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

This clinical trial targets adult patients with major depressive disorder who have not shown an adequate response to antidepressant monotherapy. It will be conducted as a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of lurasidone as an adjunctive therapy.

The clinical trial will be conducted on 364 adult patients across 19 domestic institutions, including Jeju National University Hospital. The plan is to administer 20mg, 40mg, or 60mg of lurasidone once daily for 8 weeks as an adjunctive therapy to evaluate changes in the depression rating scale (MADRS) as well as safety and tolerability.

Bukwang Pharm applied for the clinical trial on December 22, 2025, and received approval on June 2, 2026. The clinical trial period is expected to be approximately 24 months, though it may vary depending on the patient enrollment rate.

Latuda Tab is a medication that has already received domestic product approval and is currently on the market as of 2023. This clinical trial is highly significant in that it is intended to expand the indications of an existing treatment, rather than the development of a new drug. Following the completion of the clinical 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.

The company expects that this clinical trial will expand treatment options for MDD patients who do not adequately respond to existing treatments.

However, through a cautionary statement for investors, the company stated, "The statistical probability of the clinical trial drug receiving final approval is around 10%," and added, "Depending on the clinical results, the commercialization plan may be changed or discontinued."