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Clinical trial register · European Union · CTIS

Clinical Trials in Spain

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 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
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
428 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype
2024-518213-25-00Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Germany, Romania, Greece, Norway, Netherlands, Poland, Lithuania, Czechia, Slovakia, Spain
06/07/2026
Phase III
AugmENtation witH cAnnabidiol iN first episode psyChosis: a doublE blind randomised controlled trial (STEP-ENHANCE Trial)
2025-521929-32-01First Episode Psychosis (FEP)
University Of Oxford
Mental Disorders
Netherlands, Greece, Germany, Italy, Austria, Spain
01/07/2026
Phase III
"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"
2025-523815-12-00Relapsed or Refractory Multiple Myeloma
Janssen Cilag International
Neoplasms
Poland, Spain, Czechia, France, Italy, Germany, Greece
01/07/2026
Phase III
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
2025-522167-15-00Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S
Neoplasms
Finland, Belgium, Hungary, France, Denmark, Austria, Germany, Italy, Spain, Czechia, Norway, Poland
01/07/2026
Phase III
A Phase 3 Multicenter Double-blind Randomized Study of Taletrectinib Versus Placebo in Patients With ROS1-Fusion Positive Stage IB-IIIA Non-Small Cell Lung Cancer Who Have Undergone Complete Tumor Resection
2025-521971-29-00Non Small Cell Lung Cancer (NSCLC)
Nuvation Bio Inc.
Respiratory Tract Diseases
Spain, Belgium, France, Italy, Germany
30/06/2026
Phase III
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
2025-521769-29-00Pulmonary Hypertension Associated with Interstitial Lung Di…
Insmed Inc.
Respiratory Tract Diseases
Greece, France, Italy, Belgium, Denmark, Germany, Poland, Czechia, Portugal, Austria, Spain, Romania
30/06/2026
Phase III
A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination with Chemotherapy in Participants with High-Risk Neuroblastoma
2025-524397-42-00Participants with relapsed HRNB and participants with HRNB…
Renaissance Pharma Limited
Nervous System Diseases
France, Spain, Denmark, Ireland, Germany
30/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
2025-524855-30-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Skin and Connective Tissue Diseases
Germany, Romania, France, Bulgaria, Belgium, Spain, Poland, Greece, Italy, Czechia
29/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care
2025-523871-44-00Cutaneous Manifestations of Lupus Erythematosus With or Wit…
Merck Healthcare KGaA
Immune System Diseases
Spain, Belgium, France, Germany, Slovakia, Romania, Bulgaria, Italy, Poland, Greece
29/06/2026
Phase III
AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
2025-521712-19-00Colorectal Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Greece, Portugal, Germany, Belgium, Spain
29/06/2026
Phase III
A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
2025-525009-18-00Pancreatic Ductal Adenocarcinoma
Incyte Corp.
Neoplasms
Poland, Italy, Netherlands, Sweden, Denmark, Finland, Spain, France, Germany, Belgium, Norway, Austria
26/06/2026
Phase III
A PHASE III, OPEN-LABEL, SINGLE-ARM, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND USE OF AN ON-BODY DELIVERY SYSTEM FOR THE SUBCUTANEOUS HOME ADMINISTRATION OF OCRELIZUMAB IN PATIENTS WITH MULTIPLE SCLEROSIS
2025-523726-40-00Multiple Sclerosis
F. Hoffmann-La Roche AG
Immune System Diseases
Spain, France, Poland, Italy
24/06/2026
Phase III
A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
2025-521353-16-00Hereditary Angioedema
Adarx Pharmaceuticals Inc.
Immune System Diseases
Poland, Italy, Hungary, France, Austria, Czechia, Belgium, Spain, Bulgaria, Germany, Croatia
22/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
2025-524322-18-00Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC
Nervous System Diseases
Germany, Bulgaria, Netherlands, Sweden, Portugal, Croatia, Italy, Austria, Spain, Poland, France, Denmark, Hungary, Romania, Estonia, Slovakia, Belgium, Czechia, Norway, Lithuania, Greece, Slovenia
22/06/2026
Phase III
