As announced, Napo has previously provided crofelemer powder for oral solution to treat select infant and pediatric IF patients with MVID in relevant expanded access programs in the U.S. under Single-Patient Investigational New Drug (sIND) applications for physicians assuming direct medical responsibility. Napo has also provided crofelemer powder for oral solution for use in the ongoing investigator-initiated proof-of-concept trial in pediatric patients with IF due to MVID and short bowel syndrome (SBS-IF) in the United Arab Emirates.

In June 2026, as announced, data was presented at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) Meeting in Lille, France from ongoing investigational studies with oral liquid crofelemer in pediatric patients with IF due to MVID and SBS-IF. The results of ongoing investigations of liquid oral crofelemer demonstrate substantial reductions of PS and PS normalized to body weight in pediatric IF patients dosed orally for more than one year, with no significant clinical or laboratory abnormalities. In one MVID patient, the weekly PS requirements normalized to body weight have been reduced by up to 48% following >12 months of liquid oral high-dose crofelemer therapy. In two pediatric SBS-IF patients, weekly PS requirements normalized to body weight were reduced up to 40% following >12 months of liquid oral high dose crofelemer therapy. To put this in context, even a 5-10% reduction is typically considered clinically relevant.

IF patients, 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 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, often fatal complications.