Drugs / Ustekinumab
Regulatory milestones approvals, filings & regulatory actions · 11 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (9) | US (FDA) | STELARA | — | 2009-12-30 – 2026-04-15 | fda.gov ↗ |
| Approved | US (FDA) | STELARA | — | 2009-09-25 | fda.gov ↗ |
| Approved | EU (EMA) | Stelara | — | 2009-01-16 | europa.eu ↗ |
Trials 109 · started per year
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT06742606 | Jan 2025 → Apr 2026 overdue | — | Ain Shams University | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT04549792 | Apr 2021 → Jan 2024 | ichthyosis | Northwestern University | Completed | No outcome recorded |
| Phase 112 trials | ||||||
| Phase 1 | NCT05725876 | Jan 2025 → Jul 2026 overdue | Crohn disease, psoriasis | University Medical Center Groningen | Recruiting | No outcome recorded |
| Phase 1 | NCT05890118 | Aug → Nov 2023 | — | RANI Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT05252533 | May 2022 → Jan 2024 | psoriasis, psoriasis-related juvenile idiopathic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04744363 | May 2021 → Mar 2022 | psoriasis | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 1 | NCT04772274 | Feb 2021 → Apr 2022 | — | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04093531 | Jan 2020 → May 2022 | Sjogren syndrome | University of Rochester | Completed | No outcome recorded |
| Phase 1 | NCT04030533 | Nov 2019 → Dec 2020 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT03358706 | Feb 2018 → Nov 2021 | Crohn disease, ulcerative colitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 1 | NCT02968108 | Jan 2017 → Sep 2018 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT02156375 | May → Dec 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01276847 | Mar → Dec 2011 | psoriasis | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT01081704 | Oct 2009 → Jun 2010 | — | Centocor, Inc. | Completed | No outcome recorded |
| Phase 1/25 trials | ||||||
| Phase 1/2 | NCT03366142 | Jul 2018 → Oct 2024 | leukocyte adhesion deficiency 1 | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT02955147 | Dec 2016 → Jul 2019 | temporal arteritis | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 1/2 | NCT02199496 | Oct 2015 → Aug 2019 | diarrhea, glucose-stimulated secretory, with common variable immunodeficiency, gastrointestinal mucositis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/2 | NCT02117765 | Mar 2015 → Feb 2017 | type 1 diabetes mellitus | University of British Columbia | Unknown | No outcome recorded |
| Phase 1/2 | NCT01647152 | Jul 2012 → Jun 2015 | uveitis | National Eye Institute (NEI) | Withdrawn | No outcome recorded |
| Phase 230 trials | ||||||
| Phase 2 | NCT07268534 | Apr 2026 → Nov 2029 expected | Quinquaud's folliculitis decalvans | Assistance Publique - Hôpitaux de Paris | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06807593 | Feb 2026 → Mar 2027 expected | cancer | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT07138898 | Dec 2025 → Jan 2028 expected | rheumatic disorder | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 2 | NCT06453317 | Feb 2025 → Apr 2028 expected | ulcerative colitis | Medical University of Lodz | Recruiting | No outcome recorded |
| Phase 2 | NCT07582991 | Mar 2024 → Feb 2026 | Behcet disease, myelodysplastic syndrome | Liu Tian | Completed | No outcome recorded |
| Phase 2 | NCT04572815 | May 2021 → Oct 2025 overdue | hematopoietic and lymphoid system neoplasm | Fred Hutchinson Cancer Center | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03651518 | Oct 2020 → Nov 2025 | autoimmune disease, inflammatory disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT04117932 | Mar 2020 → Dec 2022 | bullous pemphigoid | Reims University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT03847272 | Aug 2019 → Oct 2023 | — | Centre Hospitalier Universitaire Dijon | Terminated | No outcome recorded |
| Phase 2 | NCT03881059 | Apr 2019 → Apr 2020 | psoriatic arthritis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT03711448 | Jan 2019 → Sep 2024 | temporal arteritis | Centre Hospitalier Universitaire Dijon | Completed | No outcome recorded |
| Phase 2 | NCT02648581 | Jun 2017 → May 2019 | Behcet disease | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2 | NCT02911116 | Mar 2017 → Mar 2020 | uveitis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT02877134 | Aug 2016 → Dec 2020 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02204397 | Nov 2015 → Mar 2017 | type 1 diabetes mellitus | Jewish General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02349061 | Oct 2015 → May 2017 | systemic lupus erythematosus | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01999868 | Mar 2014 → Dec 2017 | psoriasis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2 | NCT01945086 | Sep 2013 → Dec 2014 | atopic eczema | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 2 | NCT01806662 | Mar 2013 → Mar 2015 | atopic eczema | Rockefeller University | Completed | No outcome recorded |
| Phase 2 | NCT01713400 | Feb 2013 → Oct 2014 | graft versus host disease | H. Lee Moffitt Cancer Center and Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01645280 | Aug 2012 → Dec 2013 | rheumatoid arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT01704534 | May 2012 → Jan 2014 | hidradenitis suppurativa | University Medical Center Groningen | Completed | No outcome recorded |
| Phase 2 | NCT01330901 | Oct 2011 → Apr 2013 | ankylosing spondylitis | Charite University, Berlin, Germany | Completed | No outcome recorded |
| Phase 2 | NCT01389973 | Sep 2011 → Jun 2013 | primary biliary cholangitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00955279 | Nov 2009 → May 2012 | sarcoidosis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00771667 | Dec 2008 → May 2010 | Crohn disease | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00267956 | Dec 2005 → Mar 2007 | psoriatic arthritis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00207727 | Jul 2004 → Mar 2006 | multiple sclerosis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00265122 | Apr 2004 → Nov 2005 | Crohn disease | Centocor, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00320216 | Nov 2003 → Jun 2004 | psoriasis | Centocor, Inc. | 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 | NCT03941132 | Jan 2021 → Feb 2026 overdue | type 1 diabetes mellitus | University of British Columbia | 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 336 trials | ||||||
| Phase 3 | NCT05083182 | Aug 2022 → Jan 2026 overdue | arthritic joint disease | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05092269 | Oct 2021 → Sep 2027 expected | Crohn disease, psoriatic arthritis, ulcerative colitis | Janssen Research & Development, LLC | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04882072 | Sep 2021 → May 2023 | Takayasu arteritis | Janssen Pharmaceutical K.K. | Terminated | No outcome recorded |
| Phase 3 | NCT05299931 | Sep 2021 → Jun 2026 overdue | Crohn disease | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04673357 | Apr 2021 → Nov 2024 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04761627 | Mar 2021 → Feb 2023 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04630028 | Mar 2021 → May 2025 | ulcerative colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT04632927 | Dec 2020 → Oct 2024 | psoriatic arthritis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT04607980 | Nov 2020 → Jan 2022 | psoriasis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT04610476 | Oct 2020 → Oct 2024 | psoriatic arthritis, substance withdrawal syndrome | University of Erlangen-Nürnberg Medical School | Unknown | No outcome recorded |
| Phase 3 | NCT04435600 | Jul 2020 → Feb 2024 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT04060888 | Jul 2020 → Jan 2022 | systemic lupus erythematosus | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT04089345 | Jun 2020 → Dec 2022 | pouchitis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 3 | NCT03981744 | Jul 2019 → Jan 2022 | dermatomyositis | Janssen Pharmaceutical K.K. | Terminated | No outcome recorded |