Effects of bempedoic acid/ezetimibe/high-intensity statin on plaque regression and stabilisation of coronary atherosclerosis among patients without cardiovascular events
2025-524625-41-00Coronary atherosclerosis
Daiichi Sankyo Europe GmbH
Cardiovascular Diseases
Italy, Spain, Germany
22/06/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study to Compare the Efficacy and Safety of BMS-986353, CD19-targeted NEX-T CAR T Cells, Versus Standard of Care in Participants with Active Systemic Sclerosis (Breakfree-SSc)
2025-524337-11-00Systemic Sclerosis
Celgene Corp.
Immune System Diseases
Spain, Germany, France, Italy, Belgium
19/06/2026
Phase III
Paclitaxel plus ramucirumab and tislelizumab as switch maintenance versus continuation of chemotherapy and tislelizumab in patients with advanced HER2-negative and PD-L1 positive gastroesophageal adenocarcinoma: the ARMANI-2/ENGIC08 trial by GONO
2025-524048-36-00Advanced HER2-negative and PD-L1 positive gastroesophageal …
Fondazione GONO G.I.
Neoplasms
Spain, Germany, Italy
18/06/2026
Phase III
IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis
2025-522373-10-00Progressive pulmonary fibrosis and Idiopathic pulmonary fib…
Bristol-Myers Squibb Services Unlimited Company
Respiratory Tract Diseases
Finland, Portugal, Hungary, Ireland, Poland, Greece, France, Belgium, Denmark, Italy, Spain, Netherlands, Austria, Germany
17/06/2026
Phase III
A Phase III, Multicentre, Randomised Controlled Study of Sonesitatug vedotin in Combination with Capecitabine with or without Rilvegostomig in First-line Claudin18.2-positive, HER2-negative, Advanced/Metastatic Gastric, Gastroesophageal Junction, or Esophageal Adenocarcinoma (CLARITY-Gastric 02)
2024-519787-40-00Gastric Cancer, Gastroesophageal Junction Adenocarcinoma, E…
AstraZeneca AB
Neoplasms
France, Italy, Spain, Hungary, Poland, Belgium, Germany, Netherlands
16/06/2026
Phase III
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
2025-522643-18-00Stage I NSCLC
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, Italy, Hungary, Germany, Netherlands, France, Spain
16/06/2026
Phase III
A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of each of two dose levels of sarilumab in adults with early polymyalgia rheumatica
2024-511296-15-00Musculoskeletal diseases
Sanofi-Aventis Recherche & Developpement
Musculoskeletal Diseases
France, Netherlands, Germany, Czechia, Belgium, Austria, Hungary, Greece, Spain
15/06/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo- and Active-Comparator-Controlled Study of MK-1084 Plus Durvalumab Versus Placebo Plus Durvalumab in Participants With Locally Advanced, Unresected KRAS G12C-Mutant Non-Small Cell Lung Cancer Without Disease Progression Following Definitive Platinum-Based Chemoradiotherapy (KANDLELIT-015)
2025-522038-29-00Locally advanced, unresected (unresectable or medically ino…
Merck Sharp & Dohme LLC
Neoplasms
Italy, Netherlands, France, Germany, Spain, Poland, Greece
12/06/2026
Phase III
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
2025-522267-15-00​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Merck Sharp & Dohme LLC
Neoplasms
Greece, Netherlands, Sweden, France, Italy, Spain, Denmark
12/06/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, 3-Arm Study to Investigate the Safety and Tolerability of Efimosfermin Alfa in Participants With Known or Suspected F2- or F3-Stage Metabolic Dysfunction-Associated Steatohepatitis (MASH) (ZENITH-2)
2025-523674-16-00Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Glaxosmithkline Research & Development Limited
Nutritional and Metabolic Diseases
Greece, Germany, Belgium, Netherlands, Poland, Italy, France, Spain, Bulgaria, Austria
12/06/2026
Phase III
Evaluation of the Non-Inferiority of Topical Chloramphenicol Versus Topical Ciprofloxacin in the Resolution of Otorrhea in Adults With Chronic Suppurative Otitis Media (CSOM) – Protocol OMCOS
2026-525540-15-00chronic suppurative otitis media (CSOM)
Institut De Recerca Biomedica De Lleida Fundacio Dr. Pifarre
Otorhinolaryngologic Diseases
Spain
11/06/2026
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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/spain

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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.