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adrulipase alfa
- Development stage
- Phase 2
- Lead developer
- Entero Therapeutics
- Modality
- Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes
- Administration
- Oral
01
Overview
Adrulipase alfa (MS1819) is a recombinant, non-porcine pancreatic lipase biologic derived from the yeast *Yarrowia lipolytica*. Developed by Entero Therapeutics (formerly First Wave BioPharma and AzurRx BioPharma), it is designed as an oral enzyme replacement therapy for the treatment of exocrine pancreatic insufficiency (EPI), particularly in patients with cystic fibrosis or chronic pancreatitis. As a non-animal-derived alternative to traditional porcine pancreatic enzyme replacement therapy (PERT), adrulipase alfa provides a vegetarian option and potentially avoids the variability associated with animal-sourced products. The drug functions within the gastrointestinal tract to break down triacylglycerols (dietary fats) into absorbable free fatty acids and glycerol. It has been investigated in various formulations, including enteric-coated and immediate-release capsules, through Phase 2 clinical trials such as the OPTION 2 study.
- Other names
- Yarrowia lipolytica lipase
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