Drugs / Guselkumab
Regulatory milestones approvals, filings & regulatory actions · 10 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (8) | US (FDA) | TREMFYA | — | 2019-01-29 – 2026-05-28 | fda.gov ↗ |
| Approved | EU (EMA) | Tremfya | — | 2017-11-10 | europa.eu ↗ |
| Approved | US (FDA) | TREMFYA | — | 2017-07-13 | fda.gov ↗ |
Trials 84 · started per year
today
US approved 2017
EU approved 2017
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04084665 | Jun → Jul 2020 | hidradenitis suppurativa | Rockefeller University | Withdrawn | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT05083078 | Nov 2021 → Jul 2022 | psoriatic arthritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT04704843 | Jun → Sep 2021 | celiac disease | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 1 | NCT04736966 | Mar 2021 → Mar 2024 | alcoholic liver disease | University of California, San Diego | Completed | No outcome recorded |
| Phase 1 | NCT04617691 | Nov 2020 → Jul 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04030533 | Nov 2019 → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04147338 | Oct 2019 → Sep 2021 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03649971 | Nov 2018 → Sep 2021 | classic or attenuated familial adenomatous polyposis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03536325 | May → Oct 2018 | — | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT02570373 | Sep 2015 → Jan 2016 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02397382 | Jun 2015 → Aug 2016 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01866007 | May → Sep 2013 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01484587 | Aug 2011 → Apr 2013 | psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 1 | NCT00925574 | Jun 2009 → Oct 2010 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 217 trials | ||||||
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06651489 | Mar 2025 → Dec 2026 expected | Hailey-Hailey disease | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT06563323 | Feb 2025 → Aug 2027 expected | pyoderma gangrenosum, ulcer disease | Oregon Health and Science University | Recruiting | No outcome recorded |
| Phase 2 | NCT05242484 | Sep 2022 → May 2025 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05242471 | Jul 2022 → May 2025 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05071664 | Oct 2021 → May 2024 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT04683029 | Feb 2021 → May 2023 | systemic sclerosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT04633447 | Dec 2020 → May 2024 | temporal arteritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT04376827 | Sep 2020 → Feb 2023 | lupus nephritis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 2 | NCT03975153 | Oct 2019 → Aug 2022 | pityriasis rubra pilaris | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT04061395 | Oct 2019 → Dec 2021 | hidradenitis suppurativa | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT03662542 | Nov 2018 → Dec 2020 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03628924 | Sep 2018 → May 2020 | hidradenitis suppurativa | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02319759 | Mar 2015 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01845987 | Jun 2013 → Sep 2014 | palmoplantar pustulosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT01645280 | Aug 2012 → Dec 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01483599 | Nov 2011 → Nov 2012 | psoriasis | Janssen, LP | Completed | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05535738 | Nov 2022 → Jan 2027 expected | allergic contact dermatitis | Wei-Che Ko | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04033445 | Sep 2019 → Sep 2023 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT03466411 | Apr 2018 → Oct 2023 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 330 trials | ||||||
| Phase 3 | NCT07499232 | Apr 2026 → Nov 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06663332 | Oct 2024 → Dec 2031 expected | Crohn disease, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06408935 | Apr 2024 → Jun 2027 expected | Crohn disease | Janssen-Cilag Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05923073 | Mar 2024 → Oct 2027 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06260163 | Jan 2024 → Feb 2027 expected | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06039189 | Aug 2023 → Apr 2025 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT05669833 | Jul 2023 → Oct 2026 expected | psoriatic arthritis | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 3 | NCT05347095 | Sep 2022 → Mar 2027 expected | perianal Crohn disease | Janssen-Cilag Ltd. | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05528510 | Sep 2022 → Apr 2024 overdue | ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05083182 | Aug 2022 → Jan 2026 overdue | arthritic joint disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05272150 | Jul 2022 → May 2025 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT05197049 | Jan 2022 → Jul 2023 overdue | Crohn disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04936308 | Sep 2021 → Oct 2024 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04882098 | Jun 2021 → Dec 2024 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04397263 | Jun 2020 → Feb 2024 | Crohn disease | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT03998683 | Sep 2019 → Mar 2021 | psoriasis | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03796858 | Mar 2019 → Nov 2020 | psoriatic arthritis | Janssen Pharmaceutica N.V., Belgium | Completed | No outcome recorded |
| Phase 3 | NCT03818035 | Feb 2019 → Mar 2022 | psoriasis | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 3 | NCT03451851 | Jul 2018 → Jul 2023 overdue | psoriasis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03162796 | Aug 2017 → Mar 2019 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03158285 | Jul 2017 → Feb 2019 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03090100 | Apr 2017 → Aug 2018 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02905331 | Feb 2017 → Feb 2018 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02951533 | Dec 2016 → Sep 2017 | psoriasis | Janssen-Cilag GmbH | Completed | No outcome recorded |
