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New Orexin-Like pill could fight extreme daytime sleepiness

NCT ID NCT06812078

Symptom relief Sponsor: Takeda Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 96 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. The participant weighs greater than or equal to (≥) 40 kilograms (kg) and has a body mass index (BMI) between 16 and 38 kilograms per meter square (kg/m\^2) \[inclusive\]. 2. The participant has a documented, current diagnosis of IH. Key Exclusion Criteria: 1. The participant has a current medical disorder associated with excessive daytime sleepiness (EDS) \[other than IH\]. 2. The participant has medically significant thyroid disease. 3. The participant has a history of cancer in the past 5 years. (This exclusion does not apply to participants with carcinoma in situ \[such as basal cell carcinoma\] that has been treated and is stable, or who have been stable without further treatment. These participants may be included after approval by the medical monitor.) 4. The participant has any of the following viral infections based on a positive test result: Hepatitis B surface antigen (at screening), hepatitis C virus antibody (at screening), human immunodeficiency virus (HIV) antibody/antigen (at screening). 5. The participant has a clinically significant history of head injury or head trauma. 6. The participant has history of epilepsy, seizure, or convulsion (exception for a single febrile seizure in childhood). 7. The participant has a history of cerebral ischemia, transient ischemic attack (less than \[\<\]5 years from screening), intracranial aneurysm, or arteriovenous malformation.

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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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 5 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    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

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