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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.

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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 21 Sep 2026, 03:16 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 587 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 587 Netherlands 524 Belgium 426 Czechia 327
All 28 states
362 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
2025-523552-31-00Systemic Lupus Erythematosus
Janssen Cilag International
Immune System Diseases
Denmark, Hungary, Portugal, Italy, Norway, Greece, Slovakia, Czechia, France, Poland, Bulgaria, Germany, Spain, Romania, Finland
05/05/2026
Phase III
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 2)
2024-520441-23-00Overweight or obesity, and type 2 diabetes
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Italy, Croatia, Hungary, Slovakia, Romania
04/05/2026
Phase III
A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy
2024-519638-22-00IgA nephropathy
Novartis Pharma AG
Immune System Diseases
Belgium, France, Czechia, Croatia, Greece, Germany, Italy, Spain
04/05/2026
Phase III
A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)
2024-516993-31-00Renal Cell Carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Denmark, Spain, Netherlands, Germany, France, Czechia, Poland, Italy, Greece
04/05/2026
Phase III
A phase III randomised, double-blind, placebo-controlled, multicentre efficacy and safety clinical trial of angiotensin II in paediatric patients of 0 to 17 years of age with refractory hypotension in distributive shock receiving fluid resuscitation and standard-of-care vasopressors
2025-523750-14-00refractory hypotension in distributive shock
Paion Pharma GmbH
Cardiovascular Diseases
Italy, Germany, France, Spain
30/04/2026
Phase III
A Phase III Open-label, Randomised, Multicentre Study Comparing AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR-T) Therapy Directed Against BCMA and CD19, versus Standard Regimens in Participants with Relapsed Refractory Multiple Myeloma (DURGA-4)
2025-523285-25-00Relapsed or Refractory Multiple Myeloma
AstraZeneca AB
Neoplasms
Norway, Poland, Spain, Germany, France, Italy
30/04/2026
Phase III
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.
2024-520218-23-00Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc.
Cardiovascular Diseases
Spain, Poland, Italy, Belgium, Latvia, Denmark, Czechia, Germany, France, Netherlands, Portugal, Ireland, Austria, Greece, Lithuania
28/04/2026
Phase III
A two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases
2025-524498-17-00Pretreated Unresectable Locally Advanced or Metastatic huma…
F. Hoffmann-La Roche AG
Neoplasms
Belgium, France, Italy, Austria, Romania, Poland, Portugal, Czechia, Germany, Spain, Hungary
28/04/2026
Phase III
A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants with Myotonic Dystrophy Type 1
2025-522957-20-00Myotonic Dystrophy Type 1
Dyne Therapeutics Inc.
Musculoskeletal Diseases
Netherlands, Spain, Italy, Denmark, Germany, Belgium, France
28/04/2026
Phase III
Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
2023-509176-42-00Obesity and T2D
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Slovakia, Austria, Spain, Romania, Portugal, Italy, Denmark, Belgium, Sweden, Poland, Netherlands, Croatia, Hungary, Bulgaria
28/04/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)
2023-508047-40-00Ovarian cancer
Merck Sharp & Dohme LLC
Neoplasms
Norway, Ireland, Spain, Greece, France, Poland, Denmark, Austria, Hungary, Belgium, Czechia, Finland, Germany, Italy, Sweden
28/04/2026
Phase III
Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Clemizole HCl as Adjunctive Therapy in Patients with Lennox-Gastaut Syndrome
2025-522552-20-00Lennox-Gastaut Syndrome
Epygenix Therapeutics Inc.
