naronapride (ATI-7505) / Renexxion, ARYx - LARVOL DELTA

A PHASE 2B RANDOMIZED CLINICAL TRIAL OF NARONAPRIDE IN PATIENTS WITH IDIOPATHIC AND DIABETIC GASTROPARESIS (UEGW 2026) - No abstract available

Clinical • P2b data • Gastrointestinal Disorder

Serotonergic signaling in gastric physiology and motility disorders. (PubMed, Gastroenterology) - "In FD, serotonergic therapies may be selectively considered for off-label use based on the symptom profile, including mirtazapine (5-HT2 antagonist) in patients with early satiety and weight loss, and buspirone (5-HT1A agonist) in those with early satiety, postprandial fullness or bloating. Recent data on naronapride, a newer 5-HT4 agonist, suggest that more selective agents may offer clinically relevant benefit while mitigating cardiovascular safety risks associated with earlier agents. By integrating molecular, physiological, and clinical data, this review aims to clarify the relevance of serotonergic signaling in gastric physiology and motility disorders, define its therapeutic applications, and identify key remaining evidence gaps."

Journal • Review • Cardiovascular • Dyspepsia • Gastrointestinal Disorder • Pain

Prokinetic drugs that stimulate 5-HT4-serotonin receptors in the human atrium. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "Several gastrointestinal drugs like bromopride, cinitapride, cisapride, clebopride, felcisetrag, metoclopramide, mosapride, naronapride, prucalopride, renzapride, tegaserod, velusetrag, and zacopride are probably agonists at 5-HT4-serotonin receptors in the intestine. We will present our view where there are remaining pre-clinical or clinical research needs. One may repurpose some of these drugs to act on cardiac 5-HT4-serotonin receptors and discuss for which indications this may offer additional benefits."

Journal • Review

MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis (clinicaltrials.gov) - P2 | N=328 | Completed | Sponsor: Dr. Falk Pharma GmbH | Recruiting ➔ Completed

Trial completion • Gastrointestinal Disorder

MOVE-IT: Different Doses of Naronapride Vs. Placebo in Gastroparesis (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Jan 2025 ➔ Sep 2025

Trial completion date • Trial primary completion date • Gastrointestinal Disorder

MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis (clinicaltrials.gov) - P2 | N=320 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Phase classification: P2b ➔ P2

Phase classification • Gastrointestinal Disorder

Renexxion Ireland Ltd. Announces FDA Clearance of Investigational New Drug (IND) Application for Naronapride to Treat PPI-Non-Responsive Symptomatic GERD (GlobeNewswire) - "Renexxion Ireland Limited...announces U.S Food and Drug Administration (FDA) clearance of the Investigational New Drug (IND) application of naronapride for the treatment of patients with proton-pump inhibitor (PPI) non-responsive symptomatic gastroesophageal reflux disease (GERD) (PPI-nrsGERD)....'We expect to begin enrolling patients at sites in the U.S. in a Phase 2b clinical study later this year...'"

IND • New P2b trial • Gastroenterology • Gastrointestinal Disorder

Renexxion Ireland Announces Issuance of Two U.S. Patents Covering a Novel Crystal Isoform of Naronapride (GlobeNewswire) - "Renexxion Ireland Limited...announced today that the United States Patent Office ('USPTO') has issued a new composition of matter patent (Patent no. 11,643,409) and a method of use patent (Patent no. 11,827,631), both covering a novel crystal isoform of naronapride....The current naronapride patent estate includes composition of matter, method of use and formulation patents. Renexxion is currently prosecuting these patents in EP, Japan, and greater China."

Patent • Cystic Fibrosis • Gastrointestinal Disorder

MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis (clinicaltrials.gov) - P2b | N=320 | Recruiting | Sponsor: Dr. Falk Pharma GmbH | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder

Renexxion Announces Opening of Investigational New Drug (IND) Application for Naronapride for the Treatment of Gastrointestinal Dysmotility in Cystic Fibrosis Patients (PRNewswire) - "Renexxion Ireland Limited (Renexxion)...is pleased to announce opening of the Investigational New Drug (IND) application with the U.S Food and Drug Administration (FDA) for naronapride for the treatment of GI motility disorders in patients with cystic fibrosis (CF)...'We have received constructive input from the FDA on both our clinical development plan and Phase II clinical trial design. Receiving IND clearance represents a major milestone in moving forward with our clinical development plan in parallel with our partner in EU in gastroparesis'..."

IND • Cystic Fibrosis

Pharmacotherapeutic advances for chronic idiopathic constipation in adults. (PubMed, Expert Opin Pharmacother) - "Among emerging agents, elobixibat, a drug blocking the reabsorption of bile acids, is a promising one, especially in slow transit constipation. Linaclotide, lubiprostone and plecanatide, by a secretacogue action, improve stool consistency and increase colonic transit. Apart from prucalopride, approved in Europe for refractory chronic idiopathic constipation patients, the selective 5-HT4 agonists velusetrag and naronapride are in advanced development. In addition, relamorelin, a ghrelin agonist, seems promising for accelerating colonic transit...On the other hand, the experience with these new agents is still limited, especially for long-term treatment. Another important point is that these new treatments for chronic idiopathic constipation are not available worldwide and their use could be somewhat limited by their still relatively high cost."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

MOVE-IT: Different Doses of Naronapride vs. Placebo in Gastroparesis (clinicaltrials.gov) - P2b | N=320 | Not yet recruiting | Sponsor: Dr. Falk Pharma GmbH

New P2b trial • Gastrointestinal Disorder

Prokinetic actions of luminally acting 5-HT receptor agonists. (PubMed, Neurogastroenterol Motil) - "Non-absorbed 5-HT R agonists, based on prucalopride and naronapride, were assessed for potency at the 5-HT R in vitro, and for tissue and serum distribution in vivo in mice. Immunoreactivity for 5-HT R is present in the epithelial layer of the human small and large intestines. These findings demonstrated that stimulation of epithelial 5-HT Rs can potentiate propulsive motility and support the concept that mucosal 5-HT Rs could represent a safe and effective therapeutic target for the treatment of constipation."

Journal • Constipation • Gastroenterology • Gastrointestinal Disorder

Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis. (PubMed, Lancet Gastroenterol Hepatol) - "Almost all drugs studied were superior to placebo, according to either failure to achieve three or more CSBMs per week or or failure to achieve an increase of one or more CSBM per week over baseline. Although diphenyl methane laxatives ranked first at 4 weeks, patients with milder symptoms might have been included in these trials. Prucalopride ranked first at 12 weeks, and many of the included trials recruited patients who previously did not respond to laxatives, suggesting that this drug is likely to be the most efficacious for patients with chronic idiopathic constipation. However, because treatment duration in most trials was 4-12 weeks, the long-term relative efficacy of these drugs is unknown."

Journal • Retrospective data • Review • Constipation • Pain

"Hopefully, naronapride will succeed in Phase 3 and meet this need." (,@DanteYeh)

P3 data