DeepMed Research

Bilastine

Generic Name: Bilastine

Brand Names: Blexten

Drug Type: Small Molecule

Chemical Formula: C_₂₈H_₃₇N_₃O_₃

CAS Number: 202189-78-4

Unique Ingredient Identifier: PA1123N395

Background: Bilastine is a novel new-generation antihistamine that is highly selective for the H1 histamine receptor, has a rapid onset and prolonged duration of action.

Indication: For symptomatic relief of nasal and non-nasal symptoms of seasonal rhinitis in patients 12 years of age and older and for symptomatic relief in chronic spontaneous urticaria in patients 18 years of age and older .

Associated Conditions: Chronic Spontaneous Urticaria, Seasonal Allergic Rhinitis

Clinical Trials

Bioequivalence Study of Bilastine Tablets in Healthy Chinese Subjects

Phase 1

Not yet recruiting

Conditions: Healthy

Interventions: Drug: Test (T) Bilastine
Drug: Reference (R) Bilastine

First Posted Date: 2023-10-24

Last Posted Date: 2023-10-24

Lead Sponsor: The Affiliated Hospital of Qingdao University

Target Recruit Count: 40

Registration Number: NCT06098261

Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in Children

Phase 3

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Placebo
Drug: Bilastine

First Posted Date: 2021-03-23

Last Posted Date: 2023-03-16

Lead Sponsor: Faes Farma, S.A.

Target Recruit Count: 59

Registration Number: NCT04810390

Locations: 🇪🇸
Instituto Oftálmologico Quironsalud A Coruña, A Coruña, Spain
🇪🇸
Hospital Universitari German Trias i Pujol (HGTiP),, Badalona, Spain
🇪🇸
Hospital Universitari Dexeus, Barcelona, Spain

and more 15 locations

Different Level of Single-dose and Multiple-dose Bilastine PK Study in Chinese Population

Phase 1

Conditions: Pharmacokinetics

Interventions: Drug: Bilastine 40mg single dose
Drug: Bilastine 20mg single-dose followed by multiple-dose

First Posted Date: 2018-08-16

Last Posted Date: 2019-01-10

Lead Sponsor: A.Menarini Asia-Pacific Holdings Pte Ltd

Target Recruit Count: 24

Registration Number: NCT03633760

Locations: 🇨🇳
Phase I Clinical Trial Centre, Chinese University of Hong Kong, Hong Kong, Hong Kong, China

A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.

Phase 3

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Ketotifen Ophthalmic Solution 0.025% (Zaditen)
Drug: Vehicle of Bilastine Ophthalmic Solution
Drug: Bilastine Ophthalmic Solution 0.6%

First Posted Date: 2018-03-27

Last Posted Date: 2023-03-16

Lead Sponsor: Faes Farma, S.A.

Target Recruit Count: 228

Registration Number: NCT03479307

Locations: 🇺🇸
East West Eye Institute, Torrance, California, United States
🇺🇸
Philadelphia Eye Associates, Philadelphia, Pennsylvania, United States
🇺🇸
Apex Eye, Mason, Ohio, United States

and more 3 locations

A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® Model

Phase 2

Completed

Conditions: Allergic Conjunctivitis

Interventions: Drug: Bilastine 0.2%
Drug: Bilastine 0.6%
Drug: Bilastine 0%
Drug: Bilastine 0.4%

First Posted Date: 2017-07-27

Last Posted Date: 2023-03-16

Lead Sponsor: Faes Farma, S.A.

Target Recruit Count: 121

Registration Number: NCT03231969

Locations: 🇺🇸
Ora Clinical Research Center, Andover, Massachusetts, United States

Efficacy of Co-administration of Bilastine and Montelukast in Patients With SARC and Asthma

Phase 4

Completed

Conditions: Seasonal Allergic Rhinoconjunctivitis
Asthma

Interventions: Drug: Bilastine 20mg
Drug: Montelukast 10mg
Drug: Placebo Montelukast 10mg
Drug: Placebo Bilastine 20mg

First Posted Date: 2016-05-04

Last Posted Date: 2019-07-12

Lead Sponsor: Menarini International Operations Luxembourg SA

Target Recruit Count: 454

Registration Number: NCT02761252

Effects of Bilastine on F1 Simulator Driving Performance in Patients Affected by Allergic Rhinitis and/or Urticaria

Phase 4

Completed

Conditions: Urticaria
Allergic Rhinitis

Interventions: Drug: Bilastine
Drug: Placebo

First Posted Date: 2015-10-15

Last Posted Date: 2017-04-18

Lead Sponsor: Menarini International Operations Luxembourg SA

Target Recruit Count: 19

Registration Number: NCT02576041

Locations: 🇮🇹
Azienda Ospedaliero-Universitaria Policlinico, Modena, Italy

4"S" - Seasonal Symptoms Suppression Study

Phase 4

Conditions: Seasonal Allergic Rhinitis

Interventions: Drug: Xylometazoline - intranasal application
Drug: Azelastine - intranasal application
Drug: Mometasone furoate - intranasal application
Drug: Hydroxyl-propyl-methyl cellulose powder - intranasal application
Other: Placebo - Lactose powder
Drug: Bilastine 20 mg
Drug: Prednisolone 5 mg

First Posted Date: 2015-09-23

Last Posted Date: 2015-09-23

Lead Sponsor: Association Asthma, Bulgaria

Target Recruit Count: 60

Registration Number: NCT02557269

Locations: 🇧🇬
Medical University Sofia, University Hospital "Alexandrovska", Clinic of Allergy and Asthma, Sofia, Bulgaria

Quality of Life in Patients With Allergic Rhinitis: Clinical Trial With Bilastine or Loratadine

Phase 4

Completed

Conditions: Allergic Rhinitis

Interventions: Drug: Bilastine
Drug: Loratadine

First Posted Date: 2015-07-31

Last Posted Date: 2018-05-07

Lead Sponsor: Universidade do Sul de Santa Catarina

Target Recruit Count: 73

Registration Number: NCT02513290

Bilastine Updosing in Chronic Spontaneous Urticaria

Phase 3

Completed

Conditions: Chronic Urticaria

Interventions: Drug: Bilastine
Drug: Bilastin

First Posted Date: 2014-08-11

Last Posted Date: 2016-08-26

Lead Sponsor: Charite University, Berlin, Germany

Target Recruit Count: 30

Registration Number: NCT02213367

Locations: 🇩🇪
Dpt. of Dermatology and Allergy, Berlin, Germany

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