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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
66 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I/II
A Modular Phase I/II Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)
2025-522371-29-00Non-Hodgkin lymphoma (NHL)
AstraZeneca AB
Hemic and Lymphatic Diseases
Italy
18/11/2025
Phase I/II
C5731006 - A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER
2025-521003-52-00HER2 Expressing Advanced Breast Cancer
Pfizer Inc.
Neoplasms
Germany, Spain, Italy
18/11/2025
Phase I/II
A Phase I/II, Open-Label, Multicenter Study of ALE.P03 (Claudin-1 Targeted Antibody-Drug Conjugate) as a Monotherapy in Adult Patients with Selected Advanced or Metastatic CLDN1+ Solid Tumors
2025-521441-24-00Advanced or Metastatic Solid Tumors
Alentis Therapeutics AG
Neoplasms
Spain, France, Netherlands, Italy
12/11/2025
Phase I/II
A Phase I/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, and pharmacokinetics of BNT323 in combination with BNT327 in participants with advanced breast cancer
2024-517979-20-00Advanced Breast Cancer Metastatic Breast Cancer
BioNTech SE
Neoplasms
Italy, Spain, France
11/11/2025
Phase I/II
(22931) A first-in-human study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics and preliminary clinical activity of BAY 3713372, a novel 2nd generation PRMT5 inhibitor, in participants with MTAP-deleted solid tumors.
2025-520623-24-00MTAP-deleted Solid Tumors
Bayer AG
Neoplasms
Belgium, Sweden, Denmark, Italy, Spain, Netherlands, Czechia
04/11/2025
Phase I/II
A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.
2024-520197-36-00Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
Estonia, Czechia, Spain, Romania, Italy, Denmark, Belgium, Greece
03/11/2025
Phase I/II
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors
2024-517261-16-00Advanced solid tumors
BioNTech SE
Neoplasms
Belgium, Germany, Spain, Italy
17/10/2025
Phase I/II
A Phase 1/2, Open-Label, Dose Finding Study to Investigate the Safety, Tolerability, and Efficacy of ALXN2350 Gene Therapy in Adult Participants with Symptomatic BAG3 Mutation-Associated Dilated Cardiomyopathy
2024-519674-40-00BAG3 Mutation Associated Dilated Cardiomyopathy
Alexion Pharmaceuticals Inc.
Cardiovascular Diseases
Spain, Italy, Germany
16/10/2025
Phase I/II
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma
2024-517140-65-00Multiple Myeloma (MM).
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Belgium, Portugal, Sweden, Italy, France, Poland, Germany
06/10/2025
Phase I/II
An open-label, Phase 1/2, multicenter study of belumosudil in children aged 1 to <18 years requiring systemic treatment for active moderate-to-severe chronic graft versus host disease (cGVHD).
2024-511508-18-00Chronic graft versus host disease.
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
France, Italy, Belgium, Spain, Netherlands, Germany
30/09/2025
Phase I/II
A single-arm, open-label, phase I/II clinical trial of autologous hematopoietic stem and progenitor cells (HSPCs) genetically modified with a lentiviral vector (LVV) encoding for the human programmed death-ligand 1 (hPD-L1) complementary deoxyribonucleic acid (cDNA) for the treatment of patients with type 1 diabetes (T1D) at recent onset and with residual ฮฒ-cell function (Immunostem)
2025-521304-21-00Type 1 diabetes
Altheia Science S.r.l.
Nutritional and Metabolic Diseases
Italy
30/09/2025
Phase I/II
A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial of Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in Participants with Advanced or Metastatic Non-small Cell Lung Cancer whose Tumors Express PD-L1 with Tumor Proportion Score โ‰ฅ50% Without Actionable Genomic Alterations
2024-519671-26-00Advanced or Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo Inc.
Neoplasms
Spain, France, Italy
29/09/2025
Phase I/II
A phase 1/2, open label, multicenter clinical trial investigating the safety, tolerability, pharmacokinetics, and antineoplastic activity of S095035 (MAT2A inhibitor) as a single agent and in combination in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP
2025-521249-25-00MTAP-deleted advanced or metastatic solid tumors
Institut De Recherches Internationales Servier IRIS
Neoplasms
Denmark, Italy, Germany, Spain, France
26/09/2025
Phase I/II
A Phase 1b/2, Open-Label, Master Protocol Study of BTK-Degrader BGB-16673 in Combination With Other Agents in Patients With Relapsed or Refractory B-Cell Malignancies
2024-516234-35-00Relapsed or Refractory B-Cell Malignancies
BeOne Medicines AG
Neoplasms
Italy, Germany, Poland
23/09/2025
Phase I/II
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
2024-514110-12-00Thyroid Eye Disease
Amgen Inc.
Eye Diseases
France, Spain, Italy, Poland, Germany, Greece
15/09/2025
Phase I/II
A Phase 1b/2, multicenter, open-label study to evaluate the efficacy and safety of GSK5764227 alone and in combination in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors
2025-520672-26-00Gastrointestinal Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
Belgium, Italy, Norway, Finland, Poland, Netherlands, Germany, Spain, France, Sweden
27/08/2025
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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.