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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
23 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
C6491013 - A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Once-Monthly PF-08653944 in Adults with Overweight or Obesity (VESPER 6)
2026-525318-75-00Overweight or Obesity
Pfizer Inc.
Nutritional and Metabolic Diseases
Spain, France, Germany, Italy
09/09/2026
Phase II
C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer
2025-524825-42-00Early-Stage Resectable or Locally Advanced Unresectable Non…
Pfizer Inc.
Neoplasms
Spain, France, Italy, Ireland, Germany, Poland
26/08/2026
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
C6461016 - A PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JUNCTION, OR ESOPHAGEAL ADENOCARCINOMA
2025-524717-86-00LOCALLY ADVANCED OR METASTATIC GASTRIC, GASTROESOPHAGEAL JU…
Pfizer Inc.
Neoplasms
France, Spain, Italy
07/07/2026
Phase II
C6461014 - A Phase 2 Interventional Study of PF-08634404 in Combination with Chemotherapy in Participants with Previously Untreated Transformed Small Cell Lung Cancer
2025-524686-24-00Small Cell Lung Cancer
Pfizer Inc.
Neoplasms
France, Italy, Spain
29/06/2026
Phase II
C4531031 - AN INTERVENTIONAL PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, THIRD PARTY-UNBLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE EFFICACY AND SAFETY OF PF-07275315 IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
2024-518587-12-00MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (C…
Pfizer Inc.
Respiratory Tract Diseases
Spain, Germany, Poland, Czechia, Greece, Italy, Bulgaria, France, Hungary
08/06/2026
Phase III
C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY
2025-523660-21-00severe to moderately severe hemophilia B (FIX:C ≤ 2%), hemo…
Pfizer Inc.
Hemic and Lymphatic Diseases
Italy, Germany, France, Spain, Sweden, Greece
20/04/2026
Phase I/II
C6461020 - An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in combination with Different Anticancer Agents in Participants with Advanced Solid Tumors
2025-523526-40-00Advanced Solid Tumors
Pfizer Inc.
Neoplasms
Italy, Spain, France, Germany
09/04/2026
Phase I/II
C6461013 - An Interventional Open-label Phase 1b/2 Study to Evaluate Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 as Monotherapy and Combination Therapy in Adult Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma
2025-523525-17-00Unresectable Locally Advanced or Metastatic Hepatocellular …
Pfizer Inc.
Neoplasms
Spain, Italy, Germany, France
09/04/2026
Phase III
C6461004 - A GLOBAL PHASE 2/3 INTERVENTIONAL STUDY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY IN PARTICIPANTS WITH EXTENSIVE-STAGE SMALL CELL LUNG CANCER
2025-523522-41-00Extensive-Stage Small Cell Lung Cancer
Pfizer Inc.
Neoplasms
France, Italy, Germany, Spain
07/04/2026
Phase III
AN INTERVENTIONAL PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS PEMBROLIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN ADULT PARTICIPANTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
2025-523461-17-01LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER
Pfizer Inc.
Neoplasms
France, Italy, Hungary, Greece, Czechia, Spain, Poland, Germany
24/03/2026
Phase III
C6461003 - AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER
2025-523521-18-00Metastatic Colorectal Cancer
Pfizer Inc.
Neoplasms
Spain, Belgium, France, Italy, Netherlands, Germany, Poland, Denmark
23/03/2026
Phase II
C5041018 - A Phase 2 Open-Label, Single Arm Study to Evaluate the Efficacy, Pharmacokinetics, and Safety of Etrasimod in Pediatric Participants with Moderately to Severely Active Ulcerative Colitis
2025-523100-77-00Ulcerative Colitis
Pfizer Inc.
Digestive System Diseases
Finland, Poland, France, Germany, Italy, Slovakia
27/02/2026
Phase III
C2321008: A PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF MEVROMETOSTAT (PF-06821497) WITH ENZALUTAMIDE IN METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER (MEVPRO-3)
2024-519369-24-00METASTATIC CASTRATION-SENSITIVE PROSTATE CANCER
Pfizer Inc.
