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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
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 587 Netherlands 524 Belgium 426 Czechia 327
All 28 states
66 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I/II
A two-part study: open label, dose escalation phase aimed to evaluate the safety and tolerability of two different doses of allogeneic fibroblasts for the treatment of chronic refractory wounds and identifying the best dose for subsequent cohort expansion phase aimed to assess efficacy and confirm safety and tolerability
2025-522647-17-00Refractory wounds
Hmg Biologics S.r.l.
Skin and Connective Tissue Diseases
Italy
15/04/2026
Phase I/II
A Phase 1/2 open-label, multicenter study of oral GSK5460025 alone or in combination with other anti-cancer agents in adult participants with Mismatch Repair-deficient (dMMR) or Microsatellite Instability-High (MSI-H) solid tumors.
2025-522318-21-00Neoplasms, Colorectal
Glaxosmithkline Research & Development Limited
Neoplasms
Italy, Denmark, Spain, Sweden, Netherlands, France
14/04/2026
Phase I/II
An Open-label, Multicenter, Two Part, Ascending Dose Followed by a Controlled Trial to Assess the Safety and Efficacy of a Subretinal Administration of AAVB-039 in Participants with Stargardt Disease (STGD1) (CELESTE)
2025-522207-15-01Stargardt Disease (STGD1)
Aavantgarde Bio S.r.l.
Eye Diseases
Belgium, Italy, Netherlands, Norway
10/04/2026
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 I/II
A Phase Ib/II Open-Label, Multicentre Platform Study Evaluating Novel Combinations in Participants with Advanced or Metastatic Non-Small Cell Lung Cancer (ALTAIR)
2024-519786-22-01metastatic non-small cell lung cancer (NSCLC)
AstraZeneca AB
Neoplasms
Germany, Spain, France, Poland, Belgium, Netherlands, Italy
30/03/2026
Phase I/II
A Phase Ib/II, Multicenter, Open-Label Study to Evaluate Safety, Efficacy, and Pharmacokinetics of YL201 in Combination with Other Anti-Cancer Therapies in Patients with Advanced Solid Tumors
2025-523742-27-00Advanced solid tumors
Medilink Therapeutics (Suzhou) Co. Ltd.
Neoplasms
Poland, Spain, France, Romania, Italy, Belgium, Hungary, Germany
17/03/2026
Phase I/II
An Adaptive Dose Escalation and Expansion Basket Trial to Explore the Safety, Pharmacology, and Clinical Activity of TGD001 in Immune-Mediated Thrombotic Thrombocytopenic Purpura (iTTP) and Other Thrombotic Microangiopathies
2025-523802-34-00Immune-Mediated Thrombotic Thrombocytopenic Purpura, Thromb…
TargED Biopharmaceuticals B.V.
Hemic and Lymphatic Diseases
Germany, France, Italy, Spain
06/03/2026
Phase I/II
A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
2025-521859-23-00PSMA-positive mCRPC with prior exposure to at least one pri…
Novartis Pharma AG
Neoplasms
Germany, France, Spain, Italy
05/03/2026
Phase I/II
Protocol Title: KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Previously Treated of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
2024-512248-47-00Non-small Cell Lung Cancer (NSCLC)
Merck Sharp & Dohme LLC
Neoplasms
Italy, Germany, Greece, Poland, Hungary, Spain
04/03/2026
Phase I/II
A Phase Ib/II, multi-site, open-label, two-part trial to evaluate the efficacy, safety, pharmacokinetics, and recommended combination dose of BNT324 with BNT327 in participants with advanced lung cancer
2024-520238-31-01Advanced Lung Cancer
BioNTech SE
Neoplasms
Spain, France, Italy, Poland
24/02/2026
Phase I/II
A Phase 1b/2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Investigate A) the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Doses of IM-101 in Adult Participants with Generalized Myasthenia Gravis, and B) the Efficacy and Safety of Treatment of IM-101 in Adult Participants with Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
2025-522406-20-00Generalized Myasthenia Gravis and Ocular Myasthenia Gravis
Immunabs Inc.
Nervous System Diseases
Bulgaria, Poland, Spain, Italy
18/02/2026
Phase I/II
A Phase 1/2, Multicenter, Open-Label, Multi-Cohort, First-in Human Trial of DS3790a, a DXd-ADC targeting CD37, for Hematological Malignancies.
