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Crofelemer in Intestinal Failure

Crofelemer in Intestinal Failure

Patients with intestinal failure (IF) due to microvillus inclusion disease (MVID) or short bowel syndrome (SBS-IF) cannot orally absorb adequate nutrients, electrolytes and fluids, and they therefore require lifelong total parenteral nutrition (TPN) with or without supplemental intravenous fluids, which together comprise parenteral support (PS), for up to seven days per week and up to 20+ hours per day. While PS is supportive, palliative and lifesaving, it is associated with serious complications.

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There are an estimated 200 MVID patients globally and an estimated 12,500 individuals in the US with IF due to SBS1

Crofelemer’s ability to regulate ion channels in the gut normalizes the salt and water balance in the small bowel, which may lead to better absorption of fluids and nutrients in those living with MVID or SBS-IF

Research & Development

  • Jaguar family companies Napo Therapeutics S.p.A. and Napo Pharmaceuticals are focused on the development program of our novel powder for oral solution formulation of crofelemer for treatment of pediatric MVID and adult SBS-IF.

  • We are also supporting investigator-initiated proof-of-concept trials of crofelemer in pediatric MVID and SBS-IF patients; and adult SBS-IF patients.

  • We are conducting a pivotal trial in pediatric MVID patients in the US, EU and UAE and conducting a Phase 2 trial in adult SBS-IF patients in the EU.

Research & Development

  • The initial focus of Napo Therapeutics, an Italian corporation established by Jaguar Health in Italy, is on pursuing the conditional marketing authorization pathway from the European Medicines Agency for crofelemer for SBS-IF and congenital diarrheal disorders (CDD)
  • Planning to complete a global trial (in collaboration with Napo Pharmaceuticals) in SBS-IF patients suitable for the conditional approval pathway in the EU
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Orphan-Drug Designation

Crofelemer has received orphan-drug designation in the US and European Union for MVID and SBS

Orphan-Drug Designation

  • Crofelemer has received orphan-drug designation in the US and European Union for SBS
  • Crofelemer has received orphan-drug designation in the European Union for Microvillus Inclusion Disease (MVID), a rare congenital diarrheal disorder (CDD) condition
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Reference: 1. Ali A, Mitchell G, Gallivan M, Henderson J, Iyer K. Epidemiology of U.S. patients with short bowel syndrome-associated intestinal failure: a claims database analysis. Intestinal Failure. 2025;8:100325. doi:10.1016/j.intf.2025.100325.