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Clinical trial register · European Union · CTIS

Clinical Trials in Spain, 2026

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 12490 total CTIS records — a stated recency window, not the full historical archive. Synced 25 Sep 2026, 03:16 UTC
2500
Shown in this register
most recently authorised
12,490
Total on CTIS
full historical archive
741
Phase III
within the shown window
Top member states
Spain 1016 France 881 Germany 860 Italy 735 Poland 585 Netherlands 531
Narrow the registerReset
Phase
Phase I 554 Phase I/II 213 Phase II 733 Phase III 741 Phase IV 259
Lead sponsor
AstraZeneca AB 62 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 44 Novo Nordisk A/S 43
Member state
Spain 1016 France 881 Germany 860 Italy 735 Poland 585 Netherlands 531 Belgium 434 Czechia 327
All 28 states

Trials with a site in Spain

1016 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
A Phase 1 Study of IM-1021 in Participants with Advanced Cancer
2025-523160-20-00Advanced B-cell lymphomas, Advanced solid tumors
Immunome Inc.
Neoplasms
France, Spain, Denmark, Italy
16/02/2026
Phase I
A phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients with solid tumors
2025-521702-18-00Locally advanced unresectable or metastatic soft tissue sar…
Novartis Pharma AG
Neoplasms
Germany, Portugal, France, Spain, Denmark
16/02/2026
Phase I
A Phase 1 first-in-human study to evaluate SAR447754 in healthy adult participants and in adult participants with moderate-to-severe atopic dermatitis.
2025-523826-41-00Dermatitis atopic
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Belgium, Czechia, France, Hungary, Poland, Spain, Bulgaria
16/02/2026
Phase II
A Phase IIb, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AZD5148 for Prevention of Recurrence of Clostridioides difficile Infection in Individuals 18 Years of Age and Above
2025-521416-19-00Recurrence of Clostridioides difficile Infection
AstraZeneca AB
Bacterial Infections and Mycoses
Greece, Spain, France, Germany, Italy, Hungary, Denmark, Sweden
16/02/2026
Phase II
A Phase IIb, Randomised, Multicentre, Double-Blind Study to Evaluate the Effect of Baxdrostat in Combination with Dapagliflozin Compared with Baxdrostat on Albuminuria in Participants with Chronic Kidney Disease and High Blood Pressure
2025-522407-23-00Chronic kidney disease (CKD) and hypertension.
AstraZeneca AB
Cardiovascular Diseases
Spain, Bulgaria
16/02/2026
Phase III
Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia
2025-523533-25-00Cancer-associated Cachexia
CatalYm GmbH
Nutritional and Metabolic Diseases
France, Czechia, Romania, Italy, Germany, Poland, Spain, Bulgaria, Norway, Ireland, Netherlands
13/02/2026
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination with Intensive Chemotherapy in Participants with Newly Diagnosed AML with an NPM1 mutation (REVEAL-ND NPM1)
2025-522279-27-00Newly Diagnosed AML with an NPM1 mutation
Syndax Pharmaceuticals Inc.
Neoplasms
Greece, Poland, Spain, Austria, Italy, Romania, Belgium, France, Lithuania, Germany, Hungary, Czechia, Portugal
13/02/2026
Phase III
HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP).
2025-523275-27-00Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyri…
Disc Medicine Inc.
Nutritional and Metabolic Diseases
Italy, France, Ireland, Belgium, Sweden, Germany, Netherlands, Norway, Spain
12/02/2026
Phase III
A Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with FOLFOX versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer (HARMONi-GI3)
2025-521587-35-00Metastatic colorectal cancer
Summit Therapeutics Inc.
Neoplasms
Belgium, Italy, Spain, Germany, France, Poland, Czechia, Hungary
12/02/2026
Phase III
A Long-term Extension Study of the Safety and Efficacy of Cleminorexton in Participants with Narcolepsy and Idiopathic Hypersomnia Who Completed a Sponsored Cleminorexton Clinical Trial
2025-522987-34-00Narcolepsy and Idiopathic Hypersomnia
Centessa Pharmaceuticals UK Limited
Nervous System Diseases
France, Spain, Italy
12/02/2026
Phase III
A Randomized, Open-labelled, Multicenter Trial Evaluating Efficacy and Safety of A Reduced Venetoclax Exposure To Seven Days Versus Standard Continuous Venetoclax Exposure Combined With Azacitidine in Treatment Naïve Subjects with Acute Myeloid Leukemia Who Are Ineligible for Intensive Induction (SEVENAZA)
2025-521634-29-00ONCOLOGY, Acute Myeloid Leukemia
Institut Gustave Roussy
Immune System Diseases
France, Spain
11/02/2026
Phase I
A Phase 1, Randomized, Placebo-controlled Study with a Double-blind Period with Open-label Extension Period to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intrathecally Administered ALN-5288 in Adult Patients with Alzheimer’s Disease
2025-522582-30-00Alzheimer’s Disease
Alnylam Pharmaceuticals Inc.
