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Bilaxten

(Bilastine)

PreclinicalSmall 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.[1] Bilaxten is currently being investigated across 8 indications[3], with its most advanced program in Preclinical.[1]

Bilaxten is one of 93 small molecule programs targeting Urticaria. It is currently in Preclinical.

8

Indications

21

Total Trials

0

Active Trials

92

Competitors

Pipeline

Status by Indication[3][1]

Indication

UrticariaUnknown

Eczematoid DermatitisUnknown

Eye AllergyUnknown

DermatitisUnknown

Skin DiseaseUnknown

Atopic EczemaUnknown

Allergic DiseaseUnknown

UrticariaPreclinical

Unknown

Eczematoid DermatitisPreclinical

Unknown

Eye AllergyPreclinical

Unknown

DermatitisPreclinical

Unknown

Skin DiseasePreclinical

Unknown

Atopic EczemaPreclinical

Unknown

Allergic DiseasePreclinical

Unknown

Competition

Competitive Landscape

45 competitors in Atopic Eczema

#DrugCompanyPhaseTrials

Trexall

Jazz Pharmaceuticals

Medrol

Olumiant

Otezla

Rinvoq

Daliresp

Revia

Jakafi

Cibinqo

Calciferol

Jazz Pharmaceuticals

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

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

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

Completed·—·Phase 4·NCT02513290·73 enrolled

Seasonal Allergic Rhinitis3 trials

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

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

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

Efficacy Study for the Symptomatic Treatment of Seasonal Allergic Rhinitis

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

Treatment2 trials

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

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

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

Chronic Idiopathic Urticaria1 trial

Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic Urticaria

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

11 more indications

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

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

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

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

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

Otits Media With Effusion1 trial

Omega-3-Based Nutraceutical Supplementation as Adjunctive Therapy in Adults With Otitis Media With Effusion: A Multicenter, Double-Blind, Randomized Placebo-Controlled Trial

Completed·IIsola Tiberina - Gemelli Isola Hospital, Rome, Italy·Approved·NCT07721610·501 enrolled

Unspecified1 trial

Bilastine Updosing - Characterization of Underlying Mechanisms

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

Sources

References

[1]
ClinicalTrials.gov — 21 trial records for Bilastine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Bilastine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Bilastine. EMBL-EBI & Wellcome Sanger Institute.
[4]
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[2]
Modality: Small molecule[2]
Highest Phase: Preclinical[1]
Company: MMenarini International Operations Luxembourg SA

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