Takeda pauses TAK-994 clinical studies due to safety glitch

Japan’s largest drugmaker Takeda Pharmaceutical (TYO: 4502) saw its shares fall 6.4% to 3,340 yen this morning, after it revealed that a safety signal has emerged in Phase II studies of TAK-994, an investigational oral orexin agonist.

As an immediate precautionary measure, the company has suspended dosing of patients and has decided to stop both Phase II studies early. This allows for the timely interpretation of the benefit /risk profile of TAK-994 and to determine next steps for the program.

In July this year, the US Food and Drug Administration granted Breakthrough Therapy designation (BTD) to TAK-994, which was being studied for the treatment of excessive daytime sleepiness (EDS) in patients with narcolepsy type 1 (NT1), a chronic neurological disorder that alters the sleep-wake cycle.