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AS

asenapine maleate (HP 3070 / HP3070 / Secuado)

✓ Approved

Hisamitsu · DRD1 · Small Molecule

What is asenapine maleate?

asenapine maleate is a small molecule developed by Hisamitsu. It is approved for therapeutic indications via transdermal.

Drug Profile

Brand NamesHP 3070, HP3070, Secuado
CompanyHisamitsu
Drug ClassSmall Molecule
Molecular TargetDRD1, DRD2, HTR2A
RouteTransdermal
StatusApproved
Sources: ClinicalTrials.gov, Hisamitsu

Mechanism of Action

Molecular Targets

asenapine maleate acts on 3 molecular targets:

DRD1dopamine receptor D1 (DADR, D1R)
DRD2dopamine receptor D2 (D2DR, D2R)
HTR2A5-hydroxytryptamine receptor 2A (5-HT2A, HTR2)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

asenapine maleate is developed for 2 unique indications across 1 therapeutic area.

Therapeutic AreaConditionPhase
Psychiatric disordersSchizophrenia✓ Approved
Psychiatric disordersBipolar disorderPhase I

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PubMedJournal of Korean medical science2026-10-13

Superior Efficacy of Besifovir in Reducing Hepatocellular Carcinoma Risk Compared to Tenofovir in Chronic Hepatitis B Patients: A Nationwide Cohort Study.

Shin Yoon E YE, Kim Jae Young JY, Kim Hyuk H, Yoo Jeong-Ju JJ et al.

Besifovir dipivoxil maleate (BSV) is a novel therapeutic option for the treatment of chronic hepatitis B (CHB). However, its long-term effectiveness in reducing the risk of hepatocellular carcinoma (HCC) remains unclear. We conducted a retrospective cohort study using the Korean Health Insurance Review and Assessment Service database from 2018 to 2022. A total of 32,383 patients with CHB were included (BSV, n = 2,358; tenofovir disoproxil fumarate [TDF], n = 30,025). Propensity score matching was conducted at a 1:3 ratio to minimize selection bias. The primary outcome was the incidence of HCC, with cirrhosis development as the secondary endpoint. In the overall population, 57 cases of HCC were reported in the BSV group (2,358 individuals, 5,918 person-years), while 1,268 cases of HCC were reported in the TDF group (30,025 individuals, 83,587 person-years). After propensity score matching, the incidence of HCC was significantly lower in the BSV group (9.63 per 1,000 person-years; 95% confidence interval [CI], 7.43-12.49) than in the TDF group (15.36 per 1,000 person-years; 95% CI, 13.72-17.18), with an incidence rate ratio of 1.59 (P = 0.001). This protective effect remained consistent in both cirrhotic (hazard ratio [HR], 1.609; P = 0.028) and non-cirrhotic subgroups (HR, 1.831; P = 0.002). BSV treatment demonstrated superior efficacy in reducing the risk of HCC compared to TDF, regardless of baseline cirrhosis status. These findings suggest that BSV may provide enhanced protection against HCC in patients with CHB.

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PubMedRevista peruana de medicina experimental y salud publica2026-10-13

Hampi Tariki Kit: thin-layer chromatography for semiquantitative screening of solid oral medicines in Peru.

Mónico-Rosales Gladys M GM, Mostacero-Rodríguez Fredy R FR, Quispe-Paitán B Rosa BR, Rodríguez-Calzado E Javier EJ et al.

To develop and validate rapid thin-layer chromatography (TLC) methods integrated into the Hampi Tariki kit for the semiquantitative screening of active pharmaceutical ingredients (APIs) in oral solid medications marketed in Peru. Eight TLC methods were developed and validated for tablets and capsules containing acyclovir, dicloxacillin, dimenhydrinate, ibuprofen, diclofenac sodium, paracetamol, norfloxacin, phenazopyridine hydrochloride, chlorphenamine maleate, and phenylephrine hydrochloride. Fifty-seven commercial samples available in the national market, from different manufacturing laboratories, including branded and generic products previously verified as compliant by official methods at the Centro Nacional de Control de Calidad (CNCC) of the Instituto Nacional de Salud (INS), were evaluated. Silica gel 60 F254 plates, reference standards, and analytical grade solvents were used. Validation was performed according to ICH Q2(R1) guideline, evaluating selectivity, linearity, precision, accuracy, visual detection limit, and robustness. The methods allowed for visual and densitometric differentiation of levels equivalent to 80%, 100%, and 120% of the declared content. Retention factor (Rf ) values were between 0.20 and 0.85, and multicomponent formulations presented chromatographic resolution ≥1.0. Correlation coefficients were greater than 0.99 for system and method linearity; repeatability showed coefficients of variation less than 3.0%, intermediate precision less than 5.0%, and bias against high-performance liquid chromatography (HPLC) remained within the ±3.00% range. Deliberate variations evaluated in robustness did not produce significant changes in Rf values. The developed methods demonstrated adequate analytical performance as rapid semiquantitative screening tests. Integrated into the Hampi Tariki kit, they constitute a proposal with potential to support the preliminary identification of suspicious samples and prioritize their confirmation by HPLC or other official methods.

