New Orexin-Like pill could fight extreme daytime sleepiness

NCT ID NCT06812078

Recruiting now Symptom relief Sponsor: Takeda Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

idiopathic hypersomnia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IDIOPATHIC HYPERSOMNIA

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Takeda Site 1
RECRUITING

Montpellier, Hrault, France
Takeda Site 10
RECRUITING

Santa Ana, California, 92705, United States
Takeda Site 11
RECRUITING

Redwood City, California, 94063, United States
Takeda Site 12
RECRUITING

Cincinnati, Ohio, 45245, United States
Takeda Site 13
RECRUITING

Columbia, South Carolina, 29201, United States
Takeda Site 14
RECRUITING

Winter Park, Florida, 32789, United States
Takeda Site 15
RECRUITING

Huntersville, North Carolina, 28078-5082, United States
Takeda Site 16
RECRUITING

Denver, North Carolina, 28037, United States
Takeda Site 17
RECRUITING

Cincinnati, Ohio, 45245, United States
Takeda Site 18
RECRUITING

San Antonio, Texas, 78229, United States
Takeda Site 19
RECRUITING

Brandon, Florida, 33511, United States
Takeda Site 2
RECRUITING

Paris, 75013, France
Takeda Site 20
RECRUITING

Kumamoto, Kumamoto, 862-0954, Japan
Takeda Site 21
RECRUITING

Yodogawa-ku, Osaka-shi, Osaka, 532-0003, Japan
Takeda Site 22
RECRUITING

Kohoku-ku, Yokohama-Shi, Kanagawa, 222-0033, Japan
Takeda Site 23
RECRUITING

Kurume-shi, Fukuoka, 830-0011, Japan
Takeda Site 24
RECRUITING

Bunkyo-ku, Tokyo, 112-0012, Japan
Takeda Site 25
RECRUITING

Fukuoka-Shi Hakata-Ku, Fukuoka, 812-0025, Japan
Takeda Site 26
RECRUITING

Verona, Veneto, Italy
Takeda Site 27
RECRUITING

Colorado Springs, Colorado, 80918, United States
Takeda Site 28
RECRUITING

Norfolk, Virginia, 23507, United States
Takeda Site 29
RECRUITING

St Louis, Missouri, 63123, United States
Takeda Site 3
RECRUITING

Nantes, Pays de Loire, 44093, France
Takeda Site 4
WITHDRAWN

Shatin, Hong Kong
Takeda Site 5
RECRUITING

Bologna, 40139, Italy
Takeda Site 6
RECRUITING

Pozzilli, Isernia, Italy
Takeda Site 7
RECRUITING

Rome, Roma, 00133, Italy
Takeda Site 8
RECRUITING

Madrid, 28043, Spain
Takeda Site 9
RECRUITING

Vitoria-Gasteiz, Alava, 1004, Spain