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Clinical trials
catalyst calendar across sponsors →Studies where FAE.MC is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
17 interventional · 2 with posted results
government filings 180d: none disclosed
| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Updated |
|---|---|---|---|---|---|---|---|
| Phase III Multicentre Trial of Oral Mesalazine in Patients With Mild to Moderate Ulcerative Colitis.NCT06176560To assess the percentage of patients with clinical remission [Mayo Modified Score (MMS) ≤ 2] and Endoscopic remission [Mayo Endoscopic Score (MES) ≤ 1] after 8 weeks of treatment.Randomized · Triple-masked · Treatment | Phase 3 | Unknown status | Drug: Mesalazine | Colitis, Ulcerative | 376 | Aug 2025 | 2023-12-19 |
| Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated HaemorrhoidsNCT05788497Percentage of responders at T156h +30 min (day 7 hour 12 + 30min) compared to T0 (day 1 hour 0), for Hemorrane Plus and placebo; as well as the percentage of responders within 30 minutes after the application of Hemorrane Plus and Hemorrane®.Randomized · Quadruple-masked · Treatment | Phase 3 | Terminatedsponsor's stated reason: Recruitment failure | Drug: Hemorrane plus, Hemorrane, Placebo | Haemorrhoids Without Complication | 21 | 2024-01-04actual | 2024-02-28 |
| Study to Assess the Safety, Tolerability and Efficacy of Bilastine Ophthalmic Solution 0.6% in ChildrenNCT04810390Incidence of related ocular treatment-emergent adverse events (ocular r-TEAEs)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Bilastine, Placebo | Allergic Conjunctivitis | 59 | 2022-11-30actual | 2023-03-16 |
| Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D DeficiencyNCT04735926To assess efficacy for each cohort in terms of percentage of subjects achieving 25-OH-D levels ≥ 30 ng/mL and/or ≥ 20 ng/mL at 16 weeks of treatment.Randomized · Quadruple-masked · Treatment | Phase 2/3 | Completed | Drug: Calcifediol 75mcg, Calcifediol 100mcg, Calcifediol 125mcg · Other: Placebo, Placebo | Vitamin D Deficiency, Vitamin D Insufficiency | 674 | 2022-07-21actual | 2023-09-15 |
| A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.NCT03479307results2021-12-14Ocular ItchingRandomized · Double-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 3 | Completed | Drug: Bilastine Ophthalmic Solution 0.6%, Ketotifen Ophthalmic Solution 0.025% (Zaditen), Vehicle of Bilastine Ophthalmic Solution | Allergic Conjunctivitis | 228 | 2018-08-09actual | 2023-03-16 |
| A Single-Center, Phase 2 Study Evaluating Bilastine Ophthalmic Solution in the CAC® ModelNCT03231969results2021-11-24Ocular ItchingRandomized · Triple-masked · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Phase 2 | Completed | Drug: Bilastine 0.2%, Bilastine 0.4%, Bilastine 0.6%, Bilastine 0% | Allergic Conjunctivitis | 121 | 2017-10-11actual | 2023-03-16 |
| Pharmacokinetic Study of Bilastine in Children From 2 to < 12 Years of Age With Either Allergic Rhinoconjunctivitis (AR) or Chronic Urticaria (CU)NCT01081574The primary objective is to assess the pharmacokinetics of bilastine in children (aged 2 to <12 years) with allergic rhinoconjunctivitis (seasonal allergic rhinitis and/or perennial allergic rhinitis [SAR/PAR]) or chronic urticaria (CU)Open-label · Treatment | Phase 1/2 | Completed | Drug: Bilastine | Allergic Rhinoconjunctivitis, Chronic Urticaria | 36 | Jun 2012actual | 2012-09-26 |
| Oral Bioavailability of BilastineNCT01124123The area under the plasma concentration versus time curve from time zero to infinity (AUC 0-∞ ).Randomized · Open-label · Basic science | Phase 1 | Completed | Drug: Bilastine, Bilastine | Healthy | 12 | Jun 2010actual | 2012-09-26 |
| Efficacy, Safety and PK of Once or Twice Daily Bilastine (10 or 20 mg) Compared With Placebo in the Symptomatic Treatment of SARNCT00574379Change in nasal symptom scoresRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Bilastine, Placebo | Seasonal Allergic Rhinitis, Hay Fever, Allergic Conjunctivitis, Hypersensitivity | 805 | Mar 2008actual | 2019-02-15 |
| 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)NCT00574210Total Nasal Symptom Scores (TNSS)Randomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Bilastine, Placebo | Seasonal Allergic Rhinitis, Hay Fever, Rhinoconjunctivitis | 502 | Feb 2008actual | 2019-02-15 |
| Human Mass Balance Study With BilastineNCT00572611Whole blood and plasma concentrations of total radioactivity and parent drugOpen-label · Basic science | Phase 1 | Completed | Drug: [14C]-bilastine | Healthy | 6 | Dec 2007actual | 2012-09-26 |
| Efficacy Study for the Symptomatic Treatment of Chronic Idiopathic UrticariaNCT00421109Change from baseline, in the am/pm Total Symptom Score (TSS3), over the 28 days of the treatment period according to the patient's assessment in the diary card. (Reflective Symptoms)Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Bilastine, Levocetirizine, Placebo | Urticaria | 522 | Jul 2007actual | 2012-04-05 |
| A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of BilastineNCT00419783QTc Interval prolongationRandomized · Quadruple-masked · Treatment | Phase 1 | Completed | Drug: bilastine, Bilastine, Bilastine & Ketoconazole, Moxifloxacin, Placebo | Healthy | 30 | Dec 2006actual | 2012-04-05 |
| Efficacy Study for the Symptomatic Treatment of Perennial Allergic Rhinitis With a 1 Year Safety ExtensionNCT01127620Double-blind phase: AUC of TSS throughout the studyRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Bilastine, Cetirizine, Placebo | Perennial Allergic Rhinitis | 650 | Mar 2006actual | 2012-09-26 |
| Efficacy Study for the Symptomatic Treatment of Seasonal Allergic RhinitisNCT00504933Area under curve of total symptoms score (TSS) from basal visit to D14 visit, according to the patient's assessment on reflective symptoms.Randomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: bilastine, Cetirizine, Placebo | Seasonal Allergic Rhinitis | 683 | Nov 2005actual | 2012-04-05 |
| A Phase III Efficacy Study of the Symptomatic Treatment of Seasonal Allergic Rhinitis With BilastineNCT01108783AUC of TSSRandomized · Quadruple-masked · Treatment | Phase 3 | Completed | Drug: Bilastine, Desloratadine, Placebo | Seasonal Allergic Rhinitis | 720 | Aug 2003actual | 2012-04-05 |
| A Randomized, Double-Blind, 4-way Crossover Study to Evaluate the Efficacy of Bilastine in the Vienna Challenge ChamberNCT00420082Onset of action and action durationRandomized · Quadruple-masked · Treatment | Phase 2 | Completed | Drug: Bilastine, Fexofenadine, Cetirizine, Placebo | Seasonal Allergic Rhinitis | 75 | — | 2012-04-05 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19