Adrulipase alfa is under clinical development by First Wave BioPharma and currently in Phase II for Exocrine Pancreatic Insufficiency. According to GlobalData, Phase II drugs for Exocrine Pancreatic Insufficiency does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Adrulipase alfa LoA Report. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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.

For a complete picture of Adrulipase alfa’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 2 September 2023

Premium Insights


The gold standard of business intelligence.

Blending expert knowledge with cutting-edge technology, GlobalData’s unrivalled proprietary data will enable you to decode what’s happening in your market. You can make better informed decisions and gain a future-proof advantage over your competitors.


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 clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.