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Jaguar Health provides crofelemer to infant for compassionate use

September 4, 2026 8:33 AM

Jaguar Health, Inc. (NASDAQ: JAGX) announced that its subsidiary Napo Pharmaceuticals is providing crofelemer powder for oral solution to an infant patient with intestinal failure (IF) caused by congenital sodium diarrhea (CSD), the result of a mutation in the GUCY2C gene.

The treatment is being administered as adjunctive therapy to parenteral support (PS) under a compassionate use arrangement, according to a company statement. The goal is to reduce the infant's daily and weekly PS requirements, consistent with outcomes observed in other pediatric IF patients.

Jaguar said it has completed the randomized double-blind treatment phase of a pivotal clinical trial of liquid oral crofelemer in pediatric patients with microvillus inclusion disease (MVID), an ultrarare gastrointestinal disorder. The company plans to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for the MVID indication in mid-2027 and may also apply for Breakthrough Therapy Designation.

Data presented at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition meeting in June 2026 showed reductions in weekly PS needs in pediatric IF patients treated with liquid oral crofelemer for more than 12 months. In one MVID patient, PS requirements normalized to body weight were reduced by up to 48%. In two pediatric short bowel syndrome with IF patients, reductions of up to 40% were reported. No significant clinical or laboratory abnormalities were observed.

Jaguar noted that MVID has an estimated worldwide prevalence of approximately 200 patients. The company also indicated it is engaged in business development discussions that could result in non-dilutive funding from potential licensee partners for its IF program.

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