TAK-994 was discovered by Takeda's laboratory in Shonan, Japan. It is part of the Open Innovation Center of Shonan Health Innovation Park and is the main product candidate for Takeda's pioneering multi-asset orexin-focused franchise. This BTD marks an important milestone in Takeda's accelerated development efforts to bring this important potential therapy to NT1 patients.
The FDA granted TAK-994 BTD, partly based on early and preliminary clinical data. These data indicate that in NT1 patients, TAK-994 can significantly improve the objective and subjective measurement results of daytime wakefulness. Currently, TAK-994 is undergoing a phase 2 study (TAK-994-1501). The data from the completed Phase 2 study will be announced at a future scientific conference after the conclusion of the study is reached.
Sarah Sheikh, head of Takeda's neuroscience treatment field, said: “Patients with narcolepsy type 1 have excessive daytime sleepiness, which may mean that they often fall asleep at work or school. If approved, TAK-994 has the potential to change our current treatment of NT1. The way to solve the problem of internal orexin deficiency at the core of the disease. Orexin plays a key role in regulating the sleep-wake cycle of the human body, and supports the pathways in the brain that promote the body's natural wakefulness."
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