Cerubidine, Vyxeos liposomal (previously known as vyxeos)(daunorubicin)
Cerubidine, Daunorubicin, Daunoxome, Vyxeos (daunorubicin) is a small molecule pharmaceutical. Daunorubicin was first approved as Cerubidine on 1982-01-01. It is used to treat myeloid leukemia acute and precursor cell lymphoblastic leukemia-lymphoma in the USA. It has been approved in Europe to treat myeloid leukemia acute.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
Cerubidine, Daunorubicin (discontinued: Cerubidine, Daunorubicin, Daunoxome)
CombinationsVyxeos
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Daunorubicin citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DAUNOXOME | Galen Pharma | N-050704 DISCN | 1996-04-08 | 1 products |
Hide discontinued
Daunorubicin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DAUNORUBICIN HYDROCHLORIDE | Hikma Pharmaceuticals | N-050731 RX | 1998-01-30 | 1 products, RLD, RS |
Show 1 discontinued
Cytarabine
+
Daunorubicin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VYXEOS | Celator Pharmaceuticals | N-209401 RX | 2017-08-03 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| daunorubicin hydrochloride | ANDA | 2024-12-25 |
| vyxeos | New Drug Application | 2022-09-27 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CYTARABINE / DAUNORUBICIN, VYXEOS, CELATOR PHARMS | |||
| 2028-03-30 | ODE-350 | ||
| 2024-08-03 | ODE-287 | ||
| 2024-03-30 | NPP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cytarabine / Daunorubicin, Vyxeos, Celator Pharms | |||
| 10028912 | 2032-10-15 | DP | U-3149, U-3150 |
| 10166184 | 2032-10-15 | DP | U-3149 |
| 10835492 | 2032-10-15 | U-3150 | |
| 8092828 | 2029-04-01 | U-3147 | |
| 8022279 | 2027-09-14 | DP | U-3147 |
| 7850990 | 2027-01-23 | DP | U-3147 |
| 9271931 | 2027-01-23 | DP | |
| 8518437 | 2026-06-07 | DP | |
| 8431806 | 2025-04-22 | DP | U-3147 |
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01D: Cytotoxic antibiotics and related substances
— L01DB: Anthracyclines and related substances
— L01DB02: Daunorubicin
— L01X: Other antineoplastic agents in atc
— L01XY: Combinations of antineoplastic agents
— L01XY01: Cytarabine and daunorubicin
Clinical
Clinical Trials
488 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 90 | 160 | 115 | 19 | 27 | 366 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 80 | 113 | 72 | 4 | 21 | 255 |
| Myeloid leukemia | D007951 | — | C92 | 73 | 100 | 64 | 3 | 15 | 222 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 13 | 61 | 48 | 14 | 15 | 141 |
| Lymphoid leukemia | D007945 | — | C91 | 9 | 51 | 37 | 11 | 11 | 110 |
| Lymphoma | D008223 | — | C85.9 | 9 | 27 | 14 | 2 | 1 | 49 |
| Philadelphia chromosome | D010677 | — | — | 2 | 11 | 3 | 2 | — | 16 |
| Promyelocytic leukemia acute | D015473 | — | C92.4 | — | 5 | 3 | 3 | 1 | 12 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myelodysplastic syndromes | D009190 | — | D46 | 15 | 27 | 19 | — | 5 | 59 |
| Preleukemia | D011289 | — | — | 11 | 16 | 17 | — | 4 | 43 |
| Syndrome | D013577 | — | — | 8 | 11 | 13 | — | 2 | 31 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 12 | 9 | — | 1 | 26 |
| Neoplasms | D009369 | — | C80 | 8 | 9 | 4 | — | 2 | 21 |
| Recurrence | D012008 | — | — | 7 | 5 | 2 | — | 1 | 13 |
| Carcinoma | D002277 | — | C80.0 | 6 | 5 | 2 | — | — | 12 |
| Myeloproliferative disorders | D009196 | — | D47.1 | 3 | 6 | 4 | — | — | 12 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 3 | 3 | 5 | — | 1 | 11 |
| Sarcoma | D012509 | — | — | 4 | 3 | 5 | — | — | 10 |
Show 59 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 6 | 3 | — | — | — | 7 |
| B-cell lymphoma | D016393 | — | — | 5 | 4 | — | — | — | 7 |
| Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | — | 3 | 5 | — | — | — | 6 |
| Hodgkin disease | D006689 | — | C81 | 2 | 4 | — | — | — | 6 |
| Blast crisis | D001752 | — | — | 1 | 3 | — | — | — | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 3 | — | — | — | 3 |
| Residual neoplasm | D018365 | — | — | — | 2 | — | — | 1 | 3 |
| Transitional cell carcinoma | D002295 | — | — | — | 2 | — | — | — | 2 |
| Primary myelofibrosis | D055728 | — | D47.4 | 2 | 1 | — | — | — | 2 |
| Myeloid leukemia chronic-phase | D015466 | — | — | 1 | 1 | — | — | — | 2 |
Show 28 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic neoplasms | D019337 | — | — | 5 | — | — | — | 1 | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 3 | — | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | — | — | — | — | 2 |
| Fallopian tube neoplasms | D005185 | — | — | 2 | — | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | 2 | — | — | — | — | 2 |
| Stomach neoplasms | D013274 | EFO_0003897 | C16 | 2 | — | — | — | — | 2 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | 1 | — | — | — | — | 1 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | — | — | — | — | 1 |
Show 26 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Ataxia | D001259 | — | R27.0 | — | — | — | — | 1 | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | — | — | — | — | 1 | 1 |
| Telangiectasis | D013684 | — | — | — | — | — | — | 1 | 1 |
| Cerebellar ataxia | D002524 | — | — | — | — | — | — | 1 | 1 |
| Mucositis | D052016 | EFO_1001898 | — | — | — | — | — | 1 | 1 |
| Hiv | D006678 | — | O98.7 | — | — | — | — | 1 | 1 |
| Cardiomyopathies | D009202 | EFO_0000318 | I42 | — | — | — | — | 1 | 1 |
| Infertility | D007246 | EFO_0000545 | — | — | — | — | — | 1 | 1 |
| Induction chemotherapy | D060828 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Daunorubicin |
| INN | daunorubicin |
| Description | Daunorubicin is a natural product found in Actinomadura roseola. It has a role as an antineoplastic agent and a bacterial metabolite. It is an anthracycline, a member of tetracenequinones, a member of p-quinones and an aminoglycoside antibiotic. It is a conjugate base of a daunorubicin(1+). It derives from a hydride of a tetracene. ... More |
| 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(C)=O)C[C@@H]3O[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 |
Identifiers
| PDB | — |
| CAS-ID | 20830-81-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL178 |
| ChEBI ID | 41977 |
| PubChem CID | 30323 |
| DrugBank | DB00694 |
| UNII ID | ZS7284E0ZP (ChemIDplus, GSRS) |
Target
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Variants
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Vyxeos – Jazz Pharmaceuticals
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Safety
Black-box Warning
Black-box warning for: Vyxeos
Adverse Events
Top Adverse Reactions
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15,616 adverse events reported
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