CUBICIN RF

Peak

daptomycin

NDAINTRAVENOUSPOWDERPriority Review

Approved

Sep 2003

Lifecycle

Peak

Competitive Pressure

8/100

Clinical Trials

Mechanism of Action

12.1 Mechanism of Action Daptomycin is an antibacterial drug [see ]. 12.2 Pharmacodynamics Based on animal models of infection, the antimicrobial activity of daptomycin appears to correlate with the AUC/MIC (area under the concentration-time curve/minimum inhibitory concentration) ratio for certain…

Indications (15)

pneumonia left-sided infective endocarditis due to S skin structure infections (cSSSI) caused by susceptible isolates of the following Gram-positive bacteria: Staphylococcus aureus (including methicillin-resistant isolates)Streptococcus pyogenes Streptococcus agalactiae Streptococcus dysgalactiae subsp including adult patients with right-sided infective endocarditis caused by methicillin-susceptible methicillin-resistant isolates development of drug-resistant bacteria maintain the effectiveness of CUBICIN RF other antibacterial drugs CUBICIN RF should be used only to treat prevent infections strongly suspected to be caused by susceptible bacteria

Clinical Trials (5)

NCT03643952Phase 2Completed

Safety, Efficacy, and Pharmacokinetics (PK) of Daptomycin (MK-3009) in Japanese Pediatric Subjects With Complicated Skin and Soft Tissue Infections (cSSTI) and Bacteremia (MK-3009-029)

Started Dec 2018

18 enrolled

BacteremiaSoft Tissue InfectionsSkin Diseases, Infectious

NCT02097953Phase 1Completed

Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin

Started May 2014

12 enrolled

Drug InteractionsPharmacokinetics

NCT01922011Phase 3Completed

Safety and Efficacy Study of Daptomycin Compared to Active Comparator in Pediatric Participants With Acute Hematogenous Osteomyelitis (AHO) (MK-3009-006)

Started Sep 2013

149 enrolled

Acute Hematogenous Osteomyelitis

NCT01728376Phase 4Completed

Safety & Efficacy of Daptomycin Versus Standard of Care (SOC) in 1 - 17 Year Olds With Staphylococcus Aureus Bacteremia (MK-3009-005)

Started Nov 2012

Bacteremia

NCT01515020Phase 3Terminated

Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia

Started May 2012

10 enrolled

Nosocomial InfectionHealthcare-associated Infection