Healthcare

Jaguar Health Reports Preliminary Crofelemer Findings in Adult Short Bowel Syndrome Study

Four participants completed an ongoing open-label crofelemer pilot study, with reported changes in ostomy volume, parenteral-support volume and urinary output.

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Jaguar Health, Inc. (Nasdaq:JAGX) and family company Napo Pharmaceuticals reported preliminary findings from an ongoing open-label pilot study of crofelemer in adults with Type 1 short bowel syndrome and intestinal failure. The results were presented on October 13, 2026 at the American College of Gastroenterology Annual Scientific Meeting.

#Study design and preliminary findings

The study is assessing liquid crofelemer in patients with Type 1 short bowel syndrome who were receiving stable parenteral support. Participants received 3 mg/kg/dose orally three times daily for 12 weeks.

The trial plans to enrol 6 subjects and is using reduction in ostomy volume as its primary endpoint. Four participants had completed the protocol when the results were reported.

Two subjects recorded lower ostomy volume after 12 weeks of treatment, with an average reduction of 5%. Three subjects experienced an average increase of 23% in ostomy output after crofelemer treatment ended.

One subject recorded a 9% reduction in parenteral-support volume at 12 weeks. Three subjects had improved urinary output at that point, with an average increase of 88%. The company said the urinary-output improvement remained in place at 4-weeks post cessation of oral crofelemer therapy.

No significant adverse events were observed in the subjects, and Napo said crofelemer was well tolerated. The pilot study remains ongoing.

#Context for intestinal failure patients

Patients with intestinal failure, including people with short bowel syndrome and paediatric patients with microvillus inclusion disease, cannot absorb sufficient nutrients, electrolytes and fluids by mouth. They may therefore require total parenteral nutrition, with or without supplemental intravenous fluids, as part of parenteral support for up to seven days per week and up to 20+ hours per day.

The company said parenteral support is supportive and lifesaving but can be associated with serious, sometimes fatal complications. It also noted that patients with Type 1 short bowel syndrome, defined in the update as having less than 200 cm of small bowel length to ostomy, can experience high-volume ostomy output, electrolyte disturbances and reduced quality of life.

#Broader crofelemer development programme

Napo said it remains focused on global development programmes for oral crofelemer in intestinal-failure patients receiving parenteral support, including patients with short bowel syndrome with intestinal failure and paediatric microvillus inclusion disease.

The company also referred to ongoing investigations of liquid oral crofelemer in paediatric intestinal-failure patients. It said patients receiving treatment orally for more than one year showed substantial reductions in weekly parenteral-support needs and in parenteral support normalised to body weight, with no significant clinical or laboratory abnormalities.

Napo is conducting a multicentre, randomised, double-blind, placebo-controlled Phase 2 clinical trial in adult Type 1 short bowel syndrome patients without colin-in-continuity. Jaguar said results are expected to be available early in the second half of 2027. The company described this timing as a prediction based largely on current expectations and projections and subject to risks, uncertainties and assumptions, some of which are beyond its control.

#Planned regulatory filing

Jaguar said its intestinal-failure programme is expected to include a planned New Drug Application filing for crofelemer in microvillus inclusion disease in mid-2027. The company identified this expectation as a forward-looking statement and said it is subject to risks, uncertainties and assumptions.

#Jaguar Health and Napo Pharmaceuticals

Jaguar Health develops prescription drugs derived from plants for complicated gastrointestinal disease states. Its family companies Napo Pharmaceuticals, Inc. and Napo Therapeutics S.p.A. are focused on crofelemer powder for oral solution for rare and orphan gastrointestinal disorders involving intestinal failure, including microvillus inclusion disease and short bowel syndrome.

#Key Takeaways

  • Jaguar Health and Napo Pharmaceuticals reported preliminary findings from an ongoing open-label crofelemer study presented on October 13, 2026.
  • The study plans to enrol 6 subjects, with 4 participants having completed the protocol at the time of the update.
  • Reported findings included an average 5% reduction in ostomy volume for two subjects and an average 88% improvement in urinary output for three subjects.
  • One subject recorded a 9% reduction in parenteral-support volume, while three subjects had an average 23% increase in ostomy output after treatment stopped.
  • Jaguar said it expects a planned mid-2027 NDA filing for microvillus inclusion disease and expects Phase 2 results early in the second half of 2027; both statements are subject to stated uncertainties.

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