 
Author: Massimo Radaelli, President and CEO, Napo Therapeutics
Massimo Radaelli, Ph. He is the CEO of Napo Therapeutics, a pharmaceutical company founded in Milan, Italy, in 2021 by California-based Jaguar Health to develop and sell the plant-based drug crofelemer in Europe, with a particular focus on rare gastroenterological diseases. Radaelli explained to World Finance why a drug derived continuously from the Amazon rainforest tree could offer a new treatment option for patients with intestinal failure due to microvillus inclusion disease (MVID) and short bowel syndrome (SBS-IF).
Congratulations on your recent awards. What makes you most excited about being recognized?
I am delighted to have been recognized by World Finance’s sister brand, CEO Europe, as the winner of the ‘Global CEO Excellence Award 2025–26.’ I believe this new award also recognizes, at an international level, my lifelong commitment to the research and development of orphan drugs to treat patients with rare diseases. I am grateful to have been recognized and able to spend decades focused on helping patients suffering from rare diseases around the world.
What makes intestinal failure such a serious condition?
Intestinal failure often requires patients to receive life-sustaining fluids, electrolytes and nutrients through intravenous administration, which consists of total parenteral nutrition (TPN) and additional intravenous fluids, including parenteral support. Many patients with intestinal failure need parental support up to seven days a week, and sometimes 20 hours or more a day.
Although important for patients with gastrointestinal dysfunction, many of whom are infants or young children, parenteral support is associated with significant toxicity, similar to other chemotherapy-related toxicities, which often cause serious health problems including infections, metabolic problems, and liver and kidney problems.
Intestinal failure in MVID and SBS-IF patients remains a critical unmet medical need. There are no approved treatments for MVID, and there are limited options, such as teduglutide and GLP-2 analogs, for a subset of SBS-IF patients. Together with Jaguar Health and our sister company Napo Pharmaceuticals, we are developing crofelemer powder for oral solution – a revolutionary first-stage drug with clinical proof-of-concept data in these indications of orphan gastrointestinal failure. Given the lethal natural history of parenteral support therapy, crofelemer may prolong the life of MVID and SBS-IF patients by reducing their required dose of parenteral support.
What updates can you provide regarding crofelemer’s clinical and commercial development efforts for these rare diseases?
An independent proof-of-concept study of crofelemer in pediatric gastrointestinal failure patients is ongoing in the UAE, with participating patients now receiving crofelemer treatment for over a year. The first results from the study, presented in November 2025 at the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition Annual Meeting, show a change in the progression of the disease with crofelemer by reducing parental support that was from 12 to 37 percent.
With continued demonstration of clinical benefit in Jaguar Health’s ongoing pivotal placebo-controlled trial of crofelemer in pediatric MVID patients, which is expected to be completed in the second half of 2026, and because MVID is a very rare disease for which there is currently no approved treatment, we hope to achieve Breakthrough Therapy designation from the US regulatory pathology market. crofelemer for the European Medicines Agency’s PRIME program for MVID to speed up approval in the EU.
We are seeking a global or regional partner to develop and/or commercialize crofelemer for MVID and SBS-IF, and will consider potential licensing, co-promotion, or strategic product acquisition opportunities. The near-term value driver is MVID, given the potential to accelerate regulatory approaches to market.
With an estimated worldwide prevalence of about 200 MVID patients, a trial of crofelemer in a small number of patients is expected to be statistically meaningful and support registration. SBS-IF, the subject of our ongoing Phase II trial of crofelemer, represents a major franchise opportunity, with a limited number of approximately 12,000 patients in the US alone.
What are the benefits of the botanical drug development approach?
Crofelemer is continuously found in the red water of the bark of the Croton lechleri tree – a fast-growing tree common in the tropical forests of Colombia, Ecuador, Peru and Bolivia. Sap has a long history of medicinal use by indigenous peoples. Crofelemer is the active ingredient in Mytesi, a drug tablet FDA approved by Jaguar Health for the relief of symptoms of non-infectious diarrhea in adults with HIV/AIDS on antiretroviral therapy.
Mytesi is the only oral product approved under the FDA Botanical Guidance. The botanical drug development framework acts as de facto IP protection: it does not protect the molecule, but rather the entire integrated production and quality system that delivers the approved herbal medicinal product to patients, meaning that there is really no practical way to bring a generic version of the drug to market.
Additionally, because data related to prior human exposures provide a pre-existing safety profile, Investigational New Drug applications for herbal medicinals have an inherently lower chance of late-stage safety failures that often derail conventional New Chemical Entity programs, effectively halting clinical development.
