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Drug ReportsUstekinumab
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
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Imuldosa, Otulfi, Pyzchiva, Selarsdi, Stelara, Steqeyma, Wezlana, Yesintek (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
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
imuldosaBiologic Licensing Application2025-09-02
otulfiBiologic Licensing Application2025-06-09
pyzchivaBiologic Licensing Application2025-08-04
selarsdiBiologic Licensing Application2025-02-28
stelaraBiologic Licensing Application2025-07-10
steqeymaBiologic Licensing Application2025-04-21
ustekinumabBiologic Licensing Application2025-04-08
ustekinumab-aeknBiologic Licensing Application2025-02-28
ustekinumab-ttweBiologic Licensing Application2025-03-18
wezlanaBiologic Licensing Application2025-04-01
Show 1 more
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
psoriatic arthritisEFO_0003778D015535L40.5
psoriasisEFO_0000676D011565L40
ulcerative colitisEFO_0000729D003093K51
crohn diseaseEFO_0000384D003424K50
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
243 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
PsoriasisD011565EFO_0000676L401—1——2
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
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)Loading
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-ID—
RxCUI—
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
No data
Financial
Revenue by drug
$
€
£
â‚£
Stelara – Johnson & Johnson
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,869 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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93,315 adverse events reported
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