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Priya Life Science Compound trial record
Compound · clinical trials

Daptomycin clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Canada, Australia, Germany, France, Netherlands, Sweden, Japan, Singapore and Israel registers that name Daptomycin as an intervention. Synced 10 Nov 2026
2Current trials
2Recruiting now
2Lead sponsors
9Country registers
At a glance

Daptomycin is named as an intervention in 2 current clinical trials in our Canada, Australia, Germany, France, Netherlands, Sweden, Japan, Singapore and Israel registers. 2 are recruiting patients now. All registered phases are Phase 4. The sponsor with the most trials is University of Melbourne (1). The most-studied condition is Staphylococcus Aureus Bacteremia. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.

Where Daptomycin is approved

All regulators →

Of the three regulators tracked here, the first to approve Daptomycin was the US, on 12 Sep 2003. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
12 Sep 2003
Cubicin
NDA021572 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
19 Jan 2006
Cubicin
EMA product page
First centralised authorisation
CACanada (Health Canada)
24 Sep 2007
Cubicin
Notice of Compliance 9041
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Daptomycin patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Daptomycin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Daptomycin, Daptomycin In 0.9% Sodium Chloride
  • 5 listed patents; the last listed expires 9 Jan 2043 (US 12629337).
See the Orange Book listing for NDA 209949
Patents and exclusivities above are pooled across 6 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Daptomycin

All medicines →
ENNHS England
Not dispensed in the community in England in the last 12 months under this name
Net ingredient cost, community prescriptions
USUS Medicaid
$25.7m
116,225 prescriptions in 2025 · Daptomycin, daptomycin, Daptomycin
-7% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

How Daptomycin works

All drug targets →
Diseases it has been tested for in clinical trials, by furthest phase
  • FeverPhase 3
  • NeutropeniaPhase 3
  • OsteomyelitisPhase 3
  • Pneumococcal pneumoniaPhase 3
  • Staphylococcus aureus infectionPhase 3
  • Pneumococcal meningitisPhase 2
  • Bacterial meningitisPhase 1

Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL387675, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 10904, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.

Patient leaflets for Daptomycin

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

  • IE
    Ireland: 16 products on the HPRA list
    Each product record links to the HPRA, which publishes the leaflet and SmPC.
  • EU
    European Union: Cubicin, Daptomycin Hospira (generic)
    EMA product information: package leaflet and summary of product characteristics in every EU language.
  • UK
    United Kingdom: Search MHRA Products
    Patient information leaflets and SmPCs for UK-licensed products.
  • US
    United States: Search DailyMed
    FDA-approved labels, including patient and medication guides.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Reference identifiers for Daptomycin

ChEMBL
CHEMBL387675
PubChem CID
170851048
CAS number
103060-53-3
Wikidata
Q63413234

Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.

Trials by status

  • Recruiting2100%

Trials by phase

  • Phase 42100%
01

Clinical trials of Daptomycin

2 trials
StudyPhaseStatusLead sponsorRegisters
Staphylococcus Aureus Network Adaptive Platform Trial
NCT05137119 · Staphylococcus Aureus Bacteremia
Phase 4 Recruiting University of Melbourne Germany, France, Netherlands, Sweden, Canada, Japan, Singapore, Australia, Israel
Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
NCT06637332 · ClinicalTrials.gov ↗ · Staphylococcus Aureus Septicemia, Staphylococcus Aureus Bacteremia, S. Aureus Bacteremia
Phase 4 Recruiting Todd C. Lee MD MPH FIDSA Canada, Australia

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Daptomycin in the EU trials register (CTIS)

1 trial

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Daptomycin. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.

StudyPhaseStatusSponsorCountries
Efficacy and safety of Dalbavancin in the treatment of infective Endocarditis caused by gram-positive cocci
2026-526149-91-00 · Bacterial Infections and Mycoses
Phase 3 Authorised Friedrich-Schiller-Universitaet Jena Germany
03

Daptomycin across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

16 single-substance products containing Daptomycin on the HPRA medicines list.

All 16 Irish products →

Supply shortages

  • Daptomycin InjectionUS (FDA) · Resolved · updated 30 Jun 2026
04

Conditions studied with Daptomycin

4 conditions
Staphylococcus Aureus Bacteremia2Staphylococcus Aureus Septicemia1S. Aureus Bacteremia1S. Aureus Bloodstream Infection1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
University of Melbourne1
Todd C. Lee MD MPH FIDSA1
06

By country register

RegisterTrialsRecruiting
Clinical trials in Canada22
Clinical trials in Australia22
Clinical trials in Germany11
Clinical trials in France11
Clinical trials in Netherlands11
Clinical trials in Sweden11
Clinical trials in Japan11
Clinical trials in Singapore11
Clinical trials in Israel11
EU register (CTIS)1—

A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.

07

Related compounds

08

Questions about Daptomycin trials

How many clinical trials are testing Daptomycin?

2 current trials in our Canada, Australia, Germany, France, Netherlands, Sweden, Japan, Singapore and Israel registers name Daptomycin as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.

Are Daptomycin trials recruiting patients?

Yes. 2 of the 2 trials are recruiting: 2 with sites in Canada, 2 with sites in Australia, 1 with sites in Germany, 1 with sites in France, 1 with sites in Netherlands, 1 with sites in Sweden, 1 with sites in Japan, 1 with sites in Singapore and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Daptomycin clinical trials?

University of Melbourne (1) and Todd C. Lee MD MPH FIDSA (1). The number in brackets is how many trials each organisation leads.

Is Daptomycin licensed in Ireland?

Yes. The HPRA medicines list includes 16 single-substance products containing Daptomycin, for example Daptomycin 350 mg powder for solution for injection/infusion (Reddy Holding GmbH). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Daptomycin shortage?

The registers we track list 1 entry for Daptomycin: US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Daptomycin works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Daptomycin works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Daptomycin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.