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Home › Conditions › Exocrine Pancreatic Insufficiency

Exocrine Pancreatic Insufficiency

1 published article · Updated continuously

Clinical Trial Landscape

Clinical Trials for Exocrine Pancreatic Insufficiency

23 trials tracked for Exocrine Pancreatic Insufficiency: 16 in phase 3 or 4 and 1 with published results. The most-cited published study has 43 citations.

23Trials tracked
16Phase 3 & 4
0Recruiting
1With published results
Phase distribution
Phase 4 4 Phase 3 12 Phase 2 3 Phase 1 1 Other / NA 3
  1. Phase 3 SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis Completed · 43 cited
  2. Phase 4 EASY: Extended Access to Sollpura Over Years Completed
  3. Phase 4 A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age Completed
  4. Phase 4 PR-018: An Open-Label, Safety Extension of Study PR-011 Completed
  5. Phase 4 Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency Completed
  6. Phase 3 SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis Completed
Show 17 more trials
  1. Phase 3 Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) Completed
  2. Phase 3 Safety and Efficacy Study of Viokase® 16 for the Correction of Steatorrhea Completed
  3. Phase 3 A Randomized, Double-Blind, Dose Response-Control, Crossover Study to Evaluate the Safety and Efficacy of Two Doses of EUR-1008 (APT-1008) in Chronic Pancreatitis (CP) Participants With Exocrine Pancreatic Insufficiency (EPI) Completed
  4. Phase 3 Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency Completed
  5. Phase 3 Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency Completed
  6. Phase 3 Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Completed
  7. Phase 3 A Study to Investigate the Effect of Delayed Release Pancrelipase on Maldigestion in Patients With Exocrine Pancreatic Insufficiency Due to Chronic Pancreatitis and Pancreatectomy Completed
  8. Phase 3 Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI) Completed
  9. Phase 3 Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency Completed
  10. Phase 3 A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency Completed
  11. Phase 2 A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI Completed
  12. Phase 2 Study to Assess an Enteric Microgranule Formulation of Adrulipase in Patients With Cystic Fibrosis Completed
  13. Phase 2 Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency Completed
  14. Phase 1 Phase 1 Study to Assess Safety and Efficacy of ANG003 Completed
  15. N/A Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Completed
  16. N/A Special Investigation of LipaCreon on Long-term Use in Patients With Pancreatic Exocrine Insufficiency Completed
  17. N/A Safety, Tolerability and Fat Absorption Using Enteral Feeding In-line Enzyme Cartridge (Relizorb) Completed

Showing the 23 most-cited and recently-updated of 23 trials. Browse the full registry →

Trial data sourced from ClinicalTrials.gov. Counts describe the research landscape and are not a treatment recommendation. Informational only — not medical advice.

What the trials found Updated — new results For clinicians

Exocrine Pancreatic Insufficiency: what the trials found

Several enzyme replacement therapies have demonstrated significant improvements in nutrient absorption for patients with Exocrine Pancreatic Insufficiency (EPI). EUR-1008 (APT-1008) showed significantly higher Coefficient of Fat Absorption (CFA%) and Coefficient of Nitrogen Absorption (CNA%) compared to placebo 9, with high responder rates observed after one week of treatment 10. Additionally, clinical improvements in growth percentiles were noted in patients receiving EUR-1008 5.

Other enzyme formulations have shown statistically significant improvements in fat and nitrogen absorption. Ultrase® MT20 11 and Viokase® 16 12 both demonstrated significantly higher CFA and CNA compared to respective controls (p<0.0001). Pancrelipase Delayed Release showed significant improvements in CFA, CNA, and a reduction in total fat excretion [16, 17]. Furthermore, specific formulations like Pancrease MT 10.5 or MT 21 demonstrated statistically significant improvements in both fat and nitrogen absorption coefficients compared to alternative options 15.

While some trials evaluated specific products like Liprotamase [2, 6, 7] and Pancreatin 8, they did not report specific p-values for primary outcomes. Panzytrat® 25,000 showed no statistically significant difference in the Coefficient of Fat Absorption compared to its comparator 4. High and low doses of EUR-1008 both showed significantly greater improvements in CFA and CNA over placebo during hospital treatment 13.

Recent results — preliminary, needs further review

  • * ANG003 was evaluated in a Phase 1 trial (N=57) for Exocrine Pancreatic Insufficiency 1.

For the clinician treating this condition

  • Multiple enzyme replacement therapies, including EUR-1008, Ultrase® MT20, Viokase® 16, and Pancrelipase Delayed Release, are established to significantly improve fat and nitrogen absorption in patients with EPI.
  • EUR-1008 is associated with high responder rates within one week of treatment 10 and has been shown to improve growth percentiles 5.
  • Panzytrat® 25,000 did not show a statistically significant difference in the Coefficient of Fat Absorption compared to its comparator 4.

AI synthesis of 10 cited trials, updated Jun 29, 2026. Informational only — not medical advice; trial data sourced from ClinicalTrials.gov. How we use AI.

HCP Mode — summaries include clinical detail, trial data, and statistical outcomes.
Patient Mode — summaries use plain language, avoiding clinical jargon.
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