New Gastroparesis Drug Naronapride Poised for Spotlight at Major Medical Meeting

FREIBURG, Germany – April 16, 2026 – A promising new therapy for gastroparesis, a severe and chronic gastrointestinal disorder, is set to take center stage at one of the world's premier medical conferences. Dr. Falk Pharma and Renexxion Ireland announced today that pivotal data from their global Phase 2b study of the drug naronapride has been accepted for a late-breaking oral presentation at Digestive Disease Week (DDW) 2026 in Chicago.

The selection for a late-breaker session, reserved for highly significant and timely research, suggests the findings from the MOVE-IT trial could represent a major step forward for patients suffering from a condition with notoriously limited treatment options. The presentation will unveil the results from a study involving 328 adults with moderate-to-severe gastroparesis, a disease that can severely impair quality of life.

A Desperate Need for New Therapies

Gastroparesis, which translates to "stomach paralysis," is a debilitating condition where the stomach empties food too slowly without any physical blockage. Patients endure a relentless barrage of symptoms, including chronic nausea, vomiting, debilitating abdominal pain, early satiety, and severe bloating. The condition can lead to malnutrition, dehydration, and unpredictable blood sugar levels, particularly in patients with diabetic gastroparesis.

For years, the treatment landscape has been frustratingly sparse. The only FDA-approved drug in the United States, metoclopramide, carries a "black box" warning for the risk of serious and potentially irreversible neurological side effects, limiting its long-term use. Other options, like the antibiotic erythromycin, can lose effectiveness over time, while domperidone is not widely available in the U.S. due to cardiac safety concerns. This leaves many patients and their physicians navigating a difficult path of off-label medications, dietary restrictions, and invasive procedures like gastric electrical stimulation, often with unsatisfactory results.

"There are considerable unmet needs in the treatment of gastroparesis," according to clinical guidelines from the American Gastroenterological Association, a sentiment echoed by gastroenterologists and patient advocates alike. The search for a therapy that is both safe for long-term use and effective at controlling the multifaceted symptoms of the disease has become a critical priority in gastroenterology.

A Novel Dual-Action Mechanism

Naronapride enters this landscape with a unique scientific profile designed to overcome the limitations of its predecessors. Developed by Renexxion, the oral medication is a locally acting pan-GI prokinetic, meaning it is designed to work directly within the gastrointestinal tract with minimal absorption into the bloodstream, a key feature aimed at reducing systemic side effects.

Its power lies in a dual mechanism of action. Naronapride acts as both a 5-HT4 receptor agonist and a dopamine D2 receptor antagonist. This combination is intended to provide a one-two punch: stimulating the 5-HT4 receptors helps promote coordinated muscle contractions to move food through the digestive system, while blocking D2 receptors helps to further enhance motility and directly combat the nausea signals that plague gastroparesis patients.

This differentiated approach has been carefully designed to avoid the safety pitfalls of older GI drugs. For instance, some earlier 5-HT4 agonists were removed from the market due to cardiac risks. Naronapride, however, has already completed a Thorough QT study—the gold standard for assessing a drug's cardiac safety—which confirmed a favorable profile at both therapeutic and higher-than-therapeutic doses. Across nine Phase 1 and five previous Phase 2 trials in indications like chronic constipation and GERD, naronapride has consistently demonstrated a safety and tolerability profile comparable to a placebo.

A Strategic Alliance to Accelerate Progress

The journey of naronapride to the global stage has been fueled by a strategic partnership formed in 2021 between Renexxion, a privately held U.S. biopharmaceutical company, and Dr. Falk Pharma, a German firm with a 60-year legacy in digestive medicine. Under the agreement, Dr. Falk Pharma is leading development and commercialization in Europe and other key territories, while Renexxion retains rights for the U.S. and other major markets.

This collaboration has proven effective in streamlining the drug's clinical pathway. The MOVE-IT study, initially launched in Europe, was expanded to include U.S. clinical sites in 2024, a move designed to harmonize clinical data and regulatory submissions on both sides of the Atlantic. The successful completion of enrollment for the 328-patient trial in May 2025 set the stage for the data analysis that will now be presented at DDW. The partnership's confidence in the drug is further evidenced by a recent decision to advance naronapride into studies for a second indication: GERD that does not respond to standard proton pump inhibitors.

Market and Community Await Key Data

The presentation, titled "Naronapride in Idiopathic and Diabetic Gastroparesis: Results from a Phase 2b Randomized Control Trial," will be delivered by esteemed gastroenterologist Jan F. Tack on May 3, 2026. The medical and investment communities will be watching closely. The global market for gastroparesis treatments is valued at over $6.8 billion and is projected to grow to nearly $10 billion by 2032, driven largely by the rising prevalence of diabetes, a primary cause of the condition.

A new, safe, and effective therapy could not only capture a significant share of this market but, more importantly, fundamentally alter the treatment paradigm for millions of patients. The data from the MOVE-IT study will provide the first comprehensive look at whether naronapride can deliver on its promise to improve not just gastric emptying but also the debilitating symptoms that define the daily struggle of living with gastroparesis. For a patient community long awaiting a breakthrough, the results presented in Chicago could mark the beginning of a new era.