Latuda Adjunctive Therapy for MDD Phase 3 IND Approved, Expansion of Indication Expected
BUKWANG PHARMACEUTICAL confirmed on June 2, 2026 that the MFDS approved its Phase 3 IND for Latuda (lurasidone) as adjunctive therapy for Major Depressive Disorder (MDD).
The trial enrolls 364 adult patients with inadequate response to existing antidepressants, randomized to daily lurasidone (20/40/60mg) or placebo for 8 weeks in a double-blind, multicenter design.
Primary endpoint: change in MADRS score from baseline; secondary endpoints: safety and tolerability. Estimated duration ~24 months (may extend based on enrollment rate).
Latuda, approved as a new drug in 2023, aims to expand its label to include MDD adjunctive therapy, offering more treatment options.
Per the disclosure, the statistical probability of final drug approval is approximately 10%. Failure may lead to changes or abandonment of commercialization plans, as warned.
[AI Summary]The Phase 3 IND approval for Latuda's MDD indication is a positive step for long-term growth, but given the low success probability (≈10%) and lengthy trial period (>2 years), the stock's upside may be limited to short-term momentum, requiring cautious investment risk assessment.
KOSPI Filing Information
Filing: Investment Decision-Related Major Management Matters (Approval of Phase 3 Clinical Trial Plan (IND) for Additional Indication of Latuda)