Product Description
Guselkumab is a human monoclonal immunoglobulin G1 lambda (IgG1lambda) antibody that selectively binds to the p19 subunit of IL-23 (a protein involved in the inflammatory response) and inhibits its interaction with the IL-23 receptor. Guselkumab is used for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy (ultraviolet radiation treatment). (Sourced from: https://dermnetnz.org/topics/guselkumab)
Mechanisms of Action: IL23 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Subcutaneous, Intravenous
FDA Designation: *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Johnson & Johnson
Company Location: NEW BRUNSWICK NJ 08933
Company CEO: Joaquin Duato
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belarus, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Latvia, Lebanon, Lithuania, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, North Macedonia, Norway, Philippines, Poland, Portugal, Puerto Rico, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tunisia, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 63
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Crohn Disease results on 2025-10-27 for Guselkumab
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Colitis, Ulcerative results on 2025-10-07 for Guselkumab
- Clinical Outcomes Reported - Johnson & Johnson presented P3 Arthritis, Psoriatic results on 2025-06-11 for Guselkumab
Highest Development Phases
Phase 3: Arthritis, Juvenile|Arthritis, Psoriatic|Colitis, Ulcerative|Crohn Disease|Psoriasis
Phase 2: Lichen Planus, Oral|Lupus Nephritis|Oral Ulcer|Pemphigus, Benign Familial|Pyoderma Gangrenosum|Scleroderma, Diffuse|Scleroderma, Systemic|Skin Ulcer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06563323 |
GEORGE | P2 |
Not yet recruiting |
Pyoderma Gangrenosum|Skin Ulcer |
2027-08-13 |
50% |
2024-08-21 |
Primary Endpoints|Treatments |
2018-003155-38 |
ORCHID-LN | P2 |
Completed |
Lupus Nephritis |
2023-01-02 |
50% |
2022-03-13 |
Treatments |
NCT06651489 |
NCT06651489 | P2 |
Recruiting |
Pemphigus, Benign Familial |
2026-04-01 |
50% |
2025-12-05 |
|
2021-000271-36 |
2021-000271-36 | P2 |
Completed |
Lichen Planus, Oral|Oral Ulcer |
2025-01-20 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
jRCT2051200133 |
jRCT2051200133 | P2 |
Active, not recruiting |
Scleroderma, Systemic |
2024-07-05 |
|||
NCT04683029 |
CR108936 | P2 |
Active, not recruiting |
Scleroderma, Diffuse |
2023-05-17 |
50% |
2023-07-21 |
|
NCT05083182 |
PSUMMIT-Jr | P3 |
Recruiting |
Arthritis, Psoriatic|Arthritis, Juvenile |
2026-12-10 |
31% |
2025-01-10 |
|
jRCT2031220426 |
jRCT2031220426 | P3 |
Recruiting |
Colitis, Ulcerative |
2026-01-29 |
|||
NCT05669833 |
EVOLUTION | P3 |
Recruiting |
Arthritis, Psoriatic |
2026-10-01 |
61% |
2025-10-10 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-503378-19-00 |
2023-503378-19-00 | P3 |
Active, not recruiting |
Psoriasis |
2026-04-17 |
2025-05-02 |
Treatments |
|
2020-006165-11 |
2020-006165-11 | P3 |
Active, not recruiting |
Crohn Disease |
2025-06-22 |
92% |
2025-05-06 |
Treatments |
NCT06260163 |
QUASAR Jr | P3 |
Recruiting |
Colitis, Ulcerative |
2028-05-22 |
74% |
2024-07-23 |
Primary Endpoints|Treatments |
2023-504737-41-00 |
CNTO1959CRD3004 | P3 |
Active, not recruiting |
Crohn Disease |
2028-03-27 |
2025-05-02 |
Treatments |
|
2023-504040-34-01 |
CNTO1959CRD3008 | P3 |
Recruiting |
Crohn Disease |
2028-03-26 |
2025-05-02 |
Treatments |
|
2023-504734-21-00 |
CNTO1959PSA3004 | P3 |
Active, not recruiting |
Arthritis, Psoriatic |
2028-03-15 |
2025-05-02 |
Treatments |
|
NCT06663332 |
TRILOGY | P3 |
Recruiting |
Arthritis, Juvenile|Arthritis, Psoriatic|Crohn Disease|Colitis, Ulcerative |
2031-12-12 |
61% |
2024-11-01 |
Primary Endpoints|Treatments |
2023-509560-16-00 |
CNTO1959ISD3001 | P3 |
Recruiting |
Colitis, Ulcerative|Crohn Disease|Arthritis, Juvenile|Arthritis, Psoriatic |
2031-12-12 |
61% |
2025-05-02 |
Treatments |
jRCT2071250012 |
jRCT2071250012 | P3 |
Not yet recruiting |
Arthritis, Psoriatic|Arthritis, Juvenile|Crohn Disease|Colitis, Ulcerative |
2031-08-09 |
|||
2023-504719-34-00 |
CNTO1959UCO3004 | P3 |
Active, not recruiting |
Colitis, Ulcerative |
2028-12-31 |
2025-05-02 |
Treatments |
|
jRCT2071230116 |
jRCT2071230116 | P3 |
Not yet recruiting |
Colitis, Ulcerative |
2028-08-14 |
|||
jRCT2031220308 |
jRCT2031220308 | P2 |
Recruiting |
Colitis, Ulcerative |
2033-10-12 |
|||
jRCT2031220309 |
jRCT2031220309 | P2 |
Recruiting |
Crohn Disease |
2030-07-18 |
|||
2023-504743-13-00 |
78934804UCO2001 | P2 |
Active, not recruiting |
Colitis, Ulcerative |
2029-03-27 |
12% |
2025-05-02 |
Treatments |
2023-504741-32-00 |
78934804CRD2001 | P2 |
Active, not recruiting |
Crohn Disease |
2029-03-27 |
12% |
2025-05-02 |
Treatments |
2022-502238-22-00 |
CNTO1959PUC3001 | P3 |
Recruiting |
Colitis, Ulcerative |
2028-08-14 |
74% |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/04/2025 |
News Article |
Royalty Pharma and Denali Therapeutics Announce $275 Million Royalty Funding Agreement |
|
12/04/2025 |
News Article |
Denali Therapeutics and Royalty Pharma Announce $275 Million Royalty Funding Agreement |
|
11/26/2025 |
News Article |
Royalty Pharma to Present at Upcoming Investor Conferences |
|
11/13/2025 |
News Article |
UCB's Bimzelx and AbbVie's Rinvoq Lead in EU5 Psoriatic Arthritis, Ankylosing Spondylitis, and Non-Radiographic Axial Spondyloarthritis Growth |
