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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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
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ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
1172 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 131 | 184 | 25 | 2 | 51 | 339 |
| Neoplasms | D009369 | — | C80 | 100 | 92 | 6 | 2 | 14 | 168 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 34 | 45 | 9 | 2 | 15 | 94 |
| Lung neoplasms | D008175 | — | C34.90 | 25 | 40 | 9 | 1 | 8 | 71 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 35 | 29 | 5 | 1 | 3 | 59 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 7 | 12 | 5 | 2 | 9 | 32 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 9 | 12 | 3 | 1 | 1 | 23 |
| Immunotherapy | D007167 | — | — | 1 | 3 | — | 1 | 4 | 8 |
| Radiotherapy | D011878 | — | — | — | 1 | 1 | 1 | — | 3 |
| Oncogenes | D009857 | — | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 49 | 76 | 23 | — | 14 | 136 |
| Carcinoma | D002277 | — | C80.0 | 34 | 54 | 11 | — | 14 | 98 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 20 | 46 | 14 | — | 7 | 74 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 17 | 40 | 12 | — | 2 | 59 |
| Colorectal neoplasms | D015179 | — | — | 26 | 32 | 4 | — | 2 | 51 |
| Prostatic neoplasms | D011471 | — | C61 | 20 | 32 | 3 | — | 1 | 49 |
| Cutaneous malignant melanoma | D000096142 | — | — | 18 | 28 | 5 | — | 2 | 44 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 24 | 23 | 1 | — | 2 | 42 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 21 | 24 | 1 | — | 2 | 41 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 23 | 28 | 2 | — | — | 41 |
Show 27 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Transitional cell carcinoma | D002295 | — | — | 15 | 17 | — | — | 1 | 24 |
| Triple negative breast neoplasms | D064726 | — | — | 12 | 13 | — | — | — | 19 |
| Lymphoma | D008223 | — | C85.9 | 14 | 5 | — | — | — | 16 |
| Urologic neoplasms | D014571 | — | C64-C68 | 12 | 9 | — | — | 1 | 16 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 9 | 11 | — | — | — | 16 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 11 | 6 | — | — | — | 14 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 3 | 12 | — | — | — | 14 |
| Myelodysplastic syndromes | D009190 | — | D46 | 10 | 2 | — | — | — | 12 |
| Multiple myeloma | D009101 | — | C90.0 | 9 | 6 | — | — | — | 12 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 10 | 1 | — | — | — | 11 |
Show 171 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloproliferative disorders | D009196 | — | D47.1 | 5 | — | — | — | — | 5 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 4 | — | — | — | — | 4 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | — | C92.2 | 3 | — | — | — | — | 3 |
| Preleukemia | D011289 | — | — | 3 | — | — | — | — | 3 |
| Syndrome | D013577 | — | — | 3 | — | — | — | — | 3 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 3 | — | — | — | — | 3 |
| T-cell lymphoma peripheral | D016411 | — | — | 3 | — | — | — | — | 3 |
| Mycosis fungoides | D009182 | — | C84.0 | 3 | — | — | — | — | 3 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | — | — | — | — | 2 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 2 | — | — | — | — | 2 |
Show 46 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 3 | 3 |
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 3 | 3 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 3 | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | — | — | 2 | 2 |
| Microbiota | D064307 | — | — | — | — | — | — | 2 | 2 |
| Metagenome | D054892 | — | — | — | — | — | — | 2 | 2 |
| Multiple primary neoplasms | D009378 | — | — | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Pericarditis | D010493 | EFO_0007427 | I30 | — | — | — | — | 1 | 1 |
Show 13 more
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
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Imjudo – AstraZeneca
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,772 adverse events reported
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