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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
1023 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524757-14-00Ocular Myasthenia Gravis
UCB Biopharma
Immune System Diseases
Hungary, France, Greece, Poland, Spain, Italy, Germany
25/08/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Efficacy and Safety Study of HBS-301 in Participants with Narcolepsy Followed by an Open-label Extension
2025-523821-17-00narcolepsy
Harmony Biosciences Management Inc.
Nervous System Diseases
Belgium, Italy, Germany, France, Spain, Poland
25/08/2026
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults with Moderate-to-Severe Atopic Dermatitis
2026-525673-39-00Atopic Dermatitis (AD)
Apollo Therapeutics Limited
Skin and Connective Tissue Diseases
Hungary, Czechia, Germany, Bulgaria, Poland, Spain
25/08/2026
Phase II
Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma
2025-524793-42-00Relapsed/Refractory Multiple Myeloma
Janssen Cilag International
Neoplasms
Sweden, Spain, Greece, Portugal, France, Hungary
25/08/2026
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 I
A Phase 1 Study of TT125-802 as Monotherapy and in Combination with Pomalidomide and Dexamethasone in Participants with Multiple Myeloma
2025-523536-39-00Relapsed and Refractory Multiple Myeloma
TOLREMO therapeutics AG
Neoplasms
Italy, Spain
24/08/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)
2025-524928-21-00Pancreatic Adenocarcinoma
Revolution Medicines Inc.
Neoplasms
Sweden, Spain, France, Poland, Italy, Norway, Belgium, Germany, Czechia, Austria, Netherlands, Denmark
24/08/2026
Phase III
Evaluation of the efficacy and safety of photodynamic therapy with BF-200 ALA (Ameluz®) in immunosuppressed patients with actinic keratoses and superficial basal cell carcinoma at any location.
2026-526649-85-00Immunosuppressed patients with premalignant and malignant s…
Dra. Elena González Guerra
Skin and Connective Tissue Diseases
Spain
24/08/2026
Phase III
A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (both in Combination with the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women with HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)
2025-524846-85-00​​HR-positive, HER2-negative, inoperable locally advanced o…
Laboratorios Farmaceuticos Rovi S.A.
Neoplasms
Romania, Spain, Bulgaria, Czechia, Latvia, Poland, Croatia, Slovakia
21/08/2026
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
2025-524669-25-00Polycythemia Vera
Deciphera Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Austria, Czechia, Italy, Portugal, Germany, France, Hungary, Spain, Poland
21/08/2026
Phase III
A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)
2025-524934-24-00Neoplasms, Gastrointestinal Stromal
Glaxosmithkline Research & Development Limited
Neoplasms
Italy, Portugal, Germany, Sweden, Poland, Romania, Finland, Greece, Norway, Spain, Netherlands, France, Hungary
21/08/2026
Phase III
A Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytruda® as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection
2025-525093-11-00Stage IIB/C-III Melanoma
Alvotech Swiss AG
Neoplasms
Romania, Spain
21/08/2026
Phase III
A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
2025-524641-27-00High-Grade Serous Ovarian, Fallopian Tube, or Primary Perit…
K-Group Beta Inc.
Neoplasms
Germany, Spain, Italy, Belgium, Poland, France, Ireland
21/08/2026
Phase III
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
2025-523252-31-00High Risk Smoldering Multiple Myeloma (HR-SMM)
Regeneron Pharmaceuticals Inc.
Neoplasms
Italy, Spain, Poland, France, Norway, Greece, Germany
20/08/2026
Phase III
A Phase 3 Multicenter, Double-Masked, Randomized, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Gildeuretinol Acetate (ALK-001) on the Progression of Stargardt Disease (STGD) - NORTHSTAR
2026-525296-60-00Stargardt Disease (STGD1)
Alkeus Pharmaceuticals Inc.
Eye Diseases
Belgium, France, Spain, Italy, Germany
20/08/2026
Phase I/II
A Modular Open-label, Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Ascending Doses of AZD4956 as Monotherapy, and in Combination with Anti-Cancer Agents in Participants with Advanced/Metastatic Homologous Recombination Repair Defective Solid Tumours (PARTHENON)
2025-524171-22-00Solid Tumors
AstraZeneca AB
Neoplasms
Spain
20/08/2026
Phase IV
An Open-Label Study to Investigate the Long-Term Effects of Acoramidis on Cardiac Function, Structure and Cardiac Amyloid Burden in Participants with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)
2026-526068-19-00Transthyretin Amyloidosis
Eidos Therapeutics Inc.
Cardiovascular Diseases
Spain, Denmark
20/08/2026
Phase II
J2S-MC-GZMS: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-D
2025-524973-17-00Irritable Bowel Syndrome Diarrhea
Eli Lilly & Co.
Digestive System Diseases
Germany, Poland, Spain, Belgium
20/08/2026
Phase III
JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)
2025-522310-24-00Depressive Disorder, Major
Eli Lilly & Co.
Mental Disorders
Poland, Greece, Spain, Germany
19/08/2026
Phase I
A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
2026-526777-42-00Metastatic Castration-Resistant Prostate Cancer
Janux Therapeutics Inc.
Neoplasms
Spain
19/08/2026
Phase I/II
A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
2025-525036-34-00Solid Tumours
Terremoto Biosciences Inc.
Neoplasms
Spain, Ireland, Hungary, Romania, France, Portugal, Belgium, Poland
18/08/2026
Phase III
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524756-54-00Ocular Myasthenia Gravis
UCB Biopharma
Immune System Diseases
Hungary, Greece, Italy, Spain, Germany, Poland, France
18/08/2026
Phase II
A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab
2025-524591-30-00Hepatocellular Carcinoma
Akeso Biopharma Co. Ltd.
Neoplasms
Poland, France, Spain, Italy
18/08/2026
Phase II
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-7262 as Monotherapy and when Coadministered with Enlicitide Decanoate in Adults With Elevated Lipoprotein(a)
2025-525102-38-00Elevated lipoprotein(a)
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Netherlands, Denmark, Germany, Spain
18/08/2026
Phase II
A Phase 2, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 48-week SAR448851 treatment followed by open-label extension in participants with early Alzheimer’s disease.
2025-524581-14-00Dementia Alzheimer's type
Sanofi-Aventis Recherche & Developpement
Nervous System Diseases
Spain, Germany
18/08/2026
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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.