Lytgobi(futibatinib)
Lytgobi (futibatinib) is a small molecule pharmaceutical. Futibatinib was first approved as Lytgobi on 2022-09-30. It has been approved in Europe to treat cholangiocarcinoma. It is known to target fibroblast growth factor receptor 3, fibroblast growth factor receptor 2, fibroblast growth factor receptor 1, and fibroblast growth factor receptor 4.
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EMA approval date
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Study first post date
Last update post date
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Commercial
Trade Name
FDA
EMA
Lytgobi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Futibatinib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LYTGOBI | Taiho Oncology | N-214801 RX | 2022-09-30 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lytgobi | New Drug Application | 2024-04-23 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FUTIBATINIB, LYTGOBI, TAIHO ONCOLOGY | |||
| 2029-09-30 | ODE-410 | ||
| 2027-09-30 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
22 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 |
|---|---|---|---|---|---|---|---|---|---|
| Cholangiocarcinoma | D018281 | — | C22.1 | 1 | 2 | 1 | — | 1 | 4 |
| Biliary tract neoplasms | D001661 | — | C24.9 | 1 | — | 1 | — | — | 2 |
| Sarcoma | D012509 | — | — | — | — | 1 | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 3 | 6 | — | — | — | 8 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 2 | 2 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | — | 3 | — | — | — | 3 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 3 | 1 | — | — | — | 3 |
| Esophageal neoplasms | D004938 | — | C15 | 2 | 1 | — | — | — | 3 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | 1 | — | — | — | 2 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | 1 | — | — | — | 2 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Congenital abnormalities | D000013 | EFO_0003915 | Q89.9 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | — | — | — | — | 3 |
| Colorectal neoplasms | D015179 | — | — | 2 | — | — | — | — | 2 |
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Head and neck neoplasms | D006258 | — | — | 1 | — | — | — | — | 1 |
| Alveolar soft part sarcoma | D018234 | — | — | 1 | — | — | — | — | 1 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma of lung | D000077192 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anesthesia | D000758 | — | — | — | — | — | — | 1 | 1 |
| Respiratory aspiration | D053120 | EFO_1001839 | — | — | — | — | — | 1 | 1 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Futibatinib |
| INN | futibatinib |
| Description | Futibatinib, sold under the brand name Lytgobi, is an anti-cancer medication used for the treatment of cholangiocarcinoma (bile duct cancer). It is a kinase inhibitor. It is taken by mouth.
|
| Classification | Small molecule |
| Drug class | tyrosine kinase inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=CC(=O)N1CC[C@H](n2nc(C#Cc3cc(OC)cc(OC)c3)c3c(N)ncnc32)C1 |
Identifiers
| PDB | — |
| CAS-ID | 1448169-71-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3701238 |
| ChEBI ID | — |
| PubChem CID | 71621331 |
| DrugBank | DB15149 |
| UNII ID | 4B93MGE4AL (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
FGFR3
FGFR3
FGFR2
FGFR2
FGFR1
FGFR1
FGFR4
FGFR4
Organism
Homo sapiens
Gene name
FGFR3
Gene synonyms
JTK4
NCBI Gene ID
Protein name
fibroblast growth factor receptor 3
Protein synonyms
CD333, FGFR-3, fibroblast growth factor receptor 3-S, hydroxyaryl-protein kinase, tyrosine kinase JTK4
Uniprot ID
Mouse ortholog
Fgfr3 (14184)
fibroblast growth factor receptor 3 (Q63834)
Variants
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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78 adverse events reported
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