Jaguar Health's Napo Pharma Announces Expanded-Access Benefit Of Crofelemer In Congenital Sodium Diarrhea Patient; Plans To File NDA For Crofelemer For MVID In Mid-2027

Mutation of the GUCY2C gene is the third IF-related congenital enteropathy, in addition to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), for which crofelemer has demonstrated benefit in reducing parenteral support needs in pediatric patients

Company plans to file NDA for crofelemer for MVID in mid-2027 to obtain FDA approval

SAN FRANCISCO, CA / ACCESS Newswire / October 21, 2026 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals (Napo) has been continuing to provide the company's novel crofelemer powder for oral solution for several weeks for the treatment of intestinal failure (IF) in an infant patient with GUCY2C mutation resulting in congenital sodium diarrhea (CSD). Liquid oral crofelemer therapy is well tolerated by this patient and has demonstrated reduced needs for daily and weekly parenteral support (PS) with no significant clinical or laboratory abnormalities. CSD due to mutation of the GUCY2C gene is the third IF-related congenital enteropathy being evaluated under expanded access, in addition to pediatric microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF), for which crofelemer has demonstrated benefit in reducing weekly parenteral support needs normalized to body weight. The company plans to file a New Drug Application (NDA) for crofelemer for MVID in mid-2027 to obtain FDA approval based on data that will include results from an ongoing pivotal trial which has completed enrollment.

Patients with IF, including those with short bowel syndrome (SBS) or MVID, 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 and lifesaving, it is associated with serious, sometimes fatal complications.

Pediatric CSD patients with GUCY2C mutation have a significant challenge for managing nutritional and electrolyte deficiencies, given the higher impact on growth and developmental needs. This pediatric patient with IF due to CSD requires significant daily PS, and liquid oral crofelemer therapy has reduced their daily PS needs by approximately 15% within the first several weeks, consistent with what was observed in pediatric IF patients with MVID and SBS.

Napo remains sharply focused on its ongoing global development program for oral crofelemer as adjunctive therapy to PS for pediatric rare IF diseases. 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 formulations demonstrate substantial reductions in weekly PS needs as well as in 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.