| Phase 3 | NCT03782376 | Dec 2018 → Aug 2022 | Crohn disease | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT03517722 | Apr 2018 → Nov 2020 | systemic lupus erythematosus | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT03464136 | Mar 2018 → Dec 2020 | Crohn disease | Janssen Scientific Affairs, LLC | Completed | No outcome recorded |
| Phase 3 | NCT03107793 | Apr 2017 → Apr 2020 | Crohn disease | Janssen-Cilag Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02698475 | May 2016 → Dec 2017 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT02437162 | Sep 2015 → Mar 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02438787 | Jul 2015 → Aug 2017 | spondyloarthropathy | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02407223 | Jul 2015 → Sep 2017 | ankylosing spondylitis | Janssen Research & Development, LLC | Terminated | No outcome recorded |
| Phase 3 | NCT02407236 | Jul 2015 → Aug 2018 | ulcerative colitis | 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 3 | NCT01550744 | Mar 2012 → May 2015 | psoriasis | Janssen Biotech, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01369355 | Sep 2011 → Jun 2015 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01369342 | Jul 2011 → Aug 2014 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01369329 | Jul 2011 → Jun 2013 | Crohn disease, colitis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01090427 | May 2010 → Jan 2013 | psoriasis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01077362 | Mar 2010 → Mar 2012 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01009086 | Dec 2009 → Oct 2011 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 3 | NCT01008995 | Oct 2009 → Jul 2011 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00747344 | Dec 2008 → Sep 2009 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00454584 | Mar 2007 → Jan 2008 | psoriasis | Centocor, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00267969 | Dec 2005 → Jul 2006 | psoriasis | Centocor Research & Development, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT00307437 | May 2005 → Dec 2006 | psoriasis | Centocor Research & Development, Inc. | Completed | No outcome recorded |
| Phase 416 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 | NCT07576452 | Jun 2026 → Jun 2030 expected | ulcerative colitis | University Hospital, Clermont-Ferrand | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07303686 | Oct 2025 → Apr 2027 expected | Crohn disease, ulcerative colitis | McGill University Health Centre/Research Institute of the McGill University Health Centre | Recruiting | No outcome recorded |
| Phase 4 | NCT06788340 | Sep 2025 → Aug 2027 expected | Crohn disease, ulcerative colitis | Odense University Hospital | Not yet 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 | NCT06045754 | Apr 2024 → Jun 2027 expected | Crohn disease | Takeda | Recruiting | No outcome recorded |
| Phase 4 | NCT05861167 | Jun 2023 → Jun 2024 | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 4 | NCT05270733 | Nov 2022 → Dec 2026 expected | psoriasis | University Hospitals Cleveland Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05169593 | Sep 2022 → Oct 2027 expected | Crohn disease | Universitaire Ziekenhuizen KU Leuven | Recruiting | No outcome recorded |
| Phase 4 | NCT04629196 | Feb 2022 → Jan 2024 | Crohn disease | NYU Langone Health | Terminated | No outcome recorded |
| Phase 4 | NCT05029921 | Dec 2021 → May 2025 | Crohn disease | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 4 | NCT04996485 | Mar 2021 → Mar 2023 | inherited ichthyosis | National Medical Research Center for Children's Health, Russian Federation | Unknown | No outcome recorded |
| Phase 4 | NCT04496063 | Nov 2020 → Jun 2025 overdue | perianal Crohn disease | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Active not recruiting | No outcome recorded |
