Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with…


ROSCREA, Ireland, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Renexxion Ireland Limited (“Renexxion”), a private biopharmaceutical company committed to delivering innovative drugs to patients with high unmet need in gastrointestinal (“GI”) disorders, announced today that it has completed a successful pre-Investigational New Drug (pre-IND) consultation with the U.S. Food and Drug Administration (U.S. FDA) to discuss development of naronapride for patients with proton-pump inhibitor non-responsive symptomatic gastroesophageal reflux disease (PPI-nrsGERD). PPI-nrsGERD affects over 20 million patients in the U.S., and current treatments are focused solely on the mechanism of acid suppression without addressing gastrointestinal (GI) motility. Naronapride, Renexxion’s lead drug candidate, is a potential best-in-class oral, locally acting pan-GI prokinetic, which works by modulating two validated targets, 5-HT4 receptor agonism and D2 receptor antagonism, with a well-differentiated pharmaceutical, pharmacokinetics, safety, and efficacy profile from other 5-HT4 agonists.

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Renexxion Ireland has Completed a Successful Pre-IND Consultation with the United States FDA for Development of Naronapride for Patients with...

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