Long-term safety study of a new bipolar mania treatment

Plain-English translation of NCT06929273 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated July 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This trial is testing a medication called to see how safe it is when used over the long term for treating manic episodes in people with bipolar-I disorder. The study will follow patients for an extended period to carefully monitor how well the medication is tolerated and whether any side effects emerge over time. This is a later-stage trial (Phase 3) to confirm findings from earlier research.

While earlier studies showed promise that this medication could help control manic symptoms, doctors need to understand how safe it is when people take it for months or longer. This trial fills that gap by carefully tracking side effects and safety over an extended period.

Do you qualify?

You likely qualify if…

you have been diagnosed with bipolar-I disorder with current manic or mixed manic symptoms
you are experiencing moderate to severe manic symptoms (based on standardized symptom rating scales)
you either completed an earlier KarXT study OR you are newly diagnosed and meet the study's symptom criteria
you are not currently hospitalized for acute mania or at high risk of needing emergency hospitalization
you are willing to take the study medication and attend regular visits to monitor your health

You likely don't qualify if…

you have had thoughts of harming yourself or have attempted suicide recently
you have other serious psychiatric conditions (other than mild anxiety) in addition to bipolar-I disorder
you have a history of severe constipation, bowel problems, difficulty urinating, or certain eye conditions that could be worsened by this medication
you have used drugs or alcohol heavily in the past year or are currently using them
you experience very rapid mood cycling (four or more separate mood episodes per year)

What participation looks like

If you join this study, you will take the medication regularly as prescribed and attend clinic visits regularly so doctors can check your health and monitor for any side effects. The study lasts several months, and you'll have blood tests, psychiatric symptom assessments, and physical exams at different visits. You may be continuing from an earlier trial, or you may be new to this study — either way, the goal is to help researchers understand whether this treatment is safe for long-term use in mania.

AI-generated summary from trial data · Jul 2, 2026 · Not medical advice

Trial locations(174 sites)

United States

Local Institution - 0120, Glendale, Arizona

Pillar Clinical Research - Richardson, Bentonville, Arkansas

Pillar Clinical Research- Little Rock, Little Rock, Arkansas

Woodland International Research Group, Little Rock, Arkansas

Woodland Research Northwest, Rogers, Arkansas