🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Priya Life Science Clinical trial register
TrackersDrugsComparisonsAPI
Trackers› Clinical trials› Italy
Clinical trial register · European Union · CTIS

Clinical Trials in Italy

The most recently authorised trials on the EU Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation (536/2014). CTIS holds a far larger historical archive than any one list can usefully show — this register states both numbers rather than picking one.

Download CSV
Source: EMA Clinical Trials Information System (CTIS). Showing the 2500 most recently authorised of 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 20 Sep 2026, 03:17 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
31 of 2500 shown studies
Download
Phase
Study
Lead sponsor
Area
Member states
Decision
Phase IV
AIRITY: A hybrid cross-sectional and prospective study to assess patient characteristics, disease burden, disease control, phenotypes, endotypes, and outcomes in a real-world setting in patients with asthma
2025-524916-13-00Asthma
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
France, Spain, Germany, Italy
09/09/2026
Phase IV
A double-blind, randomised, 30-week placebo-controlled phase IV study to assess the efficacy and safety of osilodrostat in patients with hypertension caused by hypercortisolaemia due to Cushing’s Syndrome
2025-524649-28-00Cushing's syndrome
Recordati AG
Hormonal diseases
Germany, Bulgaria, France, Romania, Italy, Poland, Spain
08/09/2026
Phase IV
A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation
2025-524392-23-00Chronic obstructive pulmonary disease (COPD)
Regeneron Pharmaceuticals Inc.
Respiratory Tract Diseases
Belgium, Italy, Spain
13/08/2026
Phase IV
Prospective, multicenter, randomized study on combined LT4 + LT3 therapy versus LT4 in the control of TSH in patients with advanced thyroid cancer treated with tyrosine kinase inhibitors.
2026-526113-28-00Advanced thyroid carcinoma. Post-thyroidectomy hypothyroidi…
Ceinge Biotecnologie Avanzate Franco Salvatore S.c.a.r.l.
Hormonal diseases
Italy
26/06/2026
Phase IV
Sample Collection Study to Monitor the Risk of Malignancy Due to Insertional Oncogenesis in Early Onset Patients with Metachromatic Leukodystrophy Treated with OTL-200 in the Clinical Development Program
2025-522275-28-00Metachromatic leukodystrophy
Orchard Therapeutics (Europe) Limited
Musculoskeletal Diseases
Netherlands, Germany, Italy, Sweden, France
22/06/2026
Phase IV
Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)
2025-524487-37-00C3 Glomerulopathy (C3G), Primary Immune Complex Membranopro…
Swedish Orphan Biovitrum AB (publ)
Immune System Diseases
France, Italy, Spain, Germany, Belgium
15/06/2026
Phase IV
OCTAGON:A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab
2025-522555-26-00Generalized Myasthenia Gravis
Alexion Pharmaceuticals Inc.
Nervous System Diseases
Italy, Germany
08/06/2026
Phase IV
Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
2026-525267-40-00Renal cell carcinoma
Centro Di Riferimento Oncologico Di Aviano
Neoplasms
Italy
21/05/2026
Phase IV
Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.
2025-524821-42-00COPD
ASST Fatebenefratelli Sacco
Respiratory Tract Diseases
Italy
20/05/2026
Phase IV
A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative
2025-525005-20-00Male Infertility
Martin-Luther-Universitaet Halle-Wittenberg
Reproductive and Urinary Physiological Phenomena
Italy, Spain, Germany
18/05/2026
Phase IV
A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.
2025-524289-56-00Asthma
Chiesi Farmaceutici S.p.A.
Respiratory Tract Diseases
Germany, Romania, Italy, Bulgaria, Poland, Slovakia, Spain, France
18/05/2026
Phase IV
PHASE IV, PROSPECTIVE, OPEN-LABEL, SINGLE ARM STUDY ON THE PAIN-RELIEF EFFECT OF BENZYDAMINE HYDROCHLORIDE LOZENGES 3 MG MINT TASTE (TANTUM VERDE) IN NON STREPTOCOCCAL PHARYNGOTONSILLITIS IN PEDIATRIC AGE (6-11 YEARS OLD).
2025-521526-15-00NON STREPTOCOCCAL PHARYNGOTONSILLITIS
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesc O A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
Respiratory Tract Diseases
Italy
30/04/2026
Phase IV
