Ozmosi | Guselkumab Drug Profile

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 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

Map of Global Clinical Trials for Guselkumab

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

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

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Guselkumab

Alternative Names: guselkumab, cnto 1959, cnto-1959, tremfya, cnto1959 Clinical Status: Active Latest Update: 2025-12-04 Latest Update Note: News Article