Clinical Trials

Several clinical trials have evaluated bilastine across Phase 1 through Phase 3, investigating indications such as chronic urticaria, cold contact urticaria, allergic rhinoconjunctivitis, and pharmacokinetics in healthy participants. Sponsored by institutional and corporate entities including Charité University Berlin and Faes Farma S.A., all of these studies have reached completed status. Specific research includes a clinical trial evaluating dose-escalating efficacy in chronic urticaria and a clinical trial assessing efficacy and safety in cold contact urticaria.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02213367 Completed
Chronic Urticaria
Charite University Berlin Germany
 2014-07 Phase 3
NCT01271075 Completed
Cold Contact Urticaria
Charite University Berlin Germany|Faes Farma S.A.
 2010-09 Phase 2|Phase 3
NCT01124123 Completed
Healthy
Faes Farma S.A.
 2010-05 Phase 1
NCT01081574 Completed
Allergic Rhinoconjunctivitis|Chronic Urticaria
Faes Farma S.A.
 2010-01 Phase 1|Phase 2

(data from https://clinicaltrials.gov, updated on 2024-05-22)

Check the Bilastine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Bilastine selectively binds to peripheral histamine H1 receptors, preventing histamine-mediated activation of G-protein-coupled signaling pathways and reducing downstream biochemical cascades involved in allergic inflammatory responses. This cellular inhibition prevents vascular permeability, vasodilation, and sensory nerve stimulation, thereby providing therapeutic relief in clinical conditions such as chronic urticaria, cold contact urticaria, and allergic rhinoconjunctivitis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.