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New sleep disorder drug ORX750 tested for Long-Term safety

NCT ID NCT07096674

Disease control 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is a long-term follow-up for people with narcolepsy or idiopathic hypersomnia who previously took the experimental drug ORX750. Researchers want to see if the drug remains safe and effective over time. About 90 participants will take ORX750 orally and be monitored for side effects and symptom control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ORX750 (oral drug)
What this could lead to
If successful, this could provide a long-term treatment option to help manage excessive daytime sleepiness and improve daily functioning for people with narcolepsy or idiopathic hypersomnia.
What could go wrong
This is an early-phase, open-label extension study with no placebo group, so results may not confirm effectiveness. Side effects or lack of sustained benefit could limit its use.

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 90 people

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

Started

Aug 2025

Expected to finish

Apr 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 65 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.

Inclusion Criteria: * Diagnosis of narcolepsy (NT1 or NT2) or IH who was eligible for and completed the full treatment period in the eligible parent study ORX750-0201 (CRYSTAL-1) * Is willing and able to adhere to additional protocol requirements Exclusion Criteria: * Development of any new disease/disorder that in the opinion of the investigator would make the participant unable to continue the study * Unable to refrain from excluded medications, including those used for treatment of narcolepsy or idiopathic hypersomnia

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence idiopathic hypersomnia narcolepsy narcolepsy without cataplexy narcolepsy-cataplexy syndrome

As listed by the trial registrant

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

Idiopathic hypersomnia 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 places running it

    24 sites in 4 countries. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Abington, Pennsylvania

    RECRUITING

    Abington, Pennsylvania, 19046, United States

  • Atlanta, Georgia

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Auburn, alabama

    RECRUITING

    Auburn, Alabama, 36832, United States

  • Austin, Texas

    RECRUITING

    Austin, Texas, 30328, United States

  • Bologna

    RECRUITING

    Bologna, BO, 40139, Italy

  • Cincinnati, Ohio

    RECRUITING

    Cincinnati, Ohio, 45245, United States

  • Denver, North Carolina

    RECRUITING

    Denver, North Carolina, 28037, United States

  • Dublin

    RECRUITING

    Dublin, Ohio, 43017, United States

  • El Paso, Texas

    RECRUITING

    El Paso, Texas, 79912, United States

  • Hendersen, Navada

    RECRUITING

    Henderson, Nevada, 89052, United States

  • Henderson, Nevada

    RECRUITING

    Henderson, Nevada, 89052, United States

  • Huntersville, North Carolina

    RECRUITING

    Huntersville, North Carolina, 28070, United States

  • Miami, Florida

    RECRUITING

    Miami, Florida, 33176, United States

  • Móstoles, Madrid

    RECRUITING

    Móstoles, Madrid, 28938, Spain

  • North Charleston, South Carolina

    RECRUITING

    North Charleston, South Carolina, 29406-9196, United States

  • Orlando, Florida

    RECRUITING

    Orlando, Florida, 32807, United States

  • Santa Ana, California

    RECRUITING

    Santa Ana, California, 92705, United States

  • Sterling Heights, Michigan

    RECRUITING

    Sterling Heights, Michigan, 48314, United States

  • Stockbridge, GA

    RECRUITING

    Atlanta, Georgia, 30281, United States

  • Toronto

    RECRUITING

    Toronto, Ontario, M5S 3A3, Canada

  • Verona

    RECRUITING

    Verona, VR, 37134, Italy

  • Willow Grove, Pennsylvania

    RECRUITING

    Willow Grove, Pennsylvania, 19090, United States

  • Winter Park, FL

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Álava, Spain

    RECRUITING

    Álava, 01004, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.