bilastine / Generic mfg. - LARVOL DELTA

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

Effectiveness, safety, and cost-effectiveness of fixed-dose combination of montelukast-bilastine versus montelukast-levocetirizine in allergic rhinitis: A prospective, randomized, open-label, parallel-group study. (PubMed, Perspect Clin Res) - "Montelukast/bilastine and montelukast/levocetirizine are effective in managing AR. However, montelukast/bilastine offers a better safety profile and is more cost-effective, making it a viable option for AR treatment."

HEOR • Journal • Allergic Rhinitis • Immunology • Inflammation

A comparative study of efficacy and tolerability of cetirizine and bilastine in patients of allergic rhinitis: An open-label, randomized, parallel-group study. (PubMed, Perspect Clin Res) - "Adverse events were reported more in the cetirizine group. Bilastine is equally efficacious as cetirizine and a favorable tolerability profile may make it a more tolerable H1-antihistaminic than cetirizine."

Journal • Allergic Rhinitis • Allergy • Dermatology • Immunology • Inflammation • Otorhinolaryngology • Urticaria

Comparing Antihistamines for Chronic Urticaria: Systematic Review Dose Response and Network Meta-Analysis of Randomized Trials (ACAAI 2025) - "Sedation likely increases with higher doses, with first-generation agents among the most sedating; cetirizine, ketotifen, levocetirizine, and rupatadine among the intermediate sedating; and bilastine, desloratadine, fexofenadine, and loratadine among the least sedating. Cetirizine and loratadine are among the most effective for all components of urticaria activity, but cetirizine is intermediately sedating and loratadine has lower certainty on improving quality of life and sleep. Higher doses may have diminishing benefits and increased risks."

Retrospective data • Review • Anesthesia • Cardiovascular • CNS Disorders • Dermatology • Immunology • Pruritus • Sleep Disorder • Urticaria

Upadacitinib Effective for Dupilumab Refractory Chronic Spontaneous Urticaria: A Case Series Study of 6 Patients (ACAAI 2025) - "No significant improvements were observed in urticaria activity scores (UAS) during treatment using omalizumab and sgAH (cetirizine, rupatadine, or bilastine), with no significant changes in score when switched to dupilumab. Discussion These findings highlight upadacitinib’s potential role in treating severe refractory CSU. Just as we once presented the first case series in dupilumab for CSU, 4 it is our hope that this encourages further development through randomized controlled trials in JAK inhibitors for CSU."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • JAK1

Bioequivalence test of Bilastine orally disintegrating tablets (ChiCTR) - P=N/A | N=36 | Completed | Sponsor: The Affiliated Panyu Central Hospital, Guangzhou Medical University; The Affiliated Panyu Central Hospital, Guangzhou Medical University

New trial • Allergic Rhinitis • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pruritus • Urticaria

Ravenbhel Gets SEC Nod To Market Bilastine, Montelukast FDC, Phase IV Trial Mandated (Medical Dialogues) - "At the recent SEC meeting for Pulmonary drugs, the expert panel reviewed the justification for BE and the Phase III CT waiver presented by Ravenbhel Healthcare....Accordingly, the expert panel suggested that the firm should submit the Phase IV clinical trial protocol to CDSCO within 3 months of approval of the FDC for review by the committee."

Approval • Allergic Rhinitis • Asthma • Immunology

Diverse Immune-Related Adverse Events Associated with Nivolumab: A Case Series from a Single Center (EADV 2025) - "The patient responded well to topical super-potent corticosteroids, bilastine, and omalizumab, allowing continuation of nivolumab therapy. The third case describes a 16-year-old male with metastatic melanoma receiving combination nivolumab and ipilimumab therapy...Treatment included systemic corticosteroids (1 mg/kg) and tocilizumab (10 mg/kg/day)... As nivolumab use continues to expand, clinicians must remain vigilant for rare but severe immune-related toxicities. Early recognition and intervention, coupled with a multidisciplinary approach, are crucial for optimal patient outcomes while balancing oncologic efficacy and immune-related toxicity management."

Adverse events • Clinical • Anemia • Atopic Dermatitis • Bladder Cancer • Chronic Kidney Disease • Dermatology • Dermatomyositis • Diabetes • Diabetic Nephropathy • Genito-urinary Cancer • Hepatology • Immunology • Liver Failure • Melanoma • Metabolic Disorders • Myositis • Nephrology • Pruritus • Renal Disease • Solid Tumor • Vasculitis

Efficacy of Vitamin D3 Supplementation as an Adjunct to Bilastine 40 mg in Chronic Spontaneous Urticaria Patients with Vitamin D3 Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study (EADV 2025) - "Exclusion criteria included recent use of systemic immunomodulators (past 1 month), omalizumab (past 12 months), pregnancy, lactation, terminal illness, or significant systemic disease. Vitamin D3 supplementation in CSU patients with low serum vitamin D3 levels significantly enhances the therapeutic response to Bilastine. Patients receiving vitamin D3 demonstrated faster and more pronounced improvements in disease activity and control compared to those on Bilastine alone. These findings suggest that vitamin D3 supplementation could be a beneficial adjunct therapy in CSU management."