EaRly impAct theraPy with ceftazidime-avibactam via rapID diagnostics versus standard of care antibiotics and diagnostics in patients with bloodstream infection, hospital-acquired pneumonia or ventilator-associated pneumonia due to Pseudomonas aeruginosa or carbapenemase producing Enterobacterales ("RAPID")
2024-520067-13-00Bloodstream Infection, Ventilator Associated Pneumonia and …
National University Of Singapore
Bacterial Infections and Mycoses
Italy, Greece
29/04/2026
Phase IV
A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
2025-522362-78-00severely active ulcerative colitis (US) and CD (Crohn’s dis…
Eli Lilly & Co.
Immune System Diseases
Spain, Denmark, Germany, Italy, Poland
27/04/2026
Phase IV
Effect of Romosozumab vs. Denosumab on Coronary Atherosclerotic Damage in Postmenopausal Osteoporotic Women: A Phase IV, Low-Risk, Pharmacological Intervention Study. ATRIO Study.
2025-522592-29-00Coronary atherosclerotic status in women with postmenopausa…
Ospedale Galeazzi S.p.A.
Musculoskeletal Diseases
Italy
23/02/2026
Phase IV
(23026) A prospective, single-arm, Phase 4 study to evaluate the course of serum transthyretin (TTR) level with acoramidis in adult patients with variant or wild-type transthyretin amyloidosis with cardiomyopathy (ATTR-CM) previously treated with tafamidis.
2025-521831-35-00Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
Bayer Consumer Care AG
Cardiovascular Diseases
Austria, Germany, Italy, Belgium
07/02/2026
Phase IV
Changes in Coronary Plaque Composition By Semaglutide Use in Diabetic Patients With Acute Coronary Syndrome: A Randomized Optical Coherence Tomography Trial - ARMYDA - 10 study
2025-523977-40-00non-ST-elevation myocardial infarction (NSTEMI); unstable a…
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Cardiovascular Diseases
Italy
28/01/2026
Phase IV
Tailored antiplatelet secondary prevention in non-cardioembolic ischemic stroke: a phase IV gender-stratified randomized controlled trial (TAILOR trial)
2025-523065-16-00Non-cardioembolic ischemic stroke
Azienda Unita Sanitaria Locale Di Bologna
Cardiovascular Diseases
Italy
28/01/2026
Phase IV
International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis
2024-519550-36-00Allergic rhinoconjunctivitis
Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Immune System Diseases
Poland, Spain, Italy
19/01/2026
Phase IV
Arthritis interception with Guselkumab in subclinical psoriatic arthritis patients in clinical transition from skin to joint disease: a randomized clinical trial.
2025-523551-54-00PSORIATIC ARTHRITIS PATIENTS IN CLINICAL TRANSITION
Azienda Sanitaria Universitaria Friuli Centrale
Musculoskeletal Diseases
Italy
14/01/2026
Phase IV
A multicentre randomised study on percutaneous stellate ganglion block as first line treatment in patients with electrical storm: the STAR 2 study
2024-520387-34-00electrical storm
Fondazione IRCCS Policlinico San Matteo
Cardiovascular Diseases
Italy
25/11/2025
Phase IV
Pharmacological optimization in prevention in Heart Failure: A Sex-gap? (PopS-HF Trial)
2025-520660-18-00Heart Failure
Policlinico San Donato S.p.A.
Cardiovascular Diseases
Italy
17/11/2025
Phase IV
Remimazolam versus propofol for deep sedation during Endoscopic Ultrasound (EUS) procedures. A randomized controlled trial.
2025-521784-12-00Gastric and pancreatic cancer
Ospedale San Raffaele S.r.l.
Digestive System Diseases
Italy
11/11/2025
Phase IV
Phase IV multicenter immunogenicity and safety study of the Seqirus licensed zoonotic influenza vaccine (H5N8) in adults immunized with an H5N1/MF59 influenza vaccine, approximately 20 years before the trial, compared to H5 naive adult participants.
2025-522116-16-00Avian Influenza
University Of Antwerp
Virus Diseases
Italy, Belgium
06/10/2025
Phase IV
A biomarker enrichment trial of anti-EGFR agents in patients with advanced colorectal cancer (aCRC) with wild-type RAS and right primary tumour location (right-PTL) - ARIEL-ENGIC 04 EU trial
2025-521209-42-00advanced colorectal cancer with wild-type RAS and right pri…
Fondazione GONO G.I.
Neoplasms
Italy, Germany, Spain
06/10/2025
Rows per page Showing 1–25 of 31
1 2 Next
Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 20 September 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

Query this register directly
GET /api/export.php?register=trials-eu&format=json Try it now →
Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.