guselkumab
Trade name: tremfya
mAbapproved
Approved
Jul 13, 2017
Guselkumab, sold under the brand name Tremfya, is a monoclonal antibody against interleukin-23 used for the treatment of plaque psoriasis, psoriatic arthritis, and ulcerative colitis. — Wikipedia
Clinical trial activity
81 trials · 22 clinical orgs · 1 marketing orgs
Phase 1
14
Phase 2
47
Phase 3
32
Phase 4
14
Earliest trial started Jun 1, 2009 (NCT00925574)
Timeline
2000s
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
- Apr 30, 2009
Johnson and Johnson — IND Organization
- Apr 30, 2009
Johnson and Johnson — IND Organization
2010s
- Jan 1, 2011
Johnson and Johnson — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2014
Johnson and Johnson — Earliest Phase 3 Sponsor(trial)
- Jul 13, 2017
Johnson and Johnson — Earliest FDA Approval
- Jul 13, 2017
Johnson and Johnson — Marketing Organization
- Jul 13, 2017
Johnson and Johnson — NDA Organization
Indications
Approved for
Studied for
- Adenomatous Polyposis Coli · Phase 1
- Anus Diseases · Phase 3
- Arthritis, Juvenile · Phase 3
- Arthritis, Psoriatic · Phase 4
- Arthritis, Rheumatoid · Phase 2
- Celiac Disease · Phase 1
- Colitis, Ulcerative · Phase 3
- Crohn Disease · Phase 3
- Dermatitis, Allergic Contact · Phase 2/Phase 3
- Giant Cell Arteritis · Phase 2
- Healthy Volunteers · Phase 1
- Hidradenitis Suppurativa · Phase 2
- Inflammation · Phase 2/Phase 3
- Liver Diseases, Alcoholic · Phase 1
- Lupus Nephritis · Phase 2
- Pemphigus, Benign Familial · Phase 2
- Pityriasis Rubra Pilaris · Phase 2
- Pouchitis · Phase 4
- Pyoderma · Phase 2
- Pyoderma Gangrenosum · Phase 2
- Rheumatic Diseases · Phase 2
- Scleroderma, Systemic · Phase 2
- Skin Diseases · Phase 2
- Skin Ulcer · Phase 2
- Wound Healing · Phase 2
Mechanism of action
- Interleukin-23 subunit alphaINHIBITOR
IL23A inhibitor
- Interleukin-37INHIBITOR
IL37 inhibitor
- Interleukin-23INHIBITOR
Interleukin-23 inhibitor
Alpha (p19) subunit is binding site
Approval history
- approvedPriority reviewJul 13, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
First in class
Sources
- WikipediaGuselkumab ↗
- NCATS089658A12D ↗
- ChEMBLCHEMBL2364648 ↗
Also known as
- cnto 1959
- cnto 1959
- ctno 1959
- guselkumab
- guselkumab
- guselkumab
- guselkumab
- guselkumab
- guselkumab
- tremfya
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07310095 | Phase 4 | Jan 16, 2026 | Johnson and Johnson |
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT06916390 | Phase 4 | Sep 30, 2025 | Katholieke Universiteit Leuven |
| NCT07141004 | Phase 4 | Aug 12, 2025 | Johnson and Johnson |
| NCT06563323 | Phase 2 | Jan 1, 2025 | Janssen Pharmaceutica NV, Ohio State University, Oregon Health and Science University |
| NCT06651489 | Phase 2 | Nov 30, 2024 | Janssen Pharmaceutica NV, Yale University |
| NCT06663332 | Phase 3 | Oct 28, 2024 | — |
| NCT06398106 | Phase 4 | Sep 1, 2024 | Ghent University, Katholieke Universiteit Leuven |
| NCT06586281 | N/A | Sep 1, 2024 | Janssen Pharmaceutica NV, University of California, San Diego |
| NCT06974474 | Phase 4 | Jun 18, 2024 | Fondazione Policlinico Universitario Campus Bio-Medico |
| NCT06408935 | Phase 3 | Apr 17, 2024 | Johnson and Johnson |
| NCT06260163 | Phase 3 | Jan 19, 2024 | — |
| NCT05923073 | Phase 3 | Dec 15, 2023 | — |
| NCT06039189 | Phase 3 | Aug 24, 2023 | — |
| NCT05669833 | Phase 3 | Jul 14, 2023 | Janssen Pharmaceutica NV, University of Pennsylvania |
| NCT05858632 | Phase 4 | Jul 1, 2023 | Janssen Pharmaceutica NV, University of California, San Francisco |
| NCT05784129 | Phase 3 | Feb 21, 2023 | — |
| NCT05503875 | N/A | Jan 1, 2023 | Zhejiang University |
| NCT05347095 | Phase 3 | Sep 27, 2022 | Johnson and Johnson |
| NCT05242484 | Phase 2 | Sep 19, 2022 | — |
Showing 20 of 81 trials
Page 1 / 5
Organizations
Research & Development (22)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 32 | 31 | 4 | 2011 |
| Janssen Pharmaceutica NV | For profit | 31 | 18 | 5 | 2011 |
| Katholieke Universiteit Leuven | Academic/Hospital | 3 | 1 | 1 | 2020 |
| Ghent University | Academic/Hospital | 2 | 1 | 1 | 2020 |
| New York University | Academic/Hospital | 2 | 2 | 2 | 2021 |
| Oregon Health and Science University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| University of California, San Diego | Academic/Hospital | 2 | 2 | 2 | 2021 |
| University of California, San Francisco | Academic/Hospital | 2 | 2 | 1 | 2021 |
| Centocor | For profit | 1 | 1 | 1 | 2009 |
| Eli Lilly | For profit | 1 | 1 | 1 | 2018 |
| Fondazione Policlinico Universitario Campus Bio-Medico | Academic/Hospital | 1 | 1 | 1 | 2024 |
| Leiden University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Leo Pharma | For profit | 1 | 1 | 1 | 2020 |
| Ohio State University | Academic/Hospital | 1 | 0 | 1 | 2025 |
| Radboud University | Academic/Hospital | 1 | 1 | 1 | 2020 |
| Rockefeller University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Groningen | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Massachusetts | Academic/Hospital | 1 | 1 | 1 | 2022 |
| University of Pennsylvania | Academic/Hospital | 1 | 1 | 1 | 2023 |
| Yale University | Academic/Hospital | 1 | 1 | 1 | 2024 |
22 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Johnson and Johnson | For profit | MKTG | Jul 13, 2017 |
| Johnson and Johnson | For profit | NDA | Jul 13, 2017 |
| Johnson and Johnson | For profit | IND | Apr 30, 2009 |