Dalbavancin is under clinical development by AbbVie and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Dalbavancin’s likelihood of approval (LoA) and phase transition for Methicillin-Resistant Staphylococcus aureus (MRSA) Infections took place on 26 Feb 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Dalbavancin Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Dalbavancin overview

Dalbavancin (Dalvance, Xydalba) is a second generation, semi-synthetic lipoglycopeptide. It is formulated as injection powder for concentrate solution for intravenous route of administration. Dalbavancin is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

Dalbavancin is under development for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections, acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA) in pediatric patients.

It was also under development for the treatment of community-acquired pneumonia, infective endocarditis, bacteremia, catheter-related bloodstream infections (CRBSIs), acute hematogenous osteomyelitis of the long bones known or suspected to be due to gram-positive organisms in pediatric subjects, osteomyelitis in adult and Neisseria gonorrhoeae infections.

AbbVie overview

AbbVie is a specialty biopharmaceutical company, which discovers, develops, manufactures, and commercializes drugs for the treatment of chronic and complex diseases. Its drugs are indicated for the treatment of metabolic diseases, rheumatological diseases, neurological disorders, viral diseases, skin diseases, complications associated with cystic fibrosis, pain related to endometriosis, diseases of the gastrointestinal tract, various types of cancer, and other serious health conditions. AbbVie is also advancing its pipeline programs for the treatment of cystic fibrosis, women’s health, various cancers, neurological disorders and other autoimmune diseases. The company markets its products directly to wholesalers, distributors, health care facilities, government agencies, specialty pharmacies and independent retailers through its own distribution centers and public warehouses worldwide. AbbVie is headquartered in North Chicago, Illinois, the US.

Quick View Dalbavancin LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Dalbavancin
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Cardiovascular
  • Infectious Disease
Key Developers
  • Sponsor Company: AbbVie
  • Originator: Vicuron Pharmaceuticals
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.