Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) family company Napo Pharmaceuticals (Napo) today announced that all randomized pediatric MVID patients in Napo's pivotal crossover clinical trial have entered the single-blind extension phase to receive blinded doses of crofelemer to support longer-term safety and efficacy for crofelemer powder for oral solution as adjunctive therapy to parenteral support (PS). The trial is ongoing at multiple centers in the United States, the European Union, and the United Arab Emirates. This trial is expected to support a New Drug Application (NDA) filing for the treatment of the MVID indication in mid-2027.
Patients with intestinal failure (IF), including those with MVID or short bowel syndrome (SBS), cannot orally absorb adequate nutrients, electrolytes and fluids, and require lifelong total parenteral nutrition (TPN) with or without supplemental intravenous fluids, which together comprise 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, sometimes fatal complications.
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