ustekinumab
Trade name: stelara
Approved
Sep 25, 2009
Ustekinumab, sold under the brand name Stelara among others, is a monoclonal antibody medication used for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis, targeting both IL-12 and IL-23. It is administered either by intravenous infusion or subcutaneous injection. The antibody targets a subunit of human interleukin 12 and interleukin 23, which are naturally occurring proteins that regulate the immune system and immune-mediated inflammatory disorders. Ustekinumab is a fully human IgG1κ monoclonal antibody that binds to the p40 subunit of interleukin 12 and 23, thereby preventing them from binding to the IL 12Rβ1 receptor expressed on the surface of immune cells. By doing so, ustekinumab prevents the activation of the Th1 and Th17 cytokine pathways, which are central to the pathology of plaque psoriasis, psoriatic arthritis and Crohn's disease. Ustekinumab was developed by Centocor Ortho Biotech. — Wikipedia
Clinical trial activity
155 trials · 89 clinical orgs · 8 marketing orgs
Earliest trial started Nov 1, 2003 (NCT00320216)
Timeline
2000s
- Jan 1, 2003
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2005
Earliest Phase 3 Sponsor(trial)
- Jan 1, 2009
Earliest Phase 1 Sponsor(trial)
- Sep 25, 2009
Johnson and Johnson — Earliest FDA Approval
- Sep 25, 2009
Johnson and Johnson — Marketing Organization
- Sep 25, 2009
Johnson and Johnson — NDA Organization
2020s
- Apr 16, 2024
Alvotech — Marketing Organization
- Jun 28, 2024
Samsung — Marketing Organization
- Sep 27, 2024
Fresenius — Marketing Organization
- Oct 10, 2024
Accord Research — Marketing Organization
- Nov 29, 2024
Biocon Limited — Marketing Organization
- Dec 17, 2024
Celltrion — Marketing Organization
- May 22, 2025
Biothera — Marketing Organization
Indications
Approved for
Studied for
- Acute Generalized Exanthematous Pustulosis · Phase 3
- Arthritis, Juvenile · Phase 3
- Arthritis, Rheumatoid · Phase 2
- Autoimmune Diseases · Phase 2
- Axial Spondyloarthritis · Phase 3
- Behcet Syndrome · Phase 2
- Carcinoma, Giant Cell · Phase 2
- Cardiovascular Diseases · Phase 4
- Colitis · Phase 3
- Colitis, Ulcerative · Phase 4
- Crohn Disease · Phase 4
- Dermatitis, Allergic Contact · Phase 2/Phase 3
- Dermatitis, Atopic · Phase 2
- Dermatomyositis · Phase 3
- Diabetes Mellitus, Type 1 · Phase 2/Phase 3
- Diagnosis · Phase 2
- Giant Cell Arteritis · Phase 1/Phase 2
- Graft vs Host Disease · Phase 2
- Healthy Volunteers · Phase 1
- Hidradenitis Suppurativa · Phase 2
- Ichthyosis · Phase 4
- Inflammation · Phase 2/Phase 3
- Inflammatory Bowel Diseases · Phase 4
- Intestinal Diseases · Phase 1/Phase 2
- Intestinal Neoplasms · Phase 1/Phase 2
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukocytes · Phase 2
- Liver Cirrhosis, Biliary · Phase 2
- Lupus Erythematosus, Systemic · Phase 3
- Lymphoma · Phase 2
- Multiple Sclerosis · Phase 2
- Neoplasms · Phase 2
- Pemphigoid, Bullous · Phase 2
- Pharmacokinetics · Early Phase 1
- Polymyositis · Phase 3
- Pouchitis · Phase 3
- Rheumatic Diseases · Phase 2
- Sarcoidosis · Phase 2
- Sjogren's Syndrome · Phase 1
- Spondylitis, Ankylosing · Phase 3
- Substance Withdrawal Syndrome · Phase 3
- Takayasu Arteritis · Phase 3
- Uveitis · Phase 2
Mechanism of action
- Interleukin-23 subunit alphaINHIBITOR
IL23A inhibitor
- Interleukin-12 subunit betaINHIBITOR
IL12B inhibitor
- Interleukin-23INHIBITOR
Interleukin-23 inhibitor
Beta subunit is binding site
- Interleukin-12INHIBITOR
Interleukin-12 inhibitor
Beta subunit is binding site
Approval history
- approvedSep 25, 2009
