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# FDA Accepts Renzapride Cardiac Safety Trial
- URL: https://www.fdaweb.com/fda-accepts-renzapride-cardiac-safety-trial/
- Published: 2018-05-16T12:00:00.000Z
- Updated: 2026-09-15T00:05:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141461

FDA has accepted the EndoLogic cardiac safety trial for renzapride is patients with gastroparesis. The company says the study demonstrated no evidence of QTc prolongation in the EKG findings. “FDA views this study as sufficient to characterize renzapride’s QTc prolongation potential at both therapeutic (4 mg/day) and supra-therapeutic (20 mg/day) doses of the compound in patients with gastroparesis,” the company says.

It adds that a pilot Phase 2 study in patients with diabetic gastroparesis showed significant improvement in gastric emptying in a dose-dependent manner. It plans to conduct a Phase 2 study to identify the best dose to treat gastroparesis for the second pivotal trial.