Product Description
Bilastine is a potent and highly selective H1-antihistamine approved for the treatment of allergic rhinoconjunctivitis and urticaria.
Mechanisms of Action: H1 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: *
Approval Status: Not Approved
Approved Countries: Algeria | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Greece | Hong Kong | Hungary | Iceland | India | Ireland | Israel | Italy | Japan | Jordan | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Faes Farma
Company Location:
Company CEO:
Additional Commercial Interests: None
Clinical Description

Countries in Clinic: Germany, India
Active Clinical Trial Count: 2
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Conjunctivitis, Allergic|Rhinitis, Allergic
Phase 1: Urticaria
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
---|---|---|---|---|---|---|---|
25-VIN-0229 | P1 |
Completed |
Conjunctivitis, Allergic|Urticaria |
2025-06-16 |
2025-07-01 |
Primary Endpoints|Treatments |
|
T502-SIT-073 | P3 |
Active, not recruiting |
Rhinitis, Allergic|Conjunctivitis, Allergic |
2025-06-13 |
2025-05-02 |
Treatments |
Recent News Events
Date |
Type |
Title |
---|---|---|
12/04/2024 |
News Article |
Sunshine Biopharma Launches a New Generic Prescription Drug |
05/10/2024 |
PubMed |
Pharmacokinetics and Safety of Bilastine 10 mg/d in Children Aged 2 to 5 Years With Allergic Rhinoconjunctivitis or Urticaria: A Phase 3 Clinical Trial. |
05/01/2024 |
PubMed |
Bilastine for the treatment of allergic rhinoconjunctivitis and urticaria: results from an international Delphi study. |
11/01/2023 |
PubMed |
Role of Bilastine in Allergic Rhinitis: A Narrative Review. |
09/25/2023 |
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