Nervous System Diseases
Spain, Netherlands
10/02/2026
Phase II
A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Cutaneous Squamous Cell Carcinoma patients progressing on or intolerant to systemic treatment.
2025-523231-19-00Cutaneous Squamous Cell Carcinoma
Philogen S.p.A.
Neoplasms
Italy, Germany, Greece, Spain, Austria, France, Netherlands
10/02/2026
Phase II
A Phase 2 controlled randomized study of the efficacy of L19IL2 or L19TNF or L19IL2/L19TNF intralesional injections for the treatment of locally advanced basal cell carcinoma patients.
2025-523229-16-00locally advanced basal cell carcinoma patients
Philogen S.p.A.
Skin and Connective Tissue Diseases
Greece, Italy, Germany, Spain
10/02/2026
Phase III
An Open-label, Randomized Phase 3 Study of Linvoseltamab Monotherapy and Linvoseltamab plus Carfilzomib versus Standard of Care Combination Regimens in Patients with Relapsed/Refractory Multiple Myeloma
2024-519504-27-00Relapsed Refractory Multiple Myeloma
Regeneron Pharmaceuticals Inc.
Neoplasms
Greece, Spain, Poland, Italy, Austria, Czechia, Belgium, Germany, Netherlands, France
10/02/2026
Phase II
A Phase 2 study of intratumoral administration of L19IL2/L19TNF in locally advanced Basal Cell Carcinoma patients progressed on or intolerant to systemic treatment.
2025-523230-77-00Patients with locally advanced Basal Cell Carcinoma (LaBCC)…
Philogen S.p.A.
Neoplasms
Germany, Italy, Greece, Spain
10/02/2026
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants with Obstructive Sleep Apnea on Positive Airway Pressure Therapy and Living with Overweight or Obesity (MARITIME-OSA-1)
2025-522703-14-00"Moderate to severe obstructive sleep apnea (OSA) in adults…
Amgen Inc.
Respiratory Tract Diseases
Poland, Germany, Czechia, Hungary, Spain, France
10/02/2026
Phase II
A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to less than 18 Years of age With Generalized Myasthenia Gravis (gMG)
2025-520993-20-00Generalized Myasthenia Gravis
Amgen Inc.
Nervous System Diseases
Spain, Italy, Poland, France
09/02/2026
Phase I
A Phase 1 Study of AJ1-11095 in Adults with Myelofibrosis Failed by a JAK2 Inhibitor
2025-522033-64-00Myelofibrosis
Ajax Therapeutics Inc.
Neoplasms
Italy, France, Spain
09/02/2026
Phase I
A Phase 1/1b First-in-Human Study of BMS-986506 in ccRCC
2025-522543-18-00Advanced Clear Cell Renal Cell Carcinoma
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Spain, France
09/02/2026
Phase IV
Long-term Safety Outcomes in Patients Treated With Replimune Oncolytic Immunotherapy Products
2025-521621-33-00Hepatocellular Carcinoma, Melanoma, Metastatic Melanoma, Ad…
Replimune Group Inc.
Neoplasms
Germany, Greece, France, Poland, Spain
09/02/2026
Phase III
Phase 2/3 Open Label Randomized Study of Telisotuzumab Adizutecan, Monotherapy or in Combination with Osimertinib, Compared to Standard of Care in Subjects with Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer After Progression on a Third-Generation EGFR TKI - AndroMETa-Lung-713
2025-521124-29-00Non-Small Cell Lung Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Portugal, Italy, Spain, Poland, Netherlands, Germany, Belgium, Austria, France
09/02/2026
Phase III
A Phase 3 Trial to Evaluate the Long-Term Safety and Efficacy of Navenibart in Participants with Hereditary Angioedema – ORBIT-EXPANSE
2025-521142-22-00Hereditary Angioedema
Astria Therapeutics Inc.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Netherlands, Spain, Poland, Germany, Czechia, Austria, Portugal, Hungary, France, Italy, Bulgaria
09/02/2026
Phase III
A Multicenter, Multinational, Randomized, Double-blind, Placebo-Controlled, Phase 3 Maintenance Study to Evaluate the Efficacy and Safety of Duvakitug in Participants with Moderately to Severely Active Ulcerative Colitis
2025-521038-27-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Slovakia, Germany, Austria, Italy, Czechia, Netherlands, Poland, Belgium, Hungary, Lithuania, Greece, France, Bulgaria, Spain, Norway
09/02/2026
Phase III
A multicenter, multinational, randomized, double-blind, placebo-controlled Phase 3, induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis.
