bilastine / Generic mfg. - LARVOL DELTA

Skin Rash Following Initiation of Methimazole Therapy: A Diagnostic and Management Challenge in Graves’ Disease (ETA 2026) - "Treatment with methimazole, propranolol and insulin were initiated, and the patient was subsequently followed in the endocrinology clinic with progressive adjustment of insulin and methimazole dosages...Suspecting a hypersensitivity reaction to methimazole, treatment was switched to propylthiouracil until October 2025. During this period, she reported persistent pruritus without maculopapular lesions, leading to the switch back to methimazole with concomitant therapy with bilastine... Chronic spontaneous urticaria is commonly linked to underlying autoimmune conditions, particularly autoimmune thyroid disease, and may resemble antithyroid drug hypersensitivity, complicating the management of Graves disease. Therefore, the onset of urticaria after starting antithyroid drug therapy should not be automatically interpreted as drug hypersensitivity, and alternative diagnoses should be considered. This case emphasizes the importance of a multidisciplinary approach to ensure..."

Chronic Spontaneous Urticaria • Dermatology • Diabetes • Endocrine Disorders • Grave’s Disease • Immunology • Metabolic Disorders • Pruritus • Urticaria

Montelukast and Bilastine Combination Therapy in Allergic Rhinitis: A Narrative Review of Evidence. (PubMed, Cureus) - "Although combined bilastine and montelukast therapy is supported by growing clinical evidence, data on their comparative effectiveness against other commercially available AR treatments remain limited. Further research is needed to establish optimal treatment strategies and long-term safety."

Journal • Review • Allergic Rhinitis • Anesthesia • Immunology • Inflammation • Otorhinolaryngology

Second-generation H1 antihistamines for the treatment of chronic urticaria: a network meta-analysis. (PubMed, Front Med (Lausanne)) - "To evaluate the efficacy and safety of 10 commonly used second-generation H1 antihistamines (cetirizine, levocetirizine, loratadine, desloratadine, ebastine, bilastine, olopatadine, rupatadine, fexofenadine, and mizolastine) at licensed doses in treating chronic urticaria using network meta-analysis. In addition, fexofenadine had the lowest incidence of adverse reactions. However, the conclusions of this study still need to be validated by further high-quality randomized controlled trials."

Journal • Retrospective data • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Exogenous coreactant-free electrochemiluminescence sensing of antihistamine bilastine by harnessing electrode deactivation driven luminescence enhancement. (PubMed, Biosens Bioelectron) - "Leveraging this phenomenon, a highly sensitive ECL flow injection analysis (ECL-FIA) platform was developed, exhibiting two linear detection ranges for BIL with limits of detection of 0.162 μM and 2.22 μM, respectively. The proposed strategy offers a novel paradigm in designing of self-enhanced ECL systems where partial surface deactivation is harnessed to improve ECL performance, enabling reliable detection of electrochemically challenging small-molecule drugs."

Journal • Allergy

A prospective, observational study of efficacy and safety of desloratadine and bilastine in patients of chronic spontaneous urticaria. (PubMed, Perspect Clin Res) - "Adverse events were reported more in the desloratadine group. Bilastine is equally efficacious as desloratadine, and a favourable safety profile may make it a more tolerable H1-antihistaminic than desloratadine."

Journal • Observational data • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

OMENUTS: Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial (clinicaltrials.gov) - P4 | N=501 | Completed | Sponsor: Isola Tiberina - Gemelli Isola Hospital, Rome, Italy

New P4 trial • Otorhinolaryngology

The incidence of sleepiness in newer-generation antihistamine users: a systematic review and network meta-analysis. (PubMed, Eur J Clin Pharmacol) - "All nonsedating antihistamines administered at their usual doses have a higher prevalence of sleepiness compared to the placebo. However, most of the prevalence values are not statistically different from those of the placebo."

Clinical • Journal • Retrospective data • Review

Pregnancy Outcome Following First-Trimester Exposure to Bilastine: A Comparative Observational Cohort Study from the Israeli Teratology Information Service. (PubMed, J Clin Med) - "Pregnancy outcomes were compared with fexofenadine-exposed pregnancies. This cohort study, although small, provides preliminary reassurance for counseling regarding inadvertent early pregnancy exposure to bilastine. Larger studies are needed to validate these findings."

Journal • Observational data

Blood–brain barrier permeability of antihistamines and risk of depression in children and adolescents: a real-world cohort study (CINP 2026) - "Exposure groups were defined by antihistamine BBB permeability: the low-BBB cohort (fexofenadine, bilastine, ebastine, olopatadine, acrivastine) and the high-BBB cohort (diphenhydramine, chlorpheniramine, hydroxyzine, promethazine, doxylamine, triprolidine, pheniramine). This large-scale, real-world analysis suggests that high-BBB-penetrant antihistamines may confer an elevated risk of depression in children and adolescents with allergic rhinitis. The absence of associations for negative-control outcomes supports the internal validity of this finding and implicates BBB permeability as a plausible factor influencing psychiatric vulnerability. Clinically, these results highlight the importance of considering BBB penetrability when selecting antihistamines for pediatric patients, particularly those with emotional or behavioral risk factors."