Clinical • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Pruritus • Urticaria

Efficacy, Safety, and Tolerability of Bilastine Versus Levocetirizine for Chronic Spontaneous Urticaria: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (EADV 2025) - "A total of 5 RCTs involving 1,127 patients were included, comparing bilastine 20 mg (n = 462) to levocetirizine 5 mg (n = 449), with 216 patients assigned to placebo or fexofenadine in third-arm studies. The consistently lower risk of somnolence with bilastine reinforces its role as a better- tolerated alternative. High heterogeneity across efficacy outcomes limits certainty, highlighting the need for further high-quality, head-to-head trials."

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

The not-so-obvious face of urticaria after treatment with antithymocyte globulin. (EADV 2025) - "antibiotic and steroid therapy- Clindamycin and continuation of Methylprednisolone 2. topical compresses of 2% tannin solution (on the breast)- 2x a day for 10-15 minutes each for 3-4 days Fluticasone ointment 1x a day for 7 days on erythematous lesions (in the area of: breast, left shoulder and back)...antihistaminic drug, e.g. bilastine After 4 days, the patient's condition was observed to improve after the implemented treatment... A small number of cases of cutaneous complications of the use of horse antithymocyte globulin have been described. What is noteworthy, in the available literature, this globulin is characterized by a faster and stronger reduction in T-cell numbers in comparison with the rabbit version of antithymocyte globulin. Unfortunately, its action may be associated with a stronger allergic response in patients who have not been previously exposed to horse proteins."

Anemia • Aplastic Anemia • Cardiovascular • Dermatology • Dermatopathology • Hematological Disorders • Immunology • Musculoskeletal Pain • Pruritus • Thrombosis • Urticaria

Mpox in Brazil: Clinical Presentation, Diagnostic Workup, and Patient Management (EADV 2025) - "Initial treatment included cefalexin and bilastine, and PCR for Mpox was requested, along with serologies for syphilis, HIV, and viral hepatitis...Despite medical advice, he did not comply with isolation guidelines and sought treatment at an emergency service due to fear of Mpox, receiving azithromycin, benzathine penicillin, and topical corticosteroids...Awareness, early isolation, and contact tracing are key to containing outbreaks. This case highlights the importance of maintaining a high index of suspicion and implementing public health protocols promptly, even in the absence of confirmatory PCR results."

Clinical • CNS Disorders • Dermatology • General Anxiety Disorder • Hepatology • Human Immunodeficiency Virus • Infectious Disease • Inflammation • Mood Disorders • Pruritus • Psychiatry

A Rare Case of Eosinophilic Cellulitis - Nodular Type in a 43-Year-Old Filipino Male (EADV 2025) - "He was also prescribed Loratadine 10 mg twice daily for 14 days, and Clobetasol Propionate 0.05% lotion...A 5-mm punch biopsy was done on a lesion at the upper back and the patient was sent home with Prednisone 20 mg twice daily for 4 days, then once daily for 3 days; Bilastine 20 mg twice daily for 14 days; Ciprofloxacin 500 mg twice daily for 7 days and Clobetasol Propionate 0.05% lotion providing resolution of the lesions leaving behind hyperpigmented plaques... Well's Syndrome is a great mimicker that must be kept in our list of differentials especially for cases that present atypically, are unresponsive to standard therapy, and have a recurrent and relapsing course. The value of antihistamines as a part of therapy should also be explored because some patients may benefit from its use."

Clinical • Dermatitis • Dermatology • Immunology • Inflammation • Urticaria • Vasculitis

Perforating folliculitis - a rare disease with a good response to isotretinoin treatment (EADV 2025) - "She sought medical help mainly due to intense e worsening pruritus and was treated with loratadine, bilastine, fexofenadine, dexchlorpheniramine, prednisone, fluconazole, and topical ketoconazole by different practitioners with no satisfactory response...Her previous pathological history included asthma and systemic hypertension, well controlled with daily administration of budesonide/formoterol inhaler and hydrochlorothiazide, respectively... Isotretinoin seems to work well on pruritus related to PF and it helps flatten papules out or even makes them less keratotic."

