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Drug

Dalbavancin hydrochloride

Approved · EMA

Late-stage development

Also known as Dalbavancin, dalbavancin (as hydrochloride), dalbavancin HCl.

3

Active clinical trials

1

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Efficacy of Dalbavancin in Osteoarticular Infections Associated With Hip and Knee Replacements

Clinical trial2026-06-22Results expected Q3 2026 · ClinicalTrials.gov

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Clinical trial2026-05-01Primary completion · ClinicalTrials.gov

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

Clinical trial2026-02-03Results expected Q3 2030 · ClinicalTrials.gov

An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy

Clinical trial2025-07-01Withdrawn · ClinicalTrials.gov

Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated S. Aureus Bacteremia

Clinical trial2024-12-10Results posted · ClinicalTrials.gov

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

Clinical trial2024-09-19Results posted · ClinicalTrials.gov

Preliminary Evaluation of Dalbavancin's Efficacy in People Who Use Drugs With Severe Gram-positive Infections

Clinical trial2023-10-05Terminated · ClinicalTrials.gov

Dalbavancin For The Treatment Of Gram Positive Osteomyelitis Or Joint Infections Including Prosthetic Hip Or Knee Infections

Clinical trial2022-12-31Completed · ClinicalTrials.gov

Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

Clinical trial2021-10-14Terminated · ClinicalTrials.gov

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

Clinical trial2020-04-10Results posted · ClinicalTrials.gov

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

Clinical trial2020-01-18Results posted · ClinicalTrials.gov

Approval: Xydalba (EMA)

Regulatory2015-02-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Dalbavancin hydrochloride

Aliases & brands

Dalbavancindalbavancin (as hydrochloride)dalbavancin HCl

RxNorm CUI

1541465

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-02-19

Latest approval

2015-02-19

Authorities

EMA

Total events

1

emaEuropean Medicines Agency· 1 event

2015-02-19Approval

Approval: Xydalba (EMA)

Indication: Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and… Show full indication

Xydalba is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and paediatric patients from birth (see sections 4.4 and 5.1).Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

23 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

23

registered trials across all phases

LATEST COMPLETION 2024

3

Active studies

2

Recruiting

14

Late-stage (III+)

11

Completed

9

Discontinued

PHASE DISTRIBUTIONn = 23

Phase 14Phase 25Phase 2 / 31Phase 36Phase 46Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

RecruitingPH IVUniversity of Colorado, Denvern=1002026

An Open-label, Pilot Clinical Trial of Dalbavancin for the Treatment of Susceptible Gram-positive Infections Requiring Prolonged Intravenous Antibiotic Therapy

WithdrawnPH IVWake Forest University Health Sciences2025

Dalbavancin For The Treatment Of Gram Positive Osteomyelitis Or Joint Infections Including Prosthetic Hip Or Knee Infections

CompletedPH IVInfectious Diseases Physicians, Inc.n=412022

Hospital Avoidance Strategies for Treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI)

TerminatedPH IVWashington University School of Medicinen=112021

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

CompletedPH IVAllergann=3132019

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 3, Multicenter, Open-Label, Randomized, Comparator Controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Pediatric Subjects With Acute Bacterial Skin and Skin Structure Infections

CompletedPH IIIAbbVien=1992024

Dalbavancin as an Option for Treatment of S. Aureus Bacteremia (DOTS): A Phase 2b, Multicenter, Randomized, Open-Label, Assessor-Blinded Superiority Study to Compare the Efficacy and Safety of Dalbavancin to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated S. Aureus Bacteremia

CompletedPH IINational Institute of Allergy and Infectious Diseases (NIAID)n=2002023

Dalbavancin For The Treatment Of Gram Positive Osteomyelitis Or Joint Infections Including Prosthetic Hip Or Knee Infections

CompletedPH IVInfectious Diseases Physicians, Inc.n=412022

A Pragmatic Trial Designed to Evaluate a New Critical Pathway for Treatment of Patients With Acute Bacterial Skin and Skin Structure Infections

CompletedPH IVAllergann=3132019

Development of a New Critical Pathway for Treatment of Acute Bacterial Skin and Skin Structure Infections

CompletedPH IVAllergann=912018

A Phase 2, Single-center, Open-label, Randomized, Comparator-controlled Trial of the Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis Known or Suspected to be Due to Gram-Positive Organisms

CompletedPH IIDurata Therapeutics Inc., an affiliate of Allergan plcn=802017

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.