Clinical • Real-world • Real-world evidence • Acne Vulgaris • Allergic Rhinitis • CNS Disorders • Depression • Immunology • Inflammation • Mental Retardation • Mood Disorders • Psychiatry

MG58-SIT-084: A prospective, randomized, double-blind, placebo-controlled, multicentre, dose-finding clinical trial with polymerised mannan-conjugated allergoid Dactylis glomerata/Phleum pratense administered subcutaneously to patients with grass pollen-induced allergic rhinitis or rhinoconjunctivitis. (clinicaltrialsregister.eu) - P2/3 | N=450 | Not yet recruiting | Sponsor: Inmunotek S.L.

New P2/3 trial • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Ocrelizumab-Induced Atopic Dermatitis-like Drug Eruption: A Case Report (EADV-Sp 2026) - "The patient was prescribed emollients, topical methylprednisolone aceponate, and oral bilastine. The pathophysiological mechanism may involve B-cell depletion induced by ocrelizumab, resulting in subsequent immune dysregulation. Although further investigation is warranted to elucidate this association, clinicians should maintain heightened vigilance for cutaneous manifestations when administering novel biological agents."

Case report • Clinical • Alopecia • Ataxia • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Movement Disorders • Multiple Sclerosis • Psoriasis • Pyoderma Gangrenosum • Vasculitis

Rare case of a Netherton syndrome in a Bulgarian patient: case presentation and focus on new therapeutic horizons (EADV-Sp 2026) - "After the reevaluation of the diagnosis a systemic therapy with acitretin 10 mg daily, local pimecrolimus 1%, emollients, and bilastine 20 mg once daily was initiated. New hopes are placed on targeted or anti- cytokine therapy, based on inhibiting the inflammatory component of the disease. Innovative therapeutic options, including modern medications such as dupilumab, infliximab, secukinumab, anakinra, omalizumab, and others are the new hope for succesful management of the disease."

Clinical • Atopic Dermatitis • Dermatitis • Food Hypersensitivity • Immunology • Mood Disorders • Psoriasis • Vitiligo

Baclofen in Refractory Dyspepsia With Chronic Belching: A Case Report. (PubMed, Cureus) - "Her medications included desvenlafaxine, multiple benzodiazepines, mirtazapine, trazodone, and apixaban...Despite repeated medical evaluations and multiple therapeutic approaches, including proton pump inhibitors, sucralfate, domperidone, simethicone, and bilastine, symptoms persisted without significant improvement. Functional dyspepsia was therefore suspected, and treatment with baclofen 10 mg twice daily was initiated, resulting in significant clinical improvement and enhanced quality of life. This report highlights the potential benefit of baclofen in patients with persistent belching and dyspeptic symptoms refractory to conventional therapy, particularly in the context of psychiatric comorbidity."

Journal • Cardiovascular • CNS Disorders • Cough • Depression • Dyspepsia • Gastroenterology • Infectious Disease • Mood Disorders • Otorhinolaryngology • Psychiatry • Pulmonary Embolism • Respiratory Diseases

Graham-Little-Piccardi-Lassueur syndrome and its relation to Antigen mimicry (EADV-Sp 2026) - "These findings were consistent with lichen planus hypertrophicus 2a: cicatricial alopecia HE x 40 2b: Lichen planus hypertrophicus HE x 40 2c: Lichen hypertrophicus HE x 100 Results Initial therapy included loratadine and topical clobetasol propionate. Due to the suspicion of possible drug-induced autoimmunity, the antihypertensive therapy, which consisted of valsartan, bisoprolol, spironolactone, and chlorthalidone, was discontinued and replaced with moxonidine...Prescribed outpatient treatment included acitretin, bilastine, and topical prednisolone for the scalp. Improvement was observed in the lesions located on the trunk and upper and lower extremities following betamethasone/salicylic acid ointment was prescribed, and methylprednisolone aceponate cream...It is this fact that suggests that polymedication could also be considered as a trigger of lichen planus and its subforms such as GLPLS. Conclusions The hypothesis about antigen / molecular mimicry, based on the..."

