Sun Pharmaceutical Industries Ltd. has announced that it has launched Fexuprazan tablets 40 mg in India under the brand name ‘FEXUCLUE’. FEXUCLUE, a novel potassium-competitive acid blocker (PCAB), is approved as a new treatment for adults with Erosive Esophagitis of all grades.

Sun Pharma has obtained rights from Daewoong Pharmaceutical Co Ltd., Korea, a biopharmaceutical company, to manufacture and commercialise FEXUCLUE (Fexuprazan) in India. As per agreement terms, Daewoong will be entitled to upfront and milestone payments, including royalties.

Commenting on the development, 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 was evaluated in a double-blind, double-dummy, comparative Phase 3 study in adult Indian population. The primary efficacy measure was healing of Erosive Esophagitis which was confirmed endoscopically. The study met its primary endpoint. Over 95 percent of the patients achieved Erosive Esophagitis healing by 8 weeks. Fexuprazan was found to be well tolerated in Indian patients.