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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
ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy
2025-523576-23-00Unresectable Stage III non-small cell lung cancer without p…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
France, Ireland, Germany, Greece, Bulgaria, Spain, Netherlands, Italy, Sweden, Romania, Hungary, Belgium, Austria, Poland
22/05/2026
Phase II
A Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2/3 Study of EIK1001 in Combination with Pembrolizumab and Chemotherapy in Participants with Stage 4 Non-Small Cell Lung Cancer (TeLuRide-008).
2025-525013-23-00Stage 4 (IV) Non-Small Cell Lung Cancer (NSCLC)
Eikon Therapeutics Inc.
Neoplasms
Germany, Spain, Netherlands, Romania, Greece, Italy, Austria, Belgium, Bulgaria, France, Hungary, Poland
21/05/2026
Phase II
An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease
2025-524367-20-00Adult patients with primary mitochondrial disease
Pharming Technologies B.V.
Metabolism
Belgium, Germany, Czechia, Spain, Denmark, Italy, France
21/05/2026
Phase IV
Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
2026-525267-40-00Renal cell carcinoma
Centro Di Riferimento Oncologico Di Aviano
Neoplasms
Italy
21/05/2026
Phase II
An Open-Label, Rollover Study for Participants With Thyroid Eye Disease Previously Enrolled in Amgen-Sponsored AMG 732 Studies and are Primary Proptosis Non-responders or who Relapsed During the Safety Follow-up
2025-523280-38-00Thyroid Eye Disease
Amgen Inc.
Eye Diseases
Spain, Poland, France, Italy, Greece
20/05/2026
Phase I/II
An Open Label, Single Arm, Phase I/II Clinical Study of Autologous CD4+ T-Cells Edited Ex-Vivo at the CD40LG Locus by CRISPR/Cas9 and IDLV-based vector in Patients with X-linked Hyper IgM Syndrome Type 1 (HIGM1)
2025-524635-39-00X-linked immunodeficiency with hyper-IgM type 1 (HIGM1)
Fondazione Telethon Ets, San Raffaele Hospital
Immune System Diseases
Italy
20/05/2026
Phase III
A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa
2025-523259-72-00Hidradenitis Suppurativa (HS)
Novartis Pharma AG
Immune System Diseases
Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy
20/05/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Global Study with an Open-Label Extension to Evaluate the Efficacy and Safety of Intravenous AOC 1044 (delpacibart zotadirsen) for the Treatment of DMD with Gene Mutations Amenable to Exon 44 Skipping
2025-523087-20-00Duchenne muscular dystrophy
Avidity Biosciences Inc.
Musculoskeletal Diseases
Italy, Germany, France, Spain, Belgium, Poland, Netherlands
20/05/2026
Phase IV
Erdosteine effect on oxidative stress, inflammatory response and immune modulation in patients with COPD. A single center, open label, double arm, controlled, 4-week, explorative, ex vivo study.
2025-524821-42-00COPD
ASST Fatebenefratelli Sacco
Respiratory Tract Diseases
Italy
20/05/2026
Phase III
Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial
2025-524408-30-01Metastatic hormone-sensitive prostate cancer
Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard
Neoplasms
Spain, Germany, France, Portugal, Italy
19/05/2026
Phase III
A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
2025-521632-12-00Patients on Factor Xa inhibitor treatment needing an urgent…
VarmX B.V.
Hemic and Lymphatic Diseases
Belgium, Germany, Italy, France, Czechia, Bulgaria, Hungary, Spain, Netherlands, Poland, Austria, Estonia, Romania, Portugal, Lithuania
19/05/2026
Phase II
PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases
2025-523425-17-00Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Nutritional and Metabolic Diseases
Portugal, Greece, Italy, Poland, Estonia, Slovakia, Sweden, Denmark, Belgium, Norway, Romania, France, Spain, Germany, Netherlands, Croatia
19/05/2026
Phase II
An Open-label, Single-arm, Global Study of Perioperative Durvalumab With Cisplatin-based Neoadjuvant Chemotherapy in Patients With Muscle-Invasive Bladder Cancer (NIAGARA-2)
2024-519246-75-01Patients With Muscle-Invasive Bladder Cancer
AstraZeneca AB
Neoplasms
Italy, Spain, France, Netherlands
19/05/2026
Phase II
A Phase II, Open-Label Randomized Study of Intravenous Tambiciclib in Combination with the Standard of care Venetoclax and Azacitidine in Patients with Newly Diagnosed AML Who Failed to Achieve at Least MLFS After the First Two Cycles of Treatment with Venetoclax and Azacitidine Alone
2025-524308-31-00Acute myeloid leukemia
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l., IIS La Fe
Neoplasms
Italy, Spain
19/05/2026
Phase III
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
2025-523735-19-00Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp.
