ADASUVE (loxapine) · NOVA PNEUMA
Loxapine capsules are indicated for the treatment of schizophrenia. Its efficacy was established in clinical trials involving acutely ill subjects across both newly hospitalized and chronically hospitalized populations. (Note: If the intended drug is the brand ADASUVE, the indication is specifically for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults).
How ADASUVE Works
Loxapine is a dibenzoxazepine antipsychotic. Although its exact mechanism of action is not fully understood, it is thought to mediate its antipsychotic effects through high-affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors. It also demonstrates affinity for noradrenergic, histaminergic, and cholinergic receptors, which contributes to its side effect profile.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-21
- Patent Cliff
- 2026
- Routes
- INHALATION
- Dosage Forms
- POWDER
ADASUVE Approval History
What ADASUVE Treats
1 indicationsADASUVE is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
ADASUVE Boxed Warning
BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, particularly in patients with lung diseases ( 4 , 5.1 ) ADASUVE is available only through a restricted program called the ADASUVE REMS ( 5.2 )...
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, particularly in patients with lung diseases ( 4 , 5.1 ) ADASUVE is available only through a restricted program called the ADASUVE REMS ( 5.2 ) Administer ADASUVE only in a certified healthcare setting that has immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate medical attention. Certified healthcare settings must have a short-acting bronchodilator available for the immediate treatment of bronchospasm ( 5.1 , 5.2 ) Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. ADASUVE is not approved for the treatment of patients with dementia-related psychosis ( 5.3 ) Bronchospasm ADASUVE can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest, particularly in patients with lung diseases. Administer ADASUVE only in a certified healthcare setting that has immediate access on site to supplies and healthcare professionals competent in the management of acute bronchospasm and access to emergency assistance for symptoms that require immediate medical attention [see Warnings and Precautions (5.1 , 5.2) ] . Certified healthcare settings must have a short-acting bronchodilator (e.g. albuterol) available for the immediate treatment of bronchospasm; this short-acting bronchodilator can be delivered by inhaler (with spacer) or nebulizer. Prior to administering ADASUVE, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and assess
ADASUVE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to ADASUVE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
3 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02820519 LOX2015PILOT | LOX_2015_PILOT 2014-005440-17 | Ph 2 | terminated | Tolerability and Analgesic Efficacy of Loxapine in Patients With Refractory, Chemotherapy-induced Neuropathic Pain |
| NCT03110900 loxapine results posted | 206292 | Ph 4 | terminated | Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation |
| NCT01193816 Sevralox | P 070106 | Ph 4 | completed | Loxapine in the Management of Restlessness During Mechanical Ventilation Weaning |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ADASUVE FDA Label Details
Indications & Usage
FDA Label (PDF)ADASUVE is indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults [see Clinical Studies ] . ADASUVE is an atypical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults . Limitations of Use: ADASUVE must be administered only in a certified healthcare setting . Limitations of Use: As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in a certified healthcare setting [see Warnings and Precautions ] .
WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. ADASUVE can cause bronchospasm that has the...
ADASUVE Patents & Exclusivity
Patents (1 active)
Pro Intelligence Preview
Deep insights for ADASUVE
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2026
- • 1 active patents
Trial Analysis
- • 4 total trials
- • Stage: Mature
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment