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Inrebic(fedratinib)
Inrebic (fedratinib) is a small molecule pharmaceutical. Fedratinib was first approved as Inrebic on 2019-08-16. It is used to treat primary myelofibrosis in the USA. It has been approved in Europe to treat myeloproliferative disorders and primary myelofibrosis. The pharmaceutical is active against tyrosine-protein kinase JAK2. In addition, it is known to target tyrosine-protein kinase JAK1, tyrosine-protein kinase JAK3, bromodomain-containing protein 4, and non-receptor tyrosine-protein kinase TYK2.
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BMS
FDA Novel Drug Approvals 2019
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
hemic and lymphatic diseasesD006425
Trade Name
FDA
EMA
Inrebic
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Fedratinib hydrochloride
Tradename
Company
Number
Date
Products
INREBICImpact BiomedicalN-212327 RX2019-08-16
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
inrebicNew Drug Application2020-09-08
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
primary myelofibrosis—D055728D47.4
Agency Specific
FDA
EMA
Expiration
Code
FEDRATINIB HYDROCHLORIDE, INREBIC, IMPACT
2026-08-16ODE-259
2024-08-16NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Fedratinib Hydrochloride, Inrebic, Impact
114000922039-09-24U-3409
103910942032-06-04DPU-2607
81381992028-06-30U-2607
75281432026-12-16DP
78252462026-12-16DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EJ: Janus-associated kinase (jak) inhibitors
— L01EJ02: Fedratinib
HCPCS
No data
Clinical
Clinical Trials
28 clinical trials
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Mock data
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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
Primary myelofibrosisD055728D47.4462—110
Hematologic neoplasmsD019337—31——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D46—1———1
Myeloid leukemia acuteD015470C92.0—1———1
Essential thrombocythemiaD013920D47.3—1———1
Polycythemia veraD011087D45—1———1
Neutrophilic leukemia chronicD015467D47.1—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—5————5
Hepatic insufficiencyD0485502————2
NeoplasmsD009369C802————2
Renal insufficiencyD051437HP_0000083N191————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameFEDRATINIB
INNfedratinib
Description
N-tert-butyl-3-[[5-methyl-2-[4-[2-(1-pyrrolidinyl)ethoxy]anilino]-4-pyrimidinyl]amino]benzenesulfonamide is a sulfonamide.
Classification
Small molecule
Drug classtyrosine kinase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Cc1cnc(Nc2ccc(OCCN3CCCC3)cc2)nc1Nc1cccc(S(=O)(=O)NC(C)(C)C)c1
Identifiers
PDB—
CAS-ID936091-26-8
RxCUI—
ChEMBL IDCHEMBL1287853
ChEBI ID—
PubChem CID16722836
DrugBankDB12500
UNII ID6L1XP550I6 (ChemIDplus, GSRS)
Target
Agency Approved
JAK2
JAK2
Organism
Homo sapiens
Gene name
JAK2
Gene synonyms
NCBI Gene ID
3717
Protein name
tyrosine-protein kinase JAK2
Protein synonyms
JAK-2, Janus kinase 2, Janus kinase 2 (a protein tyrosine kinase)
Uniprot ID
O75297
Mouse ortholog
Jak2 (16452)
tyrosine-protein kinase JAK2 (Q7TQD0)
Alternate
JAK1
JAK1
JAK3
JAK3
BRD4
BRD4
TYK2
TYK2
Organism
Homo sapiens
Gene name
JAK1
Gene synonyms
JAK1A, JAK1B
NCBI Gene ID
3716
Protein name
tyrosine-protein kinase JAK1
Protein synonyms
JAK-1, Janus kinase 1
Uniprot ID
Q9UD26
Mouse ortholog
Jak1 (16451)
tyrosine-protein kinase JAK1 (P52332)
Variants
Clinical Variant
No data
Financial
Inrebic - Bristol Myers Squibb
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,342 documents
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Safety
Black-box Warning
Black-box warning for: Inrebic
Adverse Events
Top Adverse Reactions
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288 adverse events reported
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