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bepotastine besilate (Talion OD)

✓ Approved

Mitsubishi Tanabe Pharma Corporation · HRH1 · Small Molecule

What is bepotastine besilate?

bepotastine besilate is a small molecule developed by Mitsubishi Tanabe Pharma Corporation. It is approved for therapeutic indications via oral (po).

Drug Profile

Brand NamesTalion OD
CompanyMitsubishi Tanabe Pharma Corporation
Drug ClassSmall Molecule
Molecular TargetHRH1
RouteOral (PO)
StatusApproved
Sources: ClinicalTrials.gov, Mitsubishi Tanabe Pharma Corporation

Mechanism of Action

Molecular Targets

bepotastine besilate acts on 1 molecular target:

HRH1histamine receptor H1 (HH1R, H1R)
Want deeper analysis?Noah AI can explain complex mechanisms and compare to similar drugs.

Therapeutic Indications

bepotastine besilate is developed for 4 unique indications across 3 therapeutic areas.

Therapeutic AreaConditionPhase
Immune system disordersHypersensitivity✓ Approved
Skin and subcutaneous tissue disordersPruritus✓ Approved
Respiratory, thoracic and mediastinal disordersRhinitis allergic✓ Approved
Skin and subcutaneous tissue disordersUrticaria✓ Approved

Related Research Articles

PubMedTrials2026-10-14

Evaluating sedation efficacy and perioperative safety of fospropofol disodium versus propofol in elderly patients undergoing elective TURP: study protocol for a randomized controlled trial.

Sui Hongyuan H, Wu Tong T, Gao Lijuan L, He Qingying Q et al.

Fospropofol disodium is the first novel water-soluble propofol prodrug in China. After administration, it is mainly converted to propofol by alkaline phosphatase on the surface of endothelial cells to exert its pharmacological effects. Compared with propofol, fospropofol disodium has the characteristics of longer duration of action, lower incidence of injection pain and adverse events related to the respiratory and circulatory systems, and no adverse reactions related to lipid metabolism. At present, there are few reports on the safety and efficacy of fospropofol disodium in the induction and maintenance of general anesthesia. Therefore, this study aims to evaluate the safety and efficacy of fospropofol disodium in routine anesthesia for elective surgery in the elderly, so as to provide new medication guidance for its application in the induction and maintenance stages of general anesthesia in the elderly population. Seventy elderly patients aged 65-85 years with American Society of Anesthesiologists (ASA) physical status II or III, scheduled for elective transurethral resection of the prostate under general anesthesia, will be enrolled. Patients will be randomly divided into the propofol group (group E) and the fospropofol disodium group (group F) using a random number table, with 35 cases in each group. Anesthesia induction: sufentanil 0.2-0.4 µg/kg and cisatracurium besilate 0.15 mg/kg will be administered intravenously. Group E will receive an intravenous bolus of propofol 1-1.5 mg/kg, while group F will receive an intravenous bolus of fospropofol disodium 10-15 mg/kg, both infused within 60 s. Tracheal intubation will be performed when the patient's Modified Observer's Assessment of Alertness/Sedation (MOAA/S) score decreases to 1 with BIS < 60 sustained for ≥3 min, followed by routine mechanical ventilation. For anesthesia maintenance, group E will receive continuous intravenous infusion of propofol 4-12 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump; group F will receive continuous intravenous infusion of fospropofol disodium 10-20 mg/(kg·h) and remifentanil 0.2-0.4 µg/(kg·min) via a syringe pump. During the operation, the infusion rates of maintenance anesthetics will be adjusted according to hemodynamic status to maintain blood pressure and heart rate fluctuations within 20% of the baseline values, and the Bispectral Index (BIS) value will be maintained between 40 and 60. After the operation, patients will be transferred to the post-anesthesia care unit (PACU). Primary outcomes of this study: success rate of sedation and time to onset of sedation. (1) perioperative indicators, (2) hemodynamic indices at each time point, (3) adverse reactions. Elderly patients undergoing transurethral resection of the prostate (TURP) are often complicated with multiple comorbidities, leading to a relatively high anesthetic risk. This trial takes the success rate of sedation and time to onset of sedation as the primary endpoints, to compare the application differences between fospropofol disodium and propofol. The aim of this study is to evaluate the safety and efficacy of fospropofol disodium in routine anesthesia for elective surgeries in the elderly population. The study was registered at the Chinese Clinical Trials Registry (ChiCTR2500115343) on December 24, 2025 ( http://www.chictr.org.cn/showproj.html?proj=294899 ).

