One Step Closer: Naronapride Heads Toward Phase 3
There is hopeful news for the gastroparesis community — with an important caveat up front: this is a step forward in research, not a new treatment you can get today.
On October 21, 2026, Dr. Falk Pharma and Renexxion announced they have reached alignment with both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on the Phase 3 program for naronapride in gastroparesis.
That alignment came after End of Phase 2 meetings with both agencies, following positive results from MOVE-IT (NCT05621811), a global Phase 2b, randomized, placebo-controlled trial of naronapride in adults with diabetic and idiopathic gastroparesis.
Here is what the agencies agreed on:
- Separate Phase 3 studies in diabetic and idiopathic gastroparesis
- Trial design and participant numbers
- Use of ANMS-GCSI-DD for primary and key secondary endpoints
- The planned safety database to support a future New Drug Application (NDA)
The FDA also agreed that NDA-enabling studies, including in certain specific patient populations, can run in parallel with the Phase 3 program — which the companies say may streamline the overall timeline.
The companies anticipate initiating the global Phase 3 program in the first half of 2027.
What is naronapride?
Naronapride is an oral, locally acting prokinetic designed to enhance coordinated motility across the digestive tract. According to the companies, it works through a dual mechanism — 5-HT4 receptor agonism and dopamine D2 receptor antagonism — and is designed to act locally in the gut while limiting systemic exposure. To date, it has shown a favorable safety and tolerability profile across nine Phase 1 and five Phase 2 trials in multiple indications.
That is the companies’ description of their investigational drug. Phase 3 is where that promise gets tested again, in larger studies — results are not guaranteed.
Why this matters to patients
Gastroparesis is a chronic gastrointestinal disorder characterized by delayed gastric emptying, with symptoms including nausea, vomiting, early satiety, upper abdominal pain, and postprandial fullness. Approximately 22 per 100,000 individuals across the U.S. and Europe are formally diagnosed. Despite that burden, safe and effective long-term treatment options remain limited — which is why movement toward a late-stage trial matters to patients and families living with this every day.
What this does — and does not — mean
This does not mean naronapride is approved, available, or enrolling patients through this announcement. It means regulators and the companies have agreed on how the next stage of testing should be designed, so Phase 3 can be finalized and, as anticipated, begin in the first half of 2027.
If you are living with gastroparesis, talk to your own clinician about what research news like this means for your care. GSSI does not provide medical treatment — we support patients with non-medical needs while they are being treated, such as hotel stays, food and grocery cards, and local rides when funding is available, plus gift bags. Our long-term dream remains Jennifer’s GP House, a home away from home for patients and families.
We will keep sharing research milestones like this one — clearly, and without overpromising.
Source: Dr. Falk Pharma and Renexxion, “Dr. Falk Pharma and Renexxion Reach Alignment with FDA and EMA on Phase 3 Program for Naronapride in Gastroparesis,” GlobeNewswire, October 21, 2026.
https://www.wcia.com/business/press-releases/globenewswire/1001279095/dr-falk-pharma-and-renexxion-reach-alignment-with-fda-and-ema-on-phase-3-program-for-naronapride-in-gastroparesis/
#Gastroparesis #GastroparesisAwareness #GSSI #GIMotility #Naronapride #ClinicalTrials #PatientSupport