2025-521035-37-00Immune system diseases
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Austria, France, Norway, Hungary, Bulgaria, Netherlands, Czechia, Slovakia, Germany, Lithuania, Greece, Belgium, Italy, Spain, Poland
09/02/2026
Phase II
A Double-Blind, Placebo-Controlled, Multicenter, Randomized Phase 2 Trial Evaluating the Efficacy and Safety of Felzartamab in Recipients of Kidney Transplants with Late Isolated Microvascular Inflammation (MVI)- (299AR201-TRANSPIRE)
2025-521742-15-00Treatment of Late Isolated Microvascular Inflammation in Re…
Biogen Idec Research Limited
Immune System Diseases
Germany, Austria, Spain, Czechia, France
09/02/2026
Phase II
A Phase 2 randomized, double-blind, placebo-controlled study to investigate efficacy, safety, immunogenicity, and pharmacokinetics, of GSK3862995B in participants with bronchiectasis
2025-522892-27-00Bronchiectasis
GSK PLC
Respiratory Tract Diseases
Denmark, France, Spain, Italy, Germany, Poland
09/02/2026
Phase III
A Phase 3, Randomized, Multicenter, Open-Label Study of IDRX-42 (GSK6042981) versus Sunitinib in Participants with Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST) after Imatinib Therapy (StrateGIST 3)
2025-522229-37-00Gastrointestinal Neoplasms
Glaxosmithkline Research & Development Limited
Neoplasms
France, Romania, Spain, Netherlands, Norway, Belgium, Hungary, Italy, Poland, Germany
06/02/2026
Phase IV
Adductor canal and IPACK (infiltration between the popliteal artery and the capsule of the knee) blocks versus genicular nerves block for total knee arthroplasty: A randomized clinical trial
2025-523071-34-00Knee Osteoarthritis
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Musculoskeletal Diseases
Spain
06/02/2026
Phase II
Pacritinib For The Reduction Of Bone Marrow Fibrosis In Patients With Myelofibrosis Who Have Thrombocytopenia; A Multicenter, Open-Label, Single Arm, Phase II Exploratory Study
2025-522509-39-00Patients with myelofibrosis and platelets counts between 50…
Grupo Espanol De Enfermedades Mieloproliferativas Cronicas Ph
Neoplasms
Spain
06/02/2026
Phase III
EFFICACY OF PROPRANOLOL IN TRAUMATIC BRAIN INJURY PATIENTS ADMITTED TO THE ICU: A PROSPECTIVE, RANDOMIZED, TRIPLE-BLIND STUDY (ProP TBI in ICU)
2025-524194-17-00Head injury
University Hospital Son Espases
Nervous System Diseases
Spain
05/02/2026
Phase II
A Phase 2, Randomised, Double-masked, Placebo-controlled, Parallel-group, Multi-centre Study to Evaluate K1-70 in Patients with Active Thyroid Eye Disease in Europe
2024-519292-26-00Graves’ disease and active thyroid eye disease
Av7 Limited
Eye Diseases
Spain, Italy
05/02/2026
Phase II
An Open-Label Extension, Multi-centered, Phase 2 Trial to Describe the Safety and Efficacy of TEV-56286 (Emrusolmin) in Participants with Multiple System Atrophy
2025-521642-14-00Multiple System Atrophy
Teva Branded Pharmaceutical Products R&D LLC
Nervous System Diseases
France, Germany, Italy, Spain
04/02/2026
Phase II
An Open-label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of Induction Treatment with Melphalan/HDS Followed by Consolidation Treatment with Eribulin or Vinorelbine or Capecitabine Versus Eribulin or Vinorelbine or Capecitabine Alone in Patients with Metastatic Breast Cancer with Liver Dominant Disease
2025-521966-91-00Refractory Metastatic Breast Cancer with Liver Dominant Dis…
Delcath Systems Inc.
