BLAORALTABLET
Approved
Mar 2012
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
4
Data completeness
4/8 — Partial
VIOKACE (pancrelipase) by AbbVie is lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby acting like digestive enzymes physiologically secreted by the pancreas. First approved in 2012.
Drug data last refreshed 3h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIOKACE is an oral pancrelipase replacement therapy containing lipases, proteases, and amylases that replicate physiologic pancreatic digestive function. It treats exocrine pancreatic insufficiency across multiple etiologies including chronic pancreatitis, cystic fibrosis, and pancreatic cancer by catalyzing fat, protein, and carbohydrate hydrolysis in the small intestine.
$3MPart D
PeakVIOKACE operates in a mature, niche enzyme replacement market with modest Part D spending, indicating a stable but limited commercial footprint requiring focused specialty pharmacy engagement.
Mechanism of Action
lipases, proteases, and amylases that catalyze the hydrolysis of fats to monoglyceride, glycerol and free fatty acids, proteins into peptides and amino acids, and starches into dextrins and short chain sugars such as maltose and maltotriose in the duodenum and proximal small intestine, thereby…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
Pancreaze (Pancrelipase) for Patients With Pancreatic Adenocarcinoma With Cachexia and Exocrine Pancreatic Insufficiency
Started Dec 2020
36 enrolled
Pancreatic Adenocarcinoma
A Study of Creon (Pancrelipase) in Resected and Non-resected Pancreatic Cancer Participants With Exocrine Pancreatic Insufficiency (EPI)
Started Feb 2020
1 enrolled
Exocrine Pancreatic Insufficiency (EPI)
A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency
Started Aug 2008
40 enrolled
Exocrine Pancreatic InsufficiencySteatorrheaMalabsorption Syndromes+1 more
A Study of the Enzyme Activity and Safety of Pancrelipase in Patients With Severe Exocrine Pancreatic Insufficiency (EPI)
Started Jul 2008
13 enrolled
Exocrine Pancreatic InsufficiencyPancreatitis, ChronicSteatorrhea+1 more
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.