New sleepiness drug ORX142 enters first human tests

NCT ID NCT07082829

Symptom relief Sponsor: Centessa Pharmaceuticals (UK) Limited Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called ORX142 in healthy adults and older adults to see if it is safe and how the body processes it. The study also looks at how food affects the drug and whether it can improve alertness in people who are sleep-deprived. About 208 participants will take either ORX142 or a placebo.

What this could mean

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

Active substance: ORX142 tablets
What this could lead to: If successful, this could lead to a new treatment option for people with excessive daytime sleepiness.
What could go wrong: This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if ORX142 will actually help with sleepiness. The study is small and in healthy volunteers, not patients.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 208 people

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

Started

Jun 2025

Expected to finish

Jun 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 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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. Healthy males or females as determined by assessments at the Screening Visit. For Parts A, B, C, and E: a. Participants must be at least 18 years of age and no more than 55 years of age at the Screening 2. For Part D: a .Participants must be at least 60 years of age and no more than 80 years of age at the Screening Key Exclusion Criteria: 1. Presence of significant cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, malignancy, endocrine, neurological, or psychiatric disease, as determined by medical history, physical examination, and screening investigations. 2. History of seizure disorder, any other condition that increases the risk of seizure 3. Has a clinically significant sleep disorder, including insomnia or sleep apnea.

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Conditions

The condition(s) this trial relates to.

Disorders of Excessive Somnolence hypersomnia

As listed by the trial registrant

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

Excessive daytime sleepiness

How to take part

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

The places running it

3 sites. The list below names each one and where it is.
The official record

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

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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.

New sleepiness drug ORX142 enters first human tests

What the study statuses mean