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Stelara(ustekinumab)
Stelara (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
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
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
StelaraustekinumabJohnson & JohnsonN-125261 RX2009-09-25
3 products
StelaraustekinumabJohnson & JohnsonN-761044 RX2016-09-23
1 products
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
stelaraBiologic Licensing Application2020-12-16
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
crohn diseaseEFO_0000384D003424K50
psoriatic arthritisEFO_0003778D015535L40.5
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L04: Immunosuppressants
— L04A: Immunosuppressants
— L04AC: Interleukin inhibitors
— L04AC05: Ustekinumab
HCPCS
Code
Description
J3357
Ustekinumab, for subcutaneous injection, 1 mg
J3358
Ustekinumab, for intravenous injection, 1 mg
Clinical
Clinical Trials
160 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L4073318857
Crohn diseaseD003424EFO_0000384K50471341440
Ulcerative colitisD003093EFO_0000729K511—41713
Inflammatory bowel diseasesD015212EFO_0003767——4217
Cardiovascular diseasesD002318EFO_0000319I98———1—1
Lamellar ichthyosisD017490Q80———1—1
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Psoriatic arthritisD015535EFO_0003778L40.5—37—212
Systemic lupus erythematosusD008180EFO_0002690M32—12——3
Type 1 diabetes mellitusD003922EFO_0001359E10131——3
ColitisD003092EFO_0003872K52.9——3——3
Juvenile arthritisD001171EFO_0002609M081—1——2
PouchitisD019449EFO_0003921K91.850——1——1
DermatomyositisD003882EFO_0000398M33——1——1
PolymyositisD017285EFO_0003063M33.2——1——1
AnkylosisD000844M24.6——1——1
Takayasu arteritisD013625EFO_1001857M31.4——1——1
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Atopic dermatitisD003876EFO_0000274L20—2——13
Giant cell arteritisD013700EFO_1001209M31.612———2
UveitisD014605EFO_1001231H20.912———2
Rheumatoid arthritisD001172EFO_0000685M06.9—1———1
Autoimmune diseasesD001327EFO_0000540M30-M36—1———1
Graft vs host diseaseD006086D89.81—1———1
Bullous pemphigoidD010391EFO_0007187L12—1———1
Behcet syndromeD001528EFO_0003780M35.2—1———1
Hidradenitis suppurativaD017497L73.2—1———1
Biliary liver cirrhosisD008105K74.3—1———1
Show 3 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—6————6
IchthyosisD007057E50.81————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InflammationD007249————11
PregnancyD011247EFO_0002950Z33.1————11
Alzheimer diseaseD000544EFO_0000249F03————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameUSTEKINUMAB
INNustekinumab
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 classmonoclonal antibodies
Image (chem structure or protein)USTEKINUMAB
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
PDB3HMW, 3HMX
CAS-ID815610-63-0
RxCUI847083
ChEMBL IDCHEMBL1201835
ChEBI ID—
PubChem CID—
DrugBankDB05679
UNII IDFU77B4U5Z0 (ChemIDplus, GSRS)
Target
Agency Approved
IL12B
IL12B
Organism
Homo sapiens
Gene name
IL12B
Gene synonyms
NKSF2
NCBI Gene ID
3593
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
P29460
Mouse ortholog
Il12b (16160)
interleukin-12 subunit beta (Q9QUM1)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Stelara - Johnson & Johnson
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,196 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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6,932 adverse events reported
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