Positive Phase 2b Trial Results Announced
On May 4, 2026, Dr. Falk Pharma and Renexxion announced positive results for naronapride in a global Phase 2b trial for gastroparesis. The MOVE-IT trial met its primary endpoint, showing statistically significant improvement in gastroparesis symptoms with 20 mg and 40 mg doses of naronapride compared to a placebo. Improvements were observed in symptoms like nausea, early satiety, postprandial fullness, and upper abdominal pain.
Over 12 weeks, 328 adults with moderate-to-severe idiopathic or diabetic gastroparesis participated. They showed objective evidence of delayed gastric emptying. Participants were divided into groups receiving 10 mg, 20 mg, or 40 mg doses of naronapride, or a placebo, taken orally three times a day.
Results of the study were presented at Digestive Disease Week 2026 in Chicago, where reductions in the ANMS GCSI-DD Core Symptom Score for higher doses of naronapride were highlighted.
Dr. Kai Pinkernell, Managing Director Science & Innovation at Dr. Falk Pharma, stated, “We are excited about the outcomes showing a significant and clinically meaningful impact on gastroparesis symptoms, all combined with a favorable safety profile.”
Safety and Efficacy of Naronapride
The study revealed naronapride’s favorable safety profile, with no new safety signals detected, including cardiac or neuropsychiatric concerns. The drug’s efficacy also extended to secondary endpoints, showing improvements in Patient-Reported Quality of Life and gastric emptying rates.
In the 20 mg TID dose group, statistically significant improvements were seen with a p-value of 0.0046. The 40 mg TID dose group showed similar improvements with a p-value of 0.0156, exceeding the placebo group’s results, highlighting naronapride’s potential.
Dr. Peter Milner, Chairman and CEO of Renexxion, commented, “These Phase 2b results represent a significant milestone for the naronapride program, demonstrating statistically significant improvement in gastroparesis symptoms with a favorable safety and tolerability profile.”
Dr. Falk Pharma and Renexxion plan to advance towards late-stage development of naronapride. Their aim is to initiate registration studies and offer new hope for patients with gastroparesis.
