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AboutPricing
Drug ReportsEncorafenib
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
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
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
BRAFTOVIArray BiopharmaN-210496 RX2018-06-27
1 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
braftoviNew Drug Application2024-09-18
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
melanoma—D008545—
Agency Specific
FDA
EMA
Expiration
Code
ENCORAFENIB, BRAFTOVI, ARRAY BIOPHARMA INC
2030-10-11ODE-445
2026-10-11I-928
2025-06-27ODE-194
2023-06-27NCE
2023-04-08I-826
Patent Expiration
Patent
Expires
Flag
FDA Information
Encorafenib, Braftovi, Array Biopharma Inc
94747542033-08-05U-2802
93872082032-11-21DP
97639412032-11-21U-2335
102586222032-11-21U-2802
93144642031-07-04U-2336, U-2802, U-2803, U-3738
95930992030-08-27DP
95931002030-08-27DP
98502292030-08-27U-2337
98502302030-08-27U-2334, U-2802, U-2803, U-3738
100057612030-08-27U-2335, U-2802, U-2803, U-3738
RE495562030-02-27DS, DP
85415752030-02-26DS, DPU-2335, U-2802, U-2803, U-3738
89462502029-07-23DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01E: Protein kinase inhibitors, antineoplastic and immunomodulating agents
— L01EC: B-raf serine-threonine kinase (braf) inhibitors
— L01EC03: Encorafenib
HCPCS
No data
Clinical
Clinical Trials
94 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C806911117
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——16263—646
Colorectal neoplasmsD015179——10162—327
Colonic neoplasmsD003110—C18252——7
AdenocarcinomaD000230——341——6
Biliary tract neoplasmsD001661—C24.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289——45———8
Brain neoplasmsD001932EFO_0003833C7125———6
Neoplasm metastasisD009362EFO_0009708—15———5
Lung neoplasmsD008175HP_0100526C34.9015———5
Skin neoplasmsD012878EFO_0004198C4414———5
Cutaneous malignant melanomaD000096142——15———5
CarcinomaD002277—C80.014——15
Rectal neoplasmsD012004——23———4
Renal cell carcinomaD002292EFO_0000376—22———3
Thyroid neoplasmsD013964EFO_0003841—11———2
Show 12 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver diseasesD008107HP_0002910K70-K771————1
Hepatic insufficiencyD048550——1————1
GliomaD005910EFO_0000520—1————1
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hepatocellular carcinomaD006528—C22.0————11
Gastrointestinal neoplasmsD005770—C26.9————11
Liver neoplasmsD008113EFO_1001513C22.0————11
Gastrointestinal stromal tumorsD046152EFO_0000505C49.A————11
Neuroendocrine tumorsD018358EFO_1001901D3A.8————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameEncorafenib
INNencorafenib
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 classrapidly accelerated fibrosarcoma (RAF) kinase inhibitors
Image (chem structure or protein)Loading
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-ID1269440-17-6
RxCUI—
ChEMBL IDCHEMBL3301612
ChEBI ID—
PubChem CID50922675
DrugBankDB11718
UNII ID8L7891MRB6 (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Braftovi – Pfizer
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Braftovi – Array Biopharma
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,040 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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6,902 adverse events reported
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