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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
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
45 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
A First-in-Human Study of KK2223 in Participants with T-cell Non-Hodgkin Lymphoma
2025-522523-96-00T-cell Non-Hodgkin Lymphoma, Cutaneous T-cell lymphoma (CTC…
Kyowa Kirin Inc.
Neoplasms
Spain, Italy
01/04/2026
Phase I
A study to investigate the safety, pharmacokinetics, pharmacodynamics, and immunogenicity of a CD19/CD20 T-cell engager in participants with B-cell driven ARD.
2025-522932-15-00Systemic Lupus Erythematosus
Glaxosmithkline Research & Development Limited
Immune System Diseases
Germany, France, Italy, Spain, Poland
23/03/2026
Phase I
A Phase 1a/1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of BG-75202, Alone and in Combination with Other Agents in Patients with Advanced Solid Tumors
2025-523553-34-00Advanced and Metastatic Solid tumors
BeOne Medicines I GmbH
Neoplasms
Italy, Spain
12/03/2026
Phase I
A Study to Evaluate the Safety and Tolerability of ARV-806 in Adults with Advanced Cancer that has the KRAS G12D Mutation
2025-521062-10-00KRAS G12D Mutated Advanced Solid Tumors
Arvinas Operations Inc.
Neoplasms
Spain, Italy
12/03/2026
Phase I
Safety and Preliminary Efficacy of CTX112 in Adult Participants with Relapsed/Refractory Hematologic Autoimmune Disease
2025-523845-90-00Relapsed/Refractory Hematologic Autoimmune Disease
CRISPR Therapeutics AG
Hemic and Lymphatic Diseases
Spain, Germany, France, Denmark, Italy, Netherlands
12/03/2026
Phase I
A Phase 1 Study of IM-1021 in Participants with Advanced Cancer
2025-523160-20-00Advanced B-cell lymphomas, Advanced solid tumors
Immunome Inc.
Neoplasms
France, Spain, Denmark, Italy
16/02/2026
Phase I
A Phase 1 Study of AJ1-11095 in Adults with Myelofibrosis Failed by a JAK2 Inhibitor
2025-522033-64-00Myelofibrosis
Ajax Therapeutics Inc.
Neoplasms
Italy, France, Spain
09/02/2026
Phase I
A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)
2025-523412-36-00Systemic lupus erythematosus, Rheumatoid arthritis
Merck Sharp & Dohme LLC
Immune System Diseases
Italy, Belgium, Romania
02/02/2026
Phase I
Study to look at the safety, tolerability, and how the body processes the study medicine WAL0623 after single or repeated doses, with or without food, in healthy volunteers
2024-516446-18-00Glomerular kidney diseases with proteinuria
Walden Biosciences Inc.
Male Urogenital Diseases
Italy
27/01/2026
Phase I
A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo® in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting
2025-521919-39-00Resected stage IIB, IIC, or III melanoma requiring adjuvant…
H e x a l AG
Neoplasms
Spain, Romania, Italy, Greece
27/01/2026
Phase I
A Phase 1, Open-Label, Multicenter Study of INCB160058 in Participants With Myeloproliferative Neoplasms.
2024-520353-21-00Myeloproliferative Neoplasms
Incyte Corp.
Neoplasms
Norway, Germany, France, Italy
14/01/2026
Phase I
A Phase I study to evaluate the safety and efficacy of L19IL2 in combination with ruxolitinib in patients with advanced solid tumors.
2025-522243-17-00Advanced solid tumors, specifically: • metastatic clear ce…
Philogen S.p.A.
Neoplasms
Italy
22/12/2025
Phase I
Open-label single dose trial to evaluate pharmacokinetics, safety, and acceptability/palatability of oveporexton in children from 6 years to less than 18 years of age with narcolepsy type 1 (NT1)
2025-522034-31-00Narcolepsy with Cataplexy (Narcolepsy Type 1)
Takeda Development Center Americas Inc.
Nervous System Diseases
Italy
27/11/2025
Phase I
AMG 410 Alone and in Combination with other agents in Participants with KRAS Altered Advanced or Metastatic Solid Tumors
2025-521707-48-00KRAS Altered Advanced or Metastatic Solid Tumors
Amgen Inc.
Neoplasms
France, Netherlands, Germany, Denmark, Spain, Italy, Belgium
28/10/2025
Phase I
Phase 1b Study of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-310)
2024-515903-21-00Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Amgen Inc.
Neoplasms
France, Germany, Spain, Greece, Hungary, Italy
30/09/2025
Phase I
A Phase 1/1b Open-Label Dose-Escalation and Dose-Optimization Study of Bcl-2 Inhibitor BGB 21447 in Patients With Mature B Cell Malignancies
2025-521600-21-00mature B-Cell malignancies
Beigene Ltd.
Neoplasms
France, Italy
29/09/2025
Phase I
A research study looking at how different doses of study medicine (Inno8) work in the body of people with haemophilia A
2025-520490-38-00Haemophilia A with or without inhibitors. Proposed indicati…
Novo Nordisk A/S
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Poland, Spain, Austria, Italy, Germany, Belgium, France, Portugal, Sweden
22/09/2025
Phase I
A Multicentre, Randomised Phase Ib Trial to evaluate Neoadjuvant Immunotherapy Combination of Nivolumab alone or plus Ipilimumab with the IL-2 Superkine MDNA11 alone or with Tocilizumab in Patients with High-Risk, Surgically Resectable Melanoma – NEO-CYT
2024-519010-31-00High-Risk, Surgically Resectable Melanoma
Fondazione Melanoma Onlus
Neoplasms
Italy
15/09/2025
Phase I
A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations
2025-521480-12-00Advanced solid tumors, Breast Cancer
Atavistik Bio Inc.
Neoplasms
Belgium, Italy, Spain, France
15/09/2025
Phase I
A Phase 1/1b Study of IAM1363 in HER2 Cancers
2024-519188-17-00Relapsed/refractory malignancy with documented diagnosis of…
Iambic Therapeutics Inc.
Neoplasms
Spain, France, Ireland, Italy, Netherlands
11/09/2025
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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.