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Bilaxten

(Bilastine)

ApprovedSmall molecule

MMenarini International Operations Luxembourg SA

Bilastine is used to treat allergy symptoms like itching, sneezing, and runny nose caused by allergies. It works by blocking the body's allergic response without making you drowsy like some older allergy medicines.[2] Bilaxten is currently approved and in use across 17 indications[4].[1]

Bilaxten is one of 274 small molecule programs targeting Eye Allergy. It is currently in Approved.

17

Indications

20

Total Trials

0

Active Trials

273

Competitors

Pipeline

Status by Indication[4][1]

Indication

Eye AllergyUnknown

Atopic EczemaUnknown

Allergic ConjunctivitisActive, not recruiting

ConjunctivitisActive, not recruiting

Rhinitis, Allergic, PerennialActive, not recruiting

Eczematoid DermatitisUnknown

UrticariaUnknown

Allergic RhinitisUnknown

Cold UrticariaActive, not recruiting

Allergic DiseaseUnknown

Eye AllergyPreclinical

Unknown

Atopic EczemaPreclinical

Unknown

Allergic ConjunctivitisPhase 3

Active, not recruiting

ConjunctivitisPhase 1/Phase 2

Active, not recruiting

Rhinitis, Allergic, PerennialPhase 3

Active, not recruiting

Eczematoid DermatitisPreclinical

Unknown

UrticariaPreclinical

Unknown

Allergic RhinitisPreclinical

Unknown

Cold UrticariaPhase 2

Active, not recruiting

Allergic DiseasePreclinical

Unknown

Showing 10 of 16 indications

Competition

Competitive Landscape

1050 competitors in Asthma

#DrugCompanyPhaseTrials

Bilaxten

MMenarini International Operations Luxembourg SA

Veramyst

Xolair

Asmanex

Celexa

Blood Withdrawn

Emergent BioSolutions

Vit D

PPost Graduate Institute of Medical Education and Research, Chandigarh

Allergen Immunotherapy Extract

JJohns Hopkins University

Guanidine Hydrochloride

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

FP/SAL

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Allergic Rhinitis3 trials

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

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT02576041·19 enrolled

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

Completed·—·Phase 4·NCT02513290·73 enrolled

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

Completed·FFaes Farma, S.A.·Phase 3·NCT01127620·650 enrolled

Seasonal Allergic Rhinitis3 trials

Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

Completed·FFaes Farma, S.A.·Phase 3·NCT00504933·683 enrolled

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

Completed·YYuhan Corporation·Phase 3·NCT01400828·239 enrolled

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

Completed·FFaes Farma, S.A.·Phase 3·NCT01108783·720 enrolled

Treatment2 trials

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

Completed·FFaes Farma, S.A.·Phase 2·NCT00574379·805 enrolled

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)

Completed·FFaes Farma, S.A.·Phase 2·NCT00574210·502 enrolled

Chronic Idiopathic Urticaria1 trial

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

Completed·FFaes Farma, S.A.·Phase 3·NCT00421109·522 enrolled

Urticaria1 trial

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

Completed·GGrupo de Alergología Clínica y Experimental·Phase 4·NCT01940393·150 enrolled

10 more indications

Oral1 trial

Oral Bioavailability of Bilastine

Completed·FFaes Farma, S.A.·Phase 1·NCT01124123·12 enrolled

Conjunctivitis1 trial

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

Completed·FFaes Farma, S.A.·Phase 1/2·NCT01081574·36 enrolled

Fasting Conditions1 trial

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

Completed·HHumanis Saglık Anonim Sirketi·Phase 1·NCT07042828·42 enrolled

ESS1 trial

4"S" - Seasonal Symptoms Suppression Study

Unknown status·AAssociation Asthma, Bulgaria·Phase 4·NCT02557269·60 enrolled

Asthma1 trial

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

Completed·MMenarini International Operations Luxembourg SA·Phase 4·NCT02761252·454 enrolled

Children1 trial

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

Completed·FFaes Farma, S.A.·Phase 3·NCT04810390·59 enrolled

Double-blind1 trial

A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge Chamber

Completed·FFaes Farma, S.A.·Phase 2·NCT00420082·75 enrolled

Chronic Spontaneous Urticaria1 trial

Bilastine Updosing in Chronic Spontaneous Urticaria

Completed·—·Phase 3·NCT02213367·30 enrolled

Randomized1 trial

A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine

Completed·FFaes Farma, S.A.·Phase 1·NCT00419783·30 enrolled

Unspecified1 trial

Bilastine Updosing - Characterization of Underlying Mechanisms

Completed·—·Phase 2/3·NCT01271075·20 enrolled

Sources

References

[1]
ClinicalTrials.gov — 20 trial records for Bilastine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Bilaxten drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Bilastine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Bilastine. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Menarini International Operations Luxembourg SA company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Histamine H1 Receptor Inverse Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: MMenarini International Operations Luxembourg SA

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