SBS-IF is the second orphan disease target indication for Jaguar’s intestinal failure program, which includes microvillus inclusion disease (MVID) – for which the company completed a meeting in October 2025 with the FDA in support of a possible expedited approval pathway
SAN FRANCISCO, CA / ACCESS Newswire / December 15, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that Jaguar family company Napo Pharmaceuticals‘ (Napo’s) independent investigator at a leading SBS-IF treatment institution submitted an abstract describing preliminary findings from a clinical trial evaluating a novel oral liquid formulation of crofelemer in adult SBS-IF patients. This abstract is for consideration for presentation at the May 2-5, 2026 Digestive Disease Week® conference. The submission supports Jaguar’s strategic focus on intestinal failure in adult short bowel syndrome patients, where reducing dependence on parenteral support remains a critical unmet need. An overview of the study can be viewed on the ClinicalTrials.gov website. SBS-IF is the second orphan disease target indication for Jaguar’s intestinal failure program, which includes the ultrarare genetic disorder microvillus inclusion disease (MVID). In October 2025 the company completed a meeting with the FDA in support of a possible expedited approval pathway for crofelemer for MVID.
“Findings from independent investigator-initiated studies provide proof-of-concept data and continue to build the evidence supporting crofelemer’s ability to reduce stool and stomal output and the drug’s potential to reduce parenteral support needs in patients with intestinal failure – a core focus of the company for treating rare and orphan GI disorders,” said Lisa Conte, Jaguar’s founder, president, and CEO.
The intestines of patients with intestinal failure due to short bowel syndrome are unable to function like an intact gut, a similar situation to that in patients with intestinal failure due to MVID. Intestinal failure is a debilitating condition that often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) with supplemental intravenous fluids, which together constitute parenteral support (PS). Many intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day. While crucial for intestinal failure patients, PS is associated with significant toxicities to patients, similar to some toxicities associated with chemotherapy, often causing serious health problems including infections, metabolic complications, and liver and kidney function problems. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.
As announced, and as presented November 8, 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) Annual Meeting, the initial results of the ongoing and independent proof-of-concept trial of crofelemer in the United Arab Emirates demonstrate disease progression modification through reduction of PS in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in two pediatric SBS-IF patients who have completed treatment, the results show crofelemer reduced PS between 12.5 to 15.6% at the highest dose over the 12-week treatment period, together with reduced loose watery stools frequency. For the initial MVID patient who has completed treatment, PS needs were reduced by up to 27% at the highest dose over the initial 12-week treatment period and up to 37% during the extension period upon reinitiation of crofelemer treatment, and showed reduced frequency of loose watery stools. These findings support continued evaluation of crofelemer to reduce PS needs for pediatric intestinal failure patients.
Short bowel syndrome (SBS) affects approximately 10,000 to 20,000 people in the US, according to the Crohn’s & Colitis Foundation, and it is estimated that the population of SBS patients in Europe is approximately the same size. MVID is a devastating ultrarare pediatric disorder, with an estimated worldwide prevalence of 100-200 patients, characterized by severe malabsorption that requires life-sustaining parenteral support to meet the nutritional, fluid and electrolyte requirements of the child, and for which there are currently no approved treatments. MVID has a lethal natural history along with significant co-morbidities.
In addition to supporting the ongoing IIT at this US institution, Napo is conducting a placebo-controlled clinical trial of crofelemer in adult SBS-IF patients at sites in the EU, and a placebo-controlled clinical trial of crofelemer in pediatric MVID patients at sites in the US, EU, and Middle East. The company is also supporting evaluation of crofelemer powder for oral solution in expanded access programs to treat intestinal failure in pediatric patients with MVID in the US.
Crofelemer has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for SBS and MVID.
About Crofelemer
Crofelemer is a novel, oral plant-based highly purified prescription medicine from the crude plant latex (red bark sap), also referred to as “dragon’s blood,” of the Croton lechleri tree in the Amazon Rainforest. Napo Pharmaceuticals has established a sustainable harvesting program, under fair trade practices, for crofelemer to ensure a high degree of quality, ecological integrity, and support for indigenous communities.
About the Jaguar Health Family of Companies
Jaguar Health, Inc. (Jaguar) is a commercial stage pharmaceuticals company focused on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people and animals with gastrointestinal distress. Jaguar family companies Napo Pharmaceuticals (Napo) and Napo Therapeutics S.p.A. focus on the development and commercialization of novel crofelemer powder for oral solution for the treatment of rare and orphan gastrointestinal disorders with intestinal failure, including microvillus inclusion disease and short bowel syndrome.
For more information about:
Jaguar Health, visit https://jaguar.health
Napo Pharmaceuticals, visit www.napopharma.com
Napo Therapeutics, visit napotherapeutics.com
Forward-Looking Statements
Certain statements in this press release constitute “forward-looking statements.” These include statements regarding Jaguar’s expectation that an expedited approval pathway for crofelemer in the US may be possible. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to several risks, uncertainties, and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Contact:
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SOURCE: Jaguar Health, Inc.
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