Date: 2011-05-13
Type of information:
phase: 3
Announcement: initiation
Company: Lundbeck (Denmark) Takeda Pharmaceutical Company (Japan)
Product: Lu AA21004
Action
mechanism: Lu AA21004 is an investigational multimodal antidepressant that is thought to work through a combination of two pharmacological modes of action: reuptake inhibition and receptor activity. It functions as a 5-HT(3) and 5-HT(7) receptor antagonist, 5-HT(1A) receptor agonist, 5-HT(1B) receptor partial agonist and inhibitor of the 5-HT transporter.
In preclinical studies it has been demonstrated that Lu AA21004 enhances levels of the neurotransmitters serotonin, noradrenaline, dopamine, acetylcholine and histamine in specific areas of the brain. All of the activities are considered to be of clinical relevance and potentially involved in the mechanism of action of Lu AA21004.
Disease: major depressive disorder (MDD)
Therapeutic area: Mental diseases - CNS diseases
Country:
Trial
details: This randomized, double-blind and multi-center phase III clinical trial is expected to enroll 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.
Latest
news: Lundbeck and Takeda Pharmaceutical Company Limited have announced the initiation of a phase III clinical trial in Japan for LuAA21004 in patients with major depressive disorder (MDD). 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.
