Daewoong Pharmaceutical’s gastroesophageal reflux disease (GERD) treatment Fexuclue has shown a symptom improvement effect at a level of 96% in real-world clinical data that reflect the characteristics of actual medical practice. Similar levels of data were observed in patients aged 65 years and older, reconfirming its overall efficacy and safety.

Daewoong Pharmaceutical announced on the 3rd that an interim analysis of the post-marketing surveillance (PMS) of its GERD treatment “Fexuclue (ingredient name: fexuprazan hydrochloride)” confirmed symptom improvement in 95.75% of all patients, including elderly patients aged 65 years and older. The study results were published in “Gut and Liver,” an SCIE-indexed international journal in the field of gastroenterology.

Fexuclue is a GERD treatment developed with Daewoong Pharmaceutical’s own technology and launched in July 2022. It is also the 34th domestically developed new drug in Korea. It is a next-generation therapy in the third-generation P-CAB (potassium-competitive acid blocker) class, developed to overcome the limitations of second-generation proton pump inhibitors (PPIs). It is characterized by faster onset and longer duration of action than PPIs. In addition, it can be taken regardless of meals, which is cited as an advantage for improving treatment convenience.

Post-marketing surveillance is a study conducted to confirm the safety and efficacy of a medicine during its use in actual medical settings after marketing approval. This interim analysis was conducted based on real-world data (RWD) accumulated beyond a certain scale prior to the completion of the overall surveillance. In particular, unlike strictly controlled clinical trials, this study included a large number of challenging patient groups typically seen in real-world practice—such as elderly patients, patients with comorbidities like hypertension and diabetes, and patients on multiple concomitant medications—making it meaningful in that it verified the practical effectiveness and safety of Fexuclue.

Among the 630 patients enrolled in the study, 14% were aged 75 years or older, and 46.7% were aged 65 years or older, indicating a high proportion of elderly patients. In addition, 71.1% of all patients had comorbidities, and 78.6% were already taking other medications concomitantly. The research team administered Fexuclue 40 mg for 4 weeks up to a maximum of 8 weeks to these patients and observed the course of treatment. According to the study results, 95.75% of the patients showed symptom improvement after administration of Fexuclue. Among the elderly patient group aged 65 years and older, the symptom improvement rate was similarly high at 95.32%, comparable to that of the overall patient group. This is analyzed as evidence that Fexuclue can be widely utilized even in complex clinical environments.

Beyond simple symptom relief, the “GERD-specific health-related quality of life index (GERD-HRQL),” which measures how patients perceive their condition in daily life, also showed positive results. Daewoong Pharmaceutical explained that the mean score improved from 13.3 before treatment to 3.0 after treatment (p〈0.05, the P-value, which indicates statistical significance, is a statistical index used to determine the likelihood that the difference between two treatment groups occurred by chance. Generally, when the p-value is less than 0.05, the difference is interpreted as statistically significant). For this index, a lower score indicates less discomfort caused by symptoms.

In addition, there were no reports of serious adverse drug reactions, further confirming safety. The overall incidence rate of adverse drug reactions was tallied at 2.38%.

Principal investigator Park Moo-In, professor of gastroenterology at Kosin University Gospel Hospital, stated, “These results demonstrate that Fexuclue can be expected to provide stable treatment effects in a variety of real-world clinical settings, including in elderly patients,” and evaluated, “It is particularly meaningful in that it has established clinical evidence that Fexuclue can be used with confidence even in elderly patients or patients with impaired liver function, for whom prescribing requires caution.”

Park Hyoung-cheol, head of the ETC Marketing Division at Daewoong Pharmaceutical, stated, “This interim PMS analysis shows that Fexuclue demonstrates excellent efficacy and high safety even in complex real-world prescribing environments,” and added, “Daewoong Pharmaceutical will continue to solidify the medical evidence base through ongoing research and further strengthen the product’s competitiveness.”

Meanwhile, in May, Fexuclue obtained an additional indication from the Ministry of Food and Drug Safety for “antibiotic combination therapy for the eradication of Helicobacter pylori.” The 40 mg Fexuclue product can now be prescribed together with antibiotics for the eradication of Helicobacter pylori, which causes conditions such as gastritis, gastric ulcers, and gastric cancer. With proven efficacy and safety and the acquisition of additional indications, Fexuclue is rapidly expanding its presence in the gastrointestinal disease market.

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