TAK-360 for narcolepsy
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What is TAK-360 for narcolepsy?
TAK-360 is an experimental oral therapy being developed by Takeda Pharmaceuticals for the treatment of type 2 narcolepsy.
People with narcolepsy experience excessive sleepiness during the day because the brain can’t properly regulate sleep-wake transitions. In type 1 narcolepsy, this is related to a profound loss of the wake-promoting signaling molecule orexin, while people with type 2 narcolepsy generally have normal orexin levels.
TAK-360 is designed to mimic orexin’s effects by binding to and activating the receptor proteins that orexin normally interacts with. By further boosting orexin signaling, the therapy is expected to help combat sleepiness in people with narcolepsy.
While oveporexton (TAK-861) is designed for people with low orexin levels (type 1 narcolepsy), TAK-360 is specifically designed to interact with orexin receptors in ways that offer a more optimal safety-to-efficacy ratio for individuals with normal levels of natural orexin.
TAK-360 has received fast track designation in the U.S., a status intended to expedite its development and regulatory review. It is also being developed for the treatment of idiopathic hypersomnia, another sleep disorder.
Therapy snapshot
| Treatment name | TAK-360 |
| Administration | Oral tablets |
| Clinical testing | Currently in Phase 2 testing |
How will TAK-360Â be administered in narcolepsy?
In a Phase 2 trial involving people with narcolepsy, TAK-360 is being administered as oral tablets.
TAK-360 in narcolepsy clinical trials
The ongoing Phase 2 KYRA trial (NCT06952699) is evaluating the safety and preliminary efficacy of TAK-360 in adults with type 2 narcolepsy. The study will enroll about 88 participants, who will be randomly assigned to receive TAK-360 or a placebo for a month.
The study’s main goal is to evaluate the treatment’s safety. Secondary goals include subjective and objective measures of daytime sleepiness. The study is expected to conclude this year.
TAK-360 side effects
A Phase 2 clinical trial testing TAK-360 in people with narcolepsy is still ongoing, so its side effect profile in this patient population is not yet known. More will be known about the side effects of TAK-360 when additional clinical trial data are available.
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