What Is Dalbavancin Used For? Approved Uses, Per the Label

Dalbavancin is a prescription medicine in the United States, marketed under the brand name DALVANCE and administered intravenously in healthcare settings. It belongs to the lipoglycopeptide class, a group of semisynthetic derivatives of the older glycopeptide antibiotics such as vancomycin and teicoplanin, as summarised in a 2018 review of glycopeptide antibiotic development (PMID 29363950). This page describes only what the United States prescribing information lists as an indication, the trial evidence behind it, and the regulatory history of that indication.

This page is for educational purposes only and is not medical advice; consult a licensed physician or another qualified prescriber about whether any antibiotic is appropriate for a specific infection. No dosing information appears here.

The Labeled Indication

The US prescribing information for DALVANCE (dalbavancin for injection) carries a single therapeutic indication: the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. The label frames this as treatment of patients with ABSSSI, and it includes the standard antibacterial stewardship statement directing that the product be used only to treat infections proven or strongly suspected to be caused by susceptible bacteria.

The sources cited on this page do not state the revision month or year of the current DALVANCE label, so the revision date is not reproduced here. The authoritative text is the manufacturer's prescribing information as posted in the FDA label repository, which carries its own revision date on the last page.

Organisms Named in the Indication

Label indications for antibacterial drugs name the organisms the drug is indicated against, because the indication is defined by pathogen as well as by infection site. For dalbavancin, the Gram-positive organisms listed in the ABSSSI indication include Staphylococcus aureus, encompassing both methicillin-susceptible and methicillin-resistant isolates, along with Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, and the Streptococcus anginosus group. A 2020 review of dalbavancin in complicated Gram-positive skin and soft tissue infection described the drug's activity against Gram-positive pathogens including methicillin-resistant S. aureus as the rationale for its place in skin infection treatment (PMID 32500744).

The Trial Evidence Behind the Indication

The ABSSSI indication rests on a phase 3 development program in complicated skin and skin structure infection and in acute bacterial skin and skin structure infection. A 2015 review in Expert Review of Anti-Infective Therapy examined dalbavancin for complicated skin and skin structure infection and summarised the clinical development data supporting its use in that setting (PMID 25578881). An earlier review in Clinical Infectious Diseases characterised dalbavancin as a once-weekly lipoglycopeptide and reviewed the clinical trial experience accumulated before approval (PMID 18199045).

The distinguishing feature of that program was the extended half-life of the molecule, which allowed infrequent administration compared with daily intravenous comparators. Researchers who built a population pharmacokinetic model of dalbavancin and ran a pharmacokinetic/pharmacodynamic target attainment analysis reported that exposures achieved with the approved regimens supported activity against the target Gram-positive pathogens across the simulated patient population (PMID 31087630). That modelling work is the kind of analysis regulators review alongside clinical endpoints when a dosing regimen is modified.

What the Reviews Reported About Efficacy

• A 2015 review of dalbavancin in complicated skin and skin structure infection reported that the clinical trial data supported its role as a treatment option in that infection type (PMID 25578881).
• A 2020 review focused on complicated Gram-positive skin and soft tissue infection reported on dalbavancin's use in those infections, including infections involving methicillin-resistant S. aureus (PMID 32500744).
• A 2008 review in Clinical Infectious Diseases reported on the once-weekly administration schedule that defined the drug's clinical profile before approval (PMID 18199045).

Regulatory History of the Indication

Dalbavancin was approved by the US Food and Drug Administration in 2014 for acute bacterial skin and skin structure infections, an approval recorded in a 2014 pharmaceutical approval update that listed the new agent and its indication (PMID 25136251). It was among the first agents approved under the ABSSSI endpoint framework that replaced the older complicated skin and skin structure infection endpoints used in earlier trials, which is why the published literature uses both terms.

Since the original approval, the label has been revised. The regimen section was expanded so that the product could be given as a single-dose course in addition to the original two-dose course, a change supported by exposure modelling of the type described in the population pharmacokinetic and target attainment analysis (PMID 31087630). The indicated population was also extended beyond adults to pediatric patients in a later revision. In every version of the label, the therapeutic indication itself has remained ABSSSI caused by designated susceptible Gram-positive organisms; no second infection type has been added.

Why the Indication Matters for Care Settings

Because the indication covers an infection type that is frequently managed in emergency departments, several published studies have looked at how the labeled use fits into care pathways. A 2021 study of an emergency department pathway using a single-dose long-acting intravenous antibiotic reported a reduction in hospitalizations among patients presenting with skin infections (PMID 33780567). A 2025 article in The American Journal of Emergency Medicine examined the use of lipoglycopeptides for moderate to severe ABSSSI in the emergency department and discussed how long-acting agents are positioned within that setting (PMID 39489025). These reports describe service delivery around an approved indication rather than new indications.

