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Tibsovo(ivosidenib)
Tibsovo (ivosidenib) is a small molecule pharmaceutical. Ivosidenib was first approved as Tibsovo on 2018-07-20. It is used to treat myeloid leukemia acute in the USA. It has been approved in Europe to treat cholangiocarcinoma and myeloid leukemia acute. The pharmaceutical is active against isocitrate dehydrogenase [NADP] cytoplasmic.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Tibsovo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ivosidenib
Tradename
Company
Number
Date
Products
TIBSOVOServierN-211192 RX2018-07-20
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
tibsovoNew Drug Application2022-06-09
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
myeloid leukemia acuteD015470C92.0
Agency Specific
FDA
EMA
Expiration
Code
IVOSIDENIB, TIBSOVO, SERVIER
2028-08-25ODE-368
2026-05-02ODE-242
2025-07-20ODE-203
2025-05-25I-893
2024-08-25I-875
2023-07-20NCE
Patent Expiration
Patent
Expires
Flag
FDA Information
Ivosidenib, Tibsovo, Servier
109807882039-06-07U-3112, U-3113, U-3214, U-3383
106537102036-10-18U-3387
99685952035-03-13DPU-2351, U-2533, U-2534, U-3384
104491842035-03-13DP
107994902035-03-13DPU-2981, U-2982, U-3384
94747792033-08-19DS, DPU-2350, U-2533, U-2534, U-3213, U-3386
98502772033-01-18DS, DPU-2350, U-2533, U-2534, U-3213, U-3386
107177642033-01-18U-3215
106101252030-06-21U-2784, U-2785, U-3385
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01X: Other antineoplastic agents in atc
L01XX: Other antineoplastic agents in atc
L01XX62: Ivosidenib
HCPCS
No data
Clinical
Clinical Trials
10 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
Parkinson diseaseD010300EFO_0002508G20213
HypertensionD006973EFO_0000537I10111
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Opioid-related disordersD009293EFO_0005611F11111
Bipolar disorderD001714EFO_0000289F30.911
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Substance-related disordersD019966EFO_0003890F1311
Tobacco use disorderD014029F1711
Cigarette smokingD00007386511
SmokingD012907EFO_0003768F1711
Smoking cessationD016540EFO_000431911
CravingD06624911
Smoking reductionD00007426411
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SchizophreniaD012559EFO_0000692F2011
Psychotic disordersD011618F20.8111
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameIVOSIDENIB
INNivosidenib
Description
Ivosidenib is a tertiary carboxamide resulting from the formal condensation of the carboxy group of (2S)-1-(4-cyanopyridin-2-yl)-5-oxopyrrolidine-2-carboxylic acid with the secondary amino group of (2S)-2-(2-chlorophenyl)-N-(3,3-difluorocyclobutyl)-2-[(5-fluoropyridin-3-yl)amino]acetamide. It is approved by the FDA for the treatment of acute myeloid leukemia (AML) in patients with an isocitrate dehydrogenase-1 (IDH1) mutation. It has a role as an antineoplastic agent and an EC 1.1.1.42 (isocitrate dehydrogenase) inhibitor. It is a member of monochlorobenzenes, a cyanopyridine, a member of pyrrolidin-2-ones, an organofluorine compound, a tertiary carboxamide and a secondary carboxamide.
Classification
Small molecule
Drug classmutated isocitrate dehydrogenase (IDH) inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
N#Cc1ccnc(N2C(=O)CC[C@H]2C(=O)N(c2cncc(F)c2)[C@H](C(=O)NC2CC(F)(F)C2)c2ccccc2Cl)c1
Identifiers
PDB
CAS-ID1448347-49-6
RxCUI
ChEMBL IDCHEMBL3989958
ChEBI ID
PubChem CID71657455
DrugBankDB14568
UNII IDQ2PCN8MAM6 (ChemIDplus, GSRS)
Target
Agency Approved
IDH1
IDH1
Organism
Homo sapiens
Gene name
IDH1
Gene synonyms
PICD
NCBI Gene ID
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
Mouse ortholog
Idh1 (15926)
isocitrate dehydrogenase [NADP] cytoplasmic (Q3UAV7)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,631 documents
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Safety
Black-box Warning
Black-box warning for: Tibsovo
Adverse Events
Top Adverse Reactions
Mock data
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293 adverse events reported
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