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Drug ReportsTovorafenib
Tovorafenib
Ojemda (tovorafenib) is a small molecule pharmaceutical. Tovorafenib was first approved as Ojemda on 2024-04-23. It is used to treat glioma in the USA. It is known to target serine/threonine-protein kinase B-raf.
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Drug
Target
Variants
Financial
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Events Timeline
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Ojemda
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tovorafenib
Tradename
Company
Number
Date
Products
OJEMDADAY ONE BIOPHARMSN-218033 RX2024-04-23
1 products, RLD, RS
OJEMDADAY ONE BIOPHARMSN-217700 RX2024-04-23
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
ojemdaNew Drug Application2024-07-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
gliomaEFO_0000520D005910—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
16 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
GliomaD005910EFO_0000520—111—14
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C8012———2
CarcinomaD002277—C80.011———1
Colorectal neoplasmsD015179——11———1
Pancreatic neoplasmsD010190EFO_0003860C2511———1
Non-small-cell lung carcinomaD002289——11———1
Urinary bladder neoplasmsD001749—C6711———1
MelanomaD008545——11———1
AdenocarcinomaD000230——11———1
Papillary thyroid cancerD000077273——11———1
AstrocytomaD001254EFO_0000271—11———1
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Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTovorafenib
INNtovorafenib
Description
TAK-580 is a 1,3-thiazolecarboxamide that is 2-[(1R)-1-aminoethyl]-1,3-thiazole-5-carboxylic acid in which the carboxy group undergoes formal condensation with the amino group of 5-chloro-4-(trifluoromethyl)pyridin-2-amine and in which the amino group undergoes formal condensation with the carboxy group of 6-amino-5-chloropyrimidine-4-carboxylic acid. It is a pan-RAF kinase inhibitor which is currently in clinical development for the treatment of radiographically recurrent or progressive low-grade glioma in children and young adults. It has a role as an antineoplastic agent, an apoptosis inducer and a B-Raf inhibitor. It is a chloropyridine, an organofluorine compound, a secondary carboxamide, an aminopyrimidine, a pyrimidinecarboxamide and a 1,3-thiazolecarboxamide.
Classification
Small molecule
Drug classrapidly accelerated fibrosarcoma (RAF) kinase inhibitors
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Structure (InChI/SMILES or Protein Sequence)
C[C@@H](NC(=O)c1ncnc(N)c1Cl)c1ncc(C(=O)Nc2cc(C(F)(F)F)c(Cl)cn2)s1
Identifiers
PDB—
CAS-ID1096708-71-2
RxCUI—
ChEMBL IDCHEMBL3348923
ChEBI ID—
PubChem CID25161177
DrugBankDB15266
UNII IDZN90E4027M (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
BRAF
BRAF
Organism
Homo sapiens
Gene name
BRAF
Gene synonyms
BRAF1, RAFB1
NCBI Gene ID
Protein name
serine/threonine-protein kinase B-raf
Protein synonyms
94 kDa B-raf protein, B-Raf proto-oncogene serine/threonine-protein kinase (p94), B-Raf serine/threonine-protein, murine sarcoma viral (v-raf) oncogene homolog B1, p94, Proto-oncogene B-Raf, v-raf murine sarcoma viral oncogene homolog B, v-Raf murine sarcoma viral oncogene homolog B1
Uniprot ID
Mouse ortholog
Braf (109880)
serine/threonine-protein kinase B-raf (Q3USE9)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 198 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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18 adverse events reported
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