Not possible to specify
Belgium, Finland, France, Germany, Netherlands, Bulgaria, Spain, Slovakia, Italy, Czechia, Poland, Greece
22/12/2025
Phase III
C3651021: A PHASE 2b/3, RANDOMIZED, DOUBLE-BLIND STUDY TO INVESTIGATE THE EFFICACY, SAFETY, AND TOLERABILITY OF PONSEGROMAB (PF-06946860) COMPARED WITH PLACEBO BOTH WITH BACKGROUND FIRST-LINE CHEMOTHERAPY IN ADULT PARTICIPANTS WITH CACHEXIA AND METASTATIC PANCREATIC DUCTAL ADENOCARCINOMA
2025-522093-36-00Cancer cachexia
Pfizer Inc.
Nutritional and Metabolic Diseases
Slovakia, Italy, Belgium, Germany, Spain, France, Bulgaria, Poland
16/12/2025
Phase II
C5001004 - A Phase 2, Open-Label Extension Study to Investigate the Safety and Efficacy of PF-07868489 Administered to Adult Participants With Pulmonary Arterial Hypertension
2025-521155-23-00Pulmonary Arterial Hypertension
Pfizer Inc.
Cardiovascular Diseases
Italy, Czechia, Germany, Greece, Spain, Belgium, France
02/12/2025
Phase I/II
C5731006 - A PHASE 1B/2, OPEN-LABEL, MULTICOHORT STUDY OF DISITAMAB VEDOTIN IN ADULTS WITH HER2 EXPRESSING ADVANCED BREAST CANCER
2025-521003-52-00HER2 Expressing Advanced Breast Cancer
Pfizer Inc.
Neoplasms
Germany, Spain, Italy
18/11/2025
Phase III
C5851005 - PADLINK-005: A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY TO EVALUATE PF-08046054/SGN-PDL1V VERSUS DOCETAXEL IN ADULT PARTICIPANTS WITH PREVIOUSLY-TREATED PROGRAMMED CELL DEATH LIGAND 1 (PD-L1) POSITIVE NON-SMALL-CELL LUNG CANCER (NSCLC)
2025-521281-97-00Non-Small Cell Lung Cancer (NSCLC)
Pfizer Inc.
Neoplasms
Greece, Italy, Belgium, Slovakia, Czechia, Germany, France, Poland, Denmark, Spain, Netherlands, Sweden, Finland, Bulgaria
17/11/2025
Phase III
C4551002 - An Interventional, Open-Label, Randomized, Multicenter, Phase 3 Study of PF-07248144 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Adult Participants with Hormone Receptor-Positive, HER2-Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK4/6 Inhibitor-based Therapy
2025-520566-22-00Hormone Receptor-Positive, HER2-Negative Advanced/Metastati…
Pfizer Inc.
Neoplasms
Hungary, Bulgaria, Czechia, Slovakia, Netherlands, Spain, Greece, Finland, Belgium, Sweden, Poland, Germany, France, Italy
20/10/2025
Phase III
B7981027 - A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RITLECITINIB IN PEDIATRIC PARTICIPANTS 6 TO LESS THAN 12 YEARS OF AGE WITH SEVERE ALOPECIA AREATA
2024-515438-33-00Alopecia areata
Pfizer Inc.
Immune System Diseases
Spain, France, Czechia, Italy, Poland
14/10/2025
Phase III
B7981028 - A LONG-TERM, DOUBLE-BLIND EXTENSION STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF RITLECITINIB IN PARTICIPANTS WITH SEVERE ALOPECIA AREATA WHO PREVIOUSLY COMPLETED STUDIES B7981027 OR B7981031
2024-515439-31-00Alopecia areata
Pfizer Inc.
Immune System Diseases
Italy, France, Czechia, Poland, Spain
14/10/2025
Phase III
C4951063: An interventional efficacy and safety, Phase 3, double-blind, parallel group study to investigate intermittent prevention of Menstrual Migraine with Rimegepant compared with placebo in women participants 18 to 45 years of age
2024-517121-10-00Menstrual Migraine
Pfizer Inc.
Nervous System Diseases
Netherlands, Italy, Poland, Denmark, Germany, Spain
06/10/2025
Phase II
C4531029:A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Dose-Ranging Study to Investigate the Efficacy and Safety of PF-07275315 in Adult Participants with Inadequately Controlled Moderate-to-Severe Asthma
2024-517866-40-00Moderate-to-severe Asthma
Pfizer Inc.
Respiratory Tract Diseases
Belgium, Hungary, Spain, Bulgaria, Italy, Poland, Czechia
26/08/2025
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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.