Bukwang Pharmaceutical announced that its antipsychotic drug Latuda (active ingredient: lurasidone) has received approval from South Korea’s Ministry of Food and Drug Safety to proceed with a Phase 3 clinical trial aimed at expanding its indication to adjunctive treatment for major depressive disorder (MDD).
The planned study will enroll 364 adult patients who show an insufficient response to standard antidepressant monotherapy. In the trial, Latuda will be administered as an adjunct therapy at doses of 20 mg, 40 mg, and 60 mg once daily over an 8-week period. The primary endpoint will evaluate changes from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) compared with placebo, while secondary endpoints will assess safety and tolerability in the same patient population.
Latuda is currently approved for the treatment of schizophrenia and bipolar disorder. If the ongoing trial succeeds, its indication could be expanded into the major depressive disorder space, potentially positioning the drug as a broader psychiatric treatment option, particularly for patients with inadequate response to existing antidepressant therapies.
Industry observers note that such an expansion could significantly reshape prescribing patterns in psychiatry, as adjunctive antipsychotic therapies are increasingly used to address treatment-resistant depression. A successful outcome may also strengthen Latuda’s competitive positioning in the growing central nervous system (CNS) drug market.
Launched following regulatory approval in August 2024, Latuda has shown early commercial traction, recording sales of KRW 200 million in 2024, KRW 10.9 billion in 2025, and KRW 3.3 billion in the first quarter of the current year. Analysts suggest that approval of the additional indication could materially accelerate revenue growth by expanding the eligible patient population and driving prescription uptake.
