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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
Trade Name
FDA
EMA
Idhifa
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Enasidenib mesylate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IDHIFA | Bristol Myers Squibb | N-209606 RX | 2017-08-01 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| idhifa | New Drug Application | 2020-11-30 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ENASIDENIB MESYLATE, IDHIFA, BRISTOL MYERS SQUIBB | |||
| 2024-08-01 | ODE-151 | ||
HCPCS
No data
Clinical
Clinical Trials
113 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 4 | 15 | 10 | 1 | 28 |
| Hypertension | D006973 | EFO_0000537 | I10 | 2 | 5 | 11 | 8 | 3 | 27 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 2 | 2 | 2 | — | 6 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | 1 | 1 | 3 |
| Essential hypertension | D000075222 | I10 | 1 | 2 | — | 1 | — | 3 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | 1 | 2 |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | — | 1 | 1 | 2 | |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | — | 1 | — | 1 | — | 2 |
| Healthy volunteers/patients | — | 1 | — | — | 1 | — | 2 | ||
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | 1 | 1 | — | 2 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Congenital heart defects | D006330 | HP_0001627 | Q24.9 | — | 2 | 4 | — | — | 4 |
| Coronary disease | D003327 | — | 1 | 2 | — | 1 | 3 | ||
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | 2 | — | — | 3 |
| Dilated cardiomyopathy | D002311 | EFO_0000407 | I42.0 | — | 2 | 3 | — | — | 3 |
| Proteinuria | D011507 | HP_0000093 | R80 | — | — | 1 | — | 1 | 2 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | 1 | — | 1 | — | — | 2 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 1 | — | 1 | 2 |
| Neoplasms | D009369 | C80 | — | — | 2 | — | — | 2 | |
| Diabetic nephropathies | D003928 | EFO_0000401 | — | 1 | 1 | — | 1 | 2 | |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 1 | — | 1 | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cerebral hemorrhage | D002543 | — | 2 | — | — | 1 | 3 | ||
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 1 | — | — | 1 | 2 |
| Blood pressure | D001794 | EFO_0004325 | — | 2 | — | — | — | 2 | |
| Chronic renal insufficiency | D051436 | N18 | 1 | 1 | — | — | 1 | 2 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | 1 | — | — | — | 1 |
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Glomerulonephritis | D005921 | N05 | — | 1 | — | — | — | 1 | |
| Membranoproliferative glomerulonephritis | D015432 | — | 1 | — | — | — | 1 | ||
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | 1 | — | — | — | 1 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | 1 | — | — | — | 1 |
Show 3 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lupus nephritis | D008181 | EFO_0005761 | — | — | — | — | 1 | 1 | |
| Fabry disease | D000795 | E75.21 | — | — | — | — | 1 | 1 | |
| Prehypertension | D058246 | — | — | — | — | 1 | 1 | ||
| Exercise | D015444 | EFO_0000483 | — | — | — | — | 1 | 1 | |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | — | — | 1 | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | 1 | |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | — | — | — | 1 | 1 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | — | 1 | 1 | |
| Orthostatic hypotension | D007024 | I95.1 | — | — | — | — | 1 | 1 | |
| Intracranial hemorrhages | D020300 | EFO_0000551 | I62 | — | — | — | — | 1 | 1 |
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 | 1940332 |
| 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
Clinical Variant
No data
Financial
Idhifa - Celgene
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,412 documents
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Safety
Black-box Warning
Black-box warning for: Idhifa
Adverse Events
Top Adverse Reactions
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720 adverse events reported
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