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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Commercial
Therapeutic Areas
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 | 2024-07-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| hepatocellular carcinoma | — | D006528 | C22.0 |
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
1133 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 |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 12 | 18 | 7 | — | 3 | 34 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 9 | 6 | — | 2 | 21 |
| Neoplasms | D009369 | — | C80 | 9 | 10 | 1 | — | — | 18 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 8 | 4 | — | 4 | 17 |
| Lung neoplasms | D008175 | — | C34.90 | 4 | 7 | 5 | — | — | 16 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 6 | 4 | — | 2 | 13 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 7 | 8 | 2 | — | — | 12 |
| Squamous cell carcinoma | D002294 | — | — | 7 | 8 | 1 | — | — | 11 |
| Urinary bladder neoplasms | D001749 | — | C67 | 2 | 8 | 1 | — | — | 10 |
| Small cell lung carcinoma | D055752 | — | — | 4 | 3 | 3 | — | — | 10 |
Show 5 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adenocarcinoma | D000230 | — | — | 2 | 8 | — | — | — | 8 |
| Colorectal neoplasms | D015179 | — | — | 4 | 6 | — | — | — | 8 |
| Recurrence | D012008 | — | — | 2 | 5 | — | — | — | 6 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 2 | 4 | — | — | — | 6 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 4 | 2 | — | — | — | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | 4 | — | — | — | 6 |
| Cholangiocarcinoma | D018281 | — | C22.1 | — | 4 | — | — | — | 4 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | 3 | — | — | — | 4 |
| Prostatic neoplasms | D011471 | — | C61 | 2 | 4 | — | — | — | 4 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | 2 | — | — | — | 3 |
Show 31 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Vaginal neoplasms | D014625 | — | C52 | 1 | — | — | — | — | 1 |
| Vulvar neoplasms | D014846 | — | C51 | 1 | — | — | — | — | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | 1 | — | — | — | — | 1 |
| Anaplastic thyroid carcinoma | D065646 | — | — | 1 | — | — | — | — | 1 |
| Thyroid diseases | D013959 | — | E00-E07 | 1 | — | — | — | — | 1 |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 1 | — | — | — | — | 1 |
| Pharyngeal neoplasms | D010610 | — | C14.0 | 1 | — | — | — | — | 1 |
| Peritoneal neoplasms | D010534 | — | — | 1 | — | — | — | — | 1 |
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 | — |
| 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
No data
Financial
Revenue by drug
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Imjudo – AstraZeneca
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 9,725 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,176 adverse events reported
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