| Phase 3 | NCT02641730 | Dec 2015 → Mar 2017 | palmoplantar pustulosis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT02343744 | Jan → Dec 2015 | pustular psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT02325219 | Dec 2014 → Mar 2016 | psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 3 | NCT02207231 | Nov 2014 → Sep 2015 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02207244 | Nov 2014 → Oct 2015 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02203032 | Oct 2014 → Dec 2015 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT07352566 | Aug 2026 → Jun 2030 expected | atopic eczema, psoriasis | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07616687 | Jun 2026 → Mar 2029 expected | Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Recruiting | No outcome recorded |
| Phase 4 | NCT07654751 | Jun 2026 → Aug 2027 expected | Crohn disease, psoriasis, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07310095 | Dec 2025 → Sep 2027 expected | Crohn disease | Xian-Janssen Pharmaceutical Ltd. | Recruiting | No outcome recorded |
| Phase 4 | NCT07141004 | Aug 2025 → Jun 2027 expected | psoriatic arthritis | Johnson & Johnson Private Limited | Recruiting | No outcome recorded |
| Phase 4 | NCT07149792 | Jul 2025 → Dec 2026 expected | psoriasis, psoriatic arthritis | Taichung Veterans General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06398106 | Dec 2024 → Mar 2028 expected | psoriasis | University Hospital, Ghent | Recruiting | No outcome recorded |
| Phase 4 | NCT06974474 | Jun 2024 → Nov 2025 overdue | psoriatic arthritis | Fondazione Policlinico Universitario Campus Bio-Medico | Recruiting | No outcome recorded |
| Phase 4 | NCT05858632 | Jul 2023 → Jun 2028 expected | psoriasis | University of California, San Francisco | Recruiting | No outcome recorded |
| Phase 4 | NCT05270733 | Nov 2022 → Dec 2026 expected | psoriasis | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05004727 | Feb 2022 → Dec 2026 expected | psoriasis | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 4 | NCT05125679 | Nov 2021 → Jul 2023 | psoriasis | Janssen-Cilag Ltd. | Terminated | No outcome recorded |
| Phase 4 | NCT04929210 | Aug 2021 → Aug 2026 overdue | psoriatic arthritis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04914429 | Aug 2021 → Sep 2023 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04645355 | Mar 2021 → Apr 2025 | guttate psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT04340076 | Aug 2020 → Jan 2025 | psoriasis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT03573323 | Nov 2018 → Jul 2019 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT06586281 | Jun 2025 → Sep 2027 expected | psoriatic arthritis | University of California, San Diego | Recruiting | No outcome recorded |
| — | NCT05503875 | Jan 2023 → Dec 2027 expected | psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| — | NCT04394936 | Sep 2020 → Feb 2023 | psoriasis | Centre for Human Drug Research, Netherlands | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 35 trials | ||||||
| Phase 3 | NCT07511647 Comparator | Jun 2026 → Dec 2027 expected | psoriasis | Qilu Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 3 | NCT07577856 Comparator | May 2026 → Aug 2028 expected | ulcerative colitis | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT07577843 Comparator | May 2026 → Jun 2028 expected | Crohn disease | Janssen Research & Development, LLC | Recruiting | No outcome recorded |
| Phase 3 | NCT06274554 Background | Oct 2024 → Dec 2028 expected | Crohn disease | Weill Medical College of Cornell University | Recruiting | No outcome recorded |
| Phase 3 | NCT05784129 Comparator | Feb → Sep 2023 | Crohn disease | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06916390 Comparator | Apr 2026 → May 2028 expected | pouchitis | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04533737 Comparator | Dec 2020 → Sep 2022 | psoriasis | LEO Pharma | Terminated | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT07532486 Comparator | Jul 2024 → Jul 2027 expected | psoriasis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04948398 Background | — | classic or attenuated familial adenomatous polyposis | Janssen Research & Development, LLC | No longer available | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-05-15 | Novartis Pharmaceuticals | Novartis ARROW trial to assess mechanistic superiority of direct IL-17A inhibition (Cosentyx®) over IL-23 inhibition (Tremfya®*) novartis.com ↗ |
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 97 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | guselkumab | “Patients will be treated with ustekinumab (90mg at week 0 and week 4 by subcutaneous injection) for 8 weeks followed by treatment with guselkumab (100mg at week 0 and week 4 by...” NCT05270733 ↗86“we compared guselkumab (CNTO 1959), an anti-interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis.” PMID 26154787 ↗ Jul 2015 “IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554 ↗ “S. pyogenes + guselkumab (1.2 μg/mL)” NCT07149792 ↗ |
| Known as | CNTO 1959 | “Pharmacokinetic Study to Evaluate the Effect of a Single Dose of Guselkumab (CNTO 1959) on CYP 450 Enzyme Activities After Subcutaneous Administration in Participants With Psoriasis” NCT02397382 ↗8“A Study to Evaluate the Comparative Efficacy of CNTO 1959 (Guselkumab) and Secukinumab for the Treatment of Moderate to Severe Plaque-type Psoriasis” NCT03090100 ↗ “guselkumab (CNTO 1959) in the treatment of participants” NCT02203032 ↗ |
| Known as | GUS | “guselkumab (GUS), an interleukin-23p19 inhibitor” PMID 38332436 ↗ Feb 2024 |
| Known as | Tremfya | “Guselkumab (Tremfya®), an IL-23 inhibitor approved for the treatment of moderate-to-severe plaque psoriasis.” NCT04645355 ↗ |
| Action | Inhibit | “guselkumab, one such selective IL-23 inhibitor” PMID 37071038 ↗ Apr 2023 |
| Modality | Monoclonal antibody | “we compared guselkumab (CNTO 1959), an anti-interleukin-23 monoclonal antibody, with adalimumab in patients with moderate-to-severe plaque psoriasis.” PMID 26154787 ↗ Jul 2015 |
| Route | Intravenous | “intravenous (IV) infusion” NCT00925574 ↗ |
| Target | IL23A | “ECLIPSE is the first comparator study of an IL-23p19 inhibitor, guselkumab” PMID 31402114 ↗ Aug 2019 |