Bukwang Pharmaceutical said on June 4 that South Korea’s Ministry of Food and Drug Safety has approved a Phase 3 investigational new drug (IND) application to expand the indications of Latuda (generic name: lurasidone), a treatment for schizophrenia and bipolar depression, as an adjunctive therapy for major depressive disorder (MDD).
The clinical trial will enroll 364 adults with major depressive disorder who have not achieved an adequate response to antidepressant monotherapy.
Researchers will evaluate the efficacy of once-daily adjunctive treatment with lurasidone at doses of 20 mg, 40 mg, and 60 mg over eight weeks. The primary endpoint will compare changes from baseline in the Montgomery–Åsberg Depression Rating Scale (MADRS) score against a placebo group. Safety and tolerability will also be assessed.
Bukwang Pharmaceutical expects the indication expansion to broaden treatment options for patients whose depression does not respond sufficiently to existing antidepressant therapies.
Latuda is currently approved for the treatment of schizophrenia and bipolar depression. If the Phase 3 trial is successful and receives regulatory approval, the drug’s market scope will expand to include major depressive disorder.
Meanwhile, Latuda generated $7.9 million in sales in 2025, surpassing the $7 million mark less than a year after receiving regulatory approval in South Korea in 2024. First-quarter 2026 sales totaled $2.4 million.