Neoplasms
Poland, France, Denmark, Norway, Spain, Germany, Belgium, Netherlands, Austria, Italy
19/05/2026
Phase IV
A Multicenter Randomized Controlled Trial Assessing the Efficacy and Safety of Recombinant Human Follicle Stimulating Hormone (r-hFSH-alfa originator) and Human Chorionic Gonadotropin (hCG) in Enhancing Sperm Concentration in Men with Oligozoospermia, Low Testosterone, and Normal FSH Serum Levels (APHRODITE Group 3): A Collaborative Research Initiative
2025-525005-20-00Male Infertility
Martin-Luther-Universitaet Halle-Wittenberg
Reproductive and Urinary Physiological Phenomena
Italy, Spain, Germany
18/05/2026
Phase II
A Phase 2a, Randomized, Open-Label, Active-Controlled, Crossover Study to Evaluate Safety and Explore Efficacy of Different Doses of New Lipase NHS7108 Administered Orally in Participants with Exocrine Pancreatic Insufficiency.
2025-521816-20-00​​Exocrine Pancreatic Insufficiency​
Aimmune Nestle Health Science US R&D LLC
Nutritional and Metabolic Diseases
Poland, Hungary, Spain, Bulgaria, Italy
18/05/2026
Phase I/II
A Phase 1/2 Study of BMS-986525 as Monotherapy and in Combination with Nivolumab in Participants with Relapsed/Refractory Small Cell Lung Cancer
2025-524090-16-00Relapsed/Refractory Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Italy, Spain, Romania
18/05/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
2025-524316-11-00Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Italy, Finland, Bulgaria, Greece, Belgium, Estonia, Portugal, Spain, Germany, France, Czechia, Slovakia, Romania, Croatia, Poland, Austria, Netherlands, Denmark, Sweden, Hungary
18/05/2026
Phase II
A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation
2025-522138-29-00Philadelphia positive Chronic Myeloid leukemia in Chronic P…
Novartis Pharma AG
Neoplasms
Spain, France, Germany, Poland, Italy, Netherlands, Greece, Hungary
18/05/2026
Phase IV
A pragmatic, phase IV, randomized, open-label, multinational, multicentre, 2-arm parallel group, prospective study comparing efficacy and safety of Single Inhaler ICS/LABA/LAMA (beclometasone/formoterol fumarate/glycopyrronium bromide [87/5/9 pMDI {BD/FF/GB - 100/6/12.5 µg}]) vs Single Inhaler ICS/LABA (beclometasone dipropionate plus formoterol fumarate [200/6 pMDI {BD/FF - 200/6 µg}]) in asthma subjects.
2025-524289-56-00Asthma
Chiesi Farmaceutici S.p.A.
Respiratory Tract Diseases
Germany, Romania, Italy, Bulgaria, Poland, Slovakia, Spain, France
18/05/2026
Phase III
A Phase 3 Randomized Study Comparing JNJ-79635322 and an Anti-BCMAxCD3 Bispecific Antibody in Participants With Relapsed or Refractory Multiple Myeloma who Have Received at Least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody
2025-522007-18-00Relapsed or Refractory Multiple Myeloma
Janssen Cilag International
Neoplasms
Spain, Norway, Germany, Greece, France, Italy, Netherlands
18/05/2026
Phase III
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%
2025-523586-18-00Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Portugal, Norway, Sweden, Bulgaria, France, Belgium, Austria, Germany, Finland, Poland, Romania, Netherlands, Spain, Italy, Hungary, Czechia
15/05/2026
Phase I/II
A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Checkpoint Inhibitor Naïve Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
2026-525248-13-00Advanced Solid Tumors
Eikon Therapeutics Inc.
Neoplasms
France, Spain, Norway, Italy, Germany, Austria, Poland, Finland, Belgium, Denmark, Portugal
15/05/2026
Phase II
A Phase 2, Open-label Study of JNJ-79635322 in Participants with Relapsed or Refractory Multiple Myeloma (RRMM) who Have Received at least 3 Prior Lines of Therapy Including a PI, an IMiD, and an Anti-CD38 Antibody
2025-521976-80-00Relapsed or Refractory Multiple Myeloma (RRMM)
Janssen Cilag International
Neoplasms
Poland, Italy
14/05/2026
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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.