21 completed, 3 unknown. 8 Phase 3, 6 Phase 1, 6 Phase 4, 5 Phase 2, 1 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 8 | Completed 8 |
| Phase 1 | 6 | Completed 4, Unknown 2 |
| Phase 4 | 6 | Completed 5, Unknown 1 |
| Phase 2 | 5 | Completed 5 |
| Not applicable | 1 | Completed 1 |
Follow bilastine: new trials by email Literature Review of bilastine trials Research Report on bilastine
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial Omega-3-based nutraceutical combination (Otoair Flogo), Bilastine 20 mg, Placebo Tablet or Capsule - Otits Media With Effusion | Phase 4 | Completed | Isola Tiberina - Gemelli Isola Hospital, Rome, Italy | 501 | 2025-10-01 | 2026-07-23 |
| Efficacy of Bilastine Up-dosing (40 mg ) Versus Combination of Bilastine (20 mg )With Levocitirizine (5 mg) in the Treatment of Chronic Spontaneous Urticaria tab bilastine 20 mg, tab bilastine 20 mg + tab levocetrizine 5 mg - Chronic Spontaneous Urticaria (CSU) | Not applicable | Completed | Derma Techno Pakistan | 60 | 2025-08-18 | 2026-01-26 |
| 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 Bilastine oral dispersible tablets, Bilaxten oral dispersible tablets - Allergic Rhino-Conjunctivitis, Urticaria | Phase 1 | Completed | Humanis Saglık Anonim Sirketi | 42 | 2025-04-30 | 2025-06-29 |
| Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects Test (T) Bilastine, Reference (R) Bilastine - Healthy | Phase 1 | Unknown | The Affiliated Hospital of Qingdao University | 40 | 2023-11-21 | 2023-10-24 |
| Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children Bilastine, Placebo - Allergic Conjunctivitis | Phase 3 | Completed | Faes Farma, S.A. | 59 | 2021-03-26 | 2023-03-16 |
| Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population Bilastine 40mg single dose, Bilastine 20mg single-dose followed by multiple-dose - Pharmacokinetics | Phase 1 | Unknown | A.Menarini Asia-Pacific Holdings Pte Ltd | 24 | 2018-08-28 | 2019-01-10 |
| Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma Bilastine 20mg, Montelukast 10mg, Placebo Bilastine 20mg - Seasonal Allergic Rhinoconjunctivitis, Asthma | Phase 4 | Completed | Menarini International Operations Luxembourg SA | 454 | 2016-04-13 | 2019-07-12 |
| Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria Bilastine, Placebo - Allergic Rhinitis, Urticaria | Phase 4 | Completed | Menarini International Operations Luxembourg SA | 19 | 2015-10-01 | 2017-04-18 |
| 4"S" - Seasonal Symptoms Suppression Study Xylometazoline - intranasal application, Azelastine - intranasal application, Mometasone furoate - intranasal application - Seasonal Allergic Rhinitis | Phase 4 | Unknown | Association Asthma, Bulgaria | 60 | 2015-05-01 | 2015-09-23 |
| Bilastine Updosing in Chronic Spontaneous Urticaria Bilastine, Bilastin - Chronic Urticaria | Phase 3 | Completed | Charite University, Berlin, Germany | 30 | 2014-07-01 | 2016-08-26 |
| Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine Bilastine, Loratadine - Allergic Rhinitis | Phase 4 | Completed | Universidade do Sul de Santa Catarina | 73 | 2013-08-01 | 2018-05-07 |
| Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria Cetirizine, Desloratadine, Fexofenadine - Urticaria | Phase 4 | Completed | Grupo de Alergología Clínica y Experimental | 150 | 2013-08-01 | 2014-02-19 |
| Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis Bilastine, Desloratadine, Placebo - Seasonal Allergic Rhinitis | Phase 3 | Completed | Yuhan Corporation | 239 | 2011-06-01 | 2014-07-10 |
| Bilastine Updosing - Characterization of Underlying Mechanisms Bilastine - Cold Contact Urticaria | Phase 2 / Phase 3 | Completed | Charite University, Berlin, Germany | 20 | 2010-09-01 | 2012-05-31 |
| Oral Bioavailability of Bilastine Bilastine - Healthy | Phase 1 | Completed | Faes Farma, S.A. | 12 | 2010-05-01 | 2012-09-26 |
| Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU) Bilastine - Allergic Rhinoconjunctivitis, Chronic Urticaria | Phase 1 / Phase 2 | Completed | Faes Farma, S.A. | 36 | 2010-01-01 | 2012-09-26 |
| Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR Bilastine, Placebo - Seasonal Allergic Rhinitis, Hay Fever | Phase 2 | Completed | Faes Farma, S.A. | 805 | 2007-12-01 | 2019-02-15 |
| PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Bilastine, Placebo - Seasonal Allergic Rhinitis, Hay Fever | Phase 2 | Completed | Faes Farma, S.A. | 502 | 2007-10-01 | 2019-02-15 |
| A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber Bilastine, Fexofenadine, Cetirizine - Seasonal Allergic Rhinitis | Phase 2 | Completed | Faes Farma, S.A. | 75 | 2006-10-01 | 2012-04-05 |
| A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine bilastine, Bilastine, Bilastine & Ketoconazole - Healthy | Phase 1 | Completed | Faes Farma, S.A. | 30 | 2006-08-01 | 2012-04-05 |
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Rhinitis, Allergic, Seasonal (9) · Urticaria (7) · Rhinitis, Allergic (6) · Chronic Urticaria (3) · Nasal Obstruction (3) · Rhinitis (3) · Rhinorrhea (3) · Sneezing (3) · Conjunctivitis, Allergic (2) · Erythema (2) · Hypersensitivity (2) · Rhinitis, Allergic, Perennial (2) · Asthma (1) · Bronchiolitis Obliterans Syndrome (1) · Cold Urticaria (1)
Faes Farma, S.A. (11) · Charite University, Berlin, Germany (2) · Menarini International Operations Luxembourg SA (2) · A.Menarini Asia-Pacific Holdings Pte Ltd (1) · Association Asthma, Bulgaria (1) · Derma Techno Pakistan (1) · Grupo de Alergología Clínica y Experimental (1) · Humanis Saglık Anonim Sirketi (1) · Isola Tiberina - Gemelli Isola Hospital, Rome, Italy (1) · The Affiliated Hospital of Qingdao University (1) · Universidade do Sul de Santa Catarina (1) · Yuhan Corporation (1)
Germany (5) · Italy (3) · Spain (3) · Poland (2) · Romania (2) · United States (2) · Argentina (1) · Australia (1) · Austria (1) · Belgium (1) · Bulgaria (1) · Canada (1) · China (1) · Colombia (1) · Croatia (1)
Ander Sologuren, MD (1) · Andrea Luk, Professor (1) · Belen Sadaba, MD (1) · Deepen Patel, MD, CCFP (1) · Friedrich Horak, Professor (1) · Gunilla Hedlin, Prof. Dr. (1) · Jane da Silva, PhD (1) · Karsten Weller, MD (1)
PMID 19132976, PMID 19438584, PMID 19860762, PMID 19943178, PMID 21642470, PMID 22077106, PMID 22393898, PMID 23529786, PMID 27326985, PMID 28709817
2015 (2), 2004 (1), 2009 (1)