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Bilastine

Generic Name
Bilastine
Brand Names
Blexten
Drug Type
Small Molecule
Chemical Formula
C28H37N3O3
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

Evaluation of the Inhibitory Effect of 5 Anti-Histamines in Urticaria

First Posted Date
2013-09-12
Last Posted Date
2014-02-19
Lead Sponsor
Grupo de Alergología Clínica y Experimental
Target Recruit Count
150
Registration Number
NCT01940393
Locations
🇨🇴

Medellin, Medellin, Antioquia, Colombia

Investigate the Safety/Tolerability and Efficacy of Bilastine 20mg in Korean Patients With Seasonal Allergic Rhinitis

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2011-07-22
Last Posted Date
2014-07-10
Lead Sponsor
Yuhan Corporation
Target Recruit Count
239
Registration Number
NCT01400828
Locations
🇰🇷

Yonsei University college of Medicine, Gangnam Severance Hospital, Seoul, Korea, Republic of

Bilastine Updosing - Characterization of Underlying Mechanisms

Phase 2
Completed
Conditions
Cold Contact Urticaria
Interventions
First Posted Date
2011-01-06
Last Posted Date
2012-05-31
Lead Sponsor
Charite University, Berlin, Germany
Target Recruit Count
20
Registration Number
NCT01271075
Locations
🇩🇪

Charité-Universitätsmedizin Berlin, Berlin, Germany

Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety Extension

Phase 3
Completed
Conditions
Perennial Allergic Rhinitis
Interventions
First Posted Date
2010-05-21
Last Posted Date
2012-09-26
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
650
Registration Number
NCT01127620

Oral Bioavailability of Bilastine

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2010-05-14
Last Posted Date
2012-09-26
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
12
Registration Number
NCT01124123
Locations
🇪🇸

Unidad de Investigacion Clinica. Clinica Universidad de Navarra, Pamplona, Navarra, Spain

A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With Bilastine

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2010-04-22
Last Posted Date
2012-04-05
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
720
Registration Number
NCT01108783

Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)

Phase 1
Completed
Conditions
Allergic Rhinoconjunctivitis
Chronic Urticaria
Interventions
First Posted Date
2010-03-05
Last Posted Date
2012-09-26
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
36
Registration Number
NCT01081574
Locations
🇩🇪

Universitäts-Hautklinik, Kiel, Germany

🇦🇺

Princess Margaret Hospital for Children, Subiaco, Western Australia, Australia

🇦🇺

Royal Children's Hospital, Parkville, Victoria, Australia

and more 4 locations

Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SAR

Phase 2
Completed
Conditions
Hay Fever
Allergic Conjunctivitis
Hypersensitivity
Seasonal Allergic Rhinitis
Interventions
Drug: Placebo
First Posted Date
2007-12-17
Last Posted Date
2019-02-15
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
805
Registration Number
NCT00574379
Locations
🇺🇸

Lovelace Scientific Resources, Austin, Texas, United States

🇺🇸

Live Oak Allergy and Asthma, San Antonio, Texas, United States

🇺🇸

MetaClin Research Inc., Austin, Texas, United States

and more 10 locations

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)

Phase 2
Completed
Conditions
Hay Fever
Rhinoconjunctivitis
Seasonal Allergic Rhinitis
Interventions
Drug: Placebo
First Posted Date
2007-12-17
Last Posted Date
2019-02-15
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
502
Registration Number
NCT00574210
Locations
🇨🇦

Allied Research International - Cetero Research, Mississauga, Ontario, Canada

Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Phase 3
Completed
Conditions
Seasonal Allergic Rhinitis
Interventions
First Posted Date
2007-07-20
Last Posted Date
2012-04-05
Lead Sponsor
Faes Farma, S.A.
Target Recruit Count
683
Registration Number
NCT00504933
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