Alopecia • Dermatopathology • Immunology • Infectious Disease • Lichen Planus • Urology

Delayed hypersensitivity reaction to cetirizine suggesting involvement of piperazine ring: a case report. (PubMed, Allergol Immunopathol (Madr)) - "Importantly, oral provocation with ciprofloxacin, which also contains a piperazine ring, elicited a similar reaction, supporting that this structural moiety itself was responsible for hypersensitivity. Alternatively, AHs lacking the piperazine ring, such as in bilastine and rupatadine, were well tolerated. This case provides the first direct evidence of delayed hypersensitivity manifesting as a maculopapular drug eruption, probably because of the piperazine ring, with cross-reactivity observed between structurally unrelated drugs. Clinicians should be aware of the potential for structural moiety-driven hypersensitivity to prevent recurrence across different drug classes."

Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

BILA-4124/PED: Study to evaluate the effectiveness, safety, and quality of life of Bilaxten, an allergy medication, in children (clinicaltrialsregister.eu) - P4 | N=70 | Recruiting | Sponsor: Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l. | Not yet recruiting ➔ Recruiting

Enrollment open • HEOR • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Safety and Tolerability of Bilastine 0.6% Ophthalmic Solution in Children and Adolescents: An 8-Week Phase 3 Study. (PubMed, J Investig Allergol Clin Immunol) - "Preservative- and phosphate-free bilastine 0.6% ophthalmic solution with sodium hyaluronate was safe and well-tolerated in pediatric patients aged >2 years after a once-daily, 8-week treatment, with a safety profile comparable to that of placebo."

Journal • P3 data • Conjunctivitis • Ocular Infections • Ocular Inflammation • Ophthalmology • Pediatrics

The effects of oral second-generation antihistamines on psychomotor, cognitive, and academic performance: A systematic review (AAAAI 2026) - "Search terms included oral second-generation antihistamines approved for use in the United States and Canada, specifically cetirizine, loratadine, fexofenadine, desloratadine, levocetirizine, bilastine, and rupatadine, with the terms psychomotor, cognitive, and academic performance. Varying effects were found across these categories. Understanding these outcomes will better inform patient care via appropriate selection of antihistamines to minimize disruption on daily activities."

Review

BILA-4124/PED: Study to evaluate the effectiveness, safety, and quality of life of Bilaxten, an allergy medication, in children (clinicaltrialsregister.eu) - P4 | N=70 | Not yet recruiting | Sponsor: Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.

HEOR • New P4 trial • Allergy • Conjunctivitis • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology

Effectiveness, Safety, and Tolerability of Bilastine Up-Dosing in Chronic Spontaneous Urticaria Uncontrolled with Licensed Doses of Other Second-Generation Antihistamines-An Institution-Based, Open-Label, Single-Group Longitudinal Trial. (PubMed, Indian Dermatol Online J) - "Up-dosing of bilastine is effective, safe, and tolerable in CSU patients uncontrolled with licensed doses of other sgAHs. Almost 90% patients responded to 20-40 mg, while 80 mg did not show a significant additional benefit. A higher baseline UAS7 score may indicate the need for up-dosing."

Journal • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Pain • Urticaria

Risk of injury associated with the sedative potential of second-generation antihistamines: A nationwide retrospective cohort study. (PubMed, Br J Clin Pharmacol) - "In this large nationwide cohort of patients with allergic rhinitis, second-generation antihistamines with higher vs. lower sedative potential showed no difference in injury risk during Japan's pollen season."

Journal • Retrospective data • Allergic Rhinitis • Anesthesia • Immunology • Inflammation

Efficacy and safety of oral antihistamines for allergic rhinitis: Network meta-analysis. (PubMed, J Allergy Clin Immunol Pract) - "Although some OAH seem to be more efficacious than others, most differences between individual second-generation medications are trivial or small. In addition, we did not find relevant differences in the safety profiles of second-generation OAH."

Journal • Retrospective data • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria (clinicaltrials.gov) - P=N/A | N=60 | Completed | Sponsor: Derma Techno Pakistan

New trial • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Efficacy of a Combination Therapy of Montelukast and Antihistamines in Allergic Rhinitis: A Systematic Review and Network Meta-Analysis. (PubMed, Allergy Asthma Immunol Res) - "The treatment strategies included montelukast alone, antihistamine monotherapies (loratadine, desloratadine, levocetirizine, and fexofenadine), their respective combinations with montelukast, including bilastine. Although some comparisons require cautious interpretation, montelukast-based combination therapy demonstrated greater efficacy than monotherapy for multiple AR symptoms. These results highlight the importance of selecting therapeutic strategies based on the predominant symptom profile of individual patients."

Journal • Retrospective data • Review • Allergic Rhinitis • Conjunctivitis • Immunology • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology

The relationship between serum eosinophil peroxidase and major basic protein levels in relation to severity and response to H1 antihistamines in chronic spontaneous Urticaria. (PubMed, PLoS One) - "Serum EPO and MBP levels are neither biomarkers predicting CSU severity nor factors predicting response to antihistamine in the severe group. This lack of association may help explain why treatments targeting eosinophil proliferation and chemotaxis have not been successful in clinical trials for patients with antihistamine-refractory CSU."

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria