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Olutasidenib
Rezlidhia (olutasidenib) is a small molecule pharmaceutical. Olutasidenib was first approved as Rezlidhia on 2022-12-01. It is used to treat myeloid leukemia acute in the USA. It is known to target isocitrate dehydrogenase [NADP] cytoplasmic.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Rezlidhia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Olutasidenib
Tradename
Company
Number
Date
Products
REZLIDHIARigel PharmaceuticalsN-215814 RX2022-12-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rezlidhiaNew Drug Application2022-12-13
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acute—D015470C92.0
Agency Specific
FDA
EMA
Expiration
Code
OLUTASIDENIB, REZLIDHIA, RIGEL PHARMS INC
2029-12-01ODE-413
2027-12-01NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Olutasidenib, Rezlidhia, Rigel Pharms Inc
105320472039-05-16DP
109599942039-05-16DP
110137332039-05-16U-3496
110137342039-05-16U-3495
113762462039-05-16U-3495
114977432039-05-16U-3495
98345392035-09-18DS, DPU-3497
104147522035-09-18DP
105500982035-09-18DP
114989132035-09-18DP
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
3 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Myelodysplastic syndromesD009190D4622———2
Myeloid leukemia acuteD015470C92.022———2
Hepatocellular carcinomaD006528C22.011———1
GlioblastomaD005909EFO_000051511———1
CholangiocarcinomaD018281C22.111———1
ChondrosarcomaD00281311———1
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 nameOLUTASIDENIB
INNolutasidenib
Description
Olutasidenib, sold under the brand name Rezlidhia, is an anticancer medication used to treat relapsed or refractory acute myeloid leukemia. Olutasidenib is an isocitrate dehydrogenase-1 (IDH1) inhibitor. It is taken by mouth.
Classification
Small molecule
Drug classmutated isocitrate dehydrogenase (IDH) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
C[C@H](Nc1ccc(C#N)n(C)c1=O)c1cc2cc(Cl)ccc2[nH]c1=O
Identifiers
PDB—
CAS-ID1887014-12-1
RxCUI—
ChEMBL IDCHEMBL4297610
ChEBI ID—
PubChem CID118955396
DrugBankDB16267
UNII ID0T4IMT8S5Z (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
IDH1
IDH1
Organism
Homo sapiens
Gene name
IDH1
Gene synonyms
PICD
NCBI Gene ID
3417
Protein name
isocitrate dehydrogenase [NADP] cytoplasmic
Protein synonyms
Cytosolic NADP-isocitrate dehydrogenase, epididymis luminal protein 216, epididymis secretory protein Li 26, epididymis secretory sperm binding protein, IDPc, isocitrate dehydrogenase (NADP(+)) 1, cytosolic, isocitrate dehydrogenase 1 (NADP+), soluble, NADP(+)-specific ICDH, NADP-dependent isocitrate dehydrogenase, cytosolic, NADP-dependent isocitrate dehydrogenase, peroxisomal, Oxalosuccinate decarboxylase
Uniprot ID
Q9UKW8
Mouse ortholog
Idh1 (15926)
isocitrate dehydrogenase [NADP] cytoplasmic (Q3UAV7)
Variants
Clinical Variant
No data
Financial
Rezlidhia - Rigel Pharmaceuticals
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 100 documents
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Safety
Black-box Warning
Black-box warning for: Rezlidhia
Adverse Events
Top Adverse Reactions
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11 adverse events reported
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