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaUstekinumab ↗
- NCATSFU77B4U5Z0 ↗
- ChEMBLCHEMBL1201835 ↗
Also known as
- cnto 1275
- cnto 1275
- cnto-1275
- cnto-1275
- jnj-26113100
- stelara
- stelara
- stelara
- stelara
- stelara
- stelera
- stelera
- tt-20
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
- ustekinumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07268534 | Phase 2 | Apr 1, 2026 | Assistance Publique - Hôpitaux de Paris |
| NCT07177118 | Phase 3 | Oct 20, 2025 | Wenzhou Medical University |
| NCT07303686 | Phase 4 | Oct 8, 2025 | Janssen Pharmaceutica NV, McGill University |
| NCT07138898 | Phase 2 | Sep 30, 2025 | New York University |
| NCT07116967 | Phase 3 | Sep 22, 2025 | Bristol-Myers Squibb |
| NCT07149467 | Phase 3 | Sep 10, 2025 | Sun Yat-Sen University |
| NCT06788340 | Phase 4 | Sep 1, 2025 | University of Southern Denmark |
| NCT06807593 | N/A | Jun 30, 2025 | University of Texas at Houston |
| NCT06951828 | Phase 1 | May 30, 2025 | Celltrion |
| NCT06934226 | Phase 3 | Apr 15, 2025 | — |
| NCT06878404 | Phase 3 | Feb 21, 2025 | — |
| NCT06742606 | Early Phase 1 (Phase 1) | Jan 15, 2025 | Ain Shams University |
| NCT06738277 | Phase 1 | Jan 14, 2025 | Biocon Limited |
| NCT06912815 | N/A | Aug 1, 2024 | Sun Yat-Sen University |
| NCT06453317 | Phase 2 | Jul 31, 2024 | Government of Poland, K. Marcinkowski University of Medical Sciences, Medical University of Lodz, Poznan University |
| NCT06520397 | Phase 4 | Jul 15, 2024 | Sun Yat-Sen University |
| NCT06425549 | Phase 3 | Jun 25, 2024 | UCB |
| NCT06290934 | Phase 2 | Mar 27, 2024 | Gilead Sciences |
| NCT06045754 | Phase 4 | Jan 16, 2024 | Takeda |
| NCT05928039 | Phase 4 | Oct 25, 2023 | Robarts Clinical Trials, University of Calgary |
Organizations
Research & Development (89)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Johnson and Johnson | For profit | 31 | 29 | 4 | 2007 |
| Janssen Pharmaceutica NV | For profit | 26 | 13 | 5 | 2008 |
| Centocor | For profit | 13 | 12 | 4 | 2003 |
| AbbVie | For profit | 4 | 4 | 1 | 2016 |
| Amgen | For profit | 4 | 4 | 1 | 2012 |
| Boehringer Ingelheim | For profit | 4 | 2 | 2 | 2014 |
| Bristol-Myers Squibb | For profit | 3 | 3 | 3 | 2016 |
| Celltrion | For profit | 3 | 3 | 2 | 2020 |
| National Institute of Allergy and Infectious Diseases (NIAID) | Government | 3 | 3 | 1 | 2014 |
| Novartis | For profit | 3 | 3 | 1 | 2014 |
| Sun Yat-Sen University | Academic/Hospital | 3 | 3 | 3 | 2024 |
| Alvotech | For profit | 2 | 2 | 2 | 2021 |
| AO GENERIUM | For profit | 2 | 2 | 2 | 2022 |
| Assistance Publique - Hôpitaux de Paris | Academic/Hospital | 2 | 2 | 1 | 2018 |
| Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW | Academic/Hospital | 2 | 2 | 1 | 2020 |
| Biocon Limited | For profit | 2 | 2 | 2 | 2022 |
| Biothera | For profit | 2 | 2 | 2 | 2020 |
| Eli Lilly | For profit | 2 | 2 | 1 | 2015 |
| Juvenile Diabetes Research Foundation | Academic/Hospital | 2 | 0 | 2 | 2015 |
| Katholieke Universiteit Leuven | Academic/Hospital | 2 | 2 | 2 | 2018 |
Marketing (10)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Oct 10, 2024 |
| Alvotech | For profit | MKTG | Apr 16, 2024 |
| Biocon Limited | For profit | MKTG | Nov 29, 2024 |
| Biothera | For profit | MKTG | May 22, 2025 |
| Celltrion | For profit | MKTG | Dec 17, 2024 |
| Fresenius | For profit | MKTG | Sep 27, 2024 |
| Johnson and Johnson | For profit | MKTG | Sep 25, 2009 |
| Johnson and Johnson | For profit | SYN | Sep 23, 2016 |
| Johnson and Johnson | For profit | NDA | Sep 25, 2009 |
| Samsung | For profit | MKTG | Jun 28, 2024 |