Enasidenib
Idhifa (enasidenib) is a small molecule pharmaceutical. Enasidenib was first approved as Idhifa on 2017-08-01. It is used to treat myeloid leukemia acute in the USA. It is known to target isocitrate dehydrogenase [NADP], mitochondrial.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| idhifa | New Drug Application | 2025-01-16 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENASIDENIB MESYLATE, IDHIFA, BRISTOL MYERS SQUIBB | |||
| 2024-08-01 | ODE-151 | ||
HCPCS
No data
Clinical
Clinical Trials
49 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 |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 5 | 5 | 1 | — | 1 | 10 |
| Leukemia | D007938 | — | C95 | 5 | 5 | 1 | — | — | 9 |
| Myeloid leukemia | D007951 | — | C92 | 5 | 4 | 1 | — | — | 8 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 4 | 4 | — | — | — | 5 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 2 | 3 | — | — | — | 4 |
| Myelomonocytic leukemia juvenile | D054429 | — | C93.3 | 2 | 3 | — | — | — | 4 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | 2 | — | — | — | 3 |
| Preleukemia | D011289 | — | — | 1 | 1 | — | — | — | 2 |
| Refractory anemia with excess of blasts | D000754 | — | D46.2 | — | 1 | — | — | — | 1 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | 1 | 1 | — | — | — | 1 |
| Myeloproliferative disorders | D009196 | — | D47.1 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | — | 4 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | — | — | — | — | 2 |
| Hepatic insufficiency | D048550 | — | — | 2 | — | — | — | — | 2 |
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Enasidenib |
| INN | enasidenib |
| Description | Enasidenib is a 1,3,5-triazine which is substituted by (2-hydroxy-2-methylpropyl)nitrilo, 6-(trifluoromethyl)pyridin-2-yl and [2-(trifluoromethyl)pyridin-4-yl]nitrilo groups at positions 2,4 and 6, respectively. It is an isocitrate dehydrogenase-2 (IDH2) inhibitor which has been approved for the treatment of adults with relapsed or refractory acute myeloid leukaemia (AML). It has a role as an antineoplastic agent and an EC 1.1.1.42 (isocitrate dehydrogenase) inhibitor. It is an aminopyridine, an organofluorine compound, a secondary amino compound, a tertiary alcohol, a member of 1,3,5-triazines and an aromatic amine. |
| Classification | Small molecule |
| Drug class | mutated isocitrate dehydrogenase (IDH) inhibitors |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)(O)CNc1nc(Nc2ccnc(C(F)(F)F)c2)nc(-c2cccc(C(F)(F)F)n2)n1 |
Identifiers
| PDB | — |
| CAS-ID | 1446502-11-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3989908 |
| ChEBI ID | — |
| PubChem CID | 89683805 |
| DrugBank | DB13874 |
| UNII ID | 3T1SS4E7AG (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
IDH2
IDH2
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
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Idhifa – Celgene
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Estimated US medical usage
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Trends
PubMed Central
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Additional graphs summarizing 2,255 documents
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Safety
Black-box Warning
Black-box warning for: Idhifa
Adverse Events
Top Adverse Reactions
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3,609 adverse events reported
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