Ministry of Food and Drug Safety greenlights Phase 3 trial of Latuda as adjunctive therapy for adults who have not responded to existing antidepressants; company plans to seek a label change after trial completion, targeting the broader depression market beyond schizophrenia and bipolar disorder; the flagship drug surpassed 10 billion won in sales in its first full year and showed weight-loss benefits in a retrospective study after 16 weeks of use

Latuda tablets, approved for the treatment of schizophrenia and bipolar I disorder depression. [Bukwang Pharmaceutical]
Latuda tablets, approved for the treatment of schizophrenia and bipolar I disorder depression. [Bukwang Pharmaceutical]

Latuda (lurasidone), Bukwang Pharmaceutical's flagship drug approved for schizophrenia and bipolar depression, has entered its final clinical stage in a bid to expand its indications to cover major depressive disorder. A successful expansion would open the company's reach into the broader depression market and is expected to add momentum to medium- to long-term earnings growth.

Bukwang Pharmaceutical disclosed Monday that the Ministry of Food and Drug Safety had approved an investigational new drug application for a placebo-controlled Phase 3 trial of Latuda as adjunctive therapy for major depressive disorder. The company had filed the application with the ministry on Dec. 22, 2025.

The Phase 3 trial will enroll 364 adult patients with major depressive disorder who have shown an inadequate response to antidepressant monotherapy. The trial will be conducted at 18 sites across South Korea, including Jeju National University Hospital, and is expected to run for approximately 24 months from the date of approval.

The primary objective is to evaluate the efficacy of lurasidone — administered once daily at doses of 20, 40 or 60 milligrams for eight weeks as adjunctive therapy — by measuring changes from baseline on the Montgomery-Åsberg Depression Rating Scale against placebo. Secondary endpoints include a comprehensive assessment of the drug's safety and tolerability as adjunctive therapy in the same patient population. Upon trial completion, the company plans to file for a label change to add the new indication.

Latuda has been prescribed in the domestic market since receiving approval in 2023. Sales climbed sharply since launch — rising from 200 million won (about $132,000) in 2024 to 10.9 billion won last year, surpassing the 10 billion won mark. The drug recorded 3.3 billion won in sales in the first quarter of this year, keeping its upward trajectory intact.

Academics have taken particular note of Latuda's potential to improve metabolic side effects associated with existing treatments. A retrospective observational study by Kim Young-chan, a professor at Catholic University of Korea's St. Vincent's Hospital, was presented at the Korean Neuropsychiatric Association's regular academic conference in February. It found that switching bipolar disorder patients to Latuda and administering it for 16 weeks produced a statistically significant average weight reduction of 2.06 kilograms — about 2.8 percent — from baseline. The study also documented improvements in body mass index alongside gains across depression symptom scores (HAM-D) and clinical severity indicators (CGI-S/I).

"We expect this to expand treatment opportunities by offering a new therapeutic option for patients with depressive disorder who have not responded to existing treatments," a Bukwang Pharmaceutical official said. "We will strengthen Latuda's market position by extending its indications — currently limited to schizophrenia and bipolar disorder — into the depression market."


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