Takeda Pharmaceutical Co. Ltd. (TAK) Suspends Phase 2 Study of TAK-994 Due to a Safety Signal

Takeda Pharmaceutical Company Limited (NYSE: TAK) today announced that a safety signal has emerged in Phase 2 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 2 studies early. This allows for the timely interpretation of the benefit /risk profile of TAK-994 and to determine next steps for the program.

“Ensuring the safety of patients participating in clinical studies is of the utmost importance as we strive to develop transformative medicines. We are grateful to all of the patients, physicians and site staff who participated in these important clinical trials,” said Sarah Sheikh, Head Neuroscience Therapeutic Area Unit at Takeda. “Takeda is committed to bringing innovative, safe and effective treatments to patients with narcolepsy. We are working to quickly assess the totality of available data to inform the further development of TAK-994.”

Takeda is committed to advancing its multi-asset orexin franchise including the oral orexin agonist TAK-861, which is currently in Phase 1 development.

Takeda’s Commitment to Neuroscience

Takeda Neuroscience is driven by the unmet need of patients with neurologic and psychiatric diseases. Our mission is to bring innovative and potentially disease-modifying medicines to these individuals. Our dedication extends beyond our marketed products and research efforts. We are committed to raising awareness for these conditions, building strategic partnerships with both industry and advocacy, educating patients and physicians, and broadening access to therapies.

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