Braftovi(encorafenib)
Braftovi (encorafenib) is a small molecule pharmaceutical. Encorafenib was first approved as Braftovi on 2018-06-27. It is used to treat melanoma in the USA. It has been approved in Europe to treat colorectal neoplasms and melanoma.
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Commercial
Trade Name
FDA
EMA
Braftovi
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Encorafenib
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BRAFTOVI | Array Biopharma | N-210496 RX | 2018-06-27 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| braftovi | New Drug Application | 2022-06-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| melanoma | — | D008545 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENCORAFENIB, BRAFTOVI, ARRAY BIOPHARMA INC | |||
| 2025-06-27 | ODE-194 | ||
| 2023-06-27 | NCE | ||
| 2023-04-08 | I-826 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Encorafenib, Braftovi, Array Biopharma Inc | |||
| 9474754 | 2033-08-05 | U-2802 | |
| 9387208 | 2032-11-21 | DP | |
| 9763941 | 2032-11-21 | U-2335 | |
| 10258622 | 2032-11-21 | U-2802 | |
| 9314464 | 2031-07-04 | U-2336, U-2802, U-2803 | |
| 8501758 | 2030-08-27 | DS, DP | |
| 9593099 | 2030-08-27 | DP | |
| 9593100 | 2030-08-27 | DP | |
| 9850229 | 2030-08-27 | U-2337 | |
| 9850230 | 2030-08-27 | U-2334, U-2802, U-2803 | |
| 10005761 | 2030-08-27 | U-2335, U-2802, U-2803 | |
| 8541575 | 2030-02-26 | DS, DP | U-2335, U-2802, U-2803 |
| 8946250 | 2029-07-23 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
75 clinical trials
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | 4 | 5 | — | — | — | 8 | ||
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | 3 | — | — | — | 4 |
| Renal cell carcinoma | D002292 | 2 | 2 | — | — | — | 3 | ||
| Thyroid neoplasms | D013964 | EFO_0003841 | 1 | 1 | — | — | — | 2 | |
| Rectal neoplasms | D012004 | 1 | 1 | — | — | — | 2 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | 1 | 1 | — | — | — | 1 | |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 1 | — | — | — | 1 |
| Hairy cell leukemia | D007943 | C91.4 | — | 1 | — | — | — | 1 | |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | 1 | |
| Gliosarcoma | D018316 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic insufficiency | D048550 | 1 | — | — | — | — | 1 | ||
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ENCORAFENIB |
| INN | encorafenib |
| Description | Encorafenib, sold under the brand name Braftovi, is a medication for the treatment of certain melanoma cancers. It is a small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway. This pathway occurs in many different cancers including melanoma and colorectal cancers. The substance was being developed by Novartis and then by Array BioPharma. In June 2018, it was approved by the FDA in combination with binimetinib for the treatment of patients with unresectable or metastatic BRAF V600E or V600K mutation-positive melanoma.
|
| Classification | Small molecule |
| Drug class | rapidly accelerated fibrosarcoma (RAF) kinase inhibitors |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COC(=O)N[C@@H](C)CNc1nccc(-c2cn(C(C)C)nc2-c2cc(Cl)cc(NS(C)(=O)=O)c2F)n1 |
Identifiers
| PDB | — |
| CAS-ID | 1269440-17-6 |
| RxCUI | 2049106 |
| ChEMBL ID | CHEMBL3301612 |
| ChEBI ID | — |
| PubChem CID | 50922675 |
| DrugBank | DB11718 |
| UNII ID | 8L7891MRB6 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Braftovi - Pfizer
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Trends
PubMed Central
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Additional graphs summarizing 2,040 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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62,500 adverse events reported
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