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Drug ReportsTremelimumab
Imjudo(tremelimumab)
Imjudo, Tremelimumab (tremelimumab) is an antibody pharmaceutical. Tremelimumab was first approved as Imjudo on 2022-10-21. It is used to treat hepatocellular carcinoma in the USA. It has been approved in Europe to treat hepatocellular carcinoma and non-small-cell lung carcinoma. The pharmaceutical is active against cytotoxic T-lymphocyte protein 4.
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Events Timeline
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YTD
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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
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Imjudo
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)
Tremelimumab
Tradename
Proper name
Company
Number
Date
Products
Imjudotremelimumab-actlAstraZenecaN-761289 RX2022-10-21
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
imjudoBiologic Licensing Application2026-08-31
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hepatocellular carcinoma—D006528C22.0
Agency Specific
FDA
EMA
Expiration
Code
tremelimumab, Imjudo, AstraZeneca AB
2029-10-21Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
1256 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
Hepatocellular carcinomaD006528—C22.04115—522
Non-small-cell lung carcinomaD002289——5105—222
CarcinomaD002277—C80.09113—120
Liver neoplasmsD008113EFO_1001513C22.0296—318
NeoplasmsD009369—C80781——14
Urinary bladder neoplasmsD001749—C67273——11
Squamous cell carcinoma of head and neckD000077195——671——10
Lung neoplasmsD008175—C34.90451——10
Small cell lung carcinomaD055752——532——10
Squamous cell carcinomaD002294——681——10
Show 7 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AdenocarcinomaD000230——28———8
Colorectal neoplasmsD015179——46———8
Ovarian neoplasmsD010051EFO_0003893C5634———6
Pancreatic neoplasmsD010190EFO_0003860C2532———5
Biliary tract neoplasmsD001661—C24.923———5
Prostatic neoplasmsD011471—C6124———4
Stomach neoplasmsD013274EFO_0003897C1622———3
Urologic neoplasmsD014571—C64-C6823———3
CholangiocarcinomaD018281—C22.1—3———3
Ovarian epithelial carcinomaD000077216——12———3
Show 29 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neoplasm metastasisD009362EFO_0009708—2————2
Endometrial neoplasmsD016889EFO_0004230—1————1
Female genital neoplasmsD005833——1————1
Vaginal neoplasmsD014625—C521————1
Vulvar neoplasmsD014846—C511————1
Thyroid neoplasmsD013964EFO_0003841—1————1
Anaplastic thyroid carcinomaD065646——1————1
Thyroid diseasesD013959—E00-E071————1
Pharyngeal neoplasmsD010610—C14.01————1
Peritoneal neoplasmsD010534——1————1
Show 1 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hereditary sensory and autonomic neuropathiesD009477——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTremelimumab
INNtremelimumab
Description
Tremelimumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>5GGV:H|heavy chain QVQLVESGGGVVQPGRSLRLSCAASGFTFSSYGMHWVRQAPGKGLEWVAVIWYDGSNKYYADSVKGRFTISRDNSKNTLY LQMNSLRAEDTAVYYCARDPRGATLYYYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPE PVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH >5GGV:L|light chain DIQMTQSPSSLSASVGDRVTITCRASQSINSYLDWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQP EDFATYYCQQYYSTPFTFGPGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB5GGU, 5GGV
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL2108658
ChEBI ID—
PubChem CID—
DrugBankDB11771
UNII IDQEN1X95CIX (ChemIDplus, GSRS)
Target
Agency Approved
CTLA4
CTLA4
Organism
Homo sapiens
Gene name
CTLA4
Gene synonyms
CD152
NCBI Gene ID
Protein name
cytotoxic T-lymphocyte protein 4
Protein synonyms
CD152, celiac disease 3, CTLA-4, cytotoxic T lymphocyte associated antigen 4 short spliced form, Cytotoxic T-lymphocyte-associated antigen 4, cytotoxic T-lymphocyte-associated serine esterase-4, gluten-sensitive enteropathy, insulin-dependent diabetes mellitus 12, ligand and transmembrane spliced cytotoxic T lymphocyte associated antigen 4
Uniprot ID
Mouse ortholog
Ctla4 (12477)
cytotoxic T-lymphocyte protein 4 (P09793)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Imjudo – AstraZeneca
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 9,999 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,596 adverse events reported
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