Takeda Suspends Phase 2 Narcolepsy Drug Study Due to “Safety Signal”


Sleep Review

Takeda Pharmaceutical Company Ltd reports that a safety signal has emerged in Phase 2 studies of TAK-994, an oral orexin agonist in the trial for the treatment of excessive daytime sleepiness in patients with type 1 narcolepsy. As an immediate precaution, the company has suspended patient dosing and decided to prematurely end both Phase 2 studies. This enables a timely interpretation of the benefit-risk profile of TAK-994 and the determination of the next steps for the program.

“Ensuring the safety of patients participating in clinical trials is of paramount importance as we strive to develop transformative medicines. We are grateful to all of the patients, doctors and staff at the site who participated in these important clinical trials, ”said Sarah Sheikh, director of neuroscience therapy at Takeda, in a press release. “Takeda is committed to providing innovative, safe and effective treatments for patients with narcolepsy. We are working on quickly assessing all of the available data in order to support the further development of TAK-994. “

In the press release, Takeda stated that it is committed to advancing its multi-asset orexin franchise including the oral orexin agonist TAK-861, which is currently in phase 1 development.

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