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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 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
115 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I/II
A Multicenter First-in-human Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, Pharmacokinetics, and Efficacy of the 5T4 Antibody-Drug Conjugate TUB-030 in Patients with Advanced Solid Tumors (5-STAR 1-01)
2025-522517-35-00Patients with advanced/metastatic tumors with head and neck…
Tubulis GmbH
Neoplasms
France, Spain, Romania
03/11/2025
Phase I/II
Longitudinal study with positron emission tomography using [18F]PI-2620 in primary tauopathies. Proof-of-concept study
2025-522826-11-00Corticobasal syndrome (CBS), Progressive supranuclear palsy…
ZRO Imaging AB
Nervous System Diseases
Spain
03/11/2025
Phase I/II
A Phase 1b/2a, Open-Label, Sequential-Cohort, Dose Escalation and Expansion Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Clinical Effectiveness of Budoprutug (TNT119) in Subjects with Immune Thrombocytopenia (ITP)
2024-519745-30-01Immune Thrombocytopenia (ITP)
Climb Bio Inc.
Hemic and Lymphatic Diseases
Greece, Spain, Bulgaria
03/11/2025
Phase I/II
A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and expansion study of the oral DNA Polymerase Theta Inhibitor (POLQi) GSK4524101 and the PARP inhibitor (PARPi) niraparib in adult participants with solid tumors.
2024-520197-36-00Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
Estonia, Czechia, Spain, Romania, Italy, Denmark, Belgium, Greece
03/11/2025
Phase I/II
A Phase 1b/2a Open-Label Dose-Finding Followed by Randomized, Double-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of TGD001 in Patients with Acute Ischemic Stroke
2025-522455-26-00Acute Ischemic Stroke
TargED Biopharmaceuticals B.V.
Nervous System Diseases
Poland, Germany, Spain
31/10/2025
Phase I/II
A Phase 1b/2a, Multicenter, Open-label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of Mezigdomide in Combination with Elranatamab in Participants with Relapsed and/or Refractory Multiple Myeloma
2025-522090-11-00Relapsed or Refractory Multiple Myeloma (RRMM)
Celgene Corp.
Neoplasms
Norway, Greece, Germany, Spain
21/10/2025
Phase I/II
A Phase I/II, open-label, adaptive two-part trial to evaluate the safety, efficacy, optimal dose and pharmacokinetics of BNT326 as monotherapy and in combination with cancer immunotherapies in participants with advanced solid tumors
2024-517261-16-00Advanced solid tumors
BioNTech SE
Neoplasms
Belgium, Germany, Spain, Italy
17/10/2025
Phase I/II
A Phase 1/2, Open-Label, Dose Finding Study to Investigate the Safety, Tolerability, and Efficacy of ALXN2350 Gene Therapy in Adult Participants with Symptomatic BAG3 Mutation-Associated Dilated Cardiomyopathy
2024-519674-40-00BAG3 Mutation Associated Dilated Cardiomyopathy
Alexion Pharmaceuticals Inc.
Cardiovascular Diseases
Spain, Italy, Germany
16/10/2025
Phase I/II
A Phase I First-in-Human Dose Escalation Trial to Evaluate the Safety and Efficacy of ARI-HER2 (HER2BBz CAR-T Cells) in Patients with HER2Positive Advanced Breast Cancer
2025-521052-35-00Patients with HER2Positive Advanced Breast Cancer
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Neoplasms
Spain
15/10/2025
Phase I/II
An open-label, Phase 1/2, multicenter study of belumosudil in children aged 1 to <18 years requiring systemic treatment for active moderate-to-severe chronic graft versus host disease (cGVHD).
2024-511508-18-00Chronic graft versus host disease.
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
France, Italy, Belgium, Spain, Netherlands, Germany
30/09/2025
Phase I/II
A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial of Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in Participants with Advanced or Metastatic Non-small Cell Lung Cancer whose Tumors Express PD-L1 with Tumor Proportion Score ≥50% Without Actionable Genomic Alterations
2024-519671-26-00Advanced or Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo Inc.
Neoplasms
Spain, France, Italy
29/09/2025
Phase I/II
A phase 1/2, open label, multicenter clinical trial investigating the safety, tolerability, pharmacokinetics, and antineoplastic activity of S095035 (MAT2A inhibitor) as a single agent and in combination in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP
2025-521249-25-00MTAP-deleted advanced or metastatic solid tumors
Institut De Recherches Internationales Servier IRIS
Neoplasms
Denmark, Italy, Germany, Spain, France
26/09/2025
Phase I/II
A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects with Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)
2024-514360-70-00Low-grade upper track urothelial carcinoma (LG-UTUC)
Ferring Pharmaceuticals A/S
Female Urogenital Diseases and Pregnancy Complications
Spain, France, Netherlands
16/09/2025
Phase I/II
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
2024-514110-12-00Thyroid Eye Disease
Amgen Inc.
Eye Diseases
France, Spain, Italy, Poland, Germany, Greece
15/09/2025
Phase I/II
A Phase 1b/2, multicenter, open-label study to evaluate the efficacy and safety of GSK5764227 alone and in combination in participants with previously treated advanced unresectable or metastatic gastrointestinal solid tumors
2025-520672-26-00Gastrointestinal Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
Belgium, Italy, Norway, Finland, Poland, Netherlands, Germany, Spain, France, Sweden
27/08/2025
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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/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.