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New narcolepsy pill mimics Brain's Wake-Up signal in major trial

NCT ID NCT07598708

Symptom relief Sponsor: Centessa Pharmaceuticals (UK) Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 9 times

Summary

This study tests an experimental drug called cleminorexton in 222 adults with narcolepsy type 1 or 2. The drug mimics a natural brain protein that helps keep people awake. The goal is to see if it safely reduces daytime sleepiness and improves daily functioning. Participants must stop their current narcolepsy medications during the trial.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 222 people

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

Started

May 2026

Expected to finish

Dec 2027

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: * 18-70 years of age * Body Mass Index (BMI) within the range ≥ 17.0 and ≤ 45 kg/m\^2 (inclusive) * Meets the diagnostic criteria of Narcolepsy Type 1 (NT1) or Type 2 (NT2) according to International Classification of Sleep Disorders, 3rd edition, Text Revision edition (ICSD-3-TR) criteria * Is willing and able to discontinue all medications used for the treatment of narcolepsy * Is willing and able to adhere to additional protocol requirements Key Exclusion Criteria: * Medical disorder other than NT1 or NT2, that is associated with excessive daytime sleepiness (EDS) * Presence of significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological or psychiatric disease

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Conditions

The condition(s) this trial relates to.

Cataplexy Disorders of Excessive Somnolence Dyssomnias narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome nervous system disorder psychiatric disorder sleep-wake disorder Sleepiness

As listed by the trial registrant

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

Narcolepsy type 1 Narcolepsy type 2

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

    20 sites. 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

  • Atlanta, Georgia

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Austin, Texas

    RECRUITING

    Austin, Texas, 78731, United States

  • Birmingham, Alabama

    RECRUITING

    Birmingham, Alabama, 35213, United States

  • Brandon, Florida

    RECRUITING

    Brandon, Florida, 33511, United States

  • Cincinnati, Ohio

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Colorado Springs, Colorado

    RECRUITING

    Colorado Springs, Colorado, 80918, United States

  • Columbia, South Carolina

    RECRUITING

    Columbia, South Carolina, 29201, United States

  • Dallas, Texas

    RECRUITING

    Dallas, Texas, 75251, United States

  • Denver, North Carolina

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Dublin, Ohio

    RECRUITING

    Dublin, Ohio, 43017, United States

  • Flowood Mississippi

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Huntersville, North Carolina

    RECRUITING

    Huntersville, North Carolina, 28078, United States

  • Miami Lakes, Florida

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33155, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33166, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33176, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33186, United States

  • Orlando, Florida

    RECRUITING

    Orlando, Florida, 32807, United States

  • San Antonio, Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Sugar Land, Texas

    RECRUITING

    Sugar Land, Texas, 77478, United States

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