MedPath

Daptomycin

Generic Name
Daptomycin
Brand Names
Cubicin, Dapzura, Daptomycin Hospira
Drug Type
Small Molecule
Chemical Formula
C72H101N17O26
CAS Number
103060-53-3
Unique Ingredient Identifier
NWQ5N31VKK
Background

Daptomycin is a cyclic lipopeptide antibacterial agent with a broad spectrum of activity against Gram-positive bacteria, including methicillin-susceptible and -resistant Staphylococcus aureus (MSSA/MRSA) and vancomycin-resistant Enterococci (VRE). Chemically, daptomycin comprises 13 amino acids, including several non-standard and D-amino acids, with the C-terminal 10 amino acids forming an ester-linked ring and the N-terminal tryptophan covalently bonded to decanoic acid. Daptomycin was first discovered in the early 1980s by researchers at Eli Lilly in soil samples from Mount Ararat in Turkey. Early work on developing daptomycin was abandoned due to observed myopathy but was resumed in 1997 when Cubist Pharmaceuticals Inc. licensed daptomycin; it was found that a once-daily dosing scheme reduced side effects while retaining efficacy.

Daptomycin was approved by the FDA on September 12, 2003, and is marketed under the name CUBICIN® by Cubist Pharmaceuticals LLC (Merck & Co.).

Indication

Daptomycin is indicated for the treatment of complicated skin and skin structure infections (cSSSI) in patients one year of age and older. It is also indicated for the treatment of Staphylococcus aureus bloodstream infections (bacteremia) in patients one year of age and older, including in adult patients with right-sided infective endocarditis.

Daptomycin is not indicated for the treatment of pneumonia or left-sided infective endocarditis due to S. aureus. Use is not recommended in pediatric patients younger than one year of age due to the risk of potential effects on muscular, neuromuscular, and/or nervous systems (either peripheral and/or

central).

As with all antibacterial drugs, it is strongly suggested to perform sufficient testing before treatment initiation in order to confirm an infection caused by susceptible bacteria. Failure to do so may result in suboptimal treatment, treatment failure, and the development of drug-resistant bacteria.

Associated Conditions
Complicated Skin and Skin Structure Infection, Staphylococcus Aureus Bloodstream Infections (BSI; Bacteremia)

Cubicin(R) for Complicated Post-surgical Wound Infections

Phase 4
Terminated
Conditions
Wound Infections
First Posted Date
2008-04-02
Last Posted Date
2017-08-30
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
69
Registration Number
NCT00651131

Phase 4 Efficacy and Safety Study of Cubicin® With and Without Combination Therapy in S. Aureus Infective Endocarditis (SAIE)

Phase 4
Terminated
Conditions
Infective Endocarditis
Interventions
First Posted Date
2008-03-18
Last Posted Date
2021-02-02
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
24
Registration Number
NCT00638157
Locations
🇺🇸

Denver Health Medical Center, Denver, Colorado, United States

🇺🇸

Henry Ford Health System, Detroit, Michigan, United States

🇺🇸

Temple University School of Medicine, Philadelphia, Pennsylvania, United States

and more 1 locations

A Pilot Study of Daptomycin for Antimicrobial Prophylaxis

Phase 4
Terminated
Conditions
Antimicrobial Prophylaxis
Interventions
First Posted Date
2007-12-13
Last Posted Date
2014-07-25
Lead Sponsor
Duke University
Target Recruit Count
11
Registration Number
NCT00572260
Locations
🇺🇸

Duke University Medical Center, Durham, North Carolina, United States

Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia Due to S. Pneumoniae

Phase 3
Completed
Conditions
Pneumonia, Bacterial
First Posted Date
2007-10-05
Last Posted Date
2019-11-14
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Registration Number
NCT00540072

Comparative Study of Cidecin™ (Daptomycin) to Rocephin® (Ceftriaxone) in the Treatment of Moderate to Severe Community-Acquired Acute Bacterial Pneumonia

Phase 3
Completed
Conditions
Pneumonia, Bacterial
First Posted Date
2007-10-03
Last Posted Date
2019-11-14
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Registration Number
NCT00538694

Daptomycin in the Treatment of Catheter-Related Staphylococcus Aureus

Phase 2
Completed
Conditions
Staphylococcus Aureus
Interventions
First Posted Date
2007-07-26
Last Posted Date
2016-07-20
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
11
Registration Number
NCT00507247
Locations
🇺🇸

University of Texas MD Anderson Cancer Center, Houston, Texas, United States

Safety Study to Evaluate Daptomycin in Non-infected Adults Who Are Either on Hemodialysis or Continuous Ambulatory Peritoneal Dialysis (MK-3009-021)

Phase 1
Completed
Conditions
End-Stage Renal Disease
Interventions
First Posted Date
2007-06-25
Last Posted Date
2018-01-09
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
12
Registration Number
NCT00490737

Catheter Related - Gram Positive Bloodstream Infections

Phase 2
Completed
Conditions
Bloodstream Infection
Interventions
First Posted Date
2007-04-30
Last Posted Date
2021-02-08
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
30
Registration Number
NCT00467272
Locations
🇺🇸

UT MD Anderson Cancer Center, Houston, Texas, United States

Safety and Efficacy of Daptomycin for the Treatment of Complicated Skin and Skin-structure Infections

Phase 4
Terminated
Conditions
Staphylococcal Skin Infections
Interventions
First Posted Date
2007-04-20
Last Posted Date
2011-03-24
Lead Sponsor
Novartis
Target Recruit Count
52
Registration Number
NCT00463801
Locations
🇮🇹

Novartis Italy, Saronno, Italy

Acute Renal Failure in the Surgical Intense Care Units - NTUH-SICU-ARF (NSARF) Study

Not Applicable
Conditions
Acute Renal Failure
Sepsis
Postoperative
First Posted Date
2007-03-23
Last Posted Date
2007-03-23
Lead Sponsor
National Taiwan University Hospital
Target Recruit Count
300
Registration Number
NCT00451373
Locations
🇨🇳

National Taiwan University Hospital, Taipei, Taiwan

© Copyright 2025. All Rights Reserved by MedPath