Uses That Are Not Approved Indications

Several other settings have been studied, and none of them is an approved indication on the US label. The DOTS randomized clinical trial published in JAMA in 2025 evaluated dalbavancin for the treatment of complicated Staphylococcus aureus bacteremia against standard intravenous therapy (PMID 40802264); bloodstream infection is not a labeled indication. A 2023 review of new antimicrobials and treatment strategies for endocarditis discussed long-acting lipoglycopeptides among agents being explored for that infection (PMID 38137762), and endocarditis is likewise not a labeled indication. A 2021 laboratory report in Cell Research described dalbavancin binding ACE2 and inhibiting SARS-CoV-2 infection in animal models (PMID 33262453), which is preclinical work and not an approved use. A 2023 narrative review from the Antibacterial Resistance Leadership Group outlined research priorities in Gram-positive bacterial infection, including the design of trials for long-acting agents (PMID 37843115).

Tolerability in the Published Trials: What Studies Report

Safety information for a prescription antibiotic lives in the warnings, precautions and adverse reactions sections of the prescribing information, and that document is the reference a prescriber uses. Published summaries add context about what was observed in trials. The 2008 Clinical Infectious Diseases review of dalbavancin reported on the tolerability observed across the clinical trial experience available at that time (PMID 18199045), and the 2015 review of dalbavancin in complicated skin and skin structure infection reported safety findings from the development program alongside efficacy results (PMID 25578881).

More recent randomized evidence comes from outside the labeled indication. The DOTS trial, which studied dalbavancin in complicated S. aureus bacteremia, reported outcomes and adverse event data for the dalbavancin group compared with standard intravenous antibiotic therapy (PMID 40802264). Because the infusion is given in a healthcare setting, infusion-related monitoring is part of how the product is administered; the specifics are set out in the prescribing information rather than in this summary.

How the Indication Is Worded Compared With Related Agents

Dalbavancin sits in a class that also includes oritavancin and telavancin, and the 2018 review of glycopeptide antibiotic development traced how structural modifications to the glycopeptide scaffold produced agents with longer half-lives and altered activity profiles (PMID 29363950). Labels for these agents are not interchangeable: each product carries its own indication wording, its own organism list, and its own warnings. A statement that one lipoglycopeptide is indicated for a given infection says nothing about another.

Questions a Prescribing Clinician Answers

Every decision about whether an antibiotic fits a particular patient belongs to a licensed prescriber who can review the culture and susceptibility results, the severity and location of the infection, kidney and liver function, allergies, pregnancy status, other medicines, and the local resistance picture. The following are the kinds of questions that belong in that conversation rather than in an educational summary:

1. Whether the infection meets the ABSSSI definition used in the labeled indication.
2. Whether the causative organism is among the designated susceptible Gram-positive organisms named on the label.
3. Whether an intravenous long-acting agent or an alternative route is the better fit for the clinical situation.
4. What monitoring the prescribing information calls for during and after administration.
5. How treatment would be followed up if the infection does not respond as expected.

Key Points

• Dalbavancin is an FDA-approved prescription antibiotic marketed in the US as DALVANCE, given by intravenous infusion.
• The label carries one therapeutic indication: acute bacterial skin and skin structure infections caused by designated susceptible Gram-positive organisms, including methicillin-resistant S. aureus (PMID 32500744).
• Approval came in 2014 and was recorded in a contemporaneous approval update (PMID 25136251).
• Bloodstream infection and endocarditis have been studied but are not labeled indications (PMID 40802264).

For a broader overview of the molecule, its pharmacology and the wider research literature, see the hub page at /learn/dalbavancin/.

References

• Dalbavancin for Treatment of Staphylococcus aureus Bacteremia: The DOTS Randomized Clinical Trial (JAMA, 2025)
• Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis (Clinical Pharmacology in Drug Development, 2020)
• Developments in Glycopeptide Antibiotics (ACS Infectious Diseases, 2018)
• Dalbavancin for the Treatment of Complicated Gram-Positive Skin and Soft Tissue Infections (The International Journal of Lower Extremity Wounds, 2020)
• New Antimicrobials and New Therapy Strategies for Endocarditis: Weapons That Should Be Defended (Journal of Clinical Medicine, 2023)
• Dalbavancin (BI-387) for the treatment of complicated skin and skin structure infection (Expert Review of Anti-Infective Therapy, 2015)
• Dalbavancin: a novel once-weekly lipoglycopeptide antibiotic (Clinical Infectious Diseases, 2008)
• Pharmaceutical approval update (P&T, 2014)
• Use of lipoglycopeptides for moderate to severe ABSSSI in the emergency department (The American Journal of Emergency Medicine, 2025)
• Pathway with single-dose long-acting intravenous antibiotic reduces emergency department hospitalizations of patients with skin infections (Academic Emergency Medicine, 2021)
• Priorities and Progress in Gram-positive Bacterial Infection Research by the Antibacterial Resistance Leadership Group: A Narrative Review (Clinical Infectious Diseases, 2023)
• Dalbavancin binds ACE2 to block its interaction with SARS-CoV-2 spike protein and is effective in inhibiting SARS-CoV-2 infection in animal models (Cell Research, 2021)