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)
Associated Therapies
-

Study of Daptomycin in Subjects Undergoing Surgery for Osteomyelitis Associated With an Infected Prosthetic Caused by Staphylococci

First Posted Date
2007-01-30
Last Posted Date
2018-01-31
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
75
Registration Number
NCT00428844
Locations
🇺🇸

Dartmouth-Hitchcock Medical center, Lebanon, New Hampshire, United States

🇷🇺

Federal Healthcare Institute "Novosibirsk Scientific Research Institute of Traumatology and Orthopedy Rosmeditechnology", Novosibirsk, Russian Federation

🇺🇸

Gundersen Clinic, LTD, La Crosse, Wisconsin, United States

and more 23 locations

Phase 2 Safety and Efficacy Study of Daptomycin in Complicated Skin and Skin Structure Infections

Phase 2
Completed
Conditions
First Posted Date
2007-01-25
Last Posted Date
2010-09-14
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
100
Registration Number
NCT00426933
Locations
🇺🇸

Idaho Falls Infectious Diseases, PLLC, Idaho Falls, Idaho, United States

Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

Phase 4
Terminated
Conditions
Interventions
First Posted Date
2006-11-22
Last Posted Date
2017-05-03
Lead Sponsor
Weill Medical College of Cornell University
Target Recruit Count
6
Registration Number
NCT00401960
Locations
🇺🇸

NewYork-Presbyterian Hospital, Weill Cornell Campus, New York, New York, United States

Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

First Posted Date
2006-06-12
Last Posted Date
2017-05-09
Lead Sponsor
OHSU Knight Cancer Institute
Target Recruit Count
54
Registration Number
NCT00335478
Locations
🇺🇸

OHSU Knight Cancer Institute, Portland, Oregon, United States

Daptomycin or Vancomycin in Treating Bacteria in the Blood in Patients With Neutropenia Caused By Chemotherapy

First Posted Date
2006-02-24
Last Posted Date
2018-08-10
Lead Sponsor
Wake Forest University Health Sciences
Registration Number
NCT00296049
Locations
🇺🇸

Wake Forest University Comprehensive Cancer Center, Winston-Salem, North Carolina, United States

Study Comparing CUBICIN® (Daptomycin for Injection) With Vancomycin in Cellulitis or Erysipelas

Phase 4
Completed
Conditions
First Posted Date
2006-02-23
Last Posted Date
2017-09-07
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
80
Registration Number
NCT00295178
Locations
🇺🇸

Joseph Still Research Foundation, Augusta, Georgia, United States

Study of Single Dose Daptomycin in Pediatric Patients With Gram-positive Infection for Which They Are Receiving Standard Antibiotics

Phase 1
Completed
Conditions
First Posted Date
2005-08-29
Last Posted Date
2020-03-11
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
33
Registration Number
NCT00136292
Locations
🇺🇸

University of Texas Southwestern, Dallas, Texas, United States

🇺🇸

Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States

🇺🇸

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Daptomycin for the Treatment of Infections Due to Gram-Positive Bacteria

Phase 3
Terminated
Conditions
First Posted Date
2003-02-21
Last Posted Date
2017-06-14
Lead Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Target Recruit Count
75
Registration Number
NCT00055198
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