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
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Trade Name
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Braftovi (discontinued: 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 |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| braftovi | New Drug Application | 2025-04-16 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENCORAFENIB, BRAFTOVI, ARRAY BIOPHARMA INC | |||
| 2030-10-11 | ODE-445 | ||
| 2026-10-11 | I-928 | ||
| 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, U-3738 | |
| 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, U-3738 | |
| 10005761 | 2030-08-27 | U-2335, U-2802, U-2803, U-3738 | |
| RE49556 | 2030-02-27 | DS, DP | |
| 8541575 | 2030-02-26 | DS, DP | U-2335, U-2802, U-2803, U-3738 |
| 8946250 | 2029-07-23 | DS, DP | |
HCPCS
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Clinical
Clinical Trials
97 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 |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | — | 4 | 5 | 1 | — | 1 | 11 |
| Colorectal neoplasms | D015179 | — | — | — | 7 | 1 | — | 2 | 10 |
| Biliary tract neoplasms | D001661 | — | C24.9 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 4 | — | — | — | 4 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 3 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 3 | — | — | — | 3 |
| Carcinoma | D002277 | — | C80.0 | — | 1 | — | — | 1 | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 1 | 1 | — | — | — | 2 |
| Colonic neoplasms | D003110 | — | C18 | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 1 | — | — | — | 1 |
| Rectal neoplasms | D012004 | — | — | — | 1 | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 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 | — |
| ChEMBL ID | CHEMBL3301612 |
| ChEBI ID | — |
| PubChem CID | 50922675 |
| DrugBank | DB11718 |
| UNII ID | 8L7891MRB6 (ChemIDplus, GSRS) |
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Braftovi – Pfizer
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Braftovi – Array Biopharma
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Safety
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7,478 adverse events reported
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