Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
A Postmarketing Observational Study to Evaluate the Safety of ADASUVE® (STACCATO® Loxapine for Inhalation) in Patients With Agitation Associated With Schizophrenia or Bipolar I Disorder
Sponsor: Alexza Pharmaceuticals, Inc.
Suspended
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.
This observational or N/A phase trial investigates Agitation,Psychomotor and is currently suspended. Alexza Pharmaceuticals, Inc. leads this study, which shows 9 recorded versions since 2014 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
9 versions recorded-
Feb 2026 — Present [monthly]
Suspended
-
Nov 2025 — Feb 2026 [monthly]
Suspended
Status: Unknown → Suspended
-
Sep 2024 — Nov 2025 [monthly]
Unknown
-
Jul 2024 — Sep 2024 [monthly]
Unknown
Status: Unknown Status → Unknown
-
Nov 2022 — Jul 2024 [monthly]
Unknown Status
Status: Recruiting → Unknown Status
▶ Show 4 earlier versions
-
Jan 2021 — Nov 2022 [monthly]
Recruiting
-
Nov 2020 — Jan 2021 [monthly]
Recruiting
-
Aug 2019 — Nov 2020 [monthly]
Recruiting
-
Jun 2018 — Aug 2019 [monthly]
Recruiting
First recorded
Nov 2014
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Alexza Pharmaceuticals, Inc.
- Pharmaceutical Research Associates
For direct contact, visit the study record on ClinicalTrials.gov .