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# Takeda Pharma Stops 2 TAK-994 Studies
- URL: https://www.fdaweb.com/takeda-pharma-stops-2-tak-994-studies/
- Published: 2021-10-06T12:00:00.000Z
- Updated: 2026-09-14T17:17:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150312

An unexpected safety signal has led Takeda Pharmaceutical Co. to halt two Phase 2 studies of TAK-994, an investigational oral orexin agonist for treating narcolepsy. Without providing any details of the safety concern, Takeda says that stopping the trials “allows for the timely interpretation of the benefit/risk profile of TAK-994 and to determine next steps for the program.”

In July, FDA granted the therapy a breakthrough designation for a Phase 2 trial for excessive daytime sleepiness in patients with narcolepsy Type 1, a chronic neurological disorder that alters the sleep-wake cycle, according to the company.

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