Enasidenib mesylate
Idhifa (enasidenib mesylate) is a small molecule pharmaceutical. Enasidenib mesylate was first approved as Idhifa on 2017-08-01. It is used to treat myeloid leukemia acute in the USA.
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BMS
Commercial
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
39 clinical trials
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Indications Phases 4
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelomonocytic leukemia chronic | D015477 | C93.1 | 2 | 3 | — | — | — | 5 | |
| Hematologic neoplasms | D019337 | 2 | 1 | — | — | — | 2 | ||
| Multiple myeloma | D009101 | C90.0 | 2 | 1 | — | — | — | 2 | |
| Neoplasms | D009369 | C80 | 2 | 2 | — | — | — | 2 | |
| Biphenotypic leukemia acute | D015456 | C95.0 | — | 1 | — | — | — | 1 | |
| Glioma | D005910 | EFO_0000520 | 1 | 1 | — | — | — | 1 | |
| Cholangiocarcinoma | D018281 | C22.1 | 1 | 1 | — | — | — | 1 | |
| Chondrosarcoma | D002813 | 1 | 1 | — | — | — | 1 | ||
| Leukemia | D007938 | C95 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 4 | — | — | — | — | 4 | ||
| Hepatic insufficiency | D048550 | 2 | — | — | — | — | 2 | ||
| Prostatic neoplasms | D011471 | C61 | 1 | — | — | — | — | 1 | |
| Castration-resistant prostatic neoplasms | D064129 | 1 | — | — | — | — | 1 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | C85.9 | 1 | — | — | — | — | 1 | |
| Primary myelofibrosis | D055728 | D47.4 | 1 | — | — | — | — | 1 | |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | C91.0 | 1 | — | — | — | — | 1 | |
| B-cell chronic lymphocytic leukemia | D015451 | C91.1 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ENASIDENIB MESYLATE |
| 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.CS(=O)(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 1446502-11-9 |
| RxCUI | 1940332 |
| ChEMBL ID | CHEMBL3989931 |
| ChEBI ID | — |
| PubChem CID | 89683805 |
| DrugBank | DB13874 |
| UNII ID | 3T1SS4E7AG (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Idhifa - Celgene
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Tabular view
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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15,709 adverse events reported
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