Imjudo, Tremelimumab astrazeneca(tremelimumab)
Imjudo (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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Commercial
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 |
---|---|---|---|---|---|
Imjudo | tremelimumab-actl | AstraZeneca | N-761289 RX | 2022-10-21 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
imjudo | Biologic Licensing Application | 2022-10-21 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
tremelimumab, Imjudo, AstraZeneca AB | |||
2029-10-21 | Orphan excl. |
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
918 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 65 | 65 | 3 | — | 1 | 101 | |
Non-small-cell lung carcinoma | D002289 | 37 | 55 | 16 | — | — | 91 | ||
Prostatic neoplasms | D011471 | C61 | 17 | 29 | 2 | — | — | 43 | |
Colorectal neoplasms | D015179 | 20 | 26 | 2 | — | — | 40 | ||
Squamous cell carcinoma of head and neck | D000077195 | 18 | 20 | 1 | — | — | 32 | ||
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 12 | 21 | 5 | — | — | 32 |
Small cell lung carcinoma | D055752 | 10 | 10 | 3 | — | — | 20 | ||
Urinary bladder neoplasms | D001749 | C67 | 6 | 14 | 1 | — | — | 17 | |
Sarcoma | D012509 | 8 | 12 | 1 | — | — | 17 | ||
Glioblastoma | D005909 | EFO_0000515 | 7 | 7 | 2 | — | 1 | 16 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 21 | 18 | — | — | — | 34 |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 17 | 17 | — | — | 2 | 32 |
Uveal neoplasms | D014604 | EFO_1001230 | 13 | 15 | — | — | — | 24 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 12 | 13 | — | — | — | 19 |
Urologic neoplasms | D014571 | C64-C68 | 11 | 8 | — | — | — | 14 | |
Adenocarcinoma | D000230 | 2 | 11 | — | — | — | 13 | ||
Uterine cervical neoplasms | D002583 | 8 | 6 | — | — | 1 | 13 | ||
Myelodysplastic syndromes | D009190 | D46 | 10 | 2 | — | — | — | 12 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 9 | 7 | — | — | — | 12 | |
Myeloid leukemia acute | D015470 | C92.0 | 10 | 1 | — | — | — | 11 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 4 | — | — | — | — | 4 | |
Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 3 | — | — | — | — | 3 | |
Primary myelofibrosis | D055728 | D47.4 | 2 | — | — | — | — | 2 | |
Ovarian epithelial carcinoma | D000077216 | 2 | — | — | — | — | 2 | ||
Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
Myeloid leukemia chronic-phase | D015466 | 1 | — | — | — | — | 1 | ||
Thrombocytosis | D013922 | D75.83 | 1 | — | — | — | — | 1 | |
Small cell carcinoma | D018288 | 1 | — | — | — | — | 1 | ||
Female genital neoplasms | D005833 | 1 | — | — | — | — | 1 | ||
Hydronephrosis | D006869 | EFO_0005562 | N13.30 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | TREMELIMUMAB |
INN | tremelimumab |
Description | Tremelimumab (human mab) |
Classification | Antibody |
Drug class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | >5GGV:H|heavy chain
QVQLVESGGGVVQPGRSLRLSCAASGFTFSSYGMHWVRQAPGKGLEWVAVIWYDGSNKYYADSVKGRFTISRDNSKNTLY
LQMNSLRAEDTAVYYCARDPRGATLYYYYYGMDVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPE
PVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTHHHHHH
>5GGV:L|light chain
DIQMTQSPSSLSASVGDRVTITCRASQSINSYLDWYQQKPGKAPKLLIYAASSLQSGVPSRFSGSGSGTDFTLTISSLQP
EDFATYYCQQYYSTPFTFGPGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
PDB | 5GGU, 5GGV |
CAS-ID | 745013-59-6 |
RxCUI | — |
ChEMBL ID | CHEMBL2108658 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB11771 |
UNII ID | QEN1X95CIX (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
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1,425 adverse events reported
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