Efficacy

In a clinical trial, the right dose of ZENPEP® helped patients absorb nutrients and provided symptom relief1,2

Bar chart showing the mean difference in CFA and CNA Bar chart showing the mean difference in CFA and CNA
  • Results achieved without the use of PPIs, H2-blockers, or motility agents2
  • Vitamin A and E absorption significantly improved with ZENPEP vs placebo (P<0.001)2
  • The unique formulation of ZENPEP is designed to mimic typical exocrine pancreatic function1

CF=cystic fibrosis; CFA=coefficient of fat absorption; CI=confidence interval (the range in which we are 95% sure our mean value lies); CNA=coefficient of nitrogen absorption; EPI=exocrine pancreatic insufficiency; PPI=proton pump inhibitor.

* A randomized, double-blind, placebo-controlled, 2-treatment, crossover study (ZENPEP Study 1) in patients with EPI due to CF aged 7 to 23 years. Patients were randomized to ZENPEP or placebo for 6 to 7 days of treatment, followed by crossover to the alternate treatment for 6 to 7 days. All patients consumed ≥100 g of fat per day. The primary efficacy endpoint was the mean difference in CFA between ZENPEP and placebo, which was measured from a 72-hour stool collection during both treatments. The use of enzymes other than ZENPEP and drugs affecting gastric pH or motility was not allowed during the trial.1,2

† One patient did not have fecal fat and nitrogen readings while on placebo.2

91% of patients achieved a CFA of 80% or higher with ZENPEP2

  • 50% achieved a near-normal CFA above 90%2‡

‡ Normal CFA is defined as 93% or higher by the ACG.3

ZENPEP provided relief for a range of symptoms2

  • Decreased EPI symptoms can help patients eat with less discomfort4

Significant reduction in EPI-related GI symptoms with ZENPEP vs placebo 2§

ZENPEP symptom reductions ZENPEP symptom reductions

GI=gastrointestinal.

Percentages were derived from actual numbers in referenced data. P values were taken directly from reference.

Statistically significant improvement in mean Total Symptoms Index (TSI) score|| was demonstrated with ZENPEP vs placebo (P=0.015).5

|| TSI assesses overall improvement in the clinical symptoms of EPI.
Learn about the MOA of ZENPEP 
Review safety data 

References: 1. ZENPEP. Package insert. Aimmune Therapeutics, Inc. Bridgewater, NJ; October 2023. 2. Wooldridge JL, Heubi JE, Amaro-Galvez R, et al. EUR-1008 pancreatic enzyme replacement is safe and effective in patients with cystic fibrosis and pancreatic insufficiency. J Cyst Fibros. 2009;8(6):405-417. doi:10.1016/j.jcf.2009.07.006 3. Gardner TB, Adler DG, Forsmark CE, Sauer BG, Taylor JR, Whitcomb DC. ACG Clinical Guideline: chronic pancreatitis. Am J Gastroenterol. 2020;115(3):322-339. doi:10.14309/ajg.0000000000000535 4. Othman MO, Harb D, Barkin JA. Introduction and practical approach to exocrine pancreatic insufficiency for the practicing clinician. Int J Clin Pract. 2018;72(2):e13066. doi:10.1111/ijcp.13066 5. Data on file. CSR-1008 Nestlé Health Science.