2025-522595-87-00Hematological Malignancies
Daiichi Sankyo Inc.
Neoplasms
France, Italy
16/02/2026
Phase I/II
A Phase 1b/2 Study to Investigate the Safety, Efficacy and Pharmacokinetics of Administration of Subcutaneous (SC) Blinatumomab in Pediatric Participants with Relapsed/Refractory (R/R) and Minimal Residual Disease Positive (MRD+) B Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)
2025-521671-31-00Relapsed/Refractory (R/R) and Minimal Residual Disease Posi…
Amgen Inc.
Neoplasms
France, Netherlands, Italy
13/02/2026
Phase I/II
Phase 1/2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-4321 in Healthy Participants and Participants With Chronic Hepatitis Delta.
2025-522729-36-00Chronic Hepatitis Delta.
Gilead Sciences Inc.
Virus Diseases
Italy, Romania, Germany, Bulgaria
09/02/2026
Phase I/II
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy Who are ≥18 to ≤65 Years
2024-513579-42-00Type 1 Myotonic Dystrophy
Sarepta Therapeutics Inc.
Nervous System Diseases
Spain, Germany, Belgium, Italy
29/01/2026
Phase I/II
A First-in-Human, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of Intrathecally Administered LTX-002 in Adult Participants with Amyotrophic Lateral Sclerosis
2025-522039-33-00Amyotrophic Lateral Sclerosis
Leal Therapeutics Inc.
Nervous System Diseases
Sweden, Italy, Germany, Netherlands
23/01/2026
Phase I/II
Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
2025-520467-40-00High-risk non-muscle invasive bladder cancer (NMIBC) with c…
Merck Sharp & Dohme LLC
Neoplasms
Belgium, Greece, Austria, Spain, Norway, Netherlands, Italy, France
22/12/2025
Phase I/II
TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer
2025-521873-15-00Metastatic hormone-sensitive prostate cancer
Novartis Pharma AG
Neoplasms
Hungary, Spain, Italy, Germany, France
18/12/2025
Phase I/II
A Modular Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of AZD0516 as Monotherapy and in Combination with Anti-cancer Agents in Participants with Metastatic Prostate Cancer.
2024-520026-11-00Metastatic Prostate Cancer
AstraZeneca AB
Neoplasms
Italy, Spain, Poland
12/12/2025
Phase I/II
A Modular Phase I/II, Open-label, Multi-Centre Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of AZD3632 Monotherapy or in Combination With Anticancer Agents in Participants with Advanced Haematologic Malignancies with KMT2Ar, NPM1m, or Other Genotypes Associated with HOX Overexpression
2025-521299-76-00Relapsed or refractory acute leukaemia or Myelodysplastic S…
AstraZeneca AB
Neoplasms
Germany, Italy, Denmark
08/12/2025
Phase I/II
A Phase Ib/II, multi-site, open-label, dose finding trial to evaluate the safety, efficacy, and pharmacokinetics of BNT326 in combination with BNT327 in participants with advanced non-small cell lung cancer (NSCLC)
2024-519344-32-00Non-small Cell Lung Cancer
BioNTech SE
Neoplasms
Poland, Germany, Italy, Spain
02/12/2025
Phase I/II
TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer
2025-521880-10-00Metastatic castrate resistant prostate cancer (mCRPC)
Novartis Pharma AG
Neoplasms
Italy, Germany, Poland, France, Denmark, Spain
01/12/2025
Phase I/II
A Phase Ib/ II Multicenter, Open-Label, Randomized Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-4198 Alone and in Combination with Giredestrant in Comparison with Abemaciclib and Giredestrant in Participants with Locally Advanced or Metastatic Estrogen Receptor-Positive, HER2-Negative Breast Cancer who Have Previously Progressed During or After a CDK4/6 Inhibitor
2025-521128-31-00Locally Advanced or Metastatic Estrogen Receptor-Positive, …
Genentech Inc.
Neoplasms
Spain, Italy, France, Germany
26/11/2025
Phase I/II
A Phase 1/2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants with Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors
2025-521672-60-00Metastatic or locally advanced SST2-positive neuroendocrine…
Crinetics Pharmaceuticals Inc.
Neoplasms
Spain, France, Germany, Italy
21/11/2025
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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.