Drug intelligence / Profile preview

Pangestyme CN 10

Development stage
Discontinued
Lead developer
Ethex
Modality
Replacement Enzymes → Therapeutic Enzymes → Recombinant Proteins and Enzymes, Small Molecules
Administration
Oral
01

Overview

Pangestyme CN 10 is a pancreatic enzyme replacement therapy (PERT) formerly manufactured by Ethex, a subsidiary of KV Pharmaceutical. It contains pancrelipase, a mixture of digestive enzymes (lipase, amylase, and protease) derived from porcine pancreatic glands. The 'CN 10' formulation is specifically characterized by its strength, providing 10,000 USP units of lipase, 33,200 USP units of amylase, and 37,500 USP units of protease per capsule. The drug is formulated as enteric-coated microspheres to protect the enzymes from inactivation by gastric acid, ensuring their release in the duodenum. It was indicated for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis, chronic pancreatitis, pancreatectomy, and other conditions where the pancreas cannot produce sufficient digestive enzymes. This product was discontinued following FDA regulatory changes in the late 2000s that required all pancreatic enzyme products to obtain formal New Drug Application (NDA) approval.

Brand names
Pangestyme CN 10
Other names
pancrelipasePangestyme
02

Targets

AMY (Pancreatic alpha-amylase)PNLIP (Pancreatic triacylglycerol lipase)

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