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PubMedBulletin of environmental contamination and toxicology2026-10-12

Biochemical, Genotoxic and Somatic responses of Oreochromis Niloticus Exposed to Enalapril Maleate in Water.

da Silva Allana Kiara Peretti AKP, Colaço Otávio Augusto Wolff OAW, Mannes Yorrannys Y, Ramsdorf Wanessa Algarte WA

Pharmaceutical residues are increasingly detected in aquatic environments; however, information regarding the ecotoxicological effects of antihypertensive drugs such as enalapril maleate remains limited, particularly in fish. This study aimed to evaluate the effects of aqueous exposure to EM on somatic, biochemical, and genotoxic biomarkers in Oreochromis niloticus under controlled laboratory conditions. A 21-day subchronic bioassay was conducted using fish exposed to EM-contaminated water at nominal concentrations of 100, 500, 1000, and 2000 µg/L, alongside a control group. Genotoxic effects were evaluated using the comet assay and micronucleus test, while biochemical biomarkers - including acetylcholinesterase, catalase, glutathione S-transferase, and lipid peroxidation - were assessed to investigate oxidative stress and potential neurotoxicity. Somatic condition was also analyzed as an indicator of overall organism health. The results demonstrated genotoxic effects, evidenced by DNA damage. Biochemical analyses revealed alterations consistent with oxidative stress and potential neurotoxic responses, while somatic indices showed minor but detectable health changes. Although the observed damage levels were relatively low, these findings indicate that continuous exposure to EM and its byproducts can induce sublethal physiological disturbances with potential long-term consequences for aquatic organisms. Overall, this study highlights the relevance of ecotoxicological monitoring of EM in aquatic systems. The observed biological responses underscore its potential ecological risk, and future studies should incorporate preliminary stability assessments and evaluate long-term effects and degradation products to better understand the environmental impact of this antihypertensive drug.

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PubMedJournal of affective disorders2026-09-30

Pharmacological interventions for acute major depression and bipolar depression with mixed features: A systematic review and dose-related network meta-analysis across different age groups.

Fornaro Michele M, Di Lorenzo Chiara C, Nunez Nicolas N, Singh Balwinder B et al.

Acute mixed bipolar/major depression is relatively frequent, yet quantitative information about its pharmacological management is relatively scant, warranting network meta-analysis (NMA) of comparative efficacy/response/acceptability of pharmacological interventions accounting for dose effects across different age groups. We searched PubMed/MEDLINE/Embase/Web of Science/Scopus (from database inception to 2026.05.25) for randomized controlled trials (RCTs) comparing pharmacological interventions with each other or placebo in patients with acute major depression/bipolar depression with mixed features. Co-primary outcomes were the change in depressive symptoms and response. Tolerability, acceptability, and change in manic symptoms were secondary outcomes. Confidence-In-Network-Meta-Analysis was appraised. 22 studies assessed 5241 acute mixed bipolar depressed participants, whereas 13 studies encompassed 1852 acute mixed major depression patients. Sensitivity analyses, including those retaining low-risk-of-bias studies only, and excluding outliers for possible effect modifiers, indicated that asenapine-15 mg/day (SMD = -0.54; 95%C.I. = -1.06; -0.02), lurasidone-60 mg/day (SMD = -0.43; 95%C.I. = -0.72, -0.14), lurasidone-80 mg/day (SMD = -0.39; 95%C.I. = -0.55, -0.23) outperformed placebo for depressive symptoms reduction in bipolar patients. Lurasidone-60 mg/day (SMD = -0.43; 95%C.I. = -0.72, -0.14), lurasidone-80 mg/day (SMD = -0.38; 95%C.I. = -0.59, -0.17) outperformed placebo for bipolar children and adolescents. Lurasidone-40 mg/day (SMD = -0.80; 95% C.I. = -0.95, -0.65) outperformed placebo for major depression. Cariprazine-1.5 mg/day (RR = 1.23; 95%C.I. = 1.01, 1.51), cariprazine-3 mg/day (RR = 1.32; 95%C.I. = 1.08, 1.60), lurasidone-80 mg/day (RR = 1.36; 95%C.I. = 1.14, 1.63), olanzapine-12.5 mg/day (RR = 1.63; 95%C.I. = 1.07, 2.51), olanzapine-6 mg/day+fluoxetine-50 mg/day (RR = 2.61; 95%C.I. = 1.60, 4.39) outperformed placebo response in bipolar samples. Lumateperone-42 mg/day (RR = 1.61; 95%C.I. = 1.20; 2.18) outperformed placebo for major depression response. Quetiapine-530 mg/day in augmentation to mood stabilizers led to a significantly higher number of dropouts in bipolar patients than placebo. Meta-regression of the AMSTAR-Plus content score against efficacy and response measures showed that larger effect sizes (SMDs/logRRs) were associated with lower AMSTAR scores, reflecting lower study quality. Our findings are consistent with previous NMAs and current guidelines, yet they expand knowledge by concurrently appraising different drugs, doses, and age groups, and the quality of the evidence.