Asthma • Cardiovascular • Dermatology • Diabetes • Hypertension • Immunology • Metabolic Disorders • Pruritus • Rare Diseases • Respiratory Diseases

Validation of a green and sensitive spectrofluorimetric method for determination of Bilastine and its application to pharmaceutical preparations, content uniformity test, and spiked human plasma. (PubMed, BMC Chem) - "The suitable sensitivity and selectivity of the suggested method enabled its application successfully in analyzing BIL in pharmaceutical tablets without any interfering effect from their excipients and in spiked human plasma with appropriate recoveries from 95.72 to 97.24%. Additionally, the suggested method was utilized for content uniformity testing."

Journal • Conjunctivitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Urticaria

An Island Rash: A Case Study of Exercise-Induced Vasculitis. (PubMed, Cureus) - "Her medications included metformin and atorvastatin...Bilastine provided no relief...When triggering conditions persist, relapses are frequent. Family physicians should be aware of the characteristic presentation of exercise-induced vasculitis, as this allows early diagnosis and prevents unnecessary interventions."

Journal • Dermatology • Diabetes • Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity • Pruritus • Vasculitis

Clinical and quality of life improvement after bilastine treatment among patients with autoimmune chronic spontaneous urticaria. (PubMed, PLoS One) - "The findings suggest that bilastine is highly effective in controlling aiCSU symptoms and improving QoL."

HEOR • Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

To Compare and Evaluate the Oral Bioavailability of Bilastine 20 mg Orally Dispersible Tablet With That of Bilaxten (Bilastine) 20 mg Orally Dispersible Tablet in Healthy, Adult, Human Subjects Under Fasting Conditions (clinicaltrials.gov) - P1 | N=42 | Completed | Sponsor: Humanis Saglık Anonim Sirketi

New P1 trial • Conjunctivitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Urticaria

Efficacy of Vitamin D3 Supplementation as an Adjunct to Bilastine 40 mg in Chronic Spontaneous Urticaria Patients With Vitamin D3 Deficiency: A Randomized, Double-Blind, Placebo-Controlled Study. (PubMed, Int J Dermatol) - No abstract available

Clinical • Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Bioequivalence and Safety of Bilastine 20 mg Administered in Three Eight-Hourly Dose Versus a Single Daily Dose: A Randomized Two-Treatment, Two-Period, Cross-Over Comparative Study. (PubMed, Eur J Drug Metab Pharmacokinet) - "Our study concluded that the test product, bilastine + dextromethorphan hydrobromide + phenylephrine hydrochloride syrup (3.3 mg + 10 mg + 5 mg)/5 mL, and the reference product, bilastine solution 2.5 mg/mL, are bioequivalent with respect to the extent of absorption and were well tolerated."

Journal • Cough • Respiratory Diseases

Unspecified Degradation Impurities Identification and Characterization in Bilastine and Montelukast tablet formulations by using UPLC and LCMS/MS: Robustness by Design Expert and Green assessment. (PubMed, Ann Pharm Fr) - "The UPLC-based analytical method demonstrated in this study is an effective and efficient technique for the quantification of BLS, MTK, and their associated impurities in tablet formulations. This method has been validated in accordance with ICH Q2(R2) and USP guidelines."

Journal

Serum MRGPRX2 and substance P levels are biomarkers of disease activity rather than an antihistamine response in chronic spontaneous urticaria. (PubMed, Sci Rep) - "Severe CSU patients received 20 mg of bilastine, titrated up to 80 mg based on Urticaria Control Test (UCT) results at days 15, 30, and 60...Among the severe CSU patients, the baseline MRGPRX2 and SP levels did not significantly differ across the antihistamine response groups (P > 0.05); serum MRGRPX2 levels remained consistent over time after antihistamine treatment (P = 0.41), whereas serum SP concentrations significantly decreased (P < 0.001). Serum MRGPRX2 and SP levels are associated with disease severity in CSU patients but do not predict antihistamine response in severe cases."

Biomarker • Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Balanced discussion about bilastine as a truly non-sedating antihistamine. (PubMed, Curr Med Res Opin) - No abstract available

Journal

The new bilastine eye drop formulation protects against conjunctival dehydration and promotes corneal wound healing in a comparative in vitro study. (PubMed, Sci Rep) - "In wound healing assays, preservative-free ketotifen 0.025%, bilastine 0.6%, and azelastine 0.05% promoted corneal wound repair at 72 h, outperforming preserved formulations. Overall, preservative-free bilastine 0.6% with HA enhances corneal hydration, retention, and re-epithelialization in vitro, suggesting potential benefits for the management of allergic conjunctivitis and offering promising advancements in treating this widespread condition."

Clinical • Journal • Preclinical • Conjunctivitis • Dermatology • Immunology • Ocular Infections • Ocular Inflammation • Ophthalmology • Urticaria