Jaguar Health Secures New Patent for Crofelemer in Short Bowel Syndrome, Strengthening Global IP Position Ahead of Additional Clinical Milestones

Rhea-AI Summary

Jaguar Health (NASDAQ:JAGX) announced an Australian patent issued to Napo for methods treating short bowel syndrome (SBS), bile acid diarrhea, and post-resection diarrhea using an inhibitor of chloride-ion transport such as crofelemer (Nov 24, 2025).

Jaguar cited emerging proof-of-concept clinical data: two pediatric SBS-IF patients showed 12.5–15.6% reduction in parenteral support (PS) at 12 weeks; one MVID patient showed up to 27% reduction at 12 weeks and up to 37% on extension. Ongoing randomized trials and expanded access programs are active in US, EU, Middle East.

Positive

• Australian patent issued for crofelemer methods in SBS-IF
• Proof-of-concept PS reductions of 12.5–15.6% in SBS patients
• MVID patient PS reduction up to 27% (12 weeks) and 37% extension
• Ongoing placebo-controlled trials in US and EU
• Napo patent portfolio of ~195 patents and ~56 pending
• Crofelemer approved under FDA Botanical Guidance (unique exclusivity)

Negative

• Only two SBS patients completed treatment in initial cohort
• Initial MVID evidence from a single completed patient
• Clinical results are early, uncontrolled/limited-sample IIT data

Insights

Biotech business strategist

Australian method patent plus published proof‑of‑concept reductions in parenteral support strengthen crofelemer's commercial and IP position ahead of controlled trials.

Jaguar secured an Australian patent for using an inhibitor of chloride‑ion transport such as crofelemer to treat short bowel syndrome (SBS), bile acid diarrhea and diarrhea after small intestine resection or gallbladder removal, which extends exclusivity in that jurisdiction and supports global IP claims. The company also reports published and presented clinical data showing reductions in parenteral support (PS): SBS patients saw PS reductions of 12.5% to 15.6% over 12 weeks at the highest dose, while an initial microvillus inclusion disease (MVID) patient experienced PS reductions up to 27% over 12 weeks and up to 37% during an extension on reinitiation.

These developments create a clearer commercialization pathway by pairing enforceable method claims with early human efficacy signals. Important dependencies and risks remain: the human evidence is very limited (two SBS patients and one initial MVID patient completed treatment), results come from an investigator‑initiated trial (IIT) and independent proof‑of‑concept work, and broader regulatory or payer acceptance will require larger, controlled datasets. Monitor progress of the ongoing placebo‑controlled trials in the US, EU and Middle East, additional patent grants in major markets, and forthcoming controlled readouts following the presentations on November 8, 2025. These items will most directly affect partner interest and non‑dilutive funding potential over the coming clinical development window.

This new IP supports crofelemer's global exclusivity in rare pediatric intestinal failure coincident with published clinical data showing reductions in parenteral support requirements with crofelemer - supporting Jaguar's strategy to secure non-dilutive partnership funding

Recent publication by members of Jaguar's Scientific Advisory Board and other intestinal failure key opinion leaders: "Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)"

SAN FRANCISCO, CA / ACCESS Newswire / November 24, 2025 / Jaguar Health, Inc. (NASDAQ:JAGX) (Jaguar) today announced that the Australian Patent Office has issued a new patent to Jaguar family company Napo Pharmaceuticals (Napo) for methods for treating short bowel syndrome (SBS), bile acid diarrhea, and diarrhea associated with small intestine resection or gallbladder removal, in patients with an inhibitor of chloride-ion transport such as crofelemer, Jaguar's novel plant-based prescription drug.

"This new patent expands the international IP protection supporting crofelemer's development in short bowel syndrome with intestinal failure (SBS-IF)," said Lisa Conte, founder, president, and CEO. "Together with emerging proof-of-concept data showing reductions in parenteral support, this strengthens the foundation for our planned business development efforts to advance crofelemer in rare pediatric intestinal failure disorders."

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 UAE demonstrate disease progression modification through reduction of total parenteral support (PS) in pediatric intestinal failure patients that ranged from 12 to 37%. Specifically, in the two 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.

"The intestines of patients with intestinal failure due to short bowel syndrome often do not function properly, as is always the case with patients with intestinal failure due to the ultrarare genetic disorder microvillus inclusion disease (MVID). Intestinal failure is a debilitating, lifelong 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). Most intestinal failure patients require PS up to 7 days a week, and sometimes for 20 hours or more per day," Conte said.

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, liver and kidney function problems - as well as a risk of neurodevelopmental delay. These symptoms may emerge at any time in intestinal failure patients, and often become life-threatening.

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.

An article by Pravin Chaturvedi, PhD, Jaguar's Chief Scientific Officer and Chair of the Jaguar and Napo Scientific Advisory Board, Michela Pantaleoni of Jaguar family company Napo Therapeutics in Italy, along with other members of the company's Scientific Advisory Board and intestinal failure key opinion leaders, has been published in Clinical Nutrition Open Science, the official peer-reviewed open-access journal of ESPEN, the European Society for Clinical Nutrition and Metabolism. The article, "Targeted Literature Review and Assessment of Evidence in Microvillus Inclusion Disease (MVID)," synthesizes reported evidence on MVID's clinical manifestations, treatment, and outcomes, highlighting the disease burden and identifying key gaps in current knowledge.

In addition to supporting the ongoing IIT in the UAE, Napo is also conducting a placebo-controlled clinical trial of crofelemer in pediatric SBS-IF patients at sites in the US and 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 providing crofelemer powder for oral solution for use in two expanded access programs in intestinal failure patients with MVID in the US, and for an IIT of crofelemer to treat intestinal failure in adult SBS-IF patients in the US.

As with all potential follow-on indications, Jaguar and Napo prioritize IP protection. Napo currently holds approximately 195 patents and approximately 56 patents pending. To date, crofelemer is the only oral plant-based prescription medicine approved under the FDA's Botanical Guidance, which provides an important additional exclusivity advantage due to the inherent practicalities limiting the pathway by which a generic version of the drug could be produced.

About Crofelemer

Crofelemer is a novel, oral plant-based prescription medicine purified from the 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." 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:

hello@jaguar.health
Jaguar-JAGX

SOURCE: Jaguar Health, Inc.

View the original press release on ACCESS Newswire

FAQ

What patent did Jaguar Health (JAGX) secure on November 24, 2025?

The Australian Patent Office issued a patent to Napo for methods treating SBS, bile acid diarrhea, and diarrhea after small intestine resection using crofelemer.

How much did crofelemer reduce parenteral support (PS) in the reported SBS patients?

In two pediatric SBS-IF patients who completed treatment, crofelemer reduced PS by 12.5–15.6% at the highest dose over 12 weeks.

What PS reductions were reported for the MVID patient treated with crofelemer?

The initial MVID patient showed PS reductions up to 27% at 12 weeks and up to 37% during the extension period after reinitiation.

Where are Jaguar/Napo conducting clinical trials of crofelemer for pediatric intestinal failure?

Placebo-controlled trials and programs are ongoing at sites in the US, EU, and Middle East, plus an IIT in the UAE and expanded access programs in the US.

How extensive is Napo's intellectual property supporting crofelemer development?

Napo holds approximately 195 patents and about 56 patents pending, per the announcement.

Does crofelemer have any regulatory exclusivity advantages that affect JAGX shareholders?

Crofelemer is the only oral plant-based prescription medicine approved under the FDA Botanical Guidance, which the company says provides added practical exclusivity.