AriBio said Tuesday that it has filed an IND (investigational new drug) application with the U.S. Food and Drug Administration for a phase 3 clinical trial of its oral dementia treatment, AR1001.

AriBio added that it is developing AR1001 as a multi-effect dementia treatment that suppresses dementia progression and improves the memory and cognitive function of dementia patients.

The company’s strategy is to gather a massive subject group through the global phase 3 trial of AR1001, confirm the treatment’s differentiated efficacy and safety in long-term use, and receive the FDA’s approval.

The phase 3 trial of AR1001 will be conducted by dividing 1,600 subjects into two groups. The first phase 3 trial will be conducted in the United States in 800 subjects by administering AR1001 30mg to 400 subjects and giving a placebo to the other 400 for 52 weeks.

After the 52-week administration, researchers will give patients opportunities to participate in two years of an extended clinical trial and administer AR1001 to the control group.

The second phase 3 trial will be conducted globally in Europe and Korea by administering AR1001 30 mg or placebo to 800 subjects.

AriBio plans to start dosing in the fourth quarter of this year and announce the 52-week results in the third quarter of 2025. If it gets excellent results in the first phase 3 trial, the company will submit NDA (new drug approval) application to the U.S. FDA in the fourth quarter of 2025, separately from the progress of the second phase 3 trial.

“We have been working on researching and developing new drugs for dementia with a sense of mission that Korea’s future lies in innovative new drugs,” AriBio CEO Chung Jae-joon said. “AriBio will establish clinical strategies to ensure global competitiveness by cooperating with FDA and clinical centers across the United States and preemptively commercialize it to provide a historical turning point in overcoming dementia.

August, AriBio signed an agreement for the technological and managerial alliance with Samjin Pharm. As a result, Samjin acquired 1,111,111 AriBio shares to take a 5.47 percent equity stake. AriBio, in turn, has secured 8 percent of Samjin’s equity stake.

According to the agreement, Samjin Pharm. will lead the domestic clinical trial of AR1001. If it obtains domestic product approval, the company will also have the priority status for its sales rights.