Inadequate Responder Patients
- Immune Spatial Features of Guselkumab Cutaneous Response
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty
- Multi-Center PAMPA Study
- Optimal Care With Guselkumab in Crohn's Disease / OPTIM Study A Prospective Open Label Interventional, Multicenter Study
- Potential Role of Guselkumab in Modulating PAIN Perception and Related Gene Pathways: a Proof-of-concept Study.
- Stelara and Tremfya Pregnancy Exposure Registry OTIS Autoimmune Diseases in Pregnancy Project
Common questions
Is Guselkumab FDA-approved?
Yes, marketed as TREMFYA.
How many recruiting trials involve Guselkumab?
17 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.