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Drug ReportsVorasidenib
Vorasidenib
Voranigo (vorasidenib) is a small molecule pharmaceutical. Vorasidenib was first approved as Voranigo on 2024-08-06. It is used to treat oligodendroglioma in the USA. It is known to target isocitrate dehydrogenase [NADP], mitochondrial and isocitrate dehydrogenase [NADP] cytoplasmic.
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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
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Completion date
Results first post date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Voranigo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Vorasidenib
Tradename
Company
Number
Date
Products
VORANIGOServierN-218784 RX2024-08-06
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
voranigoNew Drug Application2024-08-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
oligodendrogliomaEFO_0000631D009837—
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GliomaD005910EFO_0000520—411—16
RecurrenceD012008————1—12
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———5————5
NeoplasmsD009369—C802———13
Myelodysplastic syndromesD009190—D462————2
Myeloid leukemia acuteD015470—C92.02————2
Hematologic neoplasmsD019337——2————2
Myeloid leukemiaD007951—C922————2
PreleukemiaD011289——2————2
LeukemiaD007938—C951————1
Myeloproliferative disordersD009196—D47.11————1
Myelomonocytic leukemia chronicD015477—C93.11————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Germ cell and embryonal neoplasmsD009373——————11
Neoplasms by histologic typeD009370——————11
Glandular and epithelial neoplasmsD009375——————11
Nerve tissue neoplasmsD009380——————11
Primitive neuroectodermal tumorsD018242——————11
Neuroepithelial neoplasmsD018302——————11
Neuroectodermal tumorsD017599——————11
Disease attributesD020969——————11
Pathologic processesD010335——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameVorasidenib
INNvorasidenib
Description
Vorasidenib is an experimental anti-cancer medication for the treatment of low-grade glioma. It is a small molecule inhibitor of isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2), which are mutated in several forms of cancer. In a phase-III-trial, it was shown to prolong progression-free survival in patients with IDH1- or IDH2-mutant low-grade glioma.
Classification
Small molecule
Drug classmutated isocitrate dehydrogenase (IDH) inhibitors
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
C[C@@H](Nc1nc(N[C@H](C)C(F)(F)F)nc(-c2cccc(Cl)n2)n1)C(F)(F)F
Identifiers
PDB—
CAS-ID1644545-52-7
RxCUI—
ChEMBL IDCHEMBL4279047
ChEBI ID—
PubChem CID117817422
DrugBankDB17097
UNII ID789Q85GA8P (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
IDH2
IDH2
IDH1
IDH1
Organism
Homo sapiens
Gene name
IDH2
Gene synonyms
NCBI Gene ID
Protein name
isocitrate dehydrogenase [NADP], mitochondrial
Protein synonyms
ICD-M, IDP, isocitrate dehydrogenase (NADP(+)) 2, mitochondrial, isocitrate dehydrogenase 2 (NADP+), mitochondrial, NADP(+)-specific ICDH, Oxalosuccinate decarboxylase
Uniprot ID
Mouse ortholog
Idh2 (269951)
isocitrate dehydrogenase [NADP], mitochondrial (Q9EQK1)
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 356 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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