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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| hemic and lymphatic diseases | D006425 |
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 |
|---|---|---|---|---|
| INREBIC | Bristol Myers Squibb | N-212327 RX | 2019-08-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| inrebic | New Drug Application | 2024-07-30 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| primary myelofibrosis | — | D055728 | D47.4 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
FEDRATINIB HYDROCHLORIDE, INREBIC, BRISTOL-MYERS | |||
| 2026-08-16 | ODE-259 | ||
| 2024-08-16 | NCE | ||
HCPCS
No data
Clinical
Clinical Trials
33 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 |
|---|---|---|---|---|---|---|---|---|---|
| Primary myelofibrosis | D055728 | — | D47.4 | 4 | 11 | 3 | — | 4 | 19 |
| Polycythemia vera | D011087 | — | D45 | 2 | 5 | 2 | — | 2 | 10 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | 1 | 5 | 2 | — | 2 | 9 |
| Polycythemia | D011086 | EFO_0005804 | D75.1 | 1 | 5 | 2 | — | 2 | 9 |
| Essential thrombocythemia | D013920 | — | D47.3 | 1 | 4 | 2 | — | 2 | 8 |
| Hematologic neoplasms | D019337 | — | — | 1 | 3 | 1 | — | — | 5 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 5 | 3 | — | — | — | 7 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 3 | 5 | — | — | — | 7 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | — | 2 | — | — | — | 2 |
| Blast crisis | D001752 | — | — | 1 | 1 | — | — | — | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 1 | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Splenomegaly | D013163 | HP_0001744 | R16.1 | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | 1 | — | — | — | 1 |
| Neutrophilic leukemia chronic | D015467 | — | D47.1 | — | 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 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Fedratinib |
| INN | fedratinib |
| 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 class | tyrosine 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-ID | 1374744-69-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1287853 |
| ChEBI ID | — |
| PubChem CID | 16722836 |
| DrugBank | DB12500 |
| UNII ID | 6L1XP550I6 (ChemIDplus, GSRS) |
Target
Variants
No data
Financial
Revenue by drug
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Inrebic – Bristol Myers Squibb
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,091 documents
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Safety
Black-box Warning
Black-box warning for: Inrebic
Adverse Events
Top Adverse Reactions
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1,192 adverse events reported
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