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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
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens
2025-524336-19-00HIV-1
Gilead Sciences Inc.
Virus Diseases
Poland, Italy, France, Spain, Germany, Netherlands
21/07/2026
Phase III
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to Long-acting Antiretroviral Therapy of Broadly Neutralizing Antibodies Teropavimab and Zinlirvimab in Combination With the Capsid Inhibitor Lenacapavir Twice-Yearly Versus Cabotegravir and Rilpivirine Every 8 Weeks in Virologically Suppressed Adults With HIV-1 on Oral Daily Antiretroviral Therapy
2025-524335-39-00HIV-1
Gilead Sciences Inc.
Virus Diseases
Netherlands, Poland, Germany, France, Spain, Italy
21/07/2026
Phase III
A Phase 3, Double-blinded, Vehicle-controlled Trial to Investigate the Efficacy and Safety of Twice-daily Delgocitinib Cream in Adult Participants with Lichen Sclerosus During a 12-Week Initial Treatment Period Followed by a 40-Week Continuation Treatment Period
2025-524873-17-00Lichen Sclerosus
Leo Pharma A/S
Skin and Connective Tissue Diseases
Italy, France, Spain, Poland, Germany
21/07/2026
Phase II
J2J-MC-JZLL - preEMBER: A Phase 2, Open-label Study Evaluating Imlunestrant in Premenopausal Women with Estrogen Receptor-Positive, HER2-Negative Breast Cancer.
2025-523258-15-00Breast Neoplasms
Eli Lilly & Co.
Neoplasms
Belgium, France, Italy, Germany
21/07/2026
Phase II
A Phase IIb, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).
2025-523908-75-00Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)
AstraZeneca AB
Cardiovascular Diseases
Germany, Italy, Spain, France, Sweden
20/07/2026
Phase III
A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease
2025-522227-99-00Huntington’s Disease
Novartis Pharma AG
Nervous System Diseases
Norway, Poland, Spain, Sweden, Bulgaria, Netherlands, Finland, Portugal, Austria, Italy, Greece, Ireland, Czechia, France, Romania, Belgium, Germany, Denmark, Slovakia, Hungary
20/07/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
2025-524711-36-00Narcolepsy Type 1
Alkermes Inc.
Nervous System Diseases
Sweden, Finland, Belgium, Spain, Austria, Netherlands, France, Norway, Germany, Italy, Poland
20/07/2026
Phase III
Triple oral therapy with bempedoic acid vs usual care in early lipid management of patients with acute coronary syndrome
2026-525740-15-00Acute Coronary Syndrome
Fondazione Per Il Tuo Cuore Onlus Denominabile Anche Fondazione Italiana Per La Lotta Alle Malattie Cardiovascolari Onlus Ed Anche Heart Care Foundation Hcf Onlus
Cardiovascular Diseases
Italy
17/07/2026
Phase II
A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid
2025-524682-24-00Ulcerative Colitis
Microbial Resource Management Health
Digestive System Diseases
Czechia, Poland, Italy
16/07/2026
Phase III
The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.
2025-524463-20-00Asthma
Glaxosmithkline Research & Development Limited
Respiratory Tract Diseases
Ireland, Spain, Germany, Czechia, Bulgaria, France, Belgium, Romania, Italy
14/07/2026
Phase III
A Randomized, Open Label, 3-arm Phase 3 Study of Precemtabart Tocentecan with or Without Bevacizumab Compared to Trifluridine/Tipiracil plus Bevacizumab in Participants with Previously Treated Metastatic Colorectal Cancer (PROCEADE-CRC-03)
2025-524648-37-00Metastatic colorectal cancer
Merck Healthcare KGaA
Neoplasms
Belgium, Germany, France, Denmark, Poland, Spain, Netherlands, Italy, Austria
14/07/2026
Phase II
A Phase II, Open-Label, Single-Arm, Multicentre Study of Immunotherapy and non-invasive response evaluation in cutaneous squamous cell carcinoma as an organ preservation strategy: a proof of concept clinical study and translational correlates - INCEPT
2025-523633-25-00cutaneous squamous cell carcinoma
Fondazione GONO Plus
Neoplasms
Italy
14/07/2026
Phase III
A Sequential Phase 2/3, Single-Arm, Open-Label Study in Adults Followed by a Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Adults and Adolescents with Focal Segmental Glomerulosclerosis
2025-524448-36-00Focal segmental glomerulosclerosis (FSGS)
Apellis Pharmaceuticals Inc.
Female Urogenital Diseases and Pregnancy Complications
France, Portugal, Spain, Slovakia, Italy, Germany, Poland
14/07/2026
Phase III
RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma
2025-525088-34-00Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc.
Digestive System Diseases
Poland, Belgium, Norway, Sweden, Austria, Germany, Denmark, Netherlands, France, Italy, Spain
14/07/2026
Phase II
A Phase 2, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Surovatamig in Adults with Antibody-mediated Kidney Disease
2025-524139-38-00Antibody-mediated Kidney Disease
AstraZeneca AB
Immune System Diseases
France, Germany, Italy, Belgium, Poland, Spain
13/07/2026
Phase I/II
A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma
2025-525105-20-00Multiple Myeloma (MM), Multiple Myeloma (MM)
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Germany, Poland, Czechia, Belgium, France, Greece, Sweden, Portugal, Italy
13/07/2026
Phase II
Master Protocol Full Title- A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis. ISA 2 to Master Protocol ARGX-999-2-MG-2000 – an Exploratory, Phase 2a, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
2025-522939-33-00AChR-Ab Seropositive Generalized Myasthenia Gravis, Myasthe…
Argenx
Immune System Diseases
Greece, Italy, Germany, Belgium, Netherlands, Spain, Poland
08/07/2026
Phase III
Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)
2023-505575-69-01Osteosarcoma
Institut Gustave Roussy
Neoplasms
Sweden, Poland, Denmark, Finland, Netherlands, Italy, France, Spain
08/07/2026
Phase II
A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of E2086 in Adults with Narcolepsy
2025-523503-30-00Narcolepsy
Eisai Limited
Nervous System Diseases
Belgium, Italy, Spain, Germany
08/07/2026
Phase II
A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
2025-524285-18-00Advanced and/or Metastatic Solid Tumors with Homozygous MTA…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Belgium, Ireland, Germany, Norway, Italy, France, Spain
07/07/2026
Phase III
Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)
2026-525594-39-00Cataract
Ntc S.r.l.
Eye Diseases
Spain, Poland, Greece, Sweden, Italy
07/07/2026
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 III
A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)
2025-523369-32-00Fibrosing interstitial lung disease
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Respiratory Tract Diseases
Belgium, Greece, Germany, France, Finland, Spain, Czechia, Poland, Italy, Netherlands, Denmark, Portugal
07/07/2026
Phase III
A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy
2025-524028-23-00Multiple Myeloma
F. Hoffmann-La Roche AG
Neoplasms
France, Germany, Italy, Greece, Denmark, Czechia, Spain, Poland
07/07/2026
Phase III
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination with FOLFOX Compared to Standard of Care in Subjects with First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288
2025-522563-15-00Metastatic Pancreatic Ductal Adenocarcinoma; PDAC
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Portugal, Spain, France, Italy, Germany, Austria
06/07/2026
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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.