Delafloxacin meglumine is under clinical development by Melinta Therapeutics and currently in the Phase II 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 Delafloxacin meglumine’s likelihood of approval (LoA) and phase transition for Urinary Tract Infections took place on 27 Oct 2020, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

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

Delafloxacin meglumine overview

Delafloxacin (Baxdela, Quofenix ) is a fluoroquinolone derivative acts as antibacterial agent which is developed based on Captisol technology. It is formulated as tablets for oral route of administration and injectable powder for solution for intravenous route of administration. Baxdela is indicated for the treatment of of acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible bacteria and indicated in adults for the treatment of community-acquired bacterial pneumonia (CABP) caused by the following susceptible microorganisms like Streptococcus pneumoniae, Staphylococcus aureus(methicillin-susceptible [MSSA] isolates only), Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosa, Haemophilus influenzae, Haemophilus para influenzae, Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae.

RX-3341 (delafloxacin) is under development for the treatment of fluoroquinolone-susceptible and fluoroquinolone-resistant staphylococcus aureus and complicated urinary tract infections (cUTI). It was also under development for the treatment of uncomplicated urogenital gonorrhea and complicated intra-abdominal infections (cIAI) and chronic bronchitis. It was under development for the treatment of surgical site infections, E.coli and pseudomonas aeruginosa infections

Melinta Therapeutics overview

Melinta Therapeutics (Melinta) is a biopharmaceutical company that focuses on the development of novel anti-infectives for the treatment of various bacterial infections. Its marketed portfolio encompasses antibiotics for the treatment of serious bacterial infections including acute bacterial skin and skin structure infections (ABSSSI), complicated urinary tract infections (cUTI), and for the prevention and treatment of other serious infections that are caused by susceptible bacteria. The company is also evaluating delafloxacin for the treatment of serious community-acquired bacterial pneumonia (CABP), meropenem and vaborbactam, oritavancin, and minocycline. Melinta’s products and pipeline candidates are built on a ribosome platform licensed from Yale University. Melinta is headquartered in New Haven, Connecticut, the US.

Quick View Delafloxacin meglumine LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Delafloxacin meglumine
Administration Pathway
  • Intravenous
  • Oral
Therapeutic Areas
  • Genito Urinary System And Sex Hormones
  • Infectious Disease
  • Respiratory
Key Developers
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.