| Phase 4 | NCT02693470 | Aug 2014 → Jul 2016 | psoriasis | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01511315 | Mar 2012 → Dec 2014 | psoriasis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 4 | NCT01059773 | Oct 2009 → Nov 2010 | psoriasis | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07529236 | Apr 2026 → Oct 2027 expected | inflammatory bowel disease | Centre Hospitalier Universitaire de Nice | Recruiting | No outcome recorded |
| — | NCT06912815 | Aug 2024 → Sep 2026 expected | Crohn disease | Xiang Gao | Recruiting | No outcome recorded |
| — | NCT03712826 | Jul 2022 | Crohn disease | Hospices Civils de Lyon | Withdrawn | No outcome recorded |
| — | NCT01090063 | Feb 2010 → Feb 2012 | psoriasis | Tufts Medical Center | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03362736 | — | Crohn disease | Janssen Research & Development, LLC | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 48 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06481215 Comparator | Mar → Sep 2022 | — | AO GENERIUM | Completed | No outcome recorded |
| Phase 1 | NCT04371185 Comparator | Aug 2020 → Apr 2021 | psoriasis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 1 | NCT04428814 Comparator | Aug 2020 → Feb 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 1 | NCT02763969 Background | May → Dec 2016 | psoriasis | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT03167437 Comparator | Oct 2017 → Jun 2035 expected | Crohn disease | National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT04978493 Background | Dec 2021 → Jul 2024 | Crohn disease | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 2 | NCT04655807 Background | Mar 2021 → May 2023 | Crohn disease | Janssen Research & Development, LLC | Withdrawn | No outcome recorded |
| Phase 2 | NCT02319759 Background | Mar 2015 → May 2016 | psoriatic arthritis | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02054481 Comparator | Feb → Nov 2014 | psoriasis | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 331 trials | ||||||
| Phase 3 | NCT07177118 Comparator | Oct 2025 → Jun 2028 expected | Crohn disease | First Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07116967 Comparator | Sep 2025 → Jan 2031 expected | psoriasis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT07149467 Comparator | Sep 2025 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06934226 Comparator | Apr → Nov 2025 overdue | psoriasis | Janssen Research & Development, LLC | Active not 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 | NCT06425549 Comparator | Jun 2024 → Aug 2028 expected | psoriasis | UCB Biopharma SRL | Recruiting | No outcome recorded |
| Phase 3 | NCT06488664 Comparator | Jul 2023 → Apr 2025 overdue | psoriasis | AO GENERIUM | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04305327 Comparator | Dec 2022 → May 2023 | psoriasis | LEO Pharma | Terminated | No outcome recorded |
| Phase 3 | NCT05335356 Comparator | Jun 2022 → Jan 2023 | psoriasis | Biocon Biologics UK Ltd | Completed | No outcome recorded |
| Phase 3 | NCT04967508 Comparator | Jul 2021 → Feb 2022 | psoriasis | Samsung Bioepis Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04728360 Comparator | Jul 2021 → Oct 2022 | psoriasis | Bio-Thera Solutions | Completed | No outcome recorded |
| Phase 3 | NCT04930042 Comparator | Jun → Dec 2021 | psoriasis | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 3 | NCT04785326 Comparator | Apr 2021 → Feb 2022 | psoriasis | Dong-A ST Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT04673786 Comparator | Jan → Aug 2021 | psoriasis | Celltrion | Completed | No outcome recorded |
| Phase 3 | NCT04595409 Comparator | Nov 2020 → Jun 2021 | psoriasis | Bioeq GmbH | Completed | No outcome recorded |
| Phase 3 | NCT04524611 Comparator | Sep 2020 → Feb 2028 expected | Crohn disease | AbbVie | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04505410 Comparator | Sep 2020 → Dec 2023 | ulcerative colitis | University of Miami | Completed | No outcome recorded |
| Phase 3 | NCT04245215 Comparator | Mar 2020 → Sep 2024 | Crohn disease | Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | Completed | No outcome recorded |
| Phase 3 | NCT03926130 Comparator | Jul 2019 → Aug 2023 | Crohn disease | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03370133 Comparator | Dec 2017 → Jan 2019 | psoriasis, psoriatic arthritis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT03148860 Comparator | Dec 2016 → Apr 2021 | psoriatic arthritis | Dr. Frank Behrens | Completed | No outcome recorded |
| Phase 3 | NCT02826603 Comparator | Jun 2016 → Jul 2018 | psoriasis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02684357 Comparator | Mar → Dec 2016 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02684370 Comparator | Feb → Dec 2016 | psoriasis | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT02561806 Comparator | Oct 2015 → May 2016 | psoriasis | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02074982 Comparator | Feb 2014 → Jun 2016 | psoriasis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT01708629 Comparator | Sep 2012 → Aug 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT01708603 Comparator | Aug 2012 → Sep 2014 | psoriasis | Bausch Health Americas, Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT02786732 Comparator | Aug 2012 → Jun 2017 | psoriasis | MedDerm Associates | Terminated | No outcome recorded |
| Phase 3 | NCT01091051 Comparator | Mar 2010 → Aug 2011 | palmoplantar pustulosis | Innovaderm Research Inc. | Terminated | No outcome recorded |
| Phase 3 | NCT00723528 Comparator | Mar 2008 → Jan 2009 | psoriasis | Janssen Pharmaceutical K.K. | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT06520397 Comparator | Jul 2024 → Dec 2026 expected | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 4 | NCT05928039 Comparator | Oct 2023 → Jul 2027 expected | Crohn disease | University of Calgary | Recruiting | No outcome recorded |
| Phase 4 | NCT03885713 Comparator | Sep 2019 → Dec 2024 | Crohn disease, ulcerative colitis | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Completed | No outcome recorded |
| Phase 4 | NCT03629379 Comparator | Jan 2019 → Jan 2021 | inflammatory bowel disease, psoriasis | Universitaire Ziekenhuizen KU Leuven | Completed | No outcome recorded |
| Phase 4 | NCT02187172 Comparator | Jul 2014 → Sep 2018 | cardiovascular disorder, psoriasis | University of Pennsylvania | Completed | No outcome recorded |
| Phase 4 | NCT02144857 Comparator | May 2014 → Sep 2023 | psoriasis | University of Athens | Unknown | No outcome recorded |
| Phase 4 | NCT01558310 Comparator | Aug 2012 → Oct 2013 | psoriasis | Paul Steven Yamauchi, MD, PhD | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04779762 Background | Jan 2022 → Jan 2025 | Crohn disease | Wolfson Medical Center | Unknown | No outcome recorded |
Press releases naming this drug 17 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab) tevapharm.com ↗ |
| 2025-05-05 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alvotech Announce FDA Approval of Interchangeability for SELARSDI™ (ustekinumab-aekn) with Stelara® (ustekinumab) tevapharm.com ↗ |
| 2025-02-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S. tevapharm.com ↗ |
| 2025-02-21 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva and Alvotech Announce SELARSDI™ (ustekinumab-aekn) Injection Now Available in the U.S. tevapharm.com ↗ |
| 2024-10-22 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce U.S. FDA Approval of Additional Presentation of SELARSDI™ (ustekinumab-aekn), Expanding its Label to Include Further Indications Approved for Reference Product, Stelara® (ustekinumab) tevapharm.com ↗ |
| 2024-04-16 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce U.S. FDA Approval of SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara® (ustekinumab) tevapharm.com ↗ |
| 2023-10-15 | AbbVie | AbbVie's SKYRIZI® (risankizumab) Versus STELARA® (ustekinumab) Head-to-Head Study in Crohn's Disease Meets All Primary and Secondary Endpoints abbvie.com ↗ |
| 2023-09-12 | AbbVie | AbbVie's SKYRIZI® (risankizumab) Met All Primary and Secondary Endpoints Versus Stelara® (ustekinumab) in Head-to-Head Study in Crohn's Disease abbvie.com ↗ |
