# Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder

> **NCT03513549** · — · SUSPENDED · sponsor: **Alexza Pharmaceuticals, Inc.** · enrollment: 10000 (estimated)

## Conditions studied

- Agitation,Psychomotor

## Interventions

- **DRUG:** Loxapine 10 MG

## Key facts

- **NCT ID:** NCT03513549
- **Lead sponsor:** Alexza Pharmaceuticals, Inc.
- **Sponsor class:** UNKNOWN
- **Phase:** —
- **Study type:** OBSERVATIONAL
- **Status:** SUSPENDED
- **Start date:** 2014-11-04
- **Primary completion:** 2027-02
- **Final completion:** 2027-09
- **Target enrollment:** 10000 (ESTIMATED)
- **Why stopped:** Suspended due to low patient enrollment resulting from low commercial usage of Adasuve. Study continuation is impractical. Alexza has been in discussions with FDA on this matter.
- **Last updated:** 2025-10-21

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT03513549

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT03513549, "Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder". Retrieved via AI Analytics 2026-07-05 from https://api.ai-analytics.org/clinical/NCT03513549. Licensed CC0.

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