Jaguar Health expands crofelemer compassionate use to EU infant

Jaguar Health, Inc. (NASDAQ: JAGX) announced that its subsidiary Napo Pharmaceuticals is providing crofelemer powder for oral solution to an infant in the European Union under a compassionate use pathway for the treatment of intestinal failure due to microvillus inclusion disease (MVID).

Napo has previously supplied crofelemer to infant and pediatric patients with MVID in the U.S. under Single-Patient Investigational New Drug applications, and has also provided the drug for an investigator-initiated proof-of-concept trial in pediatric patients in the United Arab Emirates.

According to the company, the EU patient's physician became aware of crofelemer following data presentations at the 58th Annual European Society for Pediatric Gastroenterology, Hepatology & Nutrition (ESPGHAN) meeting in Lille, France in June 2026. Data presented at that conference from ongoing investigations showed reductions in parenteral support requirements in pediatric IF patients treated with liquid oral crofelemer for more than 12 months. In one MVID patient, weekly parenteral support requirements normalized to body weight were reduced by up to 48%, while two short bowel syndrome patients saw reductions of up to 40%.

Jaguar states that enrollment has been completed in its ongoing blinded pivotal clinical trial of liquid oral crofelemer in pediatric MVID patients. The company plans to apply for Breakthrough Therapy Designation from the U.S. Food and Drug Administration and to file a New Drug Application for the MVID indication in mid-2027.

MVID is described in the press release as an ultrarare pediatric disorder with an estimated worldwide prevalence of approximately 200 patients.

Lisa Conte, Jaguar's founder, president, and CEO, noted that infants are not eligible for enrollment in the company's blinded trial, making the compassionate use pathway the available route for this patient.

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