Sun Pharmaceutical Industries (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715), along with its subsidiaries and associate companies, has announced the launch of Fexuprazan 40 mg tablets in India under the brand name FEXUCLUE. The drug, a potassium-competitive acid blocker (PCAB), has been approved for the treatment of all grades of Erosive Esophagitis in adults.
Sun Pharma has secured rights from Daewoong Pharmaceutical Co Ltd, Korea, to manufacture and commercialise the product in India. Under the terms of the agreement, Daewoong will receive upfront and milestone payments, along with royalties based on sales.
Kirti Ganorkar, CEO – India Business, Sun Pharma, said, “Erosive Esophagitis is a serious condition that greatly affects patients’ quality of life. Despite available treatments, there remains a significant unmet need in its management. FEXUCLUE is a best-in-class treatment option with the potential to bridge this gap. At Sun Pharma, we are committed to introducing innovative medicines that enhance patients’ quality of life.”
Fexuprazan’s clinical profile was evaluated in a double-blind, double-dummy, comparative Phase 3 study conducted in an adult Indian population. The study’s primary efficacy measure was endoscopically confirmed healing of Erosive Esophagitis. The trial met its primary endpoint, with over 95 per cent of patients achieving healing by the end of eight weeks. Fexuprazan was reported to be well tolerated among Indian patients.
The launch of FEXUCLUE is part of Sun Pharma’s broader strategy to expand its gastroenterology portfolio and address treatment needs in chronic and acute conditions.