Idarubicin
Idamycin, Idarubicin (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
Idarubicin (discontinued: Idamycin, Idarubicin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| idamycin pfs | New Drug Application | 2026-04-15 |
| idarubicin hydrochloride | ANDA | 2025-05-09 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
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HCPCS
Code | Description |
|---|---|
| J9211 | Injection, idarubicin hydrochloride, 5 mg |
Clinical
Clinical Trials
351 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myeloid leukemia acute | D015470 | — | C92.0 | 66 | 107 | 59 | 6 | 15 | 216 |
| Leukemia | D007938 | — | C95 | 54 | 104 | 58 | 12 | 12 | 203 |
| Myeloid leukemia | D007951 | — | C92 | 48 | 74 | 34 | 3 | 9 | 138 |
| Myelodysplastic syndromes | D009190 | — | D46 | 21 | 30 | 9 | 1 | 3 | 50 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 2 | 16 | 12 | 7 | 2 | 34 |
| Preleukemia | D011289 | — | — | 11 | 16 | 7 | 1 | 2 | 28 |
| Syndrome | D013577 | — | — | 8 | 10 | 6 | 1 | 2 | 22 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | 2 | 6 | 6 | 4 | 2 | 20 |
| Lymphoid leukemia | D007945 | — | C91 | 1 | 8 | 6 | 5 | 1 | 19 |
| Lymphoma | D008223 | — | C85.9 | 1 | 8 | 9 | 1 | 1 | 15 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatocellular carcinoma | D006528 | — | C22.0 | 3 | 8 | 1 | — | 6 | 16 |
| Monocytic leukemia acute | D007948 | — | — | 4 | 8 | 2 | — | 1 | 13 |
| Myelomonocytic leukemia acute | D015479 | — | C92.5 | 5 | 7 | 1 | — | 1 | 13 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 2 | 10 | 2 | — | — | 13 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 1 | 8 | 1 | — | 4 | 13 |
| Carcinoma | D002277 | — | C80.0 | 2 | 7 | 1 | — | 4 | 12 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 4 | 5 | 3 | — | 1 | 11 |
| Erythroblastic leukemia acute | D004915 | EFO_1001257 | C94.0 | 4 | 6 | 1 | — | 1 | 11 |
| Megakaryoblastic leukemia acute | D007947 | — | C94.2 | 3 | 6 | 1 | — | 1 | 10 |
| Recurrence | D012008 | — | — | 2 | 5 | 2 | — | — | 9 |
Show 23 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blast crisis | D001752 | — | — | 1 | 5 | — | — | — | 6 |
| Biphenotypic leukemia acute | D015456 | — | C95.0 | 3 | 5 | — | — | — | 6 |
| Neoplasms | D009369 | — | C80 | 3 | 3 | — | — | 1 | 5 |
| Residual neoplasm | D018365 | — | — | 1 | 2 | — | — | 1 | 4 |
| Basophilic leukemia acute | D015471 | — | C94.8 | 1 | 4 | — | — | — | 4 |
| Eosinophilic leukemia acute | D015472 | — | — | 1 | 4 | — | — | — | 4 |
| Hypereosinophilic syndrome | D017681 | EFO_1001467 | D72.11 | 1 | 3 | — | — | — | 3 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 1 | — | — | — | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | 2 | — | — | — | 2 |
| Lung neoplasms | D008175 | — | C34.90 | — | 2 | — | — | — | 2 |
Show 12 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | 1 | — | — | — | — | 1 |
| Fibrosis | D005355 | — | — | 1 | — | — | — | — | 1 |
| Hematologic neoplasms | D019337 | — | — | 1 | — | — | — | — | 1 |
| Neoplasms by histologic type | D009370 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | — | — | — | — | 1 | 1 |
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | — | — | 1 | 1 |
| Sclerosis | D012598 | — | — | — | — | — | — | 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 | — |
| ChEMBL ID | CHEMBL1117 |
| ChEBI ID | 42068 |
| PubChem CID | 42890 |
| DrugBank | DB01177 |
| UNII ID | ZRP63D75JW (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 9,638 documents
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Safety
Black-box Warning
Black-box warning for: Idamycin pfs, Idarubicin hydrochloride
Adverse Events
Top Adverse Reactions
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7,372 adverse events reported
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