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loxapine (Adasuve / loxapine, Staccato / AZ004)

✓ Approved

Teva Pharmaceutical Industries Ltd. · DRD2 · Small Molecule

What is loxapine?

loxapine is a small molecule developed by Teva Pharmaceutical Industries Ltd.. It is approved for therapeutic indications via inhaled.

Drug Profile

Brand NamesAdasuve, loxapine, Staccato, AZ004
CompanyTeva Pharmaceutical Industries Ltd.
Drug ClassSmall Molecule
Molecular TargetDRD2
RouteInhaled
StatusApproved
Sources: ClinicalTrials.gov, Teva Pharmaceutical Industries Ltd.

Mechanism of Action

Molecular Targets

loxapine acts on 1 molecular target:

DRD2dopamine receptor D2 (D2DR, D2R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

loxapine is developed for 1 unique indication across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersAgitation✓ Approved

Related Research Articles

PubMedComprehensive psychiatry2026-05-08

Real-world effectiveness of antipsychotic polytherapy on rehospitalization in psychotic disorders: A French nationwide cohort analysis.

Llorca Pierre-Michel PM, Falissard Bruno B, Baloche Emmanuelle E, Bournane Riad R et al.

Antipsychotic polytherapy (APP) is common in clinical practice for psychotic disorders. Previous studies suggest that APP may offer advantages over monotherapy (APM) regarding effectiveness and all-cause discontinuation. This nationwide study assessed the reproducibility and robustness of these findings. The primary objective was to compare psychiatric readmission rates between APP and APM in psychotic disorder patients METHODS: Data were extracted from the French National Health insurance database (SNDS). Patients aged 18 or older with at least one psychiatric hospitalization between 1 January 2014 and 31 December 2020 were included. The primary outcome was time to psychiatric readmission. A within-individual study design was applied to limit confounding, by comparing periods with different treatment exposures within the same patient FINDINGS: A total of 234,959 adults with at least one hospitalization for a psychotic condition were included, with a median follow-up of 7 years. Antipsychotic treatment was associated with a (20%-50%) reduction in psychiatric readmission risk compared with no treatment. Rehospitalization remained common (71.6%). The median cumulative rehospitalization duration was 67 days, and 21.8% of patients had more than four admissions. Among the 71.1% exposed to APP, several combinations demonstrated distinct benefits. Clozapine-inclusive combinations (with risperidone or amisulpride) and loxapine-amisulpride combinations reduced rehospitalization risk. Quetiapine combinations also lowered risk by (10%- 20%) compared with quetiapine monotherapy INTERPRETATION: Derived from a large cohort, our findings corroborate previous evidence that APP's benefit reduces psychiatric rehospitalization and support its utility for psychotic specific patient subpopulations. This study confirms the reproducibility and robustness of APP's effectiveness in real-world settings.

PMID 42096968
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PubMedCurrent neuropharmacology2026-04-20

Potassium Channelopathies and Precision Medicine Approaches in Epilepsy: A Systematic Review of Personalized Treatment Strategies.

Xie Changning C, Yin Fei F, Kessi Miriam M, Peng Jing J

This systematic review aimed to summarize recent progress in precision medicine for all studied potassium gene variants related to epilepsy. It analyzed studies conducted in cell and animal models and in humans. A comprehensive search was conducted on PubMed, Embase, and Cochrane databases for all years up to 2025. Approximately 2257 papers were reviewed, but only 60 met the inclusion criteria: KCNT1 [n = 38], KCNQ2 [n = 10], KCNQ5 [n = 1], KCNB1 [n = 1], KCNA2 [n = 3], KCNA1 [n = 2], KCNA3 [n = 1], KCNT2 [n = 2], and KCNC1 [n = 2]. Therapies that appear effective for some patients with KCNT1 variants include quinidine, cannabidiol, fluoxetine, and carvedilol. Potential treatments supported by cell and/or animal models include bepridil and antisense oligonucleotide therapy. There is currently no precision therapy for KCNT2 variants; however, potential treatments supported by cell model evidence include quinidine, fluoxetine, loxapine, and riluzole. Emerging potential therapies for KCNQ2-related epilepsy include ezogabine, gabapentin, retigabine, donepezil, amitriptyline, linopirdine, pynegabine, SF0034, and XEN1101. Retigabine and gabapentin are potential therapies for KCNQ5 variants. Cannabidiol is a potential therapy for KCNB1 variants. 4-Aminopyridine is useful for KCNA1 and KCNA2 variants. Gapmer antisense oligonucleotides are a potential treatment for KCNA2 variants. Fluoxetine is a potential therapy for KCNA3 variants. Fluoxetine and compound RE01 are the potential therapies for KCNC1 variants. These studies collectively offer valuable insights into precision medicines for genetic epilepsy caused by pathogenic potassium variants. This review is essential because it informs clinical decision-making, including the selection of antiepileptic drugs, thereby supporting its integration into routine clinical care for this population. However, the low level of evidence and the heterogeneity of data from the included studies limit the review.

