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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
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
cardiovascular diseasesD002318
skin and connective tissue diseasesD017437
signs and symptoms pathological conditionsD013568
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 CHLORIDEBaxterN-213645 RX2023-02-27
4 products, RLD, RS
DAPZURA RTBaxterN-213645 PEND2022-01-25
1 products, RLD
DAPTOMYCINHospiraN-210282 RX2021-06-21
2 products, RLD, RS
DAPTOMYCINSagent PharmaceuticalsN-208385 RX2017-09-12
1 products, RLD, RS
DAPTOMYCINXelliaN-209949 RX2017-10-20
1 products, RLD, RS
DAPTOMYCINXelliaN-217415 RX2023-01-30
2 products, RLD, RS
Show 2 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
cubicinNew Drug Application2022-11-22
daptomycinANDA2023-06-06
dapzura rtNew Drug Application2022-01-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
bacteremiaEFO_0003033D016470R78.81
bacterial infectionsD001424A49
bacterial skin diseasesD017192
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Daptomycin, Daptomycin In 0.9% Sodium Chloride, Baxter Hlthcare Corp
111731892041-03-11DPU-3294
Daptomycin, Daptomycin, Hospira
96559462033-09-11DPU-3175
103575352033-09-11DPU-3176
Daptomycin, Cubicin, Cubist Pharms Llc
91384562030-11-23DP
80036732028-09-04U-1180
ATC Codes
J: Antiinfectives for systemic use
J01: Antibacterials for systemic use
J01X: Other antibacterials in atc
J01XX: Other antibacterials in atc
J01XX09: Daptomycin
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
BacteremiaD016470EFO_0003033R78.8144715
EndocarditisD004696EFO_0000465I331315
Staphylococcal infectionsD013203A49.011225
Soft tissue infectionsD01846121115
SepsisD018805A41.911114
Infectious skin diseasesD0128741113
Renal insufficiencyD051437HP_0000083N191113
CellulitisD002481EFO_0003035L03.9033
Bacterial endocarditisD004697EFO_10008301113
OsteomyelitisD010019EFO_0003102M86112
Show 12 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_00005441236
Gram-positive bacterial infectionsD0169082114
Bacterial pneumoniaD018410EFO_1001272J15.922
Surgical wound infectionD013530112
Staphylococcus aureusD013211NCBITaxon_1280112
Critical careD00342211
Gram-positive bacteriaD00609411
Cross infectionD00342811
Liver cirrhosisD008103EFO_0001422K74.0111
AscitesD001201HP_0001541R18111
Show 2 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Bacterial infectionsD001424A49112
NeutropeniaD009503D70112
NeoplasmsD009369C80112
Pneumococcal meningitisD008586EFO_1001114G00.111
FeverD005334HP_0001945R50.911
Hot flashesD01958411
SweatingD01354611
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MeningitisD008581EFO_0000584G03112
Chronic kidney failureD007676EFO_0003884N18.622
Subcutaneous injectionsD00727911
PharmacokineticsD01059911
Drug interactionsD00434711
Healthy volunteers/patients11
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Drug-related side effects and adverse reactionsD064420T88.722
Fatal outcomeD01780911
Cerebral hemorrhageD00254311
Subarachnoid hemorrhageD013345EFO_0000713I6011
Drug monitoringD01690311
MediastinitisD008480J98.5111
Heart-assist devicesD00635311
Septic shockD012772A48.311
Chronic renal insufficiencyD051436N1811
Acute kidney injuryD058186HP_0001919N1711
Show 2 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDAPTOMYCIN
INNdaptomycin
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 classaptamers, 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-ID103060-53-3
RxCUI22299
ChEMBL IDCHEMBL387675
ChEBI ID600103
PubChem CID21585658
DrugBankDB00080
UNII IDNWQ5N31VKK (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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