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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
742 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
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 II
A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab
2025-524591-30-00Hepatocellular Carcinoma
Akeso Biopharma Co. Ltd.
Neoplasms
Poland, France, Spain, Italy
18/08/2026
Phase I
A clinical trial to learn about the effects of INR731 alone or with an androgen receptor pathway inhibitor (ARPI) in men with prostate cancer
2025-524080-20-00Metastatic castration resistant prostate cancer
Novartis Pharma AG
Neoplasms
France, Italy, Spain, Germany
17/08/2026
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 I/II
A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphomas (B-NHL)
2025-524915-36-00Lymphoma, Non-Hodgkin
Glaxosmithkline Research & Development Limited
Neoplasms
Italy, Germany, Spain, Finland, France
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 II
A phase IIa open-label dose-finding study with lead-in phase evaluating the safety, pharmacokinetics, and attenuating effects of trazodone on the consciousness-altering effects of psilocybin in individuals with Treatment-Resistant Depression
2025-523346-27-00Treatment-Resistant Depression
Universita' Degli Studi G. D'Annunzio Di Chieti
Mental Disorders
Italy
14/08/2026
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 II
Denosumab or Zoledronic acid for erosive hand osteoarthritis (EHOA) in patients with osteoporosis a randomized controlled trial (ZODIAC trial)
2026-526828-41-00Erosive hand osteoarthritis (EHOA)
Azienda Ospedaliera Universitaria Integrata Verona
Musculoskeletal Diseases
Italy
14/08/2026
Phase II
A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)
2025-525033-31-00heart failure
Cardurion Pharmaceuticals Inc.
Cardiovascular Diseases
Latvia, Slovakia, Lithuania, Hungary, Italy, Netherlands, Spain, Poland, Bulgaria, Czechia
14/08/2026
Phase II
A TWO-STAGE, SINGLE-ARM, PHASE II STUDY OF ZONGERTINIB PLUS FULVESTRANT IN PARTICIPANTS WITH HORMONE RECEPTOR-POSITIVE/HER2-NEGATIVE ADVANCED BREAST CANCER HARBORING HER2 MUTATIONS (AGATHA)
2026-525328-10-00HR-positive/HER2-negative advanced breast cancer
Medica Scientia Innovation Research S.L.
Neoplasms
Spain, Italy, Germany
13/08/2026
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 IV
A randomized, double blind, placebo-controlled study comparing the efficacy of dupilumab to standard of care (SOC) treatment following hospitalization for a COPD exacerbation
2025-524392-23-00Chronic obstructive pulmonary disease (COPD)
Regeneron Pharmaceuticals Inc.
Respiratory Tract Diseases
Belgium, Italy, Spain
13/08/2026
Phase II
AN OPEN LABEL, SINGLE ARM, EXPLORATIVE TRIAL TO EVALUATE EFFICACY AND SAFETY OF BEROTRALSTAT IN PREVENTING ANGIOEDEMA ATTACKS IN SUBJECTS WITH ACQUIRED ANGIOEDEMA DUE TO C1 INHIBITOR DEFICIENCY (AAE)
2025-524747-13-00Acquired angioedema due to C1 inhibitor deficiency
Policlinico San Donato S.p.A.
Genetic Phenomena
Italy
12/08/2026
Phase II
A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL OF COLCHICINE IN AMYOTROPHIC LATERAL SCLEROSIS (CO-ALS II)
2026-526460-20-00AMYOTROPHIC LATERAL SCLEROSIS
Azienda Ospedaliero Universitaria Di Modena
Musculoskeletal Diseases
Italy
12/08/2026
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 I
A dose escalation and expansion study of XB010 as a single agent and combination therapy in subjects with locally advanced or metastatic solid tumors
2025-524805-34-00Locally Advanced or Metastatic Solid Tumors
Exelixis Inc.
Neoplasms
Italy, Netherlands, France, Spain
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 II
Valproic acid and lenvatinib in Recurrent and/or Metastatic Adenoid Cystic Carcinoma
2026-525733-24-00Recurrent and/or Metastatic Adenoid Cystic Carcinom
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neoplasms
Italy
11/08/2026
Phase I
A Phase 1, Open-Label, Multicenter Study of INCA036978 in Participants With Myeloproliferative Neoplasms
2026-525217-31-00Myeloproliferative Neoplasms
Incyte Corp.
Neoplasms
Italy, Belgium, Germany, France, Spain
10/08/2026
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 II
[22961] A placebo-controlled, parallel-group, double blind, randomized, multi-cohort Phase 2 study to investigate efficacy, safety, tolerability, pharmacodynamics and pharmacokinetics of BAY 3670549 in adult participants with atrial fibrillation.
2025-523807-31-00Atrial fibrillation
Bayer AG
Cardiovascular Diseases
Belgium, Netherlands, Germany, Poland, Italy, Hungary, Bulgaria
06/08/2026
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 II
A Phase IIb Study to Evaluate the Efficacy, Safety, and Tolerability of AZD8965 in Participants with Idiopathic Pulmonary Fibrosis (IPF)) (ARGiNAUT)
2025-525016-41-00Idiopathic Pulmonary Fibrosis
AstraZeneca AB
Respiratory Tract Diseases
Poland, Hungary, Netherlands, Germany, Spain, Greece, Bulgaria, Italy, France, Denmark
04/08/2026
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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.