PMID 42003125
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PubMedToxicology and applied pharmacology2026-03-30

Effects of music on hepatic cytochrome P450 1A enzymes in Sprague Dawley rats.

Shalaby Ali H AH, Adhiya Jinal J, Al-Dajani Ala'A R AR, El-Mahrouk Sara R SR et al.

The cytochrome P450 (CYP) 1A subfamily, regulated by the aryl hydrocarbon receptor (AhR), is central to the bioactivation or deactivation of xenobiotics, endogenous substrates, and carcinogens. Music can alter hormonal and neurotransmitter concentrations, which are partly regulated by CYP-dependent pathways. This study investigated whether defined musical elements modulate hepatic CYP1A in male and female Sprague-Dawley rats. Animals were exposed for 24 h to music containing variations of rhythm, tempo, and harmony. Of all conditions tested, fast-tempo, irregular-rhythm, and atonal-harmony (FT-IR-AH) produced the greatest increases in hepatic CYP1A1 (7-ethoxyresorufin O-deethylase) and CYP1A2 (7-methoxyresorufin O-demethylase) activities. In the combined-sex cohort, FT-IR-AH music increased CYP1A1 maximum velocity (Vmax) and intrinsic clearance (CLint) by 3.2- and 3.1-fold, respectively, and increased CYP1A2 Vmax and CLint by 1.9- and 1.8-fold, respectively, without altering enzyme affinities. FT-IR-AH also increased CYP1A1 protein expression by 1.9-fold in females and 2.6-fold in males, and CYP1A2 by 1.6-fold and 1.7-fold, respectively, with concordant elevations in mRNA levels. Replication of the same music elements across different music composers yielded consistent findings, with variations in effects potentially attributed to percentages of gaps (i.e., staccato) and frequency patterns. Selective induction of AhR-regulated genes in the absence of nuclear factor erythroid 2-related factor 2-dependent antioxidant gene activation suggests that FT-IR-AH music selectively engages AhR signaling without a generalized oxidative stress response. These data identify specific music features as an external stimulus capable of modulating CYP1A expression and function, with potential implications for therapeutic responses, toxicological effects, and drug interactions.

PMID 41905667
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PubMedPediatric nephrology (Berlin, Germany)2026-03-20

Uroflowmetric characteristics of children with non-neurogenic voiding dysfunction: a large single-center cohort.

Ozbakir Cagla C, Pehlivan Zorlu Betül B, Gullu Duygu D, Cankorur Osman Orkun OO et al.

Uroflowmetry is a non-invasive test that measures changes in urinary flow rate over time and facilitates the recognition of lower urinary tract dysfunction. Most pediatric uroflowmetry studies have been conducted in healthy children to construct nomograms. This study aimed to evaluate the uroflowmetric parameters of children with non-neurogenic voiding dysfunction in a tertiary pediatric hospital. This single-center retrospective study included children aged 5-18 years with lower urinary tract symptoms who underwent uroflowmetry and pelvic floor electromyography (EMG) and met predefined functional criteria, while those with neurogenic bladder, anatomical obstruction, or neurological disorders were excluded. Uroflowmetric parameters were compared according to sex, age groups, and voiding patterns. A total of 1152 patients (median age: 9 years; 61.8% female) were included. Normal voiding patterns were observed in 64.3% of patients, followed by plateau (21.5%), staccato (7.6%), tower-shaped (3.6%), and interrupted (3.0%) patterns. Plateau patterns were more common in males, while tower-shaped patterns predominated in females (p < 0.001). Females had higher Qmax and voided volume than males (p < 0.001 and p = 0.003, respectively), whereas no difference was observed in post-void residual urine (p > 0.05). Qmax was lower in plateau and staccato patterns but higher in tower-shaped patterns (all p < 0.001). Post-void residual urine was significantly higher in staccato and interrupted patterns (p = 0.001 and p < 0.001, respectively). Uroflowmetric parameters in children with non-neurogenic voiding dysfunction differ according to sex, age, and voiding pattern. Recognition of these differences may facilitate early identification of high-risk subgroups and support the development of more targeted diagnostic and therapeutic strategies.

PMID 41857422
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PubMedPulmonary pharmacology & therapeutics2026-02-27

Pulmonary safety of Staccato alprazolam in healthy participants and participants with mild asthma: Phase 1, randomized, double-blind, placebo-controlled trial.

Miller S David SD, LaForce Craig F CF, Barlow Laura L, Watanabe Shikiko S et al.

