NDAINHALATIONPOWDER
Approved
Dec 2012
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
4
Data completeness
4/8 — Partial
ADASUVE (loxapine) by Teva is clinical pharmacology pharmacodynamics: pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. First approved in 2012.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADASUVE is an inhaled powder formulation of loxapine, an antipsychotic agent used for acute agitation in patients with schizophrenia or bipolar disorder. The drug works by modulating subcortical inhibitory areas, producing calming effects and suppression of aggressive behavior with onset within 20–30 minutes. Loxapine is rapidly absorbed, distributed to brain and other tissues, and extensively metabolized with primary excretion within 24 hours.
LOE Approaching4mo to LOE
With loss of exclusivity approaching in late 2026, the brand team faces significant commercial headwinds and likely operates with a lean, defensive workforce focused on market maintenance rather than expansion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacodynamics: Pharmacologically, loxapine is an antipsychotic for which the exact mode of action has not been established. However, changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species in association with such…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (4)
A Study of Staccato Loxapine (ADASUVE®) for Inhalation
Started Dec 2019
150 enrolled
Psychomotor AgitationSchizophreniaBipolar Disorder
Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting
Started Sep 2016
323 enrolled
Agitation
Naturalistic Adasuve Clinical Trial Study
Started Apr 2016
100 enrolled
Agitation
Study to Assess the Safety and Pharmacokinetics of ADASUVE® at Doses of 2.5, 5, or 10 mg in Children and Adolescents (10 Through 17 Years of Age) With Any Condition Warranting Chronic Use of an Antipsychotic Medication
Started Jul 2014
30 enrolled
BiPolar
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.