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Sun Pharmaceutical Industries, a Mumbai-based company, has launched a new drug called Fexuclue in India, which is a potassium competitive acid blocker (PCAB) designed to treat adults with Erosive Esophagitis of all grades. Fexuclue, also known as Fexuprazan, has the longest half-life of 9 hours among PCABs, making it a unique solution for managing acid reflux. The drug has been approved by regulatory agencies and has been evaluated in a Phase 3 clinical trial in a double-blind, double-dummy design, demonstrating its effectiveness in healing Erosive Esophagitis in Indian patients.
The clinical trial showed that over 95% of patients achieved healing of Erosive Esophagitis within 8 weeks, and the drug was well-tolerated in Indian patients. Erosive esophagitis is a common condition associated with gastroesophageal reflux disease (GERD), which causes symptoms such as heartburn and regurgitation. The prevalence of GERD in India varies between 7.6% and 30%, and erosive esophagitis occurs in almost 9% of GERD patients.
Sun Pharma obtained the rights to manufacture and commercialize Fexuclue through an agreement with Daewoong Pharmaceutical Co Ltd, a Korean company. Under the agreement, Daewoong will receive upfront and milestone payments, including royalties. The launch of Fexuclue in India provides a new treatment option for patients with Erosive Esophagitis, offering a unique solution with a longer duration of action compared to other available treatments. The company aims to provide patients with a convenient and effective treatment for managing this condition, improving their quality of life and reducing the burden of GERD and related symptoms.