Neoplasms
Italy, Spain, Sweden, France, Germany
04/02/2026
Phase III
A Phase 2b/3, Open-Label, Multicenter Trial Evaluating the Efficacy and Safety of Switching to Brelovitug for the Treatment of Chronic Hepatitis Delta Infection in Participants Receiving Bulevirtide (AZURE-3)
2025-522015-42-00Chronic Hepatitis D Infection
Mirum Pharmaceuticals Inc.
Virus Diseases
Czechia, Austria, Spain, Romania, Germany, Italy, France
03/02/2026
Phase I
A study to investigate safety, tolerability, pharmacokinetics, and pharmacodynamics of surovatamig in adult participants with rheumatoid arthritis or systemic lupus erythematosus.
2025-522273-10-00Rheumatoid Arthritis, Systemic Lupus Erythematosus
AstraZeneca AB
Immune System Diseases
Germany, Spain, Belgium
03/02/2026
Phase I/II
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D
2025-522253-19-00Urothelial carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Netherlands, France, Spain
03/02/2026
Phase III
ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients with Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease
2025-522960-34-00Hypertension, Established cardiovascular disease, High card…
Alnylam Pharmaceuticals Inc.
Cardiovascular Diseases
Belgium, Hungary, Czechia, Austria, Germany, France, Greece, Spain, Romania, Netherlands, Italy, Poland, Slovakia, Sweden, Portugal, Denmark, Bulgaria
03/02/2026
Phase III
A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluate the Efficacy and Safety of Upadacitinib for the Treatment of Adult Subjects with Moderate to Severe Atopic Dermatitis and Inadequate Response to Dupilumab (SWITCH-UP)
2025-523347-35-00Atopic Dermatitis
AbbVie Deutschland GmbH & Co. KG
Immune System Diseases
Spain, Italy, Romania
02/02/2026
Phase III
A Pilot Study on the Use of Gadopiclenol for Enhanced Cardiac MRI in Children with Congenital Heart Conditions: A self-controlled, non-randomised, open-label study to compare the image quality and diagnostic performance of gadopiclenol versus gadoterate meglumine
2025-524029-41-00Cardiomyopathy, tetralogy of Fallot, or complex congenital …
Fundacio Sant Joan De Deu
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Spain
02/02/2026
Phase I
A Study of JNJ-90301900 in Combination with Concurrent Chemoradiation Therapy in LA HNSCC
2025-522914-22-00Locally Advanced Head and Neck Squamous Cell Carcinoma (LA …
Janssen Cilag International
Neoplasms
France, Spain
02/02/2026
Phase II
A Phase 2b, Randomised, Double-Blind, Placebo-Controlled, Parallel-Arm Dose Finding Study Evaluating the Efficacy and Safety of SAB-142 for Delaying the Progression of Type 1 Diabetes (T1D) in Patients with Stage 3 New Onset of Type 1 Diabetes (NOT1D)
2025-521560-36-00Type 1 Diabetes
Sab Biotherapeutics Inc.
Nutritional and Metabolic Diseases
Austria, Germany, Poland, Italy, Denmark, Spain, Belgium, Finland, France, Lithuania, Slovenia
02/02/2026
Phase III
A Phase 2b/3, Adaptive, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of Danicamtiv in Participants with Symptomatic Genetic and Familial Dilated Cardiomyopathy (KINSHIP-DCM).
2025-522553-19-00Symptomatic genetic and familial dilated cardiomyopathy.
Kardigan Inc.
Cardiovascular Diseases
Spain, Denmark, Belgium, Hungary, Italy, Poland, France, Sweden, Netherlands
30/01/2026
Phase I/II
First-in-human, Open-label, Multi-site, Phase I/IIa, Dose Escalation Trial With Expansion Cohorts to Evaluate Safety and Preliminary Efficacy of BNT329 in Participants With Advanced Solid Tumors Known to Express CA19-9
2025-522613-26-00Advanced Solid Cancers
BioNTech SE
Neoplasms
Spain, Germany
29/01/2026
Phase I/II
A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARO-DM1 in Subjects With Type 1 Myotonic Dystrophy Who are ≥18 to ≤65 Years
2024-513579-42-00Type 1 Myotonic Dystrophy
Sarepta Therapeutics Inc.
