Skin & aging Cyclic lipopeptide antibiotic
Daptomycin
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Daptomycin (sold as Cubicin) is a cyclic lipopeptide antibiotic that kills Gram-positive bacteria, including MRSA, by puncturing their cell membrane. It is used for serious skin infections and for Staphylococcus aureus bloodstream infections, but notably not for pneumonia. It has been FDA-approved in the U.S. since 2003 and is given intravenously.
At a glance
- What it is
- A cyclic lipopeptide antibiotic active against Gram-positive bacteria
- Approved for
- Complicated skin infections and S. aureus bloodstream infection, including right-sided endocarditis
- Key fact
- In a pivotal trial it was non-inferior to standard therapy for S. aureus bacteremia and endocarditis
- Route
- Intravenous
- Evidence strength
- FDA approved
Summary
Daptomycin is an FDA-approved intravenous antibiotic for serious skin infections and Staph aureus bloodstream infections. Learn how it works and its uses.
What is daptomycin?
Daptomycin, sold under the brand Cubicin, is a cyclic lipopeptide antibiotic with a fatty tail that lets it insert into bacterial membranes. It is active against Gram-positive organisms, including drug-resistant ones like MRSA and vancomycin-resistant enterococci, which makes it valuable when first-line options fail. It was developed under the code LY146032 and approved in the United States in 2003.
How does daptomycin work?
Daptomycin works at the bacterial cell membrane rather than the cell wall. In the presence of calcium, its lipid tail inserts into the Gram-positive membrane, where multiple molecules cluster to form channels. These channels let potassium and other ions leak out, rapidly collapsing the membrane's electrical charge. Without that charge the bacterium cannot sustain DNA, RNA, and protein synthesis, and it dies quickly, without bursting open.
That membrane mechanism gives concentration-dependent, rapid killing. One important limitation follows from its chemistry: daptomycin is inactivated by lung surfactant, so it does not work for pneumonia and is not used there. In the pivotal trial for bloodstream infection, daptomycin was non-inferior to standard therapy for S. aureus bacteremia and right-sided endocarditis, with less kidney dysfunction.
Is it FDA-approved?
Editor’s note
Status: Yes. Daptomycin was approved by the FDA in 2003 for complicated skin and skin-structure infections, with the S. aureus bloodstream infection indication (including right-sided endocarditis) added afterward. It is given once daily intravenously.
Category: FDA-approved · Primary body area: Skin & aging
Yes. Daptomycin was approved by the FDA in 2003 for complicated skin and skin-structure infections, with the S. aureus bloodstream infection indication (including right-sided endocarditis) added afterward. It is given once daily intravenously.
What is daptomycin prescribed for?
Daptomycin is prescribed for complicated skin and skin-structure infections and for S. aureus bloodstream infections, including right-sided infective endocarditis, caused by susceptible Gram-positive bacteria. It is explicitly not used for pneumonia.
What are the side effects?
According to the prescribing information, common side effects include:
- Diarrhea, headache, and dizziness
- Rash
- Abnormal liver tests and rises in the muscle enzyme CPK
- Urinary tract infections
- Low blood pressure and shortness of breath
More serious considerations include:
- Muscle injury (myopathy and rarely rhabdomyolysis), so CPK is monitored and statins may be paused
- Eosinophilic pneumonia, an uncommon lung reaction
- Peripheral neuropathy
- Serious allergic reactions, including a severe drug reaction called DRESS
- Kidney inflammation (tubulointerstitial nephritis)
Sources: FDA prescribing information for Cubicin; a trial of daptomycin for S. aureus bacteremia and endocarditis (Fowler et al., The New England Journal of Medicine, 2006, DOI: 10.1056/NEJMoa053783), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
approved (PDF)
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