| 2023-09-11 | Novartis Pharmaceuticals | Sandoz announces exclusive deal to commercialize biosimilar ustekinumab, further reinforcing growing pipeline and immunology patient offering novartis.com ↗ |
| 2023-06-12 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Secure U.S. License Date for AVT04, a Proposed Biosimilar to Stelara® tevapharm.com ↗ |
| 2023-01-06 | Teva Branded Pharmaceutical Products R&D, Inc. | Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab) tevapharm.com ↗ |
| 2022-04-18 | Amgen | AMGEN ANNOUNCES POSITIVE TOP-LINE RESULTS FROM PHASE 3 STUDY OF ABP 654, BIOSIMILAR CANDIDATE TO STELARA® (USTEKINUMAB) amgen.com ↗ |
| 2019-03-05 | Novartis Pharmaceuticals | Novartis Cosentyx® shows superior improvements in psoriasis patients' quality of life versus Janssen's IL-23 Stelara®* novartis.com ↗ |
| 2018-01-16 | Novartis Pharmaceuticals | Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients novartis.com ↗ |
| 2017-07-06 | Novartis Pharmaceuticals | Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis novartis.com ↗ |
| 2016-03-05 | Novartis Pharmaceuticals | Novartis' Cosentyx superior to Stelara in delivering long-lasting skin clearance (PASI 90) for psoriasis patients at 52 weeks novartis.com ↗ |
| 2015-03-20 | Novartis Pharmaceuticals | New Novartis data shows Cosentyx(TM) is significantly superior to Stelara® and clears skin (PASI 90) in nearly 80% of psoriasis patients novartis.com ↗ |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 163 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ustekinumab | “BACKGROUND: This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab...” PMID 37212315 ↗ May 2023146“AVT04 is being developed to be a biosimilar with the European Union (EU)-licensed drug Stelara® (hereafter referred to as Stelara) ustekinumab” NCT04930042 ↗ “Ustekinumab: 260 mg (body weight ≤55kg), 390 mg (55-85kg) or 520 mg (\>85kg) IV at day 0, 90 mg SC at week 8 and every eight weeks thereafter.” NCT05169593 ↗ “new advanced therapy: Tofacitinib and Upadacitinib (JAK inhibitors), Infliximab (anti-TNF), Ustekinumab or Risankizumab (IL-23 inhibitors).” NCT04505410 ↗ “IL-23 therapy may include ustekinumab (anti-interleukin-12/23), risankizumab (anti-interleukin-23), or guselkumab (anti-interleukin-23).” NCT06274554 ↗ “The purpose of this study is to evaluate the effectiveness and safety of CNTO 1275 (ustekinumab) in patients with psoriatic arthritis.” NCT00267956 ↗ “CT-P43 is being developed as a proposed biosimilar of Stelara (ustekinumab).” NCT04428814 ↗ “A commercial formulation of ustekinumab for SC control (0.5mg)” NCT05890118 ↗ “FYB202 (Proposed ustekinumab biosimilar)” NCT04595409 ↗ “Stelara® (Ustekinumab)” NCT04967508 ↗ “Ustekinumab (Stelara)” NCT07149792 ↗ |
| Known as | CNTO 1275 | “Ustekinumab (CNTO 1275) and briakinumab (ABT-874) are monoclonal antibodies that target the standard p40 subunit of the cytokines interleukin-12 and interleukin-23...” PMID 40357993 ↗ May 20258“This is a study of the safety and efficacy of ustekinumab (CNTO 1275) in adolescent patients with moderate to severe psoriasis.” NCT01090427 ↗ “An Efficacy and Safety Study of Ustekinumab (CNTO 1275) in Participants With Plaque Psoriasis” NCT00723528 ↗ “Ustekinumab (CNTO 1275) is a monoclonal antibody directed against interleukins -12 and -23.” NCT00307437 ↗ “treatment with an experimental drug called ustekinumab (or CNTO1275) is safe or not” NCT00771667 ↗ “CNTO1275 (ustekinumab)” NCT00267956 ↗ |
| Known as | FYB202 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04595409 ↗ |
| Known as | SB17 | “Ustekinumab (SB17, EU sourced Stelara®, and US sourced Stelara®)” NCT04772274 ↗ |
