Ensifentrine is under clinical development by Verona Pharma and currently in the Phase II and 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 Ensifentrine’s likelihood of approval (LoA) and phase transition for Cystic Fibrosis took place on 07 Sep 2022, 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 Ensifentrine Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ensifentrine overview

Ensifentrine (RPL-554) is under development for the treatment of allergic asthma, mild to moderate chronic asthma, chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis, cystic fibrosis and coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The drug candidate is administered through inhalation route as a suspension. RPL-554 acts by targeting both phosphodiesterase 3 and phosphodiesterase 4 enzymes. It was also under development for the treatment of allergic rhinitis.

Verona Pharma overview

Verona Pharma is a clinical-stage biopharmaceutical company that focuses on the development and marketing of therapies for the treatment of respiratory diseases. The company’s lead investigating candidate, ensifentrine, a bronchodilator/anti-inflammatory agent intended for the treatment of chronic obstructive pulmonary disease (COPD) in Phase III clinical trials; additional formulations of ensifentrine for the treatment of COPD: a dry powder inhaler (DPI) and pressurized metered-dose inhaler (pMDI); Phase II clinical studies demonstrated positive results; and ensifentrine in several pre-clinical studies in patients with the novel corona virus (COVID-19). Verona Pharma is headquartered in London, the UK.

Quick View Ensifentrine LOA Data

Report Segments
  • Innovator
Drug Name
  • Ensifentrine
Administration Pathway
  • Inhalational
Therapeutic Areas
  • Infectious Disease
  • Respiratory
Key Developers
Highest Development Stage
  • Phase III

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.