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ADASUVE®
ADASUVE is a loxapine inhalation powder that blocks dopamine receptors in the brain to rapidly reduce agitation.
ADASUVE is a loxapine inhalation powder that blocks dopamine receptors in the brain to rapidly reduce agitation. Used for Acute agitation associated with schizophrenia or bipolar disorder.
At a glance
| Generic name | ADASUVE® |
|---|---|
| Also known as | STACCATO® Loxapine for Inhalation, Loxapine |
| Sponsor | Teva Branded Pharmaceutical Products R&D, Inc. |
| Drug class | Typical antipsychotic (dopamine antagonist) |
| Target | Dopamine D1 and D2 receptors |
| Modality | Small molecule |
| Therapeutic area | Psychiatry / Behavioral Health |
| Phase | Phase 2 |
Mechanism of action
Loxapine is a typical antipsychotic that antagonizes dopamine D1 and D2 receptors, producing rapid sedation and behavioral calming when inhaled. The inhalation route allows for faster onset compared to oral formulations, making it suitable for acute agitation management in clinical settings.
Approved indications
- Acute agitation associated with schizophrenia or bipolar disorder
Common side effects
- Sedation
- Dysarthria
- Throat irritation
- Bronchospasm
- Extrapyramidal symptoms
Key clinical trials
- Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
- Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg (PHASE1)
- 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 (PHASE1)
- Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting (PHASE4)
- A Study of Staccato Loxapine (ADASUVE®) for Inhalation (PHASE3)
- Staccato Loxapine Thorough QT/QTc Study (PHASE1)
- Staccato Loxapine Pulmonary Safety in Healthy Volunteers (PHASE1)
- Staccato Prochlorperazine Thorough QT/QTc (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- ADASUVE® CI brief — competitive landscape report
- ADASUVE® updates RSS · CI watch RSS
- Teva Branded Pharmaceutical Products R&D, Inc. portfolio CI