Staccato alprazolam (STAP) is a hand-held device that can provide rapid systemic delivery of alprazolam via pulmonary inhalation. UP0099/NCT04802746, a phase 1, randomized, double-blind, placebo-controlled trial, evaluated pulmonary safety of two consecutive doses of STAP administered 72 h apart (days 1, 4). Part A evaluated STAP 1 mg and 2 mg vs. placebo in a three-way crossover design in healthy adults. Part B evaluated STAP 2 mg vs. placebo in a two-arm parallel-group design in adults with mild asthma. In Part A (n = 30 randomized) on day 1, mean change from baseline in forced expiratory volume in 1 s (FEV1) showed a statistically significant decrease vs. placebo at 5 min postdose for STAP 1 mg and 5/20 min for STAP 2 mg. On day 4, there were no statistically significant negative changes from baseline in FEV1. Respiratory treatment-emergent adverse events (TEAEs) were reported by 8/29 and 12/29 participants on STAP 1 mg/2 mg, respectively (day 1), and 8/29 and 9/28 (day 4) (placebo: 0). In Part B (n = 25 placebo, n = 23 STAP) on days 1 and 4, mean change from baseline in FEV1 showed a statistically significant decrease for STAP 2 mg vs. placebo at 5/20 min and 6 h postdose. Respiratory TEAEs were reported by 16/23 participants on STAP 2 mg on day 1, 15/22 on day 4 (placebo: 0). Most respiratory TEAEs were mild in intensity. No evidence of clinically relevant airway obstruction or respiratory TEAEs indicative of bronchospasm with STAP were observed. Two doses of STAP (1 mg/2 mg) administered 72 h apart were well tolerated in healthy participants and those with mild asthma.

PMID 41747804
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PubMedL'Encephale2026-02-19

Coprescription of antipsychotics and benzodiazepines at hospital discharge.

Demourgues Maxime M, Richaud Alexandre A, Thiec Julie J, Debruyne Anne-Laure AL et al.

Antipsychotics and benzodiazepines (BZD) are known to increase the risk of sedation, dizziness, cognitive impairment and even confusion when used in combination because of their psycholeptic properties. Antipsychotics and BZD coprescription should therefore be minor at discharge from a psychiatric hospital, especially for conventional sedative antipsychotics (CS-AP), such as cyamemazine, levomepromazine, or loxapine which are often used as adjunctive treatments like BZD. The primary objective was to investigate the prevalence of prescription of CS-AP, long-term antipsychotics (LT-AP), and BZD among patients discharged from hospitalization in psychiatry. The secondary objective was to assess factors associated with CS-AP and BZD coprescription. A retrospective study was conducted by collecting all discharge prescriptions from patients discharged from a psychiatric hospital in 2022 and 2023. To assess prevalence, antipsychotic and BZD use was registered when at least one medication from these classes was prescribed at discharge. Multivariate logistic regression analysis was used to assess factors associated with CS-AP and BZD coprescription. Sensitivity analyses were performed to corroborate our results. In total, 5,733 psychiatric stays were associated with prescribed medications at discharge, corresponding to 4,131 different patients. Mean age was 39.8 (±18.7) years. Women represented 56.3% of the studied population. The prevalence of psychotropic drugs on discharge prescriptions was 38.7% for CS-AP, 69.1% for LT-AP, and 48.3% for BZD. The most prescribed drugs, respectively for CS-AP, LT-AP, and BZD, were cyamemazine (24.3% of prescriptions), aripiprazole (16.2%), and diazepam (24.7%). Prevalence of CS-AP+BZD and CS-AP+LT-AP+BZD coprescriptions was respectively 14.8% and 10.1%. After adjustment for age, sex, mode of admission, length of stay class, and prescription of at least one LT-AP at discharge, the CS-AP+BZD coprescription at discharge was associated with two factors: length of hospital stay≤14 days and an initial admission to a psychiatric emergency department (aOR: 1.35, 95% CI [1.14; 1.59], and aOR: 1.23, 95% CI [1.05; 1.45], respectively). Sensitivity analyses showed a similar trend, although results were not always statistically significant. Our results highlight the importance of an effective hospital-to-community care transition to optimize psycholeptic treatments and minimize the risk of adverse drug reactions in outpatient settings. Cyamemazine was the most prescribed CS-AP at discharge, probably due to its anxiolytic properties. This trend raises concerns regarding its appropriateness when combined with other anxiolytic treatments, such as BZD. The association between CS-AP+BZD coprescription and length of stay<14 days shows that the short hospitalization may hinder proper adaptation of pharmacological treatments. The association between CS-AP+BZD coprescription and initial admission to a psychiatric emergency department may reflect insufficient re-evaluation of the coprescribed drugs probably introduced during acute crisis management. However, our study has several limitations, including reliance on our classification of CS-AP and BZD, and lack of data on key confounders such as diagnoses, seriousness of the acute episode, prior treatments, and post-discharge care. Prevalence of CS-AP with BZD is high at discharge from a psychiatric hospital, especially in patients with short hospital stays (≤14 days).

PMID 41708357
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