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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 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 Clear sponsor filter
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
34 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, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression
2025-521299-76-00Relapsed or refractory acute leukaemia or Myelodysplastic S…
AstraZeneca AB
Neoplasms
Germany, Italy, Denmark
08/12/2025
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 III
A Phase III, Randomized, Open-Label, Multicenter, Global Study of Puxitatug Samrotecan (AZD8205) Monotherapy versus Physician’s Choice of Chemotherapy in Participants with B7-H4-Selected Advanced/Metastatic Endometrial Cancer Who Progressed On or After Platinum-Based Chemotherapy and Anti-PD-1/Anti-PD-L1 Therapy (Bluestar-Endometrial01)
2024-518777-34-00B7-H4-Selected Advanced/Metastatic Endometrial Cancer.
AstraZeneca AB
Neoplasms
Italy, Netherlands, Lithuania, Finland, Greece, Austria, Belgium, Hungary, Spain, Poland, Czechia, Germany, France, Denmark, Slovenia
17/11/2025
Phase III
A Randomised, Double-blind, Placebo-controlled, Phase III Study of Adjuvant Saruparib (AZD5305) in Patients with BRCAm Localised High-risk Prostate Cancer Receiving Radiotherapy with Androgen Deprivation Therapy (EvoPAR-Prostate02)
2024-513586-39-00Prostate Cancer
AstraZeneca AB
Male Urogenital Diseases
Austria, Sweden, Spain, France, Netherlands, Germany, Belgium, Finland, Hungary, Poland, Italy
12/11/2025
Phase II
An Open-label, Multinational Study Assessing the Efficacy and Safety of Dato-DXd Treatment in Patients With HR-positive, HER2 IHC 0, Locally Advanced Inoperable or Metastatic Breast Cancer Refractory to Endocrine Therapy (TROPION-Breast06)
2025-521904-23-00Locally Advanced Inoperable or Metastatic Breast Cancer Ref…
AstraZeneca AB
Neoplasms
Spain, France, Italy
05/11/2025
Phase II
A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization
2025-523009-14-00Bronchiectasis with chronic pseudomonas aeruginosa coloniza…
AstraZeneca AB
Respiratory Tract Diseases
Netherlands, Italy, Greece, Denmark, Belgium, Spain, France, Germany
31/10/2025
Phase III
A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
2024-518210-81-00Advanced Hepatocellular Carcinoma
AstraZeneca AB
Neoplasms
Italy, Germany, France, Poland, Spain, Netherlands
30/09/2025
Phase II
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Disea…
AstraZeneca AB
Respiratory Tract Diseases
Spain, Greece, Bulgaria, Germany, Denmark, Hungary, Italy, Poland
22/09/2025
Phase II
A Master Protocol for an Open-Label, Multi-Drug, Multi-Center, Phase II Platform Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Anti-Tumor Activity of Novel Agents or Combinations as Perioperative Treatment in Participants with Locally Advanced Resectable Gastroesophageal Adenocarcinoma (GEMINI-PeriOp GC)
2024-516909-23-00Locally Advanced Resectable Gastroesophageal Adenocarcinoma
AstraZeneca AB
Neoplasms
Italy, Spain
01/09/2025
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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

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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.