Nervous System Diseases
Spain, Germany, Belgium, Italy
29/01/2026
Phase III
A RANDOMIZED, PHASE 3, OPEN-LABEL STUDY OF NEOADJUVANT DAROVASERTIB IN SUBJECTS WITH PRIMARY NON-METASTATIC UVEAL MELANOMA (OptimUM-10)
2025-522387-32-00Uveal Melanoma
Ideaya Biosciences Inc.
Eye Diseases
France, Spain, Poland, Italy, Czechia, Belgium, Austria, Netherlands, Denmark, Germany
29/01/2026
Phase I/II
Guttmann NeuroRecovery – Feasibility, safety and efficacy of intrathecal Wharton's jelly-derived mesenchymal stem cells and transcutaneous spinal cord stimulation in the rehabilitation of chronic spinal cord injuries: a pilot study
2025-521877-14-00Traumatic spinal cord injury
Fundacio Institut Guttmann
Nervous System Diseases
Spain
28/01/2026
Phase II
A Multi-Center, Double-Blind, Placebo-Controlled, Phase II Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489, A Monoacylglycerol Lipase Inhibitor, as Add-On Therapy to Ocrelizumab, in Participants with Progressive Forms of Multiple Sclerosis
2025-521636-10-00Progressive Forms of Multiple Sclerosis (PMS)
F. Hoffmann-La Roche AG
Nervous System Diseases
Germany, Spain, France, Hungary, Italy, Poland, Portugal
28/01/2026
Phase IV
EFFICACY OF INFILTRATED MEPIVACAINE AS A LOCAL ANESTHETIC PRIOR TO ARTERIAL PUNCTURE: A RANDOMIZED CONTROLLED CLINICAL TRIAL
2025-522974-35-00Respiratory disease. Prescripcion o indicación de gasometrí…
University Of The Basque Country
Respiratory Tract Diseases
Spain
28/01/2026
Phase III
An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)
2025-522792-29-00Alpha-1 Antitrypsin Deficiency
Grifols Therapeutics LLC
Respiratory Tract Diseases
Poland, Denmark, Netherlands, Ireland, Sweden, Spain, Portugal, Germany, France
27/01/2026
Phase III
N1T-MC-MALO: A Master Protocol for a Randomized, Controlled, Clinical Trial of Multiple Pharmacologic Agents in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease Who Are at Increased Risk of Developing Major Adverse Liver Outcomes (SYNERGY-Outcomes); N1T-MC-TZ01 Tirzepatide in participants with high-risk MASLD; N1T-MC-RT01 Retatrutide in participants with high-risk MASLD
2025-522674-36-00Metabolic Dysfunction-Associated Steatotic Liver Disease
Eli Lilly & Co.
Nutritional and Metabolic Diseases
Czechia, France, Netherlands, Bulgaria, Norway, Austria, Poland, Spain, Italy, Hungary, Germany, Romania, Sweden, Portugal, Belgium
27/01/2026
Phase I
A PK study to compare JPB898 (proposed nivolumab biosimilar) and US-licensed Opdivo® in participants with resected stage IIB, IIC, or III melanoma in the adjuvant setting
2025-521919-39-00Resected stage IIB, IIC, or III melanoma requiring adjuvant…
H e x a l AG
Neoplasms
Spain, Romania, Italy, Greece
27/01/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallelgroup Study to Evaluate the Efficacy and Safety of Treprostinil Palmitil Inhalation Powder in Participants with Pulmonary Hypertension Associated with Interstitial Lung Disease
2025-521558-40-00Pulmonary Hypertension Associated with Interstitial Lung Di…
Insmed Inc.
Respiratory Tract Diseases
Portugal, Italy, Czechia, Poland, Denmark, Greece, Germany, Romania, Spain, France, Belgium, Austria
26/01/2026
Phase III
Patient-Centered Study of Trastuzumab Deruxtecan (T-DXd) in First-Line HER2-POsitive Metastatic Breast Cancer with Proactive Toxicity ManagementReflecting Real-World Clinical Practice / TOP-REAL Trial
2025-521805-41-00Patients with HER2-positive, locally advanced or metastatic…
Solti Group
Neoplasms
France, Germany, Spain
26/01/2026
Phase III
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia
2024-519068-42-00​Heterozygous Familial Hypercholesterolemia​ in pediatric p…
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland
26/01/2026
Phase III
A Phase 3, Randomized, Double-blind, Placebo-Controlled, Multicenter Study to Evaluate Azetukalner in Moderate-to-Severe Major Depressive Disorder
2025-523202-32-00Major Depressive Disorder
Xenon Pharmaceuticals Inc.
