New Orexin-Like pill could fight extreme daytime sleepiness
NCT ID NCT06812078
First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times
Summary
This Phase 2 trial tests TAK-360, a drug that mimics the brain chemical orexin, in 96 adults with idiopathic hypersomnia (IH). IH causes severe daytime sleepiness and trouble waking up, even after long sleep. Participants will receive either TAK-360 or a placebo to see if the drug is safe and helps them stay awake.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- TAK-360 (a drug that mimics orexin, a brain chemical that promotes wakefulness)
- What this could lead to
- If it works, this could lead to a new treatment option for people with idiopathic hypersomnia to help them stay awake during the day.
- What could go wrong
- This is an early Phase 2 trial with only 96 participants, so results may not apply to everyone. The drug may cause side effects or prove no better than a placebo.
This is an AI summary of the original study and may miss details. Read our disclaimer.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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Takeda Site 1
RECRUITINGMontpellier, Hrault, France
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Takeda Site 10
RECRUITINGSanta Ana, California, 92705, United States
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Takeda Site 11
RECRUITINGRedwood City, California, 94063, United States
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Takeda Site 12
RECRUITINGCincinnati, Ohio, 45245, United States
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Takeda Site 13
RECRUITINGColumbia, South Carolina, 29201, United States
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Takeda Site 14
RECRUITINGWinter Park, Florida, 32789, United States
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Takeda Site 15
RECRUITINGHuntersville, North Carolina, 28078-5082, United States
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Takeda Site 16
RECRUITINGDenver, North Carolina, 28037, United States
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Takeda Site 17
RECRUITINGCincinnati, Ohio, 45245, United States
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Takeda Site 18
RECRUITINGSan Antonio, Texas, 78229, United States
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Takeda Site 19
RECRUITINGBrandon, Florida, 33511, United States
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Takeda Site 2
RECRUITINGParis, 75013, France
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Takeda Site 20
RECRUITINGKumamoto, Kumamoto, 862-0954, Japan
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Takeda Site 21
RECRUITINGYodogawa-ku, Osaka-shi, Osaka, 532-0003, Japan
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Takeda Site 22
RECRUITINGKohoku-ku, Yokohama-Shi, Kanagawa, 222-0033, Japan
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Takeda Site 23
RECRUITINGKurume-shi, Fukuoka, 830-0011, Japan
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Takeda Site 24
RECRUITINGBunkyo-ku, Tokyo, 112-0012, Japan
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Takeda Site 25
RECRUITINGFukuoka-Shi Hakata-Ku, Fukuoka, 812-0025, Japan
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Takeda Site 26
RECRUITINGVerona, Veneto, Italy
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Takeda Site 27
RECRUITINGColorado Springs, Colorado, 80918, United States
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Takeda Site 28
RECRUITINGNorfolk, Virginia, 23507, United States
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Takeda Site 29
RECRUITINGSt Louis, Missouri, 63123, United States
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Takeda Site 3
RECRUITINGNantes, Pays de Loire, 44093, France
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Takeda Site 4
WITHDRAWNShatin, Hong Kong
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Takeda Site 5
RECRUITINGBologna, 40139, Italy
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Takeda Site 6
RECRUITINGPozzilli, Isernia, Italy
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Takeda Site 7
RECRUITINGRome, Roma, 00133, Italy
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Takeda Site 8
RECRUITINGMadrid, 28043, Spain
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Takeda Site 9
RECRUITINGVitoria-Gasteiz, Alava, 1004, Spain
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- New drug TAK-360 tested for Long-Term safety in sleep disorders