Nervous System Diseases
Italy, Spain, Hungary, Romania, Czechia, Poland
28/04/2026
Phase III
Phase 2/3, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of EXV-802 and EXV-801 in the Treatment of Agitation in Participants with Alzheimer’s Disease Dementia
2024-517388-22-00Agitation in Alzheimer's Disease Dementia
Exciva GmbH
Nervous System Diseases
Italy, Slovakia, Spain, Poland, Czechia, Germany
28/04/2026
Phase III
A Phase 3, Parallel-group Treatment, Blinded, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Pegtibatinase Administered Subcutaneously in Addition to Standard of Care in Participants with Classical Homocystinuria due to Cystathionine Beta Synthase Deficiency (HARMONY)
2023-504135-40-00Classical Homocystinuria
Travere Therapeutics Inc.
Nutritional and Metabolic Diseases
Belgium, Ireland, Spain, Italy, Germany, France, Portugal, Poland
27/04/2026
Phase III
Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).
2025-523804-62-00Obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Belgium, Germany, Bulgaria, France, Spain, Denmark, Italy, Netherlands
27/04/2026
Phase III
RASolute 304: A Phase 3 Multicenter, Open-label, Randomized, 2‑Arm Study of Adjuvant Daraxonrasib Versus Standard of Care Observation Following Completion of Neoadjuvant and/or Adjuvant Chemotherapy in Patients with Resected Pancreatic Ductal Adenocarcinoma (PDAC)
2025-523495-23-00Resected Pancreatic Ductal Adenocarcinoma (PDAC)
Revolution Medicines Inc.
Digestive System Diseases
France, Spain, Italy, Germany
27/04/2026
Phase III
Impact of Oral Semaglutide on Platelet Reactivity in Patients with Diabetes Mellitus or Overweight with High Risk or established Cardiovascular Disease: the SEMA-PLAT Study
2025-522486-29-01Diabetes Mellitus, Cardiovascular disease, Overweight (BMI …
Casa Di Cura Accreditata Istituto Chirurgico Ortopedico Traumatologico Marco Pasquali
Cardiovascular Diseases
Italy
23/04/2026
Phase III
A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension
2025-523481-24-00Participants with Progressive Supranuclear Palsy Richardson…
Novartis Pharma AG
Nervous System Diseases
Netherlands, Germany, Spain, Italy, France, Belgium
21/04/2026
Phase III
A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia
2025-524366-21-00treatment-naive Chronic Lymphocytic Leukemia
BeOne Medicines I GmbH
Neoplasms
Netherlands, Poland, Italy, Germany, Spain, Romania, Czechia, France, Sweden
20/04/2026
Phase III
A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma
2024-520014-22-00Locally advanced/metastatic urothelial carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Netherlands, Greece, Italy, Germany, Spain, Belgium, Sweden, France
20/04/2026
Phase III
C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY
2025-523660-21-00severe to moderately severe hemophilia B (FIX:C ≤ 2%), hemo…
Pfizer Inc.
Hemic and Lymphatic Diseases
Italy, Germany, France, Spain, Sweden, Greece
20/04/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis
2025-524002-16-00Amyotrophic Lateral Sclerosis
Ferrer Internacional S.A., Prilenia Therapeutics B.V.
Nervous System Diseases
Belgium, Netherlands, Poland, France, Germany, Ireland, Italy, Sweden, Spain
20/04/2026
Phase III
J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.
2025-522855-25-00Carcinoma, Transitional Cell, Urinary Bladder Neoplasms, Ne…
Eli Lilly & Co.
Neoplasms
Italy, Poland, Denmark, Czechia, France, Hungary, Germany, Netherlands, Spain
20/04/2026
Phase III
A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)
2025-522748-42-00Ovarian cancer
Incyte Corp.
Neoplasms
Ireland, Poland, France, Netherlands, Spain, Italy, Germany, Belgium
17/04/2026
Phase III
Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).
2025-523717-29-00HFpEF or HFmrEF and obesity
Novo Nordisk A/S
Cardiovascular Diseases
Denmark, Greece, Bulgaria, Italy, Netherlands, Spain, Poland, Czechia, Germany, France
17/04/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 21 September 2026. https://priyalifescience.com/clinical-trials-europe/country/italy

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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.