Real-World safety check for agitation inhaler

NCT ID NCT03513549

Terminated Knowledge-focused Sponsor: Alexza Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study observes the safety of ADASUVE (loxapine inhalation) in up to 10,000 adults with agitation from schizophrenia or bipolar I disorder. It tracks side effects in real-world emergency or inpatient settings. The study is observational, meaning no new treatment is given—just monitoring of routine use. It is currently suspended.

What this could mean

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

Active substance: Loxapine (ADASUVE inhalation powder)
What this could lead to: If successful, this study could confirm that ADASUVE is safe for real-world use, supporting its continued availability for calming agitation in emergencies.
What could go wrong: This is an observational study, not a controlled trial, so it cannot prove effectiveness. The study is currently suspended, and results may be delayed or incomplete.

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Conditions

The condition(s) this trial relates to.

bipolar I disorder Psychomotor Agitation schizophrenia

As listed by the trial registrant

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

AGITATION,PSYCHOMOTOR

Contacts and locations

Locations

Pharmaceutical Research Associates, Inc

Raleigh, North Carolina, 27612, United States

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