Sun Pharmaceutical Industries Ltd recently announced the launch of FEXUCLUE® (Fexuprazan) 40 mg tablets in India. Fexuprazan marks the introduction of a new class of drug—potassium-competitive acid blocker (PCAB)—in the management of Erosive Esophagitis (EE). FEXUCLUE® (Fexuprazan) represents a significant improvement in acid suppression therapy, providing rapid symptom relief and prolonged efficacy.

FEXUCLUE® is notable for its fast onset of action, stable gastric acid suppression, and independent of food intake. It has the longest half-life of any PCAB at 9 hours, which allows for more effective control of nocturnal acid reflux symptoms, which are a concern for patients with EE.

Sun Pharma has acquired exclusive rights to manufacture and market the drug in India, which was developed by Daewoong Pharmaceutical Co. Ltd., Korea. Under the agreement, Daewong will be entitled to received upfront and milestone payments as well as royalties.

When asked to comment on the launch, Kirti Ganorkar, CEO – India Business, Sun Pharma, offered some input – “Erosive Esophagitis is a severe condition that has a profound impact on patients’ quality of life. Developing our understanding of management options, such as FEXUCLUE®, can help address this significant unmet need. At Sun Pharma, we strive to deliver novel treatments to improve quality of life for patients. FEXUCLUE® is a first-in-class treatment for Erosive Esophagitis, and we are excited to be in the position to deliver this therapy as a treatment option for patients.”

In a Phase 3 study of Indian adults, the efficacy of Fexuprazan was demonstrated in a double-blind, double-dummy design. The study met its primary endpoint of endoscopic healing of Erosive Esophagitis, with greater than 95% of patients healed within eight weeks. The drug was well-tolerated in Indian patients as well.

With this launch, Sun Pharma aims to address the significant unmet clinical need in EE treatment, offering patients a new and effective therapeutic alternative.

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