Bukwang Pharmaceutical announced on June 4 that it has received approval from the Ministry of Food and Drug Safety for a Phase 3 clinical trial plan (IND) to expand the treatment indications for its schizophrenia and bipolar disorder medication, Lurasidone, to include major depressive disorder (MDD).
The clinical trial will focus on adult patients with MDD who have not shown sufficient response to existing antidepressant monotherapy. A total of 364 participants will be involved in the study.
The primary objective of the trial is to compare the change in scores on the Montgomery-Åsberg Depression Rating Scale after administering Lurasidone (20, 40, 60 mg/day) as an adjunct therapy for eight weeks against a placebo. The secondary objective will assess the safety and tolerability of the treatment in the same patient group. Bukwang Pharmaceutical believes this trial will expand treatment options for patients with limited responses to current therapies.
The company continues to expand its central nervous system (CNS) product line, focusing on Lurasidone and Aripiprazole. According to the Financial Supervisory Service's electronic disclosure system, Lurasidone surpassed 10 billion won in sales last year. Sales increased significantly from 200 million won in 2024 to 10.9 billion won last year, with 3.3 billion won recorded in the first quarter of this year.
A representative from Bukwang Pharmaceutical stated, "After the completion of the clinical trial, we plan to seek approval to add efficacy and effectiveness indications, which we expect will benefit patients with limited treatment options."
* This article has been translated by AI.
Copyright ⓒ Aju Press All rights reserved.