Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment Draft Guidance for Industry September 2025

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/symptomatic-nonerosive-gastroesophageal-reflux-disease-developing-drugs-treatment?utm_medium=email&utm_source=govdelivery FDA Has Publishes Draft Guidances on Drug Development for Erosive Esophagitis and Symptomatic Nonerosive Gastroesophageal Reflux Disease In September, the U.S. Food and Drug Administration (FDA) published draft guidance documents focused on drug development for two upper gastrointestinal tract conditions: Erosive Esophagitis and Symptomatic Nonerosive Gastroesophageal Reflux Disease. "Symptomatic Nonerosive Gastroesophageal Reflux Disease: Developing Drugs for Treatment" provides recommendations for designing and conducting clinical trials for drugs intended to treat symptomatic nonerosive gastroesophageal reflux disease (sGERD) in adults. Patients with sGERD experience chronic reflux symptoms, such as heartburn, without visible damage to the esophageal lining. “Erosive Esophagitis: Developing Drugs for Treatment" offers recommendations for designing and conducting clinical trials for drugs intended to heal erosive esophagitis (EE) and maintain healed EE in adults. Patients with EE experience reflux of acidic stomach contents into the esophagus that leads to visible damage and superficial erosions of the esophageal lining, with or without symptoms. Both draft guidance documents cover key aspects of clinical trials, including eligibility criteria, trial design features, efficacy evaluations such as endpoint assessments, and safety assessments, intended to support the indication for these conditions. Erosive Esophagitis: Developing Drugs for Treatment Draft Guidance for Industry September 2025 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/erosive-esophagitis-developing-drugs-treatment?utm_medium=email&utm_source=govdelivery