Daewoong Pharma's Fexuclue shows 95.75% symptom improvement in real-world data, including elderly patients

Daewoong Pharma said Thursday that an interim analysis of post-marketing surveillance data for Fexuclue (fexuprazan hydrochloride), its P-CAB (potassium-competitive acid blocker) treatment for gastroesophageal reflux disease, confirmed symptom improvement in 95.75% of patients, including those aged 65 and older. The findings were published in Gut and Liver, an SCIE-indexed international journal in gastroenterology.

Post-marketing surveillance verifies the safety and efficacy of a drug as it is used in actual clinical settings after regulatory approval. The interim analysis drew on real-world data accumulated beyond a certain threshold before the full surveillance period concluded.

Unlike strictly controlled clinical trials, the study validated Fexuclue's practical effectiveness and safety by enrolling a large proportion of patients typical of real clinical settings — including elderly patients, those with comorbidities such as hypertension and diabetes, and those taking multiple medications. Of the 630 patients enrolled, 14% were aged 75 or older and 46.7% were aged 65 or older, reflecting a high proportion of elderly patients. In addition, 71.1% of all patients had comorbidities and 78.6% were already taking other medications. The research team administered Fexuclue 40mg to these patients for four to eight weeks and monitored their progress.

Results showed that 95.75% of patients experienced symptom improvement after taking Fexuclue. Among patients aged 65 and older, the symptom improvement rate was similarly high at 95.32%. Beyond symptom relief, the GERD-specific health-related quality-of-life score (GERD-HRQL) — which measures the impact of symptoms on daily life — improved markedly, falling from an average of 13.3 before treatment to 3.0 afterward. A lower score indicates less discomfort from symptoms.

Safety results were also strong. No serious adverse drug reactions were reported, and the overall adverse drug reaction rate was just 2.38%. Patients with hepatic impairment showed consistent efficacy with no drug-related adverse reactions, further confirming the drug's safety profile.

Park Mu-in, a professor of gastroenterology at Kosin University Gospel Hospital and the study's principal investigator, said the results confirm that Fexuclue delivers stable therapeutic effects across diverse real-world clinical settings, including in elderly patients. "The findings are particularly meaningful in that they establish a reliable clinical basis for using the drug in elderly patients and those with reduced liver function — groups that require extra caution in prescribing," Park said.

Kim Ji-hyun, a professor of gastroenterology at Gangnam Severance Hospital and the study's first author, said drug safety is paramount in real clinical settings, where many patients present with multiple conditions. "This research has given us confidence in Fexuclue's safety and consistent treatment outcomes," Kim said.

Park Hyung-cheol, head of Daewoong Pharma's ETC marketing division, said the company will continue building a solid body of medical evidence through ongoing research and further strengthen the product's competitiveness.