Cubicin(daptomycin)
Cubicin, Dapzura Rt (daptomycin) is a protein pharmaceutical. Daptomycin was first approved as Cubicin on 2003-09-12. It is used to treat bacteremia, bacterial infections, and bacterial skin diseases in the USA. It has been approved in Europe to treat bacteremia, bacterial endocarditis, bacterial skin diseases, gram-positive bacterial infections, and soft tissue infections.
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Commercial
Trade Name
FDA
EMA
Dapzura rt (generic drugs available since 2016-03-25, discontinued: Cubicin, Cubicin rf)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Daptomycin
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
DAPTOMYCIN IN 0.9% SODIUM CHLORIDE | Baxter | N-213645 RX | 2023-02-27 | 4 products, RLD, RS |
DAPZURA RT | Baxter | N-213645 PEND | 2022-01-25 | 1 products, RLD |
DAPTOMYCIN | Hospira | N-210282 RX | 2021-06-21 | 2 products, RLD, RS |
DAPTOMYCIN | Sagent Pharmaceuticals | N-208385 RX | 2017-09-12 | 1 products, RLD, RS |
DAPTOMYCIN | Xellia | N-209949 RX | 2017-10-20 | 1 products, RLD, RS |
DAPTOMYCIN | Xellia | N-217415 RX | 2023-01-30 | 2 products, RLD, RS |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
cubicin | New Drug Application | 2022-11-22 |
daptomycin | ANDA | 2023-06-06 |
dapzura rt | New Drug Application | 2022-01-25 |
Agency Specific
FDA
EMA
No data
Patent Expiration
HCPCS
Code | Description |
---|---|
J0878 | Injection, daptomycin, 1 mg |
Clinical
Clinical Trials
87 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Bacteremia | D016470 | EFO_0003033 | R78.81 | — | 4 | 4 | 7 | — | 15 |
Endocarditis | D004696 | EFO_0000465 | I33 | — | 1 | — | 3 | 1 | 5 |
Staphylococcal infections | D013203 | A49.01 | — | 1 | 2 | 2 | — | 5 | |
Soft tissue infections | D018461 | — | 2 | 1 | 1 | 1 | 5 | ||
Sepsis | D018805 | A41.9 | 1 | 1 | — | 1 | 1 | 4 | |
Infectious skin diseases | D012874 | — | 1 | 1 | 1 | — | 3 | ||
Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | 1 | — | 3 |
Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | — | 3 | — | 3 |
Bacterial endocarditis | D004697 | EFO_1000830 | — | 1 | 1 | 1 | — | 3 | |
Osteomyelitis | D010019 | EFO_0003102 | M86 | — | 1 | — | 1 | — | 2 |
Show 12 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infections | D007239 | EFO_0000544 | — | 1 | 2 | — | 3 | 6 | |
Gram-positive bacterial infections | D016908 | 2 | 1 | 1 | — | — | 4 | ||
Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | — | 2 | — | — | 2 |
Surgical wound infection | D013530 | — | — | 1 | — | 1 | 2 | ||
Staphylococcus aureus | D013211 | NCBITaxon_1280 | — | 1 | 1 | — | — | 2 | |
Critical care | D003422 | — | — | 1 | — | — | 1 | ||
Gram-positive bacteria | D006094 | — | — | 1 | — | — | 1 | ||
Cross infection | D003428 | — | — | 1 | — | — | 1 | ||
Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 1 | — | — | 1 |
Ascites | D001201 | HP_0001541 | R18 | — | 1 | 1 | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Meningitis | D008581 | EFO_0000584 | G03 | 1 | — | — | — | 1 | 2 |
Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 2 | — | — | — | — | 2 |
Subcutaneous injections | D007279 | 1 | — | — | — | — | 1 | ||
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
Drug interactions | D004347 | 1 | — | — | — | — | 1 | ||
Healthy volunteers/patients | — | 1 | — | — | — | — | 1 |
Indications Without Phase
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 | — | — | — | — | 2 | 2 | |
Fatal outcome | D017809 | — | — | — | — | 1 | 1 | ||
Cerebral hemorrhage | D002543 | — | — | — | — | 1 | 1 | ||
Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
Drug monitoring | D016903 | — | — | — | — | 1 | 1 | ||
Mediastinitis | D008480 | J98.51 | — | — | — | — | 1 | 1 | |
Heart-assist devices | D006353 | — | — | — | — | 1 | 1 | ||
Septic shock | D012772 | A48.3 | — | — | — | — | 1 | 1 | |
Chronic renal insufficiency | D051436 | N18 | — | — | — | — | 1 | 1 | |
Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
Show 2 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | DAPTOMYCIN |
INN | daptomycin |
Description | Daptomycin, sold under the brand name Cubicin among others, is a lipopeptide antibiotic used in the treatment of systemic and life-threatening infections caused by Gram-positive organisms.
|
Classification | Small molecule |
Drug class | aptamers, classical and mirror; antibiotics (Streptomyces strain) |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CCCCCCCCCC(=O)N[C@@H](Cc1c[nH]c2ccccc12)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@@H]1C(=O)NCC(=O)N[C@@H](CCCN)C(=O)N[C@@H](CC(=O)O)C(=O)N[C@H](C)C(=O)N[C@@H](CC(=O)O)C(=O)NCC(=O)N[C@H](CO)C(=O)N[C@@H]([C@H](C)CC(=O)O)C(=O)N[C@@H](CC(=O)c2ccccc2N)C(=O)O[C@@H]1C |
Identifiers
PDB | — |
CAS-ID | 103060-53-3 |
RxCUI | 22299 |
ChEMBL ID | CHEMBL387675 |
ChEBI ID | 600103 |
PubChem CID | 21585658 |
DrugBank | DB00080 |
UNII ID | NWQ5N31VKK (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Cubicin - Merck Sharp & Dohme
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,650 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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15,015 adverse events reported
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