Doxorubicin hydrochloride
Doxil, Doxorubicin, Myocet, Pegylated (doxorubicin hydrochloride) is a small molecule pharmaceutical. Doxorubicin hydrochloride was first approved as Doxorubicin hydrochloride on 1982-01-01. It is used to treat breast neoplasms, gastrointestinal neoplasms, hodgkin disease, liver neoplasms, and lung neoplasms amongst others in the USA. It has been approved in Europe to treat breast neoplasms, kaposi sarcoma, multiple myeloma, and ovarian neoplasms. It is known to target DNA topoisomerase 2-alpha.
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Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adriamycin | ANDA | 2024-04-11 |
| doxil | New Drug Application | 2023-08-31 |
| doxorubicin hydrochloride | New Drug Application | 2024-11-19 |
| doxorubicin hydrochloride liposome | NDA authorized generic | 2022-05-31 |
| doxorubicin hydrochloride, liposomal | unapproved drug for use in drug shortage | 2023-12-19 |
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Clinical
Clinical Trials
2575 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 134 | 404 | 183 | 16 | 41 | 700 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 94 | 328 | 128 | 14 | 80 | 591 |
| Sarcoma | D012509 | — | — | 64 | 126 | 50 | 5 | 23 | 242 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 50 | 139 | 53 | 3 | 10 | 225 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 72 | 101 | 60 | 2 | 16 | 222 |
| Carcinoma | D002277 | — | C80.0 | 45 | 103 | 44 | 5 | 34 | 210 |
| B-cell lymphoma | D016393 | — | — | 57 | 120 | 46 | 4 | 8 | 200 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 46 | 99 | 47 | 6 | 11 | 185 |
| Leukemia | D007938 | — | C95 | 42 | 83 | 49 | 8 | 7 | 172 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 55 | 70 | 42 | 2 | 12 | 161 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 96 | 60 | 18 | — | 7 | 158 |
| Fallopian tube neoplasms | D005185 | — | — | 31 | 30 | 20 | — | 1 | 70 |
| Recurrence | D012008 | — | — | 24 | 34 | 13 | — | 7 | 68 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 10 | 22 | 16 | — | 3 | 51 |
| Osteosarcoma | D012516 | — | — | 10 | 20 | 11 | — | 8 | 43 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 16 | 22 | 3 | — | 4 | 41 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 5 | 20 | 18 | — | — | 41 |
| Peritoneal neoplasms | D010534 | — | — | 13 | 18 | 7 | — | 6 | 39 |
| Adenocarcinoma | D000230 | — | — | 8 | 18 | 9 | — | 2 | 32 |
| Transitional cell carcinoma | D002295 | — | — | 8 | 19 | 6 | — | 1 | 29 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Male breast neoplasms | D018567 | — | — | 5 | 12 | — | — | 4 | 17 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 2 | 12 | — | — | 1 | 15 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 8 | — | — | — | 11 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 8 | — | — | — | 11 |
| Plasmablastic lymphoma | D000069293 | — | C83.3 | 7 | 7 | — | — | — | 11 |
| Large-cell lymphoma immunoblastic | D016400 | — | — | 7 | 7 | — | — | — | 11 |
| Aids-related lymphoma | D016483 | EFO_1001365 | — | 3 | 7 | — | — | — | 10 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 4 | 6 | — | — | — | 9 |
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 4 | — | — | — | 8 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | 8 | — | — | — | 8 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 4 | — | — | — | — | 4 |
| Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | 2 | — | — | — | 2 | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | — | — | — | 1 | 2 |
| Pleural effusion | D010996 | HP_0002202 | J90 | 1 | — | — | — | 1 | 2 |
| Pleural neoplasms | D010997 | — | — | 1 | — | — | — | 1 | 2 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Primary myelofibrosis | D055728 | — | D47.4 | 1 | — | — | — | — | 1 |
| Myelomonocytic leukemia chronic | D015477 | — | C93.1 | 1 | — | — | — | — | 1 |
| Anemia | D000740 | HP_0001903 | D64.9 | 1 | — | — | — | — | 1 |
| Leukemia myeloid chronic atypical bcr-abl negative | D054438 | — | C92.2 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 3 | 3 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 2 | 2 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | — | — | — | — | 2 | 2 |
| Thrombosis | D013927 | — | — | — | — | — | — | 2 | 2 |
| Carcinoma in situ | D002278 | — | D09.9 | — | — | — | — | 2 | 2 |
| Taste disorders | D013651 | — | — | — | — | — | — | 1 | 1 |
| Dysgeusia | D004408 | — | R43.2 | — | — | — | — | 1 | 1 |
| Ageusia | D000370 | EFO_1001758 | — | — | — | — | — | 1 | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | — | — | — | — | 1 | 1 |
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doxorubicin hydrochloride |
| INN | doxorubicin |
| Description | Doxorubicin is a deoxy hexoside, an anthracycline, an anthracycline antibiotic, an aminoglycoside, a member of tetracenequinones, a member of p-quinones, a primary alpha-hydroxy ketone and a tertiary alpha-hydroxy ketone. It has a role as an Escherichia coli metabolite. It is a conjugate base of a doxorubicin(1+). 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) | COc1cccc2c1C(=O)c1c(O)c3c(c(O)c1C2=O)C[C@@](O)(C(=O)CO)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1.Cl |
Identifiers
| PDB | — |
| CAS-ID | 25316-40-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL359744 |
| ChEBI ID | — |
| PubChem CID | 31703 |
| DrugBank | DB00997 |
| UNII ID | 80168379AG (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
TOP2A
TOP2A
Organism
Homo sapiens
Gene name
TOP2A
Gene synonyms
TOP2
NCBI Gene ID
Protein name
DNA topoisomerase 2-alpha
Protein synonyms
DNA gyrase, DNA topoisomerase (ATP-hydrolyzing), DNA topoisomerase II, 170 kD, DNA topoisomerase II, alpha isozyme, topoisomerase (DNA) II alpha 170kDa
Uniprot ID
Mouse ortholog
Top2a (21973)
DNA topoisomerase 2-alpha (Q01320)
Variants
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Adriamycin, Doxil, Doxorubicin hydrochloride, Doxorubicin hydrochloride liposome
Adverse Events
Top Adverse Reactions
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99,695 adverse events reported
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