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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 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
1023 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
A Phase 2 Study Evaluating the Safety and Efficacy of Neoadjuvant Amivantamab in Combination with Lazertinib or Chemotherapy in Resectable EGFR-Mutated Non-Small Cell Lung Cancer
2025-524816-13-00Non-small Cell Lung Cancer
Janssen Cilag International
Neoplasms
Spain
27/07/2026
Phase III
A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes
2025-522488-14-00Participants with obesity with or without type 2 diabetes
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Greece, Portugal, France, Slovakia, Bulgaria, Netherlands, Romania, Italy, Austria, Poland, Hungary, Spain, Czechia, Belgium
27/07/2026
Phase III
A Phase 3 Randomized, Open Label, Multicenter Study to Evaluate the Safety and Efficacy of ABBV-706 versus Standard of Care in Subjects with Relapsed/Refractory Small Cell Lung Cancer (SCLC)
2025-523819-11-00Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Italy, Greece, Spain, Belgium, France, Austria, Germany
27/07/2026
Phase III
A Phase III Randomized, Double-blind, Placebo-controlled Multicenter Master Protocol to Evaluate the Efficacy and Safety of Elecoglipron in Participants with Obesity or Overweight with or without Type 2 Diabetes Mellitus (Embold)
2025-524688-19-00Participants Living with Obesity or Overweight with at leas…
AstraZeneca AB
Nutritional and Metabolic Diseases
Spain, Germany, Italy, Poland
27/07/2026
Phase III
An Open-Label, Randomized, Multicenter Phase 3 Study Investigating the Efficacy and Safety of BGB-43395 Plus Letrozole versus CDK4/6 Inhibitors (Abemaciclib, Palbociclib, Ribociclib) Plus Letrozole in Patients with Advanced or Metastatic HR+/HER2- Breast Cancer Who Have Not Received Prior Systemic Anticancer Treatment for Advanced or Metastatic Disease
2025-523960-19-00Advanced or Metastatic HR+/HER2- Breast Cancer
BeOne Medicines I GmbH
Neoplasms
Poland, Italy, Germany, France, Spain
27/07/2026
Phase III
An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam
2025-524054-34-00Spinal Muscular Atrophy
Biogen Idec Research Limited
Nervous System Diseases
Finland, Spain, Italy, Poland, Ireland, Germany, France
24/07/2026
Phase III
A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)
2025-523994-41-00Chronic kidney disease (CKD) in adults, with specified rang…
AstraZeneca AB
Cardiovascular Diseases
Czechia, Italy, Hungary, Romania, Bulgaria, Sweden, Denmark, Poland, Spain, Norway, Finland, Greece, France, Germany
24/07/2026
Phase II
IKF-099/D-FLOT-TNT Total Neoadjuvant Treatment with preoperative FLOT/Durvalumab plus postoperative Durvalumab for Resectable Gastroesophageal Adenocarcinoma
2026-525185-21-00Gastroesophageal Adenocarcinoma
Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH
Digestive System Diseases
Germany, Spain
23/07/2026
Phase III
A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia
2025-524282-24-00Classic Congenital Adrenal Hyperplasia (CAH)
Neurocrine Biosciences Inc.
Hormonal diseases
Czechia, Germany, Sweden, Portugal, Romania, Bulgaria, Italy, Austria, Spain
23/07/2026
Phase III
Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.
2026-525727-24-00No medical condition
Chemo Research S.L.
Not possible to specify
Sweden, Czechia, Spain, Hungary, Poland, Finland, Romania
23/07/2026
Phase III
A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants with Huntington’s Disease
2025-522263-14-00Huntington’s Disease
Skyhawk Therapeutics Inc.
Nervous System Diseases
Germany, Spain
23/07/2026
Phase I/II
A Phase 1/2, dose escalation and expansion study of TRI-611, an oral ALK molecular glue degrader in participants with advanced ALK-positive NSCLC
2025-524418-27-00Advanced ALK-positive NSCLC
Triana Biomedicines Inc.
Respiratory Tract Diseases
France, Italy, Germany, Spain
22/07/2026
Phase IV
Real-World Effectiveness of the Adjuvanted RSVPreF3 Vaccine in Adults ≥60 Years: A Pragmatic Randomized Trial (BronquiVal)
2026-526804-59-00Respiratory syncytial virus infection–related respiratory d…
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana
Respiratory Tract Diseases
Spain
22/07/2026
Phase III
Colchicine for the Reduction of Dependency and Vascular Events after an Acute Intracerebral Hemorrhage (CoVasc-ICH2)
2025-523435-18-00Major cardiovascular events (MACE), spontaneous intracerebr…
Hamilton Health Sciences Corporation, PHRI Population Health Research Institute International
Cardiovascular Diseases
Spain, Belgium
22/07/2026
Phase II
Local and systemic immune modulation by Rilvegostomig (AZD2936) in the treatment of advanced gastric cancer (RILVE Project)
2026-525620-23-00advanced gastric cancer
Vall D Hebron Institute Of Oncology
Digestive System Diseases
Spain
22/07/2026
Phase I
Tarlatamab Before and After Surgery for Recurrent High-Grade Glioma
2025-524359-30-00surgically resectable recurrent high-grade glioma
Vall D Hebron Institute Of Oncology
Neoplasms
Spain
22/07/2026
Phase I/II
A Phase 1/2a, Open-label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of BMS-986528 in Participants with Refractory Rheumatoid Arthritis
2025-520666-22-00Refractory, difficult-to-treat Rheumatoid Arthritis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Poland, Italy, Spain, Germany
22/07/2026
Phase II
A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)
2025-523390-42-00Early-Stage Down Syndrome-Associated Alzheimer’s Disease (D…
Alnylam Pharmaceuticals Inc.
Nervous System Diseases
Italy, Netherlands, Spain, Germany, Ireland
22/07/2026
Phase I
Phase 1/1b Study of BMS-986463 in Advanced Malignant Tumors
2025-523067-38-01Advanced Malignant Tumors; High-grade Serous Ovarian Carcin…
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Spain, France, Italy
21/07/2026
Phase III
A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis
2026-525242-29-00Primary Sclerosing Cholangitis
Ipsen Bioscience Inc.
Digestive System Diseases
Spain, Sweden, Germany, Romania, Finland, Portugal, Austria, Italy, Denmark, Czechia, France, Netherlands, Poland, Belgium, Norway
21/07/2026
Phase I/II
A Phase 1/2 First-Time-in-Human, open-label, multicenter, dose escalation and dose optimization study of GSK5471713 in adult participants with metastatic castration resistant prostate cancer (mCRPC).
2025-523874-17-00Neoplasms, Prostate
Glaxosmithkline Research & Development Limited
Neoplasms
Netherlands, France, Spain
21/07/2026
Phase II
A Phase 2, open-label, randomized, dose optimization study evaluating the efficacy and safety of belantamab mafodotin administered in combination with cyclophosphamide, bortezomib, and dexamethasone in adult participants with newly diagnosed amyloid light chain amyloidosis (ALANIS)
2025-522803-60-00newly diagnosed amyloid light chain amyloidosis
Glaxosmithkline Research & Development Limited
Immune System Diseases
Italy, Greece, Spain
21/07/2026
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
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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/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.