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New drug ORX489 put to the test in healthy adults

NCT ID NCT07413666

Knowledge-focused 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This early-stage study is testing a new drug called ORX489 in 212 healthy adults to see if it is safe and how the body handles it. Participants will receive single or multiple doses, and some will take it with or without food or after sleep deprivation. The goal is to gather safety and drug-level information, not to treat any disease.

Why investors are watching

Centessa Pharmaceuticals plc is running a Phase 1 trial of its experimental drug ORX489 through its subsidiary, Centessa Pharmaceuticals (UK) Limited. The trial tests the drug's safety, tolerability, and how the body processes it in 212 healthy adults. For a small company, this early readout matters because it is the first test of whether the drug is safe enough to keep developing.

If it works: If the trial shows ORX489 is safe and well tolerated, Centessa can move the drug into later-stage studies. That progress could make the company's pipeline look stronger to investors.

If it fails: Phase 1 trials fail often, and a safety problem or poor drug absorption could halt ORX489's development. A delay or negative result would leave Centessa with fewer promising assets and could hurt investor confidence.

AI-written from the trial record. Speculative, and not investment advice.

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 212 people

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

Expected to start

Feb 2026

An estimate. Start dates often move.

Expected to finish

Jun 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 60 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.

Inclusion Criteria: * Healthy males or females as determined by assessments at the Screening Visit. * For Parts A, B, C, and D: Participants must be at least 18 years of age and no more than 60 years of age at the Screening Exclusion Criteria: * 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. * History of seizure disorder, any other condition that increases the risk of seizure * Has a clinically significant sleep disorder, including insomnia or sleep apnea

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As listed by the trial registrant

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

Healthy adult male and female volunteers

How to take part

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

  1. The places running it

    1 site. 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

  • Celerion

    RECRUITING

    Lincoln, Nebraska, 68502, United States

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