Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Takeda Pharmaceutical and H Lundbeck have started a randomized, double-blind and multi-center Phase III clinical trial in Japan to investigate Lu AA21004 in patients who are suffering from major depressive disorder (MDD).
Subscribe to our email newsletter
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.