Doxorubicin hydrochloride, Caelyx pegylated liposomal(doxorubicin)
Doxil, Doxorubicin, 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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Trade Name
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Doxil, Doxorubicin (discontinued: Adriamycin, Doxorubicin, 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 | 2024-04-11 |
| doxil | New Drug Application | 2023-08-31 |
| doxorubicin hydrochloride | ANDA | 2024-12-11 |
| doxorubicin hydrochloride liposome | NDA authorized generic | 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
2606 clinical trials
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Indications Phases 4
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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 | — | 2 | 1 | — | — | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | 3 | — | — | 3 |
| Neutropenia | D009503 | — | D70 | — | 1 | 2 | — | — | 2 |
| Chemotherapy-induced febrile neutropenia | D064146 | — | — | — | 1 | 2 | — | — | 2 |
| Mucinous adenocarcinoma | D002288 | — | — | — | — | 1 | — | — | 1 |
| Ductal carcinoma breast | D018270 | — | — | — | — | 1 | — | — | 1 |
| Inflammatory breast neoplasms | D058922 | — | — | — | — | 1 | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | — | 1 | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| B-cell lymphoma | D016393 | — | — | — | 1 | — | — | — | 1 |
| Hodgkin disease | D006689 | — | C81 | — | 1 | — | — | — | 1 |
Indications Phases 1
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Indications Without Phase
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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) |
Target
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Estimated US medical usage
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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105,104 adverse events reported
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