Bukwang Pharm announced on the 2nd that it has received approval for its Phase 3 clinical trial plan (IND) from the Ministry of Food and Drug Safety (MFDS) to add an adjunctive therapy indication for the major depressive disorder (MDD) treatment 'Latuda Tab.' (active ingredient: lurasidone).

This clinical trial was planned to evaluate the efficacy and safety of lurasidone as an adjunctive therapy in adult patients with MDD who did not show an adequate response to antidepressant monotherapy. It is a Phase 3 trial conducted in a randomized, double-blind, placebo-controlled, multicenter format.

The clinical trial will be conducted on 364 adult patients at 19 domestic institutions, including Jeju National University Hospital. Patients will be administered lurasidone 20mg, 40mg, or 60mg once daily for 8 weeks as an adjunctive therapy, with plans to evaluate the change in the Montgomery-Åsberg Depression Rating Scale (MADRS), as well as safety and tolerability.

Bukwang Pharm applied for the clinical trial on December 22, 2025, and obtained approval on June 2, 2026, approximately six months later. The total clinical trial period is expected to be about 24 months, though it may vary depending on the pace of patient enrollment.

Latuda Tab. is a medication that received domestic product approval in 2023 and is already on the market. This trial is significant in that it aims to expand the indications of an existing treatment, rather than the development of a new drug. Following the completion of the trial, the company plans to apply for a change in product approval to add the clinical results related to adjunctive therapy for MDD to the approved indications.

Through this trial, Bukwang Pharm expects to expand treatment options for MDD patients who do not adequately respond to existing treatments.

However, the company stated in its investor precautions, "The statistical probability of the clinical trial drug receiving final approval is around 10%," and "Depending on the clinical results, the commercialization plan may be altered or discontinued."