Ireland
--:--IST
Latest
Priya Life Science Compound trial record
Trackers Drugs Trial finder
Compound · clinical trials

Dalbavancin clinical trials

Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our France and Australia registers that name Dalbavancin as an intervention. Synced 6 Oct 2026
2Current trials
0Recruiting now
2Lead sponsors
2Country registers
Maintained by Sreepriya Prasannan
MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany HSE Spark Ignite 2026 — Top 14 finalist
Compiled from ClinicalTrials.gov registry records · Last verified · Editorial standards
At a glance

Dalbavancin is named as an intervention in 2 current clinical trials in our France and Australia registers. None are recruiting at the moment. The most common phase is Not applicable. The sponsor with the most trials is Centre Hospitalier Universitaire de Nice (1). The most-studied condition is Osteoarticular Infection. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.

Where Dalbavancin is approved

All regulators →

Of the three regulators tracked here, the first to approve Dalbavancin was the US, on 23 May 2014. It is approved in 3 of the 3 regulators tracked here.

USUnited States (FDA)
23 May 2014
Dalvance
NDA021883 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
19 Feb 2015
Xydalba
EMA product page
First centralised authorisation
CACanada (Health Canada)
4 Sep 2018
Xydalba
Notice of Compliance 21279
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.

Dalbavancin patents and exclusivity

Expiry tracker →

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

US FDA Orange Book Dalvance
  • 1 listed patent; the last listed expires 23 May 2028 (US 6900175).
See the Orange Book listing for NDA 021883

Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 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 Dalbavancin

All medicines →
ENNHS England
£8k
10 items dispensed, Aug 2025 to Jul 2026
Net ingredient cost, community prescriptions
USUS Medicaid
$22.2m
6,621 prescriptions in 2025 · Dalvance, Dalbavancin Hydrochloride, Dalbavancin
+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.

Patient leaflets for Dalbavancin

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

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

Trials by status

  • Not yet open150%
  • Active, closed150%

Trials by phase

  • Not applicable150%
  • Observational150%
01

Clinical trials of Dalbavancin

2 trials
StudyPhaseStatusLead sponsorRegisters

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

Dalbavancin in the EU trials register (CTIS)

2 trials

Authorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Dalbavancin. 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 · Cardiovascular Diseases
Phase 3 Authorised Friedrich-Schiller-Universitaet Jena Germany
Pilot Study - Safety and Efficacy of Dalbavancin in Early Outpatient Treatment of Erysipelas and Limited Cellulitis
2025-524877-18-00 · CTIS ↗ · Skin and Connective Tissue Diseases
Phase 4 Authorised Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH Austria
03

Dalbavancin 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)

1 single-substance product containing Dalbavancin on the HPRA medicines list.

  • XydalbaAbbVie Deutschland GmbH & Co. KG · EU/1/14/986/001
All 1 Irish product →

Supply shortages

No entry for Dalbavancin in the EMA, FDA or German BfArM shortage lists we track.

04

Conditions studied with Dalbavancin

2 conditions
Osteoarticular Infection1Serious Gram-Positive Bacterial Infections1
05

Sponsors

lead sponsor per trial
Lead sponsorTrials
Centre Hospitalier Universitaire de Nice1
Kirby Institute1
06

By country register

RegisterTrialsRecruiting
Clinical trials in France10
Clinical trials in Australia10
EU register (CTIS)2—

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

Questions about Dalbavancin trials

How many clinical trials are testing Dalbavancin?

2 current trials in our France and Australia registers name Dalbavancin as a drug or biological intervention, as of the registry sync on 6 October 2026. Completed and withdrawn studies are not counted.

Are Dalbavancin trials recruiting patients?

Not at the moment. None of the 2 trials in our registers is recruiting; they are active but closed to enrolment, not yet open, or enrolling by invitation. Only the study team can confirm whether a patient is eligible.

Who sponsors Dalbavancin clinical trials?

Centre Hospitalier Universitaire de Nice (1) and Kirby Institute (1). The number in brackets is how many trials each organisation leads.

Is Dalbavancin licensed in Ireland?

Yes. The HPRA medicines list includes 1 single-substance product containing Dalbavancin, for example Xydalba (AbbVie Deutschland GmbH & Co. KG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Dalbavancin shortage?

Not in the lists we track: Dalbavancin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

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 Dalbavancin works or whether it is effective, and it is not medical advice.

Approvals, shortages and trials, every Friday

One email a week with new EMA and FDA approvals, EU and US medicine shortages, how many trials are recruiting in Ireland, and the week's Irish pharma news.

Free. Unsubscribe from any email with one click. See our privacy policy.

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 Dalbavancin 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 Dalbavancin (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 6 Oct 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.