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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 12467 total CTIS records — a stated recency window, not the full historical archive. Synced 22 Sep 2026, 03:17 UTC
2500
Shown in this register
most recently authorised
12,467
Total on CTIS
full historical archive
744
Phase III
within the shown window
Top member states
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527
Narrow the registerReset
Phase
Phase I 557 Phase I/II 211 Phase II 727 Phase III 744 Phase IV 261
Lead sponsor
AstraZeneca AB 62 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 47 Pfizer Inc. 44 Novo Nordisk A/S 43
Member state
Spain 1018 France 887 Germany 856 Italy 735 Poland 580 Netherlands 527 Belgium 424 Czechia 329
All 28 states
425 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase III
EASi-PROTKT™ - A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease
2025-521188-11-00hypertension, cardiovascular disease, Type 2 diabetes
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Cardiovascular Diseases
Lithuania, Netherlands, Ireland, Romania, France, Hungary, Finland, Latvia, Austria, Germany, Greece, Italy, Sweden, Denmark, Czechia, Belgium, Slovakia, Croatia, Spain, Norway, Bulgaria, Poland, Portugal
24/09/2025
Phase III
ARGX-113-2409: A Multicenter, Randomized, Double-blinded, Parallel-Arm, Placebo- Controlled, Pharmacokinetic and Pharmacodynamic Study Followed by an Open-Label Arm to Evaluate Efgartigimod IV in Pediatric Participants from 12 Years to Less Than 18 Years of Age with Chronic ITP
2025-521055-23-00Chronic Idiopathic thrombocytopenic purpura
Argenx
Immune System Diseases
Lithuania, Romania, Hungary, France, Italy, Spain, Poland, Germany
24/09/2025
Phase III
Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Plozasiran in Adults with Severe Hypertriglyceridemia at High Risk of Acute Pancreatitis (SHASTA-5 Study)
2024-518206-40-00Severe hypertriglyceridemia (SHTG)
Arrowhead Pharmaceuticals Inc.
Nutritional and Metabolic Diseases
Hungary, Bulgaria, Sweden, Austria, Norway, Belgium, Croatia, Czechia, Latvia, Lithuania, Spain, Slovakia
23/09/2025
Phase III
OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women
2024-519655-28-00Premenopausal patients with high-risk HR-positive/HER2-nega…
Unicancer
Neoplasms
Poland, France, Italy, Greece, Spain, Ireland, Belgium
23/09/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
2024-519345-30-00IgA nephropathy
Biogen Idec Research Limited
Immune System Diseases
Greece, Portugal, Spain, Croatia, Czechia, Belgium, Bulgaria, Germany, Italy, Poland, France
23/09/2025
Phase III
A Double-blind, Randomized,Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
2025-520554-11-00Cardiovascular Disease
Amgen Inc.
Cardiovascular Diseases
Spain, Hungary, Portugal, Greece, Germany, Italy, Austria, Ireland, Romania, Slovakia, Netherlands, Czechia, Bulgaria, Denmark, France, Poland, Belgium
22/09/2025
Phase III
INCB018424-316: A Phase 3b, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream in Children and Adolescents (6 to < 18 Years Old) With Moderate Atopic Dermatitis
2024-518156-24-00Atopic Dermatitis
Incyte Corp.
Skin and Connective Tissue Diseases
France, Germany, Spain, Belgium, Italy, Hungary, Poland
18/09/2025
Phase III
A Multicenter, Open-label, Randomized Phase 3 Study Evaluating THIO Sequenced with Cemiplimab (LIBTAYO®) vs Investigator Choice of Single-agent Chemotherapy as Third-line Treatment in Subjects with Advanced / Metastatic Non-Small Cell Lung Cancer (NSCLC)
2024-520164-33-00Non-Small Cell Lung Cancer
Maia Biotechnology Inc.
Neoplasms
Poland, Hungary, Romania, Spain, Portugal
18/09/2025
Phase III
CARESS Study: Cabergoline for the Reduction of Endometriosis Symptoms and Lesion Size
2025-522812-18-00Endometriosis
Hospital Clinico San Carlos
Female Urogenital Diseases and Pregnancy Complications
Spain
17/09/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
2024-517232-22-00KRAS G12C-mutant, Locally Advanced Unresectable or Metastat…
Merck Sharp & Dohme LLC
Neoplasms
Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary
17/09/2025
Phase III
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy
2025-520825-19-00IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also k…
Takeda Development Center Americas Inc.
Immune System Diseases
Spain, Czechia, Austria, Hungary, Germany, Norway, Slovenia, France, Sweden, Netherlands, Poland, Italy
16/09/2025
Phase III
NBI-1065845-MDD3027: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Maintenance of Effect of NBI 1065845 as an Adjunctive Treatment in Subjects with Major Depressive Disorder (MDD)
2025-520541-72-00Major Depressive Disorder
Neurocrine Biosciences Inc.
