U.S. Department of Health & Human Services Divider Arrow National Institutes of Health Divider Arrow NCATS
Dalbavancin is a second-generation lipoglycopeptide antibiotic that was designed to improve on the natural glycopeptides currently available, such as vancomycin and teicoplanin. Modifications from these older glycoprotein classes allowed a similar mechanism of action with increased activity and once weekly dosing. Its use is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), S. pyogenes, S. agalactiae, and S. anginosus group (including S. anginosus, S. intermedius, and S. constellatus). Under the brand name DALVANCE Dalbavancin is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. The bactericidal action of dalbavancin results primarily from inhibition of cell-wall biosynthesis. Specifically, dalbavancin prevents incorporation of N-acetylmuramic acid (NAM)- and N-acetylglucosamine (NAG)-peptide subunits from being incorporated into the peptidoglycan matrix; which forms the major structural component of Gram-positive cell walls. The large hydrophilic molecule is able to form hydrogen bond interactions with the terminal D-alanyl-D-alanine moieties of the NAM/NAG-peptides, which is normally a five-point interaction. Binding of dalbavancin to the D-Ala-D-Ala prevents the incorporation of the NAM/NAG-peptide subunits into the peptidoglycan matrix. In addition, dalbavancin alters bacterial-cell-membrane permeability and RNA synthesis.

CNS Activity

Curator's Comment: Dalbavancin was widely distributed into tissues, but did not cross the blood brain barrier.

Approval Year

Targets

Targets

Primary TargetPharmacologyConditionPotency
Conditions

Conditions

ConditionModalityTargetsHighest PhaseProduct
Curative
DALVANCE

Approved Use

INDICATION AND USAGE DALVANCE is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms. (1.1) To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial drugs, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. (1.2) 1.1 Acute Bacterial Skin and Skin Structure Infections DALVANCE® (dalbavancin) for injection is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI), caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (including S. anginosus, S. intermedius, S. constellatus) and Enterococcus faecalis (vancomycin susceptible strains). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of DALVANCE and other antibacterial agents, DALVANCE should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Launch Date

2014
PubMed

PubMed

TitleDatePubMed
Patents

Sample Use Guides

1. Two-dose regimen: 1000 mg followed one week later by 500 mg (2.1) 2. Dosage adjustment for patients with creatinine clearance less than 30 mL/min and not receiving regularly scheduled hemodialysis: 750 mg followed one week later by 375 mg (2.2) 3. Administer by intravenous infusion over 30 minutes (2.3)
Route of Administration: Intravenous
Nearly all (99.8%) multidrug-resistant methicillin-resistant S. aureus isolates were inhibited by dalbavancin at ≤0.12 ug/ml (MIC50/90, 0.06/0.06 ug/ml).
Name Type Language
DALBAVANCIN
INN   MART.   MI   USAN   VANDF   WHO-DD  
USAN   INN  
Official Name English
A-A-1
Code English
Dalbavancin [WHO-DD]
Common Name English
VER-001
Code English
DALBAVANCIN [VANDF]
Common Name English
BI-397
Code English
DALBAVANCIN [MART.]
Common Name English
MDL 64,397
Code English
ZEVEN
Brand Name English
BI397
Code English
DALBAVANCIN [MI]
Common Name English
MDL-64397
Code English
dalbavancin [INN]
Common Name English
DALBAVANCIN [USAN]
Common Name English
VER001
Code English
Classification Tree Code System Code
NDF-RT N0000191281
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WHO-VATC QJ01XA04
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FDA ORPHAN DRUG 459714
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NCI_THESAURUS C61101
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WHO-ATC J01XA04
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Code System Code Type Description
NDF-RT
N0000191280
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PRIMARY Lipoglycopeptides [Chemical/Ingredient]
USAN
QQ-102
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PRIMARY
CAS
171500-79-1
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MAJOR COMPONENT STRUCTURE/SEQUENCE
LACTMED
Dalbavancin
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PRIMARY
MERCK INDEX
m4070
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PRIMARY Merck Index
DAILYMED
808UI9MS5K
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PRIMARY
NCI_THESAURUS
C116741
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PRIMARY
ChEMBL
CHEMBL3301669
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PRIMARY
DRUG CENTRAL
777
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PRIMARY
CHEBI
82721
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PRIMARY
DRUG BANK
DB06219
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PRIMARY
INN
7978
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PRIMARY
FDA UNII
808UI9MS5K
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PRIMARY
EVMPD
SUB26697
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PRIMARY
MESH
C469289
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PRIMARY
RXCUI
1539239
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PRIMARY RxNorm
WIKIPEDIA
DALBAVANCIN
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PRIMARY
Definition References