PMID 42870298
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PubMedClinical pharmacology in drug development2026-10-09

Pharmacokinetic and Bioequivalence of Mirtazapine Orally Disintegrating Tablets: A Randomized, Crossover Study.

Liew Kai Bin KB, Yee Kar Ming KM, Nalaiya Jeyashanthini J, Amran Atiqah A et al.

The study aimed to assess the bioequivalence of a new generic orally disintegrating tablet (ODT) formulation containing mirtazapine 30 mg with the reference formulation, and to support biowaiver for an additional 15 mg strength. Fifty-five healthy Malaysian males completed an open-label, balanced, randomized, 2-treatment, 2-period, single oral dose study with a 14-day washout period under fasting conditions. Each participant received a single 30 mg dose of mirtazapine test or reference ODT. Plasma concentrations of mirtazapine up to 72 h post-dose were quantified using a validated high-performance liquid chromatography-tandem mass spectrometry detection method following a liquid-liquid extraction. Non-compartmental analysis was used to derive the pharmacokinetic parameters, which were then compared between the test and reference formulations using a multivariate analysis of variance. The pharmacokinetic parameters of the test formulation were not statistically different from the reference formulation. The 90% confidence intervals of mirtazapine for AUC0-72 and Cmax concentration were within 80%-125% based on the bioequivalence acceptance range criteria. The test and reference formulations of mirtazapine 30 mg ODT are bioequivalent and well tolerated under fasting conditions. These findings support the extrapolation of bioequivalence and the justification of a biowaiver for the additional mirtazapine ODT 15 mg strength.

PMID 42850927
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PubMedComputer methods in biomechanics and biomedical engineering2026-10-09

Comparing Maximally Collapsing Metric Learning and Optimized Tunable Q-Wavelet Transform for Schizophrenia Identification Using EEG Signals.

Djemili Rafik R

Electroencephalography (EEG) is a noninvasive technique for recording brain electrical activity and supporting the assessment of psychiatric disorders. This study proposes a framework for distinguishing individuals with Schizophrenia (SZ) from healthy subjects using EEG data. The approach employs a transformer based on Maximally Collapsing Metric Learning (MCML) applied to feature-vector matrices and compares it with optimized Tunable Q-Wavelet Transform (TQWT) decomposition. Eight nonlinear features are extracted from both approaches and evaluated using *k*-Nearest Neighbor (*k*-NN), Optimized Decision Tree (ODT), and Deep Neural Network (DNN) classifiers. Results achieve accuracies of 100%, 99.94%, and 99.91%, respectively, using one electrode channel.

PMID 42854099
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PubMedTransfusion2026-10-07

No difference in alloimmunization of pregnant adults with sickle cell disease exposed to chronic versus on-demand transfusions: A two-center retrospective cohort study.

Zarka Clare C, Daniel David D, Menon Vinal V, Choupa Sacha S et al.

