In the trial, the companies will investigate the safety of Lu AA21004 (5 and 10 mg) compared to placebo.
The primary endpoint of the Phase III trial is the change of MADRS total score from baseline after eight weeks.
Takeda Pharmaceutical and H Lundbeck will recruit around 360 subjects in the trial.
The previous studies conducted outside Japan have demonstrated positive results and has established the efficacy and the tolerability profile of Lu AA21004.
Lundbeck and Takeda will continuously work in collaboration to develop Lu AA21004 in order to provide the drug as soon as possible as a novel treatment with patients suffering from depression.