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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 โ€” 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 โ€” a stated recency window, not the full historical archive. Synced 19 Sep 2026, 04:26 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
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238 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Soquelitinib in Moderate to Severe Atopic Dermatitis (SIERRA1)
2025-524384-20-00Atopic dermatitis (AD)
Corvus Pharmaceuticals Inc.
Skin and Connective Tissue Diseases
Italy, Czechia
18/09/2026
Phase II
Prevention of venous thromboembolism in cirrhotic patients with hepatocellular carcinoma
2026-526857-33-00liver cirrhosis and hepatocellular carcinoma
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Neoplasms
Italy
17/09/2026
Phase II
Interventional, randomized, double-blind, parallel-group, placebo-controlled, flexible-dose trial of Lu AF28996 in adults with Parkinsonโ€™s disease experiencing motor fluctuations.
2025-524655-30-00Parkinsonโ€™s disease
H. Lundbeck A/S
Nervous System Diseases
Czechia, Spain, Italy, Germany, Sweden
15/09/2026
Phase II
Optimization of De-EscalatiON strategies in early breast cancer
2026-527524-27-00breast cancer
Istituto Di Candiolo Fondazione Del Piemonte Per L'Oncologia IRCCS
Neoplasms
Italy
14/09/2026
Phase II
A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)
2025-524496-23-00Papulopustular Rosacea (PPR)
Novartis Pharma AG
Skin and Connective Tissue Diseases
Bulgaria, France, Italy, Germany
14/09/2026
Phase II
A Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long Term Safety and Tolerability of KT-621 in Participants With Asthma Previously Enrolled in a KT-621 Asthma Study
2026-526241-98-00Uncontrolled Moderate to Severe Eosinophilic Asthma
Kymera Therapeutics Inc.
Immune System Diseases
Germany, Romania, Italy, Slovakia, Spain
09/09/2026
Phase II
Hyperthermic Intraperitoneal Chemotherapy and Regional Adrenalectomy in the management of Stage II & III Adrenocortical Carcinoma
2026-525406-36-00Adrenocortical Carcinoma
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Neoplasms
Italy
02/09/2026
Phase II
Randomized, Multicenter, Vehicle-Controlled, Double-Masked Study to Evaluate the Efficacy and Safety of Intranasal Cenegermin (Recombinant Human Nerve Growth Factor [rhNGF]) in Adult Participants with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
2025-524748-37-00Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Dompe' Farmaceutici S.p.A.
Eye Diseases
Denmark, Italy, Germany, Hungary, Netherlands, Spain, Belgium, France, Portugal
01/09/2026
Phase II
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE-791 in Subjects with Idiopathic Pulmonary Fibrosis
2025-521901-42-00Idiopathic Pulmonary Fibrosis (IPF)
Contineum Therapeutics Inc.
Respiratory Tract Diseases
Italy, Belgium, Denmark, Austria, Greece, Germany, France, Netherlands, Portugal, Poland, Spain
26/08/2026
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 Nonโ€ฆ
Pfizer Inc.
Neoplasms
Spain, France, Italy, Ireland, Germany, Poland
26/08/2026
Phase II
A Phase 2, Open-label, Multicohort, Study of Rinatabart Sesutecan (Rina S) in Participants With Advanced Gastrointestinal (GI) Cancers
2025-524130-26-00Gastrointestinal Cancers
Genmab A/S
Neoplasms
Italy, Belgium, France, Spain, Denmark, Netherlands, Germany
26/08/2026
Phase II
Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)
2025-524905-34-00Solid tumor
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Greece, Hungary, Poland, Belgium, Spain, Netherlands, Germany, France, Portugal, Italy, Romania
25/08/2026
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 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 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 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
Phase II
Immune dynamics and biomarkers of anti-tumor response in BMS-986340 (anti-CCR8) and nivolumab (anti-PD-1) co-treatment of metastatic tumors
2025-524125-40-01Metastatic solid tumors, with the following specific indicaโ€ฆ
Humanitas Mirasole S.p.A., Fondazione Humanitas Per La Ricerca Ets
Neoplasms
Italy
23/07/2026
Phase II
A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of SIR9900 in Patients with VEXAS Syndrome (SIVEX)
2025-524918-28-00VEXAS Syndrome
Sironax USA Inc.
Immune System Diseases
Italy
23/07/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 19 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.