Stelara(ustekinumab)
Imuldosa, Otulfi, Pyzchiva, Selarsdi, Stelara, Wezlana (ustekinumab) is an antibody pharmaceutical. Ustekinumab was first approved as Stelara on 2009-01-15. It is used to treat crohn disease and psoriatic arthritis in the USA. It has been approved in Europe to treat crohn disease, psoriasis, psoriatic arthritis, and ulcerative colitis. The pharmaceutical is active against interleukin-12 subunit beta.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Imuldosa, Otulfi, Pyzchiva, Selarsdi, Stelara, Wezlana (discontinued: Stelara)
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Ustekinumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Stelara | ustekinumab | Johnson & Johnson | N-125261 RX | 2009-09-25 | 3 products |
| Stelara | ustekinumab | Johnson & Johnson | N-761044 RX | 2016-09-23 | 1 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| stelara | Biologic Licensing Application | 2024-03-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| psoriatic arthritis | EFO_0003778 | D015535 | L40.5 |
| crohn disease | EFO_0000384 | D003424 | K50 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
Clinical
Clinical Trials
217 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriasis | D011565 | EFO_0000676 | L40 | 7 | 4 | 33 | 10 | 18 | 72 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 4 | 7 | 14 | 9 | 31 | 63 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | 3 | 4 | 2 | 14 | 24 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 1 | 3 | 6 | 2 | 10 | 22 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | 1 | 5 | 2 | 11 | 19 |
| Ulcer | D014456 | MPATH_579 | — | 1 | 3 | 3 | 1 | 10 | 18 |
| Intestinal diseases | D007410 | HP_0002242 | K63.9 | 1 | 2 | 1 | 1 | 3 | 7 |
| Inflammation | D007249 | MP_0001845 | — | 1 | 3 | 1 | 1 | 3 | 7 |
| Lamellar ichthyosis | D017490 | — | Q80 | 1 | — | — | 1 | — | 2 |
| Ichthyosis | D007057 | — | E50.8 | 1 | — | — | 1 | — | 2 |
Show 3 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Psoriatic arthritis | D015535 | EFO_0003778 | L40.5 | 1 | 3 | 8 | — | 11 | 23 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 1 | 4 | 6 | — | 11 | 22 |
| Spondylitis | D013166 | — | M46.9 | — | 1 | 3 | — | 4 | 8 |
| Spondylarthritis | D025241 | — | — | — | 1 | 3 | — | 3 | 7 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 3 | 1 | — | 2 | 5 |
| Ankylosing spondylitis | D013167 | EFO_0003898 | M45 | — | 1 | 1 | — | 2 | 4 |
| Axial spondyloarthritis | D000089183 | — | — | — | — | 3 | — | 1 | 4 |
| Systemic lupus erythematosus | D008180 | HP_0002725 | M32 | — | 1 | 2 | — | — | 3 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 1 | 3 | 1 | — | — | 3 |
| Arteritis | D001167 | EFO_0009011 | I77.6 | 1 | 2 | 1 | — | — | 3 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | 4 | 5 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 2 | — | — | 2 | 4 |
| Uveitis | D014605 | HP_0000554 | H20.9 | 1 | 3 | — | — | — | 3 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | 1 | — | — | 1 | 2 |
| Giant cell arteritis | D013700 | EFO_1001209 | M31.6 | 1 | 2 | — | — | — | 2 |
| Polymyalgia rheumatica | D011111 | EFO_0008518 | M35.3 | 1 | 2 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 1 | — | — | — | 1 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | — | 1 | — | — | — | 1 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | — | — | — | 1 |
| Behcet syndrome | D001528 | EFO_0003780 | M35.2 | — | 1 | — | — | — | 1 |
Show 10 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 8 | — | — | — | — | 8 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | 1 | — | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | — | 2 | 2 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | — | 1 | 1 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | — | — | — | 1 | 1 |
| Necrosis | D009336 | — | — | — | — | — | — | 1 | 1 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 1 | 1 |
| Intestinal obstruction | D007415 | — | K56.60 | — | — | — | — | 1 | 1 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ustekinumab |
| INN | ustekinumab |
| Description | Ustekinumab, sold under the brand name Stelara, is a human monoclonal antibody used to treat psoriasis. It is also approved to treat Crohn's disease in the United States, Israel and Australia, and ulcerative colitis in the U.S., and in the European Union (EU) among people who have not responded to more traditional treatments. |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >3HMW:H|USTEKINUMAB FAB HEAVY CHAIN
EVQLVQSGAEVKKPGESLKISCKGSGYSFTTYWLGWVRQMPGKGLDWIGIMSPVDSDIRYSPSFQGQVTMSVDKSITTAY
LQWNSLKASDTAMYYCARRRPGQGYFDFWGQGTLVTVSSSSTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSW
NSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTH
>3HMW:L|USTEKINUMAB FAB LIGHT CHAIN
DIQMTQSPSSLSASVGDRVTITCRASQGISSWLAWYQQKPEKAPKSLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQQYNIYPYTFGQGTKLEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 3HMW, 3HMX |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201835 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB05679 |
| UNII ID | FU77B4U5Z0 (ChemIDplus, GSRS) |
Target
Agency Approved
IL12B
IL12B
Organism
Homo sapiens
Gene name
IL12B
Gene synonyms
NKSF2
NCBI Gene ID
Protein name
interleukin-12 subunit beta
Protein synonyms
CLMF p40, Cytotoxic lymphocyte maturation factor 40 kDa subunit, IL-12 subunit p40, IL12, subunit p40, interleukin 12, p40, interleukin 12B (natural killer cell stimulatory factor 2, cytotoxic lymphocyte maturation factor 2, p40), interleukin-12 beta chain, natural killer cell stimulatory factor, 40 kD subunit, NK cell stimulatory factor chain 2, NKSF2
Uniprot ID
Mouse ortholog
Il12b (16160)
interleukin-12 subunit beta (Q9QUM1)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Stelara – Johnson & Johnson
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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80,774 adverse events reported
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