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PubMedInternational journal of pharmaceutics2026-09-29

Ionic liquid self-assembly enables high-loading inhalable delivery of remdesivir.

Akram Alaa A, Kutkat Omnia O, Gomaa Mokhtar M, Aboulhoda Basma Emad BE et al.

Clinical use of remdesivir (RDV), the first FDA-approved antiviral for COVID-19 treatment, is limited by poor aqueous solubility and intravenous administration. In this study, an inhalable dry powder (IDP) based on hyaluronic acid (HA)-coated cholinium ionic liquid (IL)-core liposomes (HA-CAGE-Lp@IDP) was developed to overcome these limitations. Two ILs, cholinium maleate (CAME) and cholinium geranate (CAGE), markedly enhanced RDV solubility. Mechanistic studies revealed distinct IL localization within liposomes, with CAME predominantly dissolved in the aqueous core, whereas CAGE self-assembled into an IL-rich dense core that enabled superior RDV solubilization and loading (30% w/w). The optimized HA-coated CAGE liposomes were lyophilized into an IDP that preserved nanoparticle integrity. HA-CAGE-Lp@IDP exhibited favorable powder flowability (Hausner's ratio = 1.08) and aerodynamic properties suitable for deep lung deposition (FPF = 53.5%; MMAD = 2.99 µm). The formulation retained potent anti-SARS-CoV-2 activity in vitro with excellent cytocompatibility (selectivity index = 296.87). In a SARS-CoV-2 hamster model, inhaled HA-CAGE-Lp@IDP achieved rapid viral suppression comparable to marketed RDV, with approximately 99% inhibition of viral replication in the lungs and trachea and marked histopathological improvement. These findings establish HA-coated IL-core liposomes as a promising inhalable platform for localized pulmonary RDV delivery and outpatient antiviral therapy.

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PubMedPharmaceutics2026-09-26

Human Factors and Device Engineering in OTC Intranasal Drug Delivery: GentleMist Technology™.

Alas-Pineda César C, Pavón-Varela Dennis J DJ, Gaitán-Zambrano Kristhel K, Coto-Tejeda Carlos C et al.

Intranasal drug delivery is noninvasive, rapid-acting, and well suited to self-administration, yet the real-world performance of nasal sprays depends on the interaction among formulation, device mechanics, nasal anatomy, and user technique rather than on the active ingredient alone. This narrative review examines how aerosol science, regional targeting, and human factors jointly shape intranasal performance, using GentleMist Technology™ as a representative example of emerging device-centered development. Computational fluid dynamics (CFD) and anatomically informed in vitro models indicate that device geometry, plume characteristics, and administration angle can significantly alter where a dose is deposited, while human factors research identifies priming, positioning, and angulation as key determinants of successful over-the-counter (OTC) use. We summarize early feasibility data suggesting that angle-optimized administration may increase posterior nasopharyngeal delivery and that essential tasks are feasible for lay users, with priming emerging as a specific usability vulnerability. We also review preliminary clinical evidence on a chlorpheniramine maleate (CPM)-based intranasal formulation in allergic rhinitis and viral upper respiratory illness. Although the strongest device-specific findings remain preliminary and require independent replication, they support an emerging shift from a formulation-centered model toward an integrated device-formulation-user paradigm.

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