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IV Dalbavancin
IV Dalbavancin is a Lipoglycopeptide antibiotic Small molecule drug developed by Durata Therapeutics Inc., an affiliate of Allergan plc. It is currently in Phase 3 development for Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, Staphylococcus aureus bacteremia including endocarditis.
Dalbavancin is a lipoglycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala peptidoglycan precursors.
Dalbavancin is a lipoglycopeptide antibiotic that inhibits bacterial cell wall synthesis by binding to D-Ala-D-Ala peptidoglycan precursors. Used for Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, Staphylococcus aureus bacteremia including endocarditis.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | IV Dalbavancin |
|---|---|
| Sponsor | Durata Therapeutics Inc., an affiliate of Allergan plc |
| Drug class | Lipoglycopeptide antibiotic |
| Target | D-Ala-D-Ala peptidoglycan precursors |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Dalbavancin binds to the D-Ala-D-Ala terminus of peptidoglycan precursors in bacterial cell walls, preventing cross-linking and disrupting cell wall integrity. This leads to bacterial cell lysis and death. The drug has an extended half-life due to its lipophilic side chain, allowing for less frequent dosing compared to vancomycin.
Approved indications
- Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria
- Staphylococcus aureus bacteremia including endocarditis
Common side effects
- Infusion-related reactions
- Headache
- Nausea
- Diarrhea
- Vomiting
Key clinical trials
- Comparing Oral Versus Parenteral Antimicrobial Therapy (PHASE4)
- Dalbavancin Versus Standard Antibiotic Therapy for Catheter-related Bloodstream Infections Due to Staphylococcus Aureus (PHASE3)
- DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia (PHASE2)
- Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections in Children, Known or Suspected to be Caused by Susceptible Gram-positive Organisms, Including MRSA (PHASE3)
- Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis (PHASE4)
- Dalbavancin Outpatient Pilot (PHASE4)
- Efficacy and Safety of Dalbavancin Compared to Standard of Care Antibiotic Therapy for the Completion of Treatment of Patients With Complicated Bacteremia or Infective Endocarditis (PHASE2)
- Evaluation of Intravenous and Intraperitoneal Pharmacokinetics of Dalbavancin in Peritoneal Dialysis Patients (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- IV Dalbavancin CI brief — competitive landscape report
- IV Dalbavancin updates RSS · CI watch RSS
- Durata Therapeutics Inc., an affiliate of Allergan plc portfolio CI
Frequently asked questions about IV Dalbavancin
What is IV Dalbavancin?
How does IV Dalbavancin work?
What is IV Dalbavancin used for?
Who makes IV Dalbavancin?
What drug class is IV Dalbavancin in?
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What does IV Dalbavancin target?
Related
- Drug class: All Lipoglycopeptide antibiotic drugs
- Target: All drugs targeting D-Ala-D-Ala peptidoglycan precursors
- Manufacturer: Durata Therapeutics Inc., an affiliate of Allergan plc — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria
- Indication: Drugs for Staphylococcus aureus bacteremia including endocarditis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing