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New pill aims to tame manic episodes in bipolar disorder

NCT ID NCT07288320

Symptom relief Sponsor: Neurocrine Biosciences 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests an experimental drug called NBI-1117568 for adults with bipolar I disorder who are hospitalized for a manic episode. Half of the 150 participants will get the drug, half a placebo, to see if it safely reduces manic symptoms over 21 days. The goal is to find a new treatment option for acute mania.

What this could mean

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

Active substance
NBI-1117568
What this could lead to
If successful, this could lead to a new medication to quickly reduce manic symptoms in bipolar I disorder.
What could go wrong
This is an early Phase 2 trial with only 150 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 150 people

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

Started

Dec 2025

Expected to finish

Feb 2028

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.

Key Inclusion Criteria: * Participant has a primary diagnosis of bipolar I disorder. * The participant has had at least 1 prior documented manic episode that required treatment. * The participant is experiencing an acute manic episode or manic episode with mixed features, with or without psychotic symptoms. Key Exclusion Criteria: * Any unstable or poorly controlled medical condition or chronic disease (including history of neurological, hepatic, renal, cardiovascular, gastrointestinal, pulmonary, autoimmune, or endocrine disease that may affect study participation or results), or malignancy within 90 days before the start of screening. * Primary diagnosis is not bipolar I disorder. * History of clozapine treatment for treatment-resistant psychosis. * History of psychiatric hospitalization(s) for ≥30 consecutive days during the 90 days before the start of screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Mania

As listed by the trial registrant

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

Bipolar I disorder Mania

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

    9 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

  • Neurocrine Clinical Site

    RECRUITING

    Little Rock, Arkansas, 72211, United States

  • Neurocrine Clinical Site

    RECRUITING

    Garden Grove, California, 92845, United States

  • Neurocrine Clinical Site

    RECRUITING

    San Diego, California, 92123, United States

  • Neurocrine Clinical Site

    RECRUITING

    Hollywood, Florida, 33024, United States

  • Neurocrine Clinical Site

    RECRUITING

    Atlanta, Georgia, 30331, United States

  • Neurocrine Clinical Site

    RECRUITING

    Gaithersburg, Maryland, 20877, United States

  • Neurocrine Clinical Site

    RECRUITING

    Marlton, New Jersey, 08053, United States

  • Neurocrine Clinical Site

    RECRUITING

    Staten Island, New York, 10314, United States

  • Neurocrine Clinical Site

    RECRUITING

    Austin, Texas, 78754, United States

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