Yervoy(ipilimumab)
Yervoy (ipilimumab) is an antibody pharmaceutical. Ipilimumab was first approved as Yervoy on 2011-03-25. It is used to treat melanoma in the USA. It has been approved in Europe to treat colorectal neoplasms, malignant mesothelioma, melanoma, non-small-cell lung carcinoma, and renal cell carcinoma. The pharmaceutical is active against cytotoxic T-lymphocyte protein 4.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Yervoy
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)
Ipilimumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Yervoy | ipilimumab | Bristol Myers Squibb | N-125377 RX | 2011-03-25 | 2 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| yervoy | Biologic Licensing Application | 2025-05-28 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ipilimumab, Yervoy, Bristol-Myers Squibb Company | |||
| 2027-10-02 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9228 | Injection, ipilimumab, 1 mg |
Clinical
Clinical Trials
904 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 2 | 15 | 4 | 1 | 6 | 27 |
| Lung neoplasms | D008175 | — | C34.90 | 7 | 9 | 3 | 1 | 2 | 18 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | 2 | 2 | 1 | 1 | 2 | 8 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 31 | 55 | 12 | — | 23 | 111 |
| Neoplasms | D009369 | — | C80 | 26 | 37 | 1 | — | 1 | 47 |
| Non-small-cell lung carcinoma | D002289 | — | — | 11 | 24 | 7 | — | 6 | 40 |
| Prostatic neoplasms | D011471 | — | C61 | 3 | 18 | 3 | — | — | 21 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 7 | 10 | 2 | — | — | 16 |
| Colorectal neoplasms | D015179 | — | — | 6 | 9 | 1 | — | — | 12 |
| Small cell lung carcinoma | D055752 | — | — | 3 | 8 | 1 | — | — | 10 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 7 | 1 | — | — | 10 |
| Carcinoma | D002277 | — | C80.0 | 3 | 3 | 1 | — | 5 | 9 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 5 | 4 | 2 | — | — | 8 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 6 | 9 | — | — | — | 12 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 8 | — | — | 1 | 10 |
| Transitional cell carcinoma | D002295 | — | — | 5 | 7 | — | — | — | 9 |
| Cutaneous malignant melanoma | D000096142 | — | — | 4 | 4 | — | — | 1 | 8 |
| Urologic neoplasms | D014571 | — | C64-C68 | 5 | 5 | — | — | — | 7 |
| Urinary bladder neoplasms | D001749 | — | C67 | 4 | 4 | — | — | — | 6 |
| Malignant mesothelioma | D000086002 | — | — | 1 | 4 | — | — | 2 | 6 |
| Multiple myeloma | D009101 | — | C90.0 | 3 | 4 | — | — | — | 5 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 2 | 3 | — | — | — | 5 |
| Uveal neoplasms | D014604 | EFO_1001230 | — | 1 | 4 | — | — | — | 5 |
Show 59 more
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 | — | 1 | — | — | — | — | 1 |
| Nerve sheath neoplasms | D018317 | EFO_0000760 | — | 1 | — | — | — | — | 1 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | 1 | — | — | — | — | 1 |
| Hiv-2 | D015498 | — | — | 1 | — | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 1 | — | — | — | — | 1 |
| Fallopian tube diseases | D005184 | EFO_0009548 | N83 | 1 | — | — | — | — | 1 |
| Laryngeal diseases | D007818 | — | J38.7 | 1 | — | — | — | — | 1 |
| Laryngitis | D007827 | — | — | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| Gata2 deficiency | D000077428 | — | D46.22 | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis c | D006526 | — | B19.2 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Hepatitis | D006505 | — | K75.9 | — | — | — | — | 1 | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Ipilimumab |
| INN | ipilimumab |
| Description | Ipilimumab (human mab) |
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >7SU0:H,I|Fab heavy chain
(PCA)VQLVESGGGVVQPGRSLRLSCAASGFTFSHYTMHWVRQAPGKGLEWVTFISYDGHNKYYADSVKGRFTISRDNSK
NTLYLQMNSLRAEDTAIYYCARTGWLGPFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVT
VSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCGGHHHHHH
>7SU0:L,M|Fab light chain
EIVLTQSPGTLSLSPGERATLSCRASQEVGESELAWYQQKPGQAPRLLIYGAFSRATGIPDRFSGSGSGTDFTLTISRLE
PEDFAVYYCQQYGSSPWTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNS
QESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 5TRU, 5XJ3, 6JC2, 6RP8, 7SU0, 7SU1 |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1789844 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB06186 |
| UNII ID | 6T8C155666 (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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Yervoy – Bristol Myers Squibb
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Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
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39,766 adverse events reported
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