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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
362 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
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
Phase III
Impact of Hyperthermic Intrathoracic Chemotherapy (HITHOC) and Pleurectomy in the local treatment of pleural tumors. A Prospective Randomized Study The Tic-Tac Trial
2026-526109-13-00malignant pleural effusion
Universita' Degli Studi Di Torino
Neoplasms
Italy
20/08/2026
Phase III
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524756-54-00Ocular Myasthenia Gravis
UCB Biopharma
Immune System Diseases
Hungary, Greece, Italy, Spain, Germany, Poland, France
18/08/2026
Phase III
C4931007 - A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
2025-523447-35-02Pneumoccoccal Immunisation
Pfizer Inc.
Bacterial Infections and Mycoses
Spain, Finland, Poland, Germany, Greece, Hungary, Italy
17/08/2026
Phase III
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
2025-524445-27-00Metastatic castration-resistant prostate cancer (mCRPC)
BioNTech SE
Male Urogenital Diseases
Belgium, Spain, Italy, Poland, Germany, Hungary
17/08/2026
Phase III
The HCC patient-journey study: a prospective, adaptive, master protocol, to assess the value of the available sequences of treatment for patients with advanced hepatocellular carcinoma. The Journey of liver cancer patient - J-LI
2026-525898-39-00Advanced hepatocellular carcinoma
Azienda Sanitaria Locale Napoli 1 Centro
Neoplasms
Italy
14/08/2026
Phase III
SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients
2025-523444-12-00Breast Cancer
AstraZeneca AB
Neoplasms
Poland, Spain, France, Germany, Italy
13/08/2026
Phase III
Premedication with dexamethasone for preventing interstitial lung disease in patients with breast cancer treated with trastuzumab deruxtecan
2025-521798-15-00Breast Cancer
Istituto Di Ricerche Farmacologiche Mario Negri
Neoplasms
Italy
11/08/2026
Phase III
A multicentre randomised study on percutaneous stellate ganglion block as first line treatment in patients with electrical storm: the STAR 2 study
2024-520387-34-01electrical storm
Fondazione IRCCS Policlinico San Matteo
Cardiovascular Diseases
Italy
11/08/2026
Phase III
A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs
2025-523333-26-00Graves' Disease (GD)
Argenx
Hormonal diseases
Italy, Czechia, Spain, Denmark, Belgium, Romania, Latvia, France, Germany, Greece, Sweden, Poland, Lithuania, Bulgaria
07/08/2026
Phase III
ROSY-F: Roll-Over Study for Participants Who Have Completed a Previous Study with Benralizumab (Fasenra) and Are Judged by the Investigator to Clinically Benefit from Continued Treatment
2025-523307-29-00Eosinophilic Granulomatosis with Polyangiitis (EGPA), Hyper…
AstraZeneca AB
Respiratory Tract Diseases
Denmark, Belgium, France, Italy, Netherlands, Austria, Poland
04/08/2026
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 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 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 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 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
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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.