Daewoong Pharma's Fexuclue safe to use with aspirin: Clinical trials

Daewoong Pharmaceutical Co., a leading South Korean pharmaceutical company, has announced the successful completion of phase 1 clinical trials for Fexuclue (fexuprazan), a potassium-competitive acid blocker (P-CAB)-based drug used to treat gastroesophageal reflux disease (GERD) when combined with aspirin, a painkiller.

According to the company on Monday, the trial results demonstrate that it is safe to administer Fexuclu and aspirin together.

The trials, conducted at the Seoul National University Hospital clinical center, involved 22 subjects who were administered Fexuclue and aspirin for two to three weeks. Blood samples were collected 48 hours later, and the results indicated that the combination of Fexuclu and aspirin did not affect the drug effect of aspirin. The trials also showed no safety or drug resistance issues associated with the combination.

Fexuclu has been approved as the 34th new drug in Korea.

Proton pump inhibitors (PPIs) are commonly recommended in combination with aspirin due to the potential side effects of gastric and duodenal ulcers caused by aspirin. However, PPIs can have limitations such as delayed drug effects, so P-CAB drugs are considered alternatives.

"Through these clinical trials, we have confirmed that there is no problem in the combination of Fexuclue and aspirin, which is expected to establish itself as a new option for patients taking aspirin," Daewoong Pharmaceutical CEO Lee Chang-jae said.

The results were published in the international academic journal Pharmaceutics under the title of "Pharmacodynamic and Pharmacokinetic Drug Interactions between Fexuprazan, a Novel Potassium-Competitive Inhibitor, and Aspirin, in Healthy Subjects."

Write to Jung-Eun Kim at likesmile@hankyung.com