Shionogi files NDA in Japan for zuranolone in MDD

27 September 2024

Japanese drugmaker Shionogi (TYO: 4507) said today that it has submitted a New Drug Application (NDA) in Japan for zuranolone, a treatment in development for major depressive disorder (MDD).

Through a strategic collaboration with Sage Therapeutics (Nasdaq: SAGE), Shionogi has been granted exclusive development and commercialization rights in Japan, Taiwan, and South Korea. The NDA submission is based on data from the Phase III program conducted by Shionogi in Japan.

The news comes just as Biogen (Nasdaq: BIIB) announced it was pulling out of a collaboration on zuranolone with Sage, following the recent failure of the drug in a Phase II study for the treatment of essential tremor.

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