Mental Disorders
Spain, Czechia, Slovakia, Romania, Poland, Finland, Germany
26/01/2026
Phase II
A Phase II, Randomized, Open-Label Study Evaluating Two Inavolisib Dose Levels in Combination with Fulvestrant in Participants with PIK3CA-Mutated, HR-Positive, HER2-Negative Locally Advanced or Metastatic Breast Cancer
2025-522805-39-00Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic su…
F. Hoffmann-La Roche AG
Neoplasms
Belgium, Spain
23/01/2026
Phase II
An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of leniolisib for immune dysregulation in patients with primary immunodeficiency
2025-522444-40-00primary immunodeficiency
Pharming Technologies B.V.
Immune System Diseases
Spain
23/01/2026
Phase II
Master Protocol: A Phase 1b / 2, Multicenter, Multi Arm Study of Evorpacept in Combination with Anti-cancer Therapies in Advanced / Metastatic Malignancies (ASPEN-09) Substudy Protocol: A Single-arm Phase 2 Multicenter Study of Evorpacept in Combination with Trastuzumab and Chemotherapy in Participants with Metastatic HER2-Positive Breast Cancer (ASPEN-09-03)
2025-522012-16-00Breast Cancer
Alx Oncology Holdings Inc.
Neoplasms
Spain, Italy, France
23/01/2026
Phase III
Phase 3 Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent and Adult Subjects with Homozygous Familial Hypercholesterolemia (YOSEMITE)
2025-521792-31-01Homozygous Familial Hypercholesterolemia (HoFH)
Arrowhead Pharmaceuticals Inc.
Cardiovascular Diseases
Greece, France, Belgium, Germany, Netherlands, Austria, Sweden, Spain, Czechia, Italy
23/01/2026
Phase II
A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 Coadministered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1.( INNOVATE Study)
2025-521918-26-00HIV Infections
Viiv Healthcare UK Limited
Virus Diseases
Spain, Belgium, France, Germany, Italy, Portugal, Poland
23/01/2026
Phase II
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Dose Comparison and Exploratory Efficacy Study of Orally Administered SAT-3247 in Ambulatory DMD Patients
2025-522522-13-01Duchenne muscular dystrophy
Satellos Bioscience Inc.
Nervous System Diseases
Spain, Belgium, Poland
22/01/2026
Phase III
Beamion LUNG-3: A randomized, controlled, multi-center trial evaluating zongertinib as an adjuvant monotherapy compared with standard of care in patients with early-stage, resectable non-small cell lung cancer (Stage II-IIIB) harboring tyrosine kinase domain activating HER2 mutations
2025-521284-12-00Non-small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Neoplasms
Austria, Portugal, Netherlands, Greece, Belgium, Spain, Germany, France, Romania, Sweden, Italy, Denmark
19/01/2026
Phase III
IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-based Chemotherapy in Patients with EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy
2025-521908-22-00EGFR-mutated Non-small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Poland, Germany, Italy, Norway, Netherlands, Belgium, Romania, France, Greece, Spain
19/01/2026
Phase II
A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations with Mirvetuximab Soravtansine in Subjects with Ovarian Cancer (FLORENZA)
2025-521606-18-00Ovarian Cancer
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Spain, Czechia, France, Belgium, Denmark
19/01/2026
Phase III
A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants with Moderate-to-Severe Plaque Psoriasis (PRAGMATYK)
2023-503766-24-00Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Romania, Bulgaria, Germany, Spain, Czechia, France, Hungary, Italy, Sweden, Poland, Denmark, Belgium
19/01/2026
Phase IV
International multicentre, open-label, phase IV clinical trial to evaluate the efficacy, safety and effect on quality of life of bilastine in children with allergic rhinoconjunctivitis
2024-519550-36-00Allergic rhinoconjunctivitis
Faes Farma S.A., A. Menarini Industrie Farmaceutiche Riunite S.r.l.
Immune System Diseases
Poland, Spain, Italy
19/01/2026
Phase I/II
A Phase 1/2 dose escalation trial with administration schedule exploration evaluating single agent TD001, a PSMA-targeted antibody-drug conjugate, in patients with PSMA-expressing metastatic castration-resistant prostate cancer
2025-523273-41-00Metastatic castration-resistant prostate cancer
T.O.A.D. Oncology S.A.