Pregnant people with sickle cell disease (SCD) experience high morbidity and mortality, even when RBC transfusion is safe and available. There is a lack of consensus on transfusion use partly due to concern for alloimmunization. This study examined alloimmunization in SCD pregnancies managed with chronic transfusion therapy (CTT) versus on-demand transfusion (ODT). A secondary aim was to quantify the proportion of SCD pregnancies that met guideline indications for CTT that received CTT in pregnancy. This is a two-center, retrospective study of pregnancy in SCD over two decades. We compared alloimmunization between those who received CTT versus ODT by examining the Sickle Cell Pregnancy and Reproductive Knowledge Syndicate database. A secondary analysis applied American Society of Hematology (2020) and/or British Society for Haematology (2021) criteria for CTT in pregnancy to calculate guideline compliance. Among 145 subjects, 26 received CTT and 119 received ODT. Alloimmunization incidence was 4%, with no significant difference by transfusion group (1/26 CTT vs. 5/119 ODT, p = 1.0). Five ODT subjects became alloimmunized (5/46). One CTT subject was alloimmunized (1/26) after receiving an unplanned ODT. Of all pregnancies, 87% met ASH criteria and 65% met BSH criteria for CTT, while 20% received CTT. For patients with SCD in pregnancy, CTT may not pose a greater alloimmunization risk than ODT. CTT may be underutilized for SCD in pregnancy. Our study is limited by incomplete data and variable antigen matching practices. Prospective research will help establish the appropriate role of CTT in SCD pregnancies.

PMID 42841532
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PubMedApplied optics2026-10-06

Refractive index gradient tomography for defect detection.

Ali Nauman N, Wang Wenjian W, Winnik Julianna J, Xiong Zihan Z et al.

Optical diffraction tomography (ODT) can measure the three-dimensional refractive index (RI) distribution of a sample, but it suffers from phase wrapping issues when imaging the 3D RI of thick or defective samples. Herein, we propose and demonstrate a 3D RI gradient optical tomography (RI-GOT) approach for 3D defect detection in optical elements, such as optical lenses. RI-GOT is implemented by recording holograms as a sample is rotated and reconstructing a 3D RI gradient map by back-projection of 2D phase gradient distributions at different angles. RI-GOT was demonstrated by defect detection in a mobile phone lens, providing accurate information on both defect locations and profiles. We envisage that the proposed technique will act as an effective approach for 3D defect detection in optical elements.

PMID 42837564
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PubMedThe World Allergy Organization journal2026-10-04

Long-term prophylactic treatment and related real-world outcomes of patients with hereditary angioedema in Germany: A retrospective analysis of German claims and medical chart data.

Greve Jens J, Picker Nils N, Jülich Fabian F, Donatz Verena V et al.

Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent swelling episodes that are potentially life threating and substantially impair quality of life. This study aimed to generate real-world evidence on the utilization of long-term prophylaxis (LTP), residual disease burden, and economic outcomes among patients with HAE in Germany. This retrospective cohort study examined LTP patterns and associated real-world outcomes using 2 anonymized German statutory health insurance datasets (AOK PLUS and GWQ) and a medical chart review (MCR) from 1 specialized HAE center. Claims datasets included patients initiating LTP between 2019 and 2023. The MCR provided complementary clinical information and was used to assess the plausibility of prescription-based estimates for attack frequency. Outcomes included LTP treatment sequences, HAE attacks requiring on-demand treatment (ODT), healthcare resource utilization and direct cost. Across the claims datasets, 77 patients initiated first-line LTP: 30 (39.0%) with intravenous C1 esterase inhibitors (C1INH IV), 24 (31.2%) with lanadelumab, 16 (20.8%) with subcutaneous C1INH, and 7 (9.1%) with berotralstat. During follow-up, 27 patients (35.1%) switched therapy, most commonly from C1INH IV to lanadelumab. Despite prophylaxis, 64% of patients experienced at least 1 HAE attack requiring ODT, while 36% remained attack-free during the first year after LTP start. Median time to first treated attack ranged from 114 to 132 days. Prescription-based attack estimates were generally consistent with physician-documented attack frequencies but tended to yield slightly higher attack rates. Annual healthcare costs were driven primarily by outpatient medications, averaging €233,190 and €206,392 per person-year in the AOK PLUS and GWQ cohorts, respectively. This study provides real-world evidence on LTP use in Germany and demonstrates that a substantial proportion of patients continues to experience treated attacks despite prophylaxis. These findings highlight the importance of ongoing monitoring, individualized treatment optimization, and continued access to ODT.

PMID 42827716
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