- The clinical phase III development programme for Lu AA21004 now startet in Japan
- Approximately 360 patients with MDD is expected to be enrolled
- The study is expected to be concluded in about 1.5 years
H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Company Limited (Takeda) today announced the initiation of a phase III clinical trial in Japan for Lu AA21004 in patients with major depressive disorder (MDD).
This randomised, double-blind and multi-centre phase III clinical trial is expected to enrol approximately 360 patients with MDD and will evaluate the efficacy and safety of Lu AA21004 (5 and 10 mg) compared to placebo. Primary endpoint is change of MADRS total score from baseline after eight weeks.
Lu AA21004 is a structurally novel compound that is different from currently available antidepressants. Data from clinical trials conducted outside Japan have shown encouraging results for the potential efficacy and the tolerability profile of Lu AA21004. In addition to the Japanese study, the ongoing clinical trial programme includes four ongoing short-term studies and two long-term safety studies.
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.