Neoplasms
Spain, France
16/01/2026
Phase II
A Phase 2a, Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fexlamose (AER 01) Inhalation Solution in the Treatment of Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease
2025-523020-50-00Chronic Obstructive Pulmonary Disease
Aer Therapeutics Inc.
Respiratory Tract Diseases
Bulgaria, Poland, Spain
16/01/2026
Phase I
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
2025-523101-15-00Relapsed or Refractory Acute Myeloid Leukemia or Higher-Ris…
Genmab A/S
Neoplasms
Denmark, Spain
16/01/2026
Phase I
A Phase 1 Study for ZW251 in Participants with Solid Tumors.
2025-523088-39-00Advanced Solid Tumors
Zymeworks Bc Inc.
Neoplasms
Portugal, Ireland, Spain
15/01/2026
Phase I
A trial to learn how safe AZD5335 is and if a drug called itraconazole changes how AZD5335 moves through the body over time in adults with ovarian, peritoneal, or fallopian tube cancer
2025-522731-34-00Ovarian cancer Primary peritoneal cancer Fallopian tube can…
AstraZeneca AB
Neoplasms
Spain, Ireland, Portugal
15/01/2026
Phase I
A Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Rilvegostomig in Adult Participants with Advanced Solid Tumors Previously Treated with Standard of Care Therapy
2025-521614-26-00Advanced Solid Tumors
AstraZeneca AB
Neoplasms
Spain
15/01/2026
Phase III
An open-label, parallel, Phase 3, two-arm study to investigate the efficacy and safety of fitusiran prophylaxis in male participants aged 1 to less than 12 years with hemophilia A or B with or without inhibitory antibodies to Factors VIII or IX
2025-521858-42-00Hemophilia
Sanofi-Aventis Recherche & Developpement
Hemic and Lymphatic Diseases
Belgium, Italy, Romania, Germany, Hungary, Spain, Poland
15/01/2026
Phase II
A Randomized, Placebo-controlled, Parallel Phase 2a Dose-ranging Study to Investigate the Efficacy, Safety, and Tolerability of Topical HT-001 for the Treatment of Skin Toxicities Associated with Epidermal Growth Factor Receptor Inhibitors CLEER Trial (Chemotherapy Longevity by Evading EGFR Inhibitor Reactions)
2025-523058-16-00Skin Toxicities Associated with Epidermal Growth Factor Rec…
Hoth Therapeutics Inc.
Skin and Connective Tissue Diseases
Spain, Hungary, Poland
15/01/2026
Phase III
HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study
2025-522767-15-00Acute Myeloid Leukemia
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Neoplasms
Belgium, Netherlands, Germany, Austria, Denmark, Estonia, Finland, Ireland, Italy, Lithuania, Spain, Sweden, Norway, Poland
15/01/2026
Phase III
A Phase 3, Randomized, Open-Label, Multicenter Study of Amivantamab in Addition to Carboplatin and Pembrolizumab, Compared to Standard of Care Platinum and Pembrolizumab and 5-FU, in Participants with Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
2025-521917-24-00Treatment-Naïve Recurrent/Metastatic Head and Neck Squamous…
Janssen Cilag International
Neoplasms
Italy, Portugal, Spain, Romania, Hungary, France, Czechia, Germany, Netherlands, Austria, Poland, Belgium
14/01/2026
Phase I
A study of gilteritinib in adults with advanced ALK-positive non-small cell lung cancer (NSCLC)
2025-522398-12-00Locally advanced or metastatic NSCLC
Astellas Pharma Global Development Inc.
Neoplasms
France, Spain
14/01/2026
Phase I
OPEN-LABEL PALATABILITY STUDY OF A NOVEL ORODISPERSIBLE PARACETAMOL/IBUPROFEN FORMULATION AFTER A SINGLE ORAL ADMINISTRATION IN HEALTHY SUBJECTS
2025-524274-41-00Healthy volunteers
Farmalider S.A.
Not possible to specify
Spain
14/01/2026
Phase III
A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)
2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…
Merck Sharp & Dohme LLC
Neoplasms
Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy
14/01/2026
Phase II
A Phase IIa, Randomised, Double-blind, Placebo-controlled, Multicentre Study to Assess the Efficacy, Safety, and Tolerability of AZD4144 in Participants with Sepsis-associated Acute Kidney Injury (SERENIA)
2025-522232-13-00Sepsis-associated acute kidney injury (AKI)
AstraZeneca AB
Not possible to specify
Germany, France, Spain, Italy, Belgium, Czechia, Greece, Denmark, Hungary
14/01/2026
Phase III
Phase II-III study to assess the efficacy and safety of sublingual immunotherapy in patients suffering from house dust mite allergy. A prospective, international, randomized, double-blind, placebo-controlled, multicentre, phase II-III trial.