Mental Disorders
Bulgaria, Estonia, Poland, Italy, Spain
16/09/2025
Phase III
A Phase 3, randomized, parallel-group, double-blind, multicenter study investigating the safety and efficacy of NT 201 compared with placebo in adult participants with moderate to severe platysma prominence in Europe
2025-520499-24-00Moderate to Severe Platysma Prominence
Merz Aesthetics GmbH
Not possible to specify
Germany, Poland, France, Spain
12/09/2025
Phase III
A Phase 3 Randomized, Controlled Study to Assess the Efficacy and Safety of NVD003 compared with Iliac Crest Bone Graft in Pediatric Participants Treated Surgically for Congenital Pseudarthrosis of the Tibia
2025-520998-39-00Congenital pseudarthrosis of the tibia
Novadip Biosciences
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
France, Spain, Belgium
08/09/2025
Phase III
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
2025-521096-31-00Chronic Hepatitis C Virus (HCV) Infection
Atea Pharmaceuticals Inc.
Virus Diseases
Romania, France, Germany, Greece, Poland, Spain
08/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase III
A Randomized, Open-Label, Controlled Phase 3 Study Comparing Daratumumab, Lenalidomide and Dexamethasone Induction followed by Linvoseltamab Versus continued Daratumumab, Lenalidomide, and Dexamethasone in Newly Diagnosed Transplant Ineligible Multiple Myeloma Patients
2024-519827-16-00Newly Diagnosed Transplant Ineligible Multiple Myeloma Pati…
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Neoplasms
Norway, Denmark, Spain, Sweden, Austria, Netherlands, Greece, Germany, Italy, Belgium, Portugal, Estonia, Croatia, Ireland, Czechia, Finland
01/09/2025
Phase III
A Phase 3, Open Label, Multicenter, Randomized Study of First Line Tarlatamab in combination with Durvalumab, Carboplatin and Etoposide versus Durvalumab, Carboplatin and Etoposide in Untreated Extensive Stage Small-Cell Lung Cancer (DeLLphi-312)
2024-520050-38-00Extensive stage small cell lung cancer (ES-SCLC). …
Amgen Inc.
Neoplasms
Portugal, Germany, Spain, Italy, Denmark, Netherlands, France, Austria, Greece, Belgium, Hungary, Poland, Romania
01/09/2025
Phase III
A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of chronic migraine (MINT-C)
2024-515682-34-00Chronic migraine
Merz Therapeutics GmbH
Nervous System Diseases
Spain, Denmark, France, Germany, Slovakia, Austria, Italy, Poland, Czechia
01/09/2025
Phase III
A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)
2024-512177-27-01High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-m…
Ferring Pharmaceuticals A/S
Male Urogenital Diseases
Spain, Denmark, Poland, Czechia, France
01/09/2025
Phase III
A Phase 3, randomized, double-blind, placebo-controlled, multicenter, clinical trial with extension period to evaluate the efficacy and safety of Xeomin® injections for the prevention of episodic migraine (MINT-E)
2024-515715-22-00Episodic migraine
Merz Therapeutics GmbH
Nervous System Diseases
Italy, Austria, Poland, Germany, France, Spain, Slovakia, Denmark, Czechia
01/09/2025
Phase III
A Phase 3, multicenter, open-label extension study to evaluate the long-term safety, tolerability, and efficacy of subcutaneous sonelokimab in participants with moderate to severe hidradenitis suppurativa
2025-520564-17-00Hidradenitis suppurativa (HS)
MoonLake Immunotherapeutics AG
Skin and Connective Tissue Diseases
Norway, Hungary, Spain, France, Germany, Poland, Czechia, Slovakia, Bulgaria, Netherlands, Italy, Portugal, Belgium
29/08/2025
Phase III
A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab with Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) with Moderately to Severely Active Ulcerative Colitis
2024-514695-41-00Ulcerative Colitis
AbbVie Deutschland GmbH & Co. KG
Digestive System Diseases
Sweden, Greece, Germany, Italy, Belgium, Spain
29/08/2025
Phase III
A Double-Blind, Randomized, Active Controlled, Parallel-group, Phase 1/3 Study to Compare Pharmacokinetics, Efficacy and Safety of Subcutaneous CT-P44 and Darzalex Faspro in Combination with Lenalidomide and Dexamethasone in Patients with Refractory or Relapsed Multiple Myeloma
2024-518588-36-00Refractory or Relapsed Multiple Myeloma
Celltrion Inc.
Neoplasms
Spain, Poland
29/08/2025
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
2024-520195-94-00BP-I mania or mania with mixed features
Bristol-Myers Squibb Services Unlimited Company
Mental Disorders
Slovakia, Spain, Croatia, Sweden, Romania
28/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 22 September 2026. https://priyalifescience.com/clinical-trials-europe/country/spain?page=5

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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.