| Known as | Stelara | “Ustekinumab (also known as STELARA) is an antibody medication that inhibits the inflammatory proteins IL-12 and IL-23 and is approved as a treatment for moderate to severe...” NCT01945086 ↗27“Our preliminary data demonstrates individual skin improvement (Responders) as well as lack of skin improvement (Non-Responders) in patients treated with monoclonal antibody...” NCT05270733 ↗ “This is a randomized (study medication assigned by chance), open-label (both the physician and subject know the assigned study medication) study to assess the safety,...” NCT01081704 ↗ “Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis, but this study will examine if ustekinumab...” NCT01369342 ↗ “BACKGROUND: This study assessed pharmacokinetic (PK) similarity, safety, and immunogenicity of AVT04, a candidate biosimilar, compared with reference product (RP) ustekinumab...” PMID 37212315 ↗ May 2023 “A Study of the Effectiveness and Safety of Ustekinumab (STELARA) and CNTO 1959 Administered Under the Skin of Patients With Active Rheumatoid Arthritis” NCT01645280 ↗ “A Study to Assess the Effect of Ustekinumab (Stelara®) and Etanercept (Enbrel®) in Participants With Moderate to Severe Psoriasis (MK-0000-206)” NCT01276847 ↗ “In the single-phase part of the study, subjects receive a single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit.” NCT02199496 ↗ “Ustekinumab (also known as Stelara) is approved as a treatment for the skin condition of moderate to severe plaque-type psoriasis” NCT01369329 ↗ “A Pilot Study to Investigate Ustekinumab (StelaraTM) for the Treatment of Active Sight-Threatening Uveitis” NCT01647152 ↗ “A Study of the Safety and Effectiveness of Ustekinumab (Stelara) in Chinese Patients With Psoriasis” NCT01008995 ↗ “sub-cutaneous injections of placebo and Stelara™ (ustekinumab) in subjects with scalp psoriasis.” NCT01558310 ↗ “effect of ustekinumab (Stelara) and placebo on reducing vascular inflammation” NCT02187172 ↗ “Ustekinumab (SB17, EU sourced Stelara®, and US sourced Stelara®)” NCT04772274 ↗ “Ustekinumab Injection [Stelara]” NCT04779762 ↗ “Ustekinumab (Stelara)” NCT07149792 ↗ |
| Known as | StelaraTM | “A Pilot Study to Investigate Ustekinumab (StelaraTM) for the Treatment of Active Sight-Threatening Uveitis” NCT01647152 ↗ |
| Known as | UST | “The investigators plan to include 20 patients, namely the first 10 patients who will be switched to ustekinumab (UST, n=10, only available for patients with CD) and the first...” NCT03629379 ↗9“To evaluate the efficacy and safety of ustekinumab (UST) in a multicentre, randomised, double-blind, placebo-controlled trial in adult Japanese patients with active...” PMID 37652554 ↗ Aug 2023 “OBJECTIVE: We investigated the impact of concomitant MTX on ustekinumab (UST) levels and antidrug antibody (ADA) formation in PsA and evaluated consequences in pharmacodynamics...” PMID 37079726 ↗ Dec 2023 “Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission...” NCT06912815 ↗ “This final long-term extension (LTE) analysis assessed the long-term efficacy and safety of ustekinumab (UST) in the Asian patient subpopulation of the UNITI/IM-UNITI study.” PMID 42427284 ↗ Jul 2026 “Investigational treatment : Group 1: Ustekinumab (UST) IntraVenous (IV) induction (6mg/kg) followed by UST SubCutaneous (SC) 90mg every 8 weeks.” NCT04496063 ↗ “Biologic therapies, such as vedolizumab (VDZ) and ustekinumab (UST), offer effective treatment options for inflammatory bowel disease.” PMID 41453773 ↗ Dec 2025 “ustekinumab (UST) can effectively induce and maintain clinical remission and mucosal healing of Crohn's disease (CD)” NCT05861167 ↗ “Ixekizumab (IXE) and ustekinumab (UST) are biologics with established efficacy in nail psoriasis.” PMID 32415575 ↗ May 2020 “patients with Crohn\"s disease (CD) and ulcerative colitis (UC) taking ustekinumab (UST)” NCT07303686 ↗ |
| Known as | Ustekinumab (Stelara) | “Ustekinumab (Stelara)” NCT02204397 ↗ |
| Action | Inhibit | “CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).” NCT00207727 ↗ |
| Modality | Monoclonal antibody | “Human Monoclonal Antibody to IL-12p40(CNTO1275)” NCT00207727 ↗ |
| Route | Subcutaneous | “Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo” NCT00207727 ↗ |
| Target | IL12B | “Anti-(Human Interleukin-12 Subunit beta (IL-12B, CLMF p40, NKSF2))” NCT04572815 ↗ |