Bukwang Pharmaceutical (003000.KS) is moving to expand the indications for Latuda (lurasidone), its treatment for schizophrenia and bipolar depression. The company plans to accelerate its push into the depression treatment market through a clinical trial targeting major depressive disorder (MDD) patients who do not adequately respond to existing antidepressants.
Bukwang Pharmaceutical announced Tuesday that it has received approval from the Ministry of Food and Drug Safety for a Phase 3 investigational new drug (IND) application to add adjunctive therapy for major depressive disorder as a new indication for Latuda.
The trial will enroll 364 adult patients with major depressive disorder who have shown an insufficient response to monotherapy with existing antidepressants. Researchers will administer lurasidone at doses of 20mg, 40mg, and 60mg once daily for eight weeks as adjunctive therapy and compare the improvement in depressive symptoms against a placebo group.
The primary endpoint is the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS). Secondary endpoints will assess safety and tolerability.
Bukwang expects the trial to offer a new option for depression patients with limited treatment alternatives. "We will be able to provide greater diversity in drug selection for major depressive disorder patients who show insufficient response to existing treatments," a company official said. "We expect this to contribute to expanding treatment opportunities."
The company plans to add the new indication through marketing approval after the trial is completed. The indication expansion is also expected to strengthen Latuda's market competitiveness. Latuda is currently used to treat schizophrenia and bipolar depression, but securing the major depressive disorder indication would broaden its application into the wider depression market.
Latuda is also drawing attention as an atypical antipsychotic with relatively less weight gain burden. According to results from a retrospective observational study presented at the regular academic conference of the Korean Psychiatric Association in February this year, bipolar disorder patients who switched from other treatments to Latuda lost an average of 2.06 kg in body weight after 16 weeks of treatment. Body mass index (BMI), the Hamilton Depression Rating Scale (HAM-D), and Clinical Global Impressions Severity and Improvement scales (CGI-S/I) also showed improvement.
Sales have been growing rapidly. Launched in Korea in August 2024, Latuda recorded 200 million won in sales in its launch year of 2024 before surging to 10.9 billion won last year, surpassing the 10 billion won annual sales mark. First-quarter sales this year totaled 3.3 billion won.
