Doxorubicin hydrochloride, Caelyx pegylated liposomal(doxorubicin)
Doxil, Myocet, Pegylated (doxorubicin) is a small molecule pharmaceutical. Doxorubicin was first approved as Doxorubicin hydrochloride on 1982-01-01. It is used to treat breast neoplasms, gastrointestinal neoplasms, hodgkin disease, lung neoplasms, and myeloid leukemia acute amongst others in the USA. It has been approved in Europe to treat breast neoplasms, kaposi sarcoma, multiple myeloma, and ovarian neoplasms.
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Commercial
Therapeutic Areas
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Trade Name
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Doxil (generic drugs available since 1989-03-17, discontinued: Adriamycin, Rubex)
Drug Products
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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 |
|---|---|---|
| adriamycin | ANDA | 2022-12-20 |
| doxil | New Drug Application | 2019-08-12 |
| doxorubicin hydrochloride | New Drug Application | 2024-01-23 |
| doxorubicin hydrochloride liposome | New Drug Application | 2022-05-31 |
| doxorubicin hydrochloride, liposomal | unapproved drug for use in drug shortage | 2023-12-19 |
Indications
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Agency Specific
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Clinical
Clinical Trials
2505 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 78 | 265 | 110 | 11 | 61 | 480 |
| Sarcoma | D012509 | — | — | 55 | 98 | 34 | 2 | 15 | 181 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 64 | 80 | 47 | 1 | 10 | 178 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 34 | 86 | 40 | 3 | 3 | 145 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 16 | 50 | 34 | 5 | 24 | 116 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 26 | 40 | 29 | 11 | 4 | 102 |
| Multiple myeloma | D009101 | — | C90.0 | 21 | 59 | 20 | 5 | 2 | 91 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 10 | 26 | 21 | 4 | 26 | 78 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 19 | 35 | 12 | 5 | 6 | 69 |
| T-cell lymphoma peripheral | D016411 | — | — | 11 | 22 | 7 | 1 | — | 36 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 26 | 111 | 52 | — | 16 | 190 |
| Neoplasms | D009369 | — | C80 | 76 | 33 | 7 | — | 5 | 107 |
| Hodgkin disease | D006689 | — | C81 | 10 | 55 | 27 | — | 6 | 89 |
| Triple negative breast neoplasms | D064726 | — | — | 13 | 43 | 9 | — | 1 | 62 |
| Fallopian tube neoplasms | D005185 | — | — | 29 | 25 | 17 | — | 1 | 62 |
| Leukemia | D007938 | — | C95 | 7 | 26 | 20 | — | 3 | 51 |
| Neuroblastoma | D009447 | EFO_0000621 | — | 10 | 21 | 16 | — | 3 | 50 |
| Peritoneal neoplasms | D010534 | — | — | 9 | 13 | 6 | — | 6 | 31 |
| Urinary bladder neoplasms | D001749 | — | C67 | 4 | 18 | 8 | — | 1 | 30 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 3 | 17 | 11 | — | — | 30 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 5 | 10 | — | — | 5 | 19 |
| Male breast neoplasms | D018567 | — | — | 5 | 9 | — | — | 3 | 13 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | 11 | — | — | — | 12 |
| Non-small-cell lung carcinoma | D002289 | — | — | 4 | 8 | — | — | — | 11 |
| Adenocarcinoma | D000230 | — | — | 3 | 6 | — | — | 1 | 9 |
| Myelodysplastic syndromes | D009190 | — | D46 | 6 | 4 | — | — | — | 8 |
| Adult t-cell leukemia-lymphoma | D015459 | — | C91.5 | 4 | 5 | — | — | — | 8 |
| Urologic neoplasms | D014571 | — | C64-C68 | 3 | 6 | — | — | — | 7 |
| Glioblastoma | D005909 | EFO_0000515 | — | 4 | 4 | — | — | — | 7 |
| Reactive arthritis | D016918 | EFO_0007460 | M02.3 | 1 | 6 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Appendiceal neoplasms | D001063 | EFO_0003880 | C18.1 | 2 | — | — | — | 2 | 4 |
| Cystadenocarcinoma | D003536 | — | — | 3 | — | — | — | — | 3 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | 1 | — | — | — | 2 | 3 |
| Myelodysplastic-myeloproliferative diseases | D054437 | — | — | 2 | — | — | — | — | 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 |
| Thrombocytosis | D013922 | HP_0001894 | D75.83 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | — | 2 | 2 |
| Pseudomyxoma peritonei | D011553 | EFO_0007456 | — | — | — | — | — | 2 | 2 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | — | 2 | 2 |
| Taste disorders | D013651 | — | — | — | — | — | — | 1 | 1 |
| Dysgeusia | D004408 | — | R43.2 | — | — | — | — | 1 | 1 |
| Ageusia | D000370 | EFO_1001758 | — | — | — | — | — | 1 | 1 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | — | — | — | — | 1 | 1 |
| Hepatitis b | D006509 | — | — | — | — | — | — | 1 | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
| Pleural effusion | D010996 | HP_0002202 | J90 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Doxorubicin |
| 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 |
Identifiers
| PDB | — |
| CAS-ID | 23214-92-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL53463 |
| ChEBI ID | 28748 |
| PubChem CID | 31703 |
| DrugBank | DB00997 |
| UNII ID | 80168379AG (ChemIDplus, GSRS) |
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Doxorubicin
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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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77,835 adverse events reported
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