Takeda Global Research & Development Center announced today that it has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) to market ramelteon (TAK-375), its investigational drug for insomnia.
Ramelteon belongs to a new class of prescription drugs with the first novel mechanism of action to be developed in 35 years in the area of sleep research. Ramelteon specifically targets the MT1 and MT2 receptors in the brain, which are believed to be critical in the regulation of the body's sleep-wake cycle.
"The NDA submission for ramelteon is a significant milestone for Takeda," said John Yates, M.D., president of Takeda Global Research & Development. "Since the discovery of the ramelteon compound by Takeda researchers in 1997, our company has been dedicated to exploring its effects in patients who have difficulty sleeping. This submission is the result of the hard work and dedication of our many employees and partner investigators."