Adrulipase alfa is under clinical development by First Wave BioPharma 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 Adrulipase alfa’s likelihood of approval (LoA) and phase transition for Exocrine Pancreatic Insufficiency took place on 14 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 Adrulipase alfa Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Adrulipase alfa overview

Adrulipase alfa is under development for the treatment of exocrine pancreatic insufficiency (EPI) in patients with chronic pancreatitis (CP) and cystic fibrosis (CF). It is administered as a oral capsule. The therapeutic candidate is an autologous Yarrowia lipolytica recombinant lipase. It is developed based on recombinant DNA technology. It was also under development for the treatment of malabsorption syndrome.

First Wave BioPharma overview

First Wave BioPharma, formerly AzurRx BioPharma, is a development-stage biopharmaceutical company that focuses on non-systemic biologics for the treatment of patients with gastrointestinal disorders. The company’s products under development include MS1819 a non-systemic yeast recombinant enzyme intended for the treatment of exocrine pancreatic insufficiency exocrine (EPI) in patients with cystic fibrosis (CF) and chronic pancreatitis (CP). MS1819 completed the phase IIa trial in partnership with Mayoly which is a European Pharmaceutical company. Its pre-clinical products include AZX1103 and AZX1101 which is a recombinant beta-lactamases enzyme for the prevention of nosocomial (hospital-acquired) infections and antibiotic-associated diarrhea. The company has operations in France and the US. First Wave BioPharma is headquartered in Brooklyn, New York, the US.

Quick View Adrulipase alfa LOA Data

Report Segments
  • Innovator
Drug Name
  • Adrulipase alfa
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
Key Developers
Highest Development Stage
  • Phase II

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.