PeptideTrace
ApprovedLipoglycopeptide Antibiotic

Dalbavancin

Dalvance, Xydalba

A

Evidence Grade A — Regulatory approved. 846 published studies. 31 registered clinical trials.

31 trials846 studiesUSEUCA

Licensed Indications

  • Bacterial Skin Infections
  • Soft Tissue Infections
  • Acute Bacterial Skin and Skin Structure Infections

User Experience Reports

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Overview

Dalbavancin (sold as Dalvance) is an intravenous antibiotic with a remarkably long duration of action — a single infusion provides therapeutic antibiotic levels for over two weeks. This makes it possible to treat serious bacterial skin infections with just one hospital visit instead of days of intravenous therapy. It is also being studied for bone and joint infections, where patients would otherwise need weeks of daily IV antibiotics.

Research Activity

846studies
Human 541
Animal 19
In-vitro 151
Reviews 264

846 published studies: 541 human, 19 animal, 151 in-vitro, 264 reviews

Regulatory Status

US
FDA-approved(FDA)
EU
EMA-authorised(EMA)
CA
Health Canada approved(Health Canada)

Legal Status

USPrescription drug (Rx)
EUPrescription medicine (EU centralised authorisation)
CAPrescription drug

Summary

Dalbavancin is marketed as Dalvance (approved May 2014). Originally approved as a two-dose regimen (Day 1 and Day 8), a single-dose regimen was approved in January 2016, and paediatric approval followed in 2021. Indicated for ABSSSI caused by susceptible gram-positive organisms.

Dalbavancin's 346-hour half-life is the longest of any approved antibiotic, and there is growing off-label interest in its use for conditions requiring prolonged antibiotic courses, such as osteomyelitis and prosthetic joint infections — conditions where patients would otherwise need weeks of daily intravenous antibiotics. The DOTS trial (2025) showed non-inferiority to standard-of-care antibiotics for bone and joint infections, potentially expanding its clinical role significantly.

Mechanism of Action

Dalbavancin works through the same fundamental mechanism as vancomycin — blocking cell wall construction by binding the D-Ala-D-Ala target on peptidoglycan precursors. However, its fatty acid chain anchors it to the bacterial membrane, concentrating the drug at exactly the site where cell wall assembly occurs. This anchoring effect, combined with the ability to form pairs (dimers) at the membrane surface, makes dalbavancin approximately 16 times more potent than vancomycin against MRSA in laboratory testing.

Research Summary

Dalbavancin's evidence for skin infections is solid, based on three Phase III trials with over 1,300 patients. Its 346-hour half-life is the longest of any approved antibiotic. The drug was initially approved as a two-dose regimen but a single-dose option followed in 2016, and paediatric approval came in 2021. The most clinically exciting development is its potential for bone and joint infections. A major trial (DOTS, published in 2025) showed dalbavancin was non-inferior to standard antibiotics for these infections — conditions that typically require prolonged IV antibiotic courses through a central line. If this use gains widespread adoption, it could fundamentally change how bone and joint infections are managed. Side effects are generally mild, though liver enzyme elevations and allergic reactions can occur.

Clinical Trials

NCT06810583Phase IRecruiting

A Prospective Trial of Dalbavancin-Based Prophylaxis in Children and Adolescents With High-Risk Leukemia

St. Jude Children's Research HospitalEndpoint: Bacterial bloodstream infectionCompletion: 2031-09-01
NCT06899906N/ARecruiting

Efficacy and Safety of Dalbavancin As Suppressive Therapy

Hospices Civils de LyonEndpoint: efficacy of DAL treatment, measured as the proportion of stable infectionCompletion: 2025-05-01
NCT06266494Phase IVRecruiting

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

University of Colorado, DenverEndpoint: The number of positive microbial wound cultures on admissionCompletion: 2026-08-01
NCT05117398Phase IIIRecruiting

Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus

Assistance Publique - Hôpitaux de ParisEndpoint: Cure rateCompletion: 2026-09-23
NCT03982030Phase IVWithdrawn

Dalbavancin Outpatient Pilot

Wake Forest University Health SciencesEndpoint: Number of participants with resolution of infectionCompletion: 2025-07-01
View all 31 trials on ClinicalTrials.gov →

Regulatory Timeline

2014
Regulatory

FDA ORIG 1

2014
Regulatory

FDA SUPPL 1

2015
Regulatory

EMA Marketing Authorisation

2015
Regulatory

FDA SUPPL 2

2016
Regulatory

FDA SUPPL 3

2016
Regulatory

FDA SUPPL 4

2018
Regulatory

FDA SUPPL 7

2021
Regulatory

Health Canada Market Authorisation

2021
Regulatory

FDA SUPPL 10

2025
Regulatory

FDA SUPPL 12

2025
Regulatory

FDA ORIG 1

2025
Regulatory

FDA ORIG 1

2025
Regulatory

FDA ORIG 1

2026
Regulatory

FDA ORIG 1

Related Compounds

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Approved
Repository ACTH Preparation

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Enfuvirtide

Approved
HIV Fusion Inhibitor (Peptide)

Enfuvirtide is marketed as Fuzeon (approved March 2003). It requires twice-daily subcutaneous injections, and injection-site reactions occur in nearly all patients (98%). In clinical trials (TORO-1 and TORO-2), enfuvirtide combined with an optimised background regimen achieved significantly greater viral suppression than background regimen alone in treatment-experienced patients. Enfuvirtide represented a major advance when HIV drug resistance was a more pressing clinical challenge, but its use has declined substantially with the arrival of more convenient oral antiretrovirals. The twice-daily injection burden, injection-site reactions, high cost, and complex manufacturing (it is one of the largest synthetic peptides manufactured at scale) have limited its role to a last-resort option for patients with highly resistant HIV.

Vancomycin

Approved
Glycopeptide Antibiotic

Vancomycin is marketed as Vancocin and Firvanq (approved 1958, with oral solution Firvanq approved 2018). It is the standard treatment for serious MRSA infections (bloodstream infections, endocarditis, pneumonia, bone infections) and is first-line for severe C. difficile colitis. Vancomycin requires therapeutic drug monitoring — blood levels must be checked regularly to ensure the dose is effective without causing kidney damage or hearing loss. The rise of vancomycin-resistant enterococci (VRE) and occasional vancomycin-intermediate S. aureus (VISA) strains represent ongoing challenges. Despite being nearly 70 years old, vancomycin remains irreplaceable for many serious infections, though newer alternatives like daptomycin and the lipoglycopeptides offer advantages in specific settings.