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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
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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
742 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
A First-in-Human Study of INCA035784 in Participants With Myeloproliferative Neoplasms
2026-525360-18-00Myeloproliferative Neoplasms
Incyte Corp.
Neoplasms
Italy, Belgium, Germany
03/08/2026
Phase III
A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)
2025-523884-39-00Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Skin and Connective Tissue Diseases
Denmark, Hungary, Sweden, Netherlands, Germany, Belgium, France, Greece, Norway, Finland, Czechia, Portugal, Bulgaria, Spain, Austria, Romania, Croatia, Poland, Estonia, Italy, Lithuania
03/08/2026
Phase III
A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease
2026-525922-39-00Moderately to Severely Active Crohn’s Disease
Janssen Cilag International
Immune System Diseases
Norway, Romania, Austria, Italy, Slovakia, Germany, Hungary, Netherlands, Belgium, France, Portugal, Czechia, Poland, Spain, Greece
03/08/2026
Phase III
A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis
2026-525923-26-00Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International
Immune System Diseases
France, Bulgaria, Romania, Slovakia, Norway, Denmark, Greece, Italy, Austria, Poland, Netherlands, Czechia, Germany, Belgium, Spain, Hungary, Portugal
03/08/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)
2026-526304-79-00Heart failure with preserved ejection fraction (HFpEF) and …
AstraZeneca AB
Cardiovascular Diseases
Spain, Hungary, Germany, Poland, Italy, Bulgaria, Netherlands, Austria, Romania, Sweden, France, Greece, Slovakia, Czechia
29/07/2026
Phase I
A Phase 1 Study of PRT12396 in Participants with Select Myeloproliferative Neoplasms
2026-525484-40-00Post-Essential Thrombocythemia Myelofibrosis, Post-Polycyth…
Prelude Therapeutics Inc.
Neoplasms
Italy, France, Spain
27/07/2026
Phase III
A Randomized Controlled Study Evaluating Short-Term Dual Antiplatelet Therapy with Low-Dose Ticagrelor (60 mg) Followed by Monotherapy versus Standard-Duration Dual Antiplatelet Therapy with Clopidogrel in Patients with Chronic Coronary Syndrome Undergoing Percutaneous Coronary Intervention: the STELAR trial
2026-526368-18-00Chronic Coronary Syndrome in patients undergoing percutaneo…
Azienda Ospedaliera Universitaria Gaetano Martino Messina
Cardiovascular Diseases
Italy
27/07/2026
Phase III
A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes
2025-522488-14-00Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Greece, Portugal, France, Slovakia, Bulgaria, Netherlands, Romania, Italy, Austria, Poland, Hungary, Spain, Czechia, Belgium
27/07/2026
Phase III
4TAZPower: A Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients with Genetically Confirmed Barth Syndrome
2025-523837-25-00Barth Syndrome
Stealth Biotherapeutics Inc.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Ireland, Netherlands, France, Italy
27/07/2026
Phase I/II
Phase I/II Trial to Determine Safety and Efficacy of non-Viral Allogeneic Dual CD123/33-Chimeric Antigen Receptor CIK (CARCIK-CD123/33) Cells in Adult and Pediatric Patients with Relapse/Refractory Acute Myeloid Leukemia (AML) and Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)
2025-524977-18-00Acute myeloid leukemia and Blastic plasmacytoid dendritic c…
Fondazione Tettamanti, Fondazione IRCCS San Gerardo Dei Tintori
Neoplasms
Italy
27/07/2026
Phase III
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)
2025-523819-11-00Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Italy, Greece, Spain, Belgium, France, Austria, Germany
27/07/2026
Phase III
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)
2025-524688-19-00Participants Living with Obesity or Overweight with at leas…
AstraZeneca AB
Nutritional and Metabolic Diseases
Spain, Germany, Italy, Poland
27/07/2026
Phase III
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
2025-523960-19-00Advanced or Metastatic HR+/HER2- Breast Cancer
BeOne Medicines I GmbH
Neoplasms
Poland, Italy, Germany, France, Spain
27/07/2026
Phase III
An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam
2025-524054-34-00Spinal Muscular Atrophy
Biogen Idec Research Limited
Nervous System Diseases
Finland, Spain, Italy, Poland, Ireland, Germany, France
24/07/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)
2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…
AstraZeneca AB
Cardiovascular Diseases
Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany
24/07/2026
Phase II
Immune dynamics and biomarkers of anti-tumor response in BMS-986340 (anti-CCR8) and nivolumab (anti-PD-1) co-treatment of metastatic tumors
2025-524125-40-01Metastatic solid tumors, with the following specific indica…
Humanitas Mirasole S.p.A., Fondazione Humanitas Per La Ricerca Ets
Neoplasms
Italy
23/07/2026
Phase II
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of SIR9900 in Patients with VEXAS Syndrome (SIVEX)
2025-524918-28-00VEXAS Syndrome
Sironax USA Inc.
Immune System Diseases
Italy
23/07/2026
Phase III
A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia
2025-524282-24-00Classic Congenital Adrenal Hyperplasia (CAH)
Neurocrine Biosciences Inc.
Hormonal diseases
Czechia, Germany, Sweden, Portugal, Romania, Bulgaria, Italy, Austria, Spain
23/07/2026
Phase I/II
A Phase 1/2, dose escalation and expansion study of TRI-611, an oral ALK molecular glue degrader in participants with advanced ALK-positive NSCLC
2025-524418-27-00Advanced ALK-positive NSCLC
Triana Biomedicines Inc.
Respiratory Tract Diseases
France, Italy, Germany, Spain
22/07/2026
Phase I/II
A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis
2025-520666-22-00Refractory, difficult-to-treat Rheumatoid Arthritis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Poland, Italy, Spain, Germany
22/07/2026
Phase III
A Randomized, Open-label, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Oral Semaglutide in Adults with Type 2 Diabetes Mellitus (Eluminate-2)
2025-523933-24-00type 2 diabetes mellitus
AstraZeneca AB
Nutritional and Metabolic Diseases
Poland, Hungary, Italy, Bulgaria, Germany
22/07/2026
Phase II
A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)
2025-523390-42-00Early-Stage Down Syndrome-Associated Alzheimer’s Disease (D…
Alnylam Pharmaceuticals Inc.
Nervous System Diseases
Italy, Netherlands, Spain, Germany, Ireland
22/07/2026
Phase I
Phase 1/1b Study of BMS-986463 in Advanced Malignant Tumors
2025-523067-38-01Advanced Malignant Tumors; High-grade Serous Ovarian Carcin…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Spain, France, Italy
21/07/2026
Phase III
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
2026-525242-29-00Primary Sclerosing Cholangitis
Ipsen Bioscience Inc.
Digestive System Diseases
Spain, Sweden, Germany, Romania, Finland, Portugal, Austria, Italy, Denmark, Czechia, France, Netherlands, Poland, Belgium, Norway
21/07/2026
Phase II
A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)
2025-522803-60-00newly diagnosed amyloid light chain amyloidosis
Glaxosmithkline Research & Development Limited
Immune System Diseases
Italy, Greece, Spain
21/07/2026
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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.