Daewoong Pharmaceutical’s intestine purifier has entered phase 3 clinical trial, creating a stir in the industry.

According to the Ministry of Food and Drug Safety, DWJ1609, Daewoong’s formulation to evacuate bowels won its approval for a phase 3 clinical trial on Tuesday.

Daewoong plans to confirm the effectiveness and safety of DWJ1609 for colonoscopy pre-cleansing through phase 3 clinical trials to be conducted in randomized, single-blindfold (trialist), parallel, and active drug-controlled methods.

It will conduct the trial at several university hospitals, including Hanyang University Guri Hospital, the Catholic University of Korea Eunpyeong St. Mary’s Hospital, and Kangbuk Samsung Hospital.

Following the release of Fexuclue (fexuprazan hydrochloride), a new treatment for gastroesophageal reflux disease (GERD), Daewoong has been busy promoting its gastrointestinal disease products by participating in gastroenterology society conferences here and abroad.

Early this month, the company set up a booth at Digestive Disease Week 2023 (DDW 2023) in Chicago, Ill., and made two presentations of its clinical data on GERD patients.

The domestic bowel cleanser market is estimated at 50 billion won ($37.3 million). Taejoon Pharma is a frontrunner in this market with various products, including Colyte and Coolprep powders.

Competition is fierce by volume and formulation. Pharmbio Korea has developed Orafang, the first pill-type product, following liquid and power products. Liquid products are also reducing volume from four to two liters.

Industry insiders pay attention to the next move of Daewoong, which seeks to create a stir in the market after it confirmed its business capability by selling Fexuclue.