Cubicin(daptomycin)
Cubicin, Daptomycin (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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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 |
| 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 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cubicin | New Drug Application | 2023-08-24 |
| cubicin rf | New Drug Application | 2023-08-14 |
| daptomycin | ANDA | 2024-01-19 |
| daptomycin in sodium chloride | New Drug Application | 2023-02-27 |
| dapzura rt | New Drug Application | 2022-01-25 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bacteremia | EFO_0003033 | D016470 | R78.81 |
| bacterial infections | — | D001424 | A49 |
| bacterial skin diseases | — | D017192 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Daptomycin, Daptomycin In 0.9% Sodium Chloride, Baxter Hlthcare Corp | |||
| 11173189 | 2041-03-11 | DP | U-3294 |
| Daptomycin, Daptomycin, Xellia Pharms Aps | |||
| 11759497 | 2038-08-28 | DP | |
| Daptomycin, Daptomycin, Hospira | |||
| 9655946 | 2033-09-11 | DP | U-3175 |
| 10357535 | 2033-09-11 | DP | U-3176 |
| Daptomycin, Cubicin, Cubist Pharms Llc | |||
| 9138456 | 2030-11-23 | DP | |
| 8003673 | 2028-09-04 | U-1180 | |
Clinical
Clinical Trials
114 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 | — | 6 | 4 | 9 | 2 | 21 |
| Endocarditis | D004696 | HP_0100584 | — | — | 1 | — | 3 | 2 | 6 |
| Staphylococcal infections | D013203 | — | A49.01 | — | 1 | 2 | 3 | — | 6 |
| Sepsis | D018805 | HP_0100806 | A41.9 | 1 | 1 | — | 1 | 2 | 5 |
| Soft tissue infections | D018461 | — | — | — | 2 | 1 | 1 | 1 | 5 |
| Osteomyelitis | D010019 | EFO_0003102 | M86 | — | 2 | — | 2 | — | 4 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | — | 1 | 1 | 1 | 4 |
| Infectious skin diseases | D012874 | — | — | — | 1 | 1 | 1 | — | 3 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | — | 3 | — | 3 |
| Bacterial endocarditis | D004697 | EFO_1000830 | — | — | 1 | 1 | 1 | — | 3 |
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 | — | 4 | 7 |
| Gram-positive bacterial infections | D016908 | — | — | 2 | 1 | 1 | — | 2 | 6 |
| 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 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | — | 1 | — | — | 1 | 2 |
| Neutropenia | D009503 | — | D70 | — | 1 | — | — | 1 | 2 |
| Neoplasms | D009369 | — | C80 | — | 1 | — | — | 1 | 2 |
| Pneumococcal meningitis | D008586 | EFO_1001114 | G00.1 | — | 1 | — | — | — | 1 |
| Fever | D005334 | HP_0001945 | R50.9 | — | 1 | — | — | — | 1 |
| Hot flashes | D019584 | — | — | — | 1 | — | — | — | 1 |
| Sweating | D013546 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Meningitis | D008581 | HP_0001287 | 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 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 2 | 2 |
| Inappropriate prescribing | D057970 | — | — | — | — | — | — | 1 | 1 |
| Fatal outcome | D017809 | — | — | — | — | — | — | 1 | 1 |
| Cerebral hemorrhage | D002543 | — | — | — | — | — | — | 1 | 1 |
| Subarachnoid hemorrhage | D013345 | EFO_0000713 | I60 | — | — | — | — | 1 | 1 |
| Drug monitoring | D016903 | — | — | — | — | — | — | 1 | 1 |
| Hemodiafiltration | D017583 | — | — | — | — | — | — | 1 | 1 |
| Mediastinitis | D008480 | — | J98.51 | — | — | — | — | 1 | 1 |
| Heart-assist devices | D006353 | — | — | — | — | — | — | 1 | 1 |
Show 4 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 | — |
| ChEMBL ID | CHEMBL387675 |
| ChEBI ID | 600103 |
| PubChem CID | 16129629 |
| DrugBank | DB00080 |
| UNII ID | NWQ5N31VKK (ChemIDplus, GSRS) |
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Cubicin – Merck Sharp & Dohme
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Daptomycin
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Safety
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9,439 adverse events reported
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