Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library
Daptomycin (Cubicin): what the evidence says
At a glance
What it is: a cyclic lipopeptide antibiotic. The Cubicin brand is listed as discontinued on Drugs@FDA; other daptomycin products are marketed. R1, R2, R3 UNVERIFIED the 13-amino-acid count, the Streptomyces roseosporus source and the reason for brand discontinuation.
What the evidence says: Human in a randomized trial of 246 patients with S. aureus bacteremia or endocarditis, daptomycin was non-inferior to standard therapy (success 44% vs 42%) with less kidney damage. R4
Biggest risks: the label says it is not for pneumonia. UNVERIFIED the label's myopathy and eosinophilic pneumonia warnings (not opened in full).
Rating
| Human Human evidence | Strong: RCT (n = 246) R4 |
| Animal Animal / lab evidence | Not reviewed |
| Regulatory | FDA-approved R1 · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page R5, R6, R7 · not named by WADA R8 |
| Established human dose | Yes, label dose (see Study details) |
Evidence verdict: S. aureus bacteremia and skin infections: Strong (RCT non-inferiority) · Pneumonia: not effective (label)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: an open-label but randomized non-inferiority trial; resistance emerged in some patients. R4
What is it?
Related pages: colistin, ll-37.
Does it work?
- Human Success 53/120 vs 48/115. R4
- Label: not indicated for pneumonia. R9
Is it safe?
- Human Kidney dysfunction 11% vs 26% on standard therapy. R4
Gray-market vials: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
Is it legal?
- US: FDA-approved, prescription; Cubicin brand discontinued, generics marketed. R1, R2, R3
- Compounding: not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R5, R6, R7
- Sport: not named on WADA's 2026 Prohibited List. R8
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Fowler 2006 | 246 S. aureus bacteremia/endocarditis | IV | 6 mg/kg daily | 42 days post-therapy | Non-inferior; less renal toxicity | PMID 16914701 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 27, 2026)
- R1 Drugs@FDA, Cubicin (daptomycin), listed discontinued, application NDA021572 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA021572
- R2 Drugs@FDA, daptomycin, Maia Pharms, application NDA217630 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=NDA217630
- R3 Drugs@FDA, daptomycin generic, application ANDA217215 (openFDA drugsfda record checked Oct 27, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=ANDA217215
- R4 Fowler VG Jr, et al. N Engl J Med. 2006. PMID 16914701
- R5 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R6 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R7 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R8 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- R9 Daptomycin for injection prescribing information, label published Apr 19, 2023 (DailyMed, checked Oct 27, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01f3f32a-fac1-4a8f-b205-4601046f0b5c
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Daptomycin (Cubicin). This is a prescription medicine. Use it only under the care of a licensed clinician; do not buy it from research-chemical or gray-market sellers. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).