Pemazyre(pemigatinib)
Pemazyre (pemigatinib) is a small molecule pharmaceutical. Pemigatinib was first approved as Pemazyre on 2020-04-17. It is used to treat cholangiocarcinoma in the USA. It has been approved in Europe to treat cholangiocarcinoma. It is known to target fibroblast growth factor receptor 1, fibroblast growth factor receptor 3, and fibroblast growth factor receptor 2.
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Events Timeline
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Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
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Completion date
Results first post date
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Commercial
Trade Name
FDA
EMA
Pemazyre
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| pemazyre | New Drug Application | 2025-06-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cholangiocarcinoma | — | D018281 | C22.1 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
PEMIGATINIB, PEMAZYRE, INCYTE CORP | |||
| 2029-08-26 | ODE-404 | ||
| 2027-04-17 | ODE-292 | ||
| 2025-08-26 | I-899 | ||
| 2025-04-17 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
48 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cholangiocarcinoma | D018281 | — | C22.1 | 3 | 4 | 1 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 3 | 7 | — | — | — | 9 |
| Transitional cell carcinoma | D002295 | — | — | — | 3 | — | — | — | 3 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 2 | — | — | — | 2 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 1 | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | 1 | 2 | — | — | — | 2 |
| Urologic neoplasms | D014571 | — | C64-C68 | — | 2 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 1 | — | — | — | 2 |
| Carcinoma | D002277 | — | C80.0 | — | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 2 | — | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pemigatinib |
| INN | pemigatinib |
| Description | Pemigatinib, sold under the brand name Pemazyre, is an anti-cancer medication used for the treatment of bile duct cancer (cholangiocarcinoma). Pemigatinib works by blocking FGFR2 in tumor cells to prevent them from growing and spreading.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN1C(=O)N(c2c(F)c(OC)cc(OC)c2F)Cc2cnc3[nH]c(CN4CCOCC4)cc3c21 |
Identifiers
| PDB | — |
| CAS-ID | 1513857-77-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297522 |
| ChEBI ID | — |
| PubChem CID | 86705695 |
| DrugBank | DB15102 |
| UNII ID | Y6BX7BL23K (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FGFR1
FGFR1
FGFR3
FGFR3
FGFR2
FGFR2
Organism
Homo sapiens
Gene name
FGFR1
Gene synonyms
BFGFR, CEK, FGFBR, FLG, FLT2, HBGFR
NCBI Gene ID
Protein name
fibroblast growth factor receptor 1
Protein synonyms
Basic fibroblast growth factor receptor 1, bFGF-R-1, BFGFR, CD331, FGFR1/PLAG1 fusion, FLT-2, FMS-like tyrosine kinase 2, fms-related tyrosine kinase 2, heparin-binding growth factor receptor, hydroxyaryl-protein kinase, N-sam, Proto-oncogene c-Fgr
Uniprot ID
Mouse ortholog
Fgfr1 (14182)
fibroblast growth factor receptor 1 (Q9QZM7)
Variants
No data
Financial
Revenue by drug
$
€
£
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Pemazyre – Incyte
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,625 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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723 adverse events reported
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