Idarubicin
Idamycin (idarubicin) is a small molecule pharmaceutical. Idarubicin was first approved as Idamycin on 1990-09-27. It is used to treat BCR-ABL positive chronic myelogenous leukemia, breast neoplasms, myeloid leukemia acute, and precursor cell lymphoblastic leukemia-lymphoma in the USA.
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Commercial
Trade Name
FDA
EMA
Idamycin (generic drugs available since 2002-05-01)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Idarubicin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| IDAMYCIN PFS | Mylan | N-050734 RX | 1997-02-17 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| idamycin pfs | New Drug Application | 2021-02-24 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bcr-abl positive chronic myelogenous leukemia | EFO_0000340 | D015464 | — |
| breast neoplasms | EFO_0003869 | D001943 | C50 |
| myeloid leukemia acute | — | D015470 | C92.0 |
| precursor cell lymphoblastic leukemia-lymphoma | — | D054198 | C91.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9211 | Injection, idarubicin hydrochloride, 5 mg |
Clinical
Clinical Trials
41 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertriglyceridemia | D015228 | EFO_0004211 | 2 | 1 | 6 | 1 | — | 10 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | 1 | 2 | 1 | 4 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | 1 | 1 | — | 3 |
| Covid-19 | D000086382 | U07.1 | — | 1 | 1 | 1 | — | 3 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | — | — | 1 | 1 | 2 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 1 | — | 1 | — | 2 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | 1 | — | 1 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | — | — | — | 1 | — | 1 |
| Heart disease risk factors | D000082742 | — | — | — | 1 | — | 1 | ||
| Respiratory tract infections | D012141 | J06.9 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonic neoplasms | D003110 | C18 | — | 1 | 1 | — | 1 | 3 | |
| Depression | D003863 | F33.9 | — | 1 | 1 | — | — | 2 | |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 1 | — | — | 1 |
| Coronary artery disease | D003324 | I25.1 | — | — | 1 | — | — | 1 | |
| Iga glomerulonephritis | D005922 | EFO_0004194 | — | — | 1 | — | — | 1 | |
| Huntington disease | D006816 | G10 | — | — | 1 | — | — | 1 | |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 1 | 2 | — | — | — | 2 | ||
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | C80 | — | 1 | — | — | — | 1 | |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | 1 | — | — | — | 1 |
| Inflammation | D007249 | — | 1 | — | — | — | 1 | ||
| Gastrointestinal microbiome | D000069196 | 1 | 1 | — | — | — | 1 | ||
| Hereditary nonpolyposis colorectal neoplasms | D003123 | EFO_0007354 | — | 1 | — | — | — | 1 | |
| Heat stress disorders | D018882 | T67.2 | — | 1 | — | — | — | 1 | |
| Combat disorders | D003130 | — | 1 | — | — | — | 1 | ||
| Major depressive disorder | D003865 | EFO_0003761 | F22 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | 1 | — | — | — | — | 1 |
| Female infertility | D007247 | EFO_0008560 | N97 | 1 | — | — | — | — | 1 |
| Dyslipidemias | D050171 | HP_0003119 | 1 | — | — | — | — | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | IDARUBICIN |
| INN | idarubicin |
| Description | Idarubicin is a monosaccharide derivative, an anthracycline antibiotic and a deoxy hexoside. It derives from a hydride of a tetracene. |
| Classification | Small molecule |
| Drug class | antineoplastic antibiotics (daunorubicin type) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)[C@]1(O)Cc2c(O)c3c(c(O)c2[C@@H](O[C@H]2C[C@H](N)[C@H](O)[C@H](C)O2)C1)C(=O)c1ccccc1C3=O |
Identifiers
| PDB | — |
| CAS-ID | 58957-92-9 |
| RxCUI | 5650 |
| ChEMBL ID | CHEMBL1117 |
| ChEBI ID | 42068 |
| PubChem CID | 42890 |
| DrugBank | DB01177 |
| UNII ID | ZRP63D75JW (ChemIDplus, GSRS) |
Target
Agency Approved
No data
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 6,491 documents
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Safety
Black-box Warning
Black-box warning for: Idamycin pfs
Adverse Events
Top Adverse Reactions
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2,028 adverse events reported
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