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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 โ€” 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 โ€” 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
742 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
Sequence Strategy of Immuneoncology (IO-IO) vs IO-tyrosine kinase inhibitors (TKI) followed by TKI in metastatic renal cell carcinoma (mRCC): A randomized phase 3 study Meet uro and FICOG trial. COMBO-Seq trial.
2025-523903-31-00Metastatic renal cell carcinoma
Fondazione IRCCS Istituto Nazionale Dei Tumori
Neoplasms
Italy
03/09/2026
Phase II
Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma
2026-525406-36-00Adrenocortical Carcinoma
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neoplasms
Italy
02/09/2026
Phase III
A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy
2026-525913-30-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Belgium, Czechia, Hungary, Sweden, Lithuania, Croatia, Netherlands, Slovakia, Poland, Austria, Norway, France, Italy, Bulgaria, Spain, Germany, Romania, Slovenia, Estonia, Portugal, Greece, Denmark
02/09/2026
Phase III
A phase III, randomized, prospective, double-blind, parallel design, multi-arm, multicenter study to compare the efficacy and safety of alogliptin and empagliflozin combination therapy versus alogliptin alone and empagliflozin alone in metformin-treated participants with type 2 diabetes mellitus and insufficient glycemic control despite diet and exercise (ODISSEIA 2026).
2025-524606-15-00Type 2 Diabetes mellitus
Tecnimede-Sociedade Tecnico-Medicinal S.A.
Nutritional and Metabolic Diseases
Poland, Germany, Portugal, Italy, Spain
02/09/2026
Phase II
Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
2025-524748-37-00Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Dompe' Farmaceutici S.p.A.
Eye Diseases
Denmark, Italy, Germany, Hungary, Netherlands, Spain, Belgium, France, Portugal
01/09/2026
Phase III
A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).
2025-524014-29-00Newly Diagnosed Multiple Myeloma
AstraZeneca AB
Neoplasms
Poland, Italy, Denmark, France, Sweden, Germany, Spain
01/09/2026
Phase III
A Phase 3, Randomized, Double-blind, Placeboโ€‘controlled Study to Assess the Efficacy and Safety of Engasertib in Subjects With Moderate to Severe Hereditary Hemorrhagic Telangiectasia (HHT)
2025-524490-17-00Hereditary Hemorrhagic Telangiectasia (HHT)
Vaderis Therapeutics AG
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Hungary, Netherlands, Germany, Bulgaria, France, Italy, Lithuania, Spain, Belgium
31/08/2026
Phase III
A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy
2025-523857-32-00Spinal Muscular Atrophy
Biogen Idec Research Limited
Nervous System Diseases
Portugal, Italy, Belgium, Croatia, Hungary, Germany, Ireland, France, Norway, Poland
31/08/2026
Phase III
Targeted versus standard peri-operative prophylaxis in patients colonized with carbapenemase-producing Enterobacterales undergoing liver transplantation: a stepped-wedge cluster randomization trial
2025-523453-34-00Patients colonized with CPE undergoing liver transplantatioโ€ฆ
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Bacterial Infections and Mycoses
Italy
31/08/2026
Phase I/II
A Phase 1/2, Open-Label, Multicenter, Multi-cohort Study of S241656 as Monotherapy or in Combination with other Antileukemic Agents in participants with Selected Myeloid Malignancies
2025-525128-88-00Patients with Acute Myeloid Leukemia (AML), Myelodysplasticโ€ฆ
Institut De Recherches Internationales Servier IRIS
Neoplasms
Netherlands, Spain, Germany, Italy, France, Finland
27/08/2026
Phase II
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis
2025-521901-42-00Idiopathic Pulmonary Fibrosis (IPF)
Contineum Therapeutics Inc.
Respiratory Tract Diseases
Italy, Belgium, Denmark, Austria, Greece, Germany, France, Netherlands, Portugal, Poland, Spain
26/08/2026
Phase II
C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer
2025-524825-42-00Early-Stage Resectable or Locally Advanced Unresectable Nonโ€ฆ
Pfizer Inc.
Neoplasms
Spain, France, Italy, Ireland, Germany, Poland
26/08/2026
Phase II
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
2025-524130-26-00Gastrointestinal Cancers
Genmab A/S
Neoplasms
Italy, Belgium, France, Spain, Denmark, Netherlands, Germany
26/08/2026
Phase III
A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524757-14-00Ocular Myasthenia Gravis
UCB Biopharma
Immune System Diseases
Hungary, France, Greece, Poland, Spain, Italy, Germany
25/08/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension
2025-523821-17-00narcolepsy
Harmony Biosciences Management Inc.
Nervous System Diseases
Belgium, Italy, Germany, France, Spain, Poland
25/08/2026
Phase II
Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)
2025-524905-34-00Solid tumor
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Greece, Hungary, Poland, Belgium, Spain, Netherlands, Germany, France, Portugal, Italy, Romania
25/08/2026
Phase I
A Phase 1 Study of TT125-802 as Monotherapy and in Combination with Pomalidomide and Dexamethasone in Participants with Multiple Myeloma
2025-523536-39-00Relapsed and Refractory Multiple Myeloma
TOLREMO therapeutics AG
Neoplasms
Italy, Spain
24/08/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)
2025-524928-21-00Pancreatic Adenocarcinoma
Revolution Medicines Inc.
Neoplasms
Sweden, Spain, France, Poland, Italy, Norway, Belgium, Germany, Czechia, Austria, Netherlands, Denmark
24/08/2026
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
2025-524669-25-00Polycythemia Vera
Deciphera Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Austria, Czechia, Italy, Portugal, Germany, France, Hungary, Spain, Poland
21/08/2026
Phase III
A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)
2025-524934-24-00Neoplasms, Gastrointestinal Stromal
Glaxosmithkline Research & Development Limited
Neoplasms
Italy, Portugal, Germany, Sweden, Poland, Romania, Finland, Greece, Norway, Spain, Netherlands, France, Hungary
21/08/2026
Phase III
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With ฮฑ- or ฮฒ-Nonโ€“Transfusion-Dependent Thalassemia (ENERGIZEKids)
2025-524706-15-00Non-Transfusion-Dependent Alpha- or Beta-Thalassemia
Agios Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Italy, Greece
21/08/2026
Phase III
A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigatorโ€™s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
2025-524641-27-00High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritโ€ฆ
K-Group Beta Inc.
Neoplasms
Germany, Spain, Italy, Belgium, Poland, France, Ireland
21/08/2026
Phase III
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With ฮฑ- or ฮฒ-Transfusion-Dependent Thalassemia (ENERGIZEKids-T)
2025-524707-71-00Transfusion-Dependent Alpha- or Beta-Thalassemia
Agios Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Italy, Greece
20/08/2026
Phase III
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
2025-523252-31-00High Risk Smoldering Multiple Myeloma (HR-SMM)
Regeneron Pharmaceuticals Inc.
Neoplasms
Italy, Spain, Poland, France, Norway, Greece, Germany
20/08/2026
Phase III
A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease (STGD) - NORTHSTAR
2026-525296-60-00Stargardt Disease (STGD1)
Alkeus Pharmaceuticals Inc.
Eye Diseases
Belgium, France, Spain, Italy, Germany
20/08/2026
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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

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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.