Efficacy & Safety

ZENPEP can deliver the symptom relief your patients with EPI need

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

CFA Chart
CFA Chart
  • 91% of patients achieved a CFA of 80% or higher with ZENPEP‡
  • ZENPEP achieved unmatched efficacy results 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
  • *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.
  • †One patient did not have fecal fat and nitrogen readings while on placebo.
  • ‡Normal CFA is defined as 93% or higher.3
  • CF=cystic fibrosis; CFA=coefficient of fat absorption; CI=confidence interval; CNA=coefficient of nitrogen absorption; EPI=exocrine pancreatic insufficiency; PPI=proton pump inhibitor.

Patients taking
ZENPEP achieved a near-normal CFA

  • ‡ Normal CFA is defined as 93% or higher.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 placebo2§

Couple dining
Decrease in symptoms

Not actual patients.

  • §Percentages were derived from actual numbers in referenced data. P values were taken directly from reference.
  • GI=gastrointestinal.
Zenpep vs Placebo

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

  • ‖TSI assesses overall improvement in the clinical symptoms of EPI.
  • Capsules not actual size.

Demonstrated safety profile with ZENPEP in
children and adults with EPI due to CF1,2

The most commonly reported AEs in Study 1 (≥6% of patients treated with ZENPEP) were headache, contusion, cough, and early satiety.

No drug-related serious AEs were observed.

Treatment Result

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

  • The short-term safety of ZENPEP was assessed in 2 clinical trials. In Study 1, AEs were defined as occurring in at least 2 patients treated with ZENPEP (≥6%) during treatment and crossover treatment periods with ZENPEP. Study 2 was an open-label, uncontrolled, 14-day study of 19 patients, ages 1 to 6 years, with EPI due to CF. The most commonly reported adverse events were gastrointestinal, including abdominal pain and steatorrhea, and were similar in type and frequency to those reported in the double-blind, placebo-controlled trial (Study 1).
  • ‖TSI assesses overall improvement in the clinical symptoms of EPI.
Review safety data
Find out how ZENPEP works

References: 1. ZENPEP. Package insert. Aimmune Therapeutics, Inc. Bridgewater, NJ; July 2025. 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.