2025-523119-12-00Patients with moderate-to-severe allergic rhinitis / rhinoc…
ROXALL Medizin GmbH
Immune System Diseases
Germany, Spain
13/01/2026
Phase IV
A multicenter randomized, controlled, single-blind, adaptive phase IV clinical trial to evaluate the efficiency and effectiveness of a pre-emptive pharmacogenetic strategy for antidepressant selection in patients with depressive disorder: The PREDICT adaptive clinical trial.
2025-522967-13-00Depressive disorder
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Mental Disorders
Spain
11/01/2026
Phase III
A Phase 2/3, multicenter, randomized open-label study of zanzalintinib vs everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors
2025-521043-20-00Neuroendocrine tumors
Exelixis Inc.
Neoplasms
France, Poland, Netherlands, Belgium, Germany, Spain, Italy, Austria
09/01/2026
Phase I/II
An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-372 as a Single Agent and in Combination with Other Anti-Tumor Agents, in Patients with Advanced KRAS Mutant Solid Tumors
2025-523086-22-00Locally advanced or metastatic solid tumors
Treeline Biosciences Inc.
Neoplasms
Spain
07/01/2026
Phase I/II
Single-center phase I/IIa study of infusion of autologous peripheral blood T cells expanded and genetically modified by Sleeping Beauty family transposons to express a chimeric antigen receptor with anti-CD19 specificity conjugated with the 4-1BB costimulatory region and CD3z and huEGFRt signal transmission (TranspoCART19) in patients with CD19+ acute lymphoblastic leukemia resistant or refractory to treatment
2025-522673-11-00refractory or resistant CD19+ acute lymphoblastic leukemia
Clinica Universidad De Navarra
Hemic and Lymphatic Diseases
Spain
02/01/2026
Phase I/II
Inhibiting the anti-apoptotic factor, BCL-2, at the time of ART initiation to promote apoptosis of HIV-infected cells and restrict the seeding of the HIV reservoir: An investigator-initiated randomised, controlled, open-label clinical trial (The INITIATE Study)
2025-521841-26-00HIV-1 infection
Region Midtjylland
Virus Diseases
Denmark, Spain
02/01/2026
Phase IV
Impact of EXercise on quality of life of early breast cancer patients on treatment with adjuvant Aromatase Inhibitors with or without CDK4/6 inhibitors. "The EX-AI study"
2025-522848-40-00Early Breast Cancer
Fundacion Grupo Espanol De Investigacion En Cancer De Mama
Neoplasms
Spain
29/12/2025
Phase I
A Phase 1, First-in-Human Study of MEN2312, a KAT6 inhibitor, as Monotherapy and in Combination in Participants with Advanced Breast Cancer
2024-514661-19-01Advanced ER+/HER2- Breast Cancer
Stemline Therapeutics Inc.
Neoplasms
Spain
29/12/2025
Phase III
J2A-MC-GZPT A Phase 3 Study to Investigate the Efficacy and Safety of Orfor-glipron Once Daily in Participants Who Have Obesity or Overweight and Osteoar-thritis of the Knee: A Multicenter, Randomized, Double-Blind, Parallel-Arm, Pla-cebo-Controlled Trial List of Intervention-Specific Appendices (ISAs): ISA1 (GZT1): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee ISA2 (GZT2): A Study to Investigate Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obesity or Overweight and Osteoarthritis of the Knee
2025-522631-34-00Osteoarthritis
Eli Lilly & Co.
Musculoskeletal Diseases
Germany, Spain
29/12/2025
Phase IV
Insulin resistance in type 2 diabetes: evaluating the pathogenic mechanisms of insulin resistance in the myocardium and the effects of the treatments with GLP-1RA and SGLT2i
2025-523374-17-01Type 2 diabetes
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Nutritional and Metabolic Diseases
Spain
23/12/2025
Phase III
A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination with Nivolumab versus Ipilimumab in Combination with Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients with Metastatic Uveal Melanoma
2023-508784-68-00metastatic uveal melanoma
Replimune Inc.
Neoplasms
Germany, Italy, France, Spain, Poland
23/12/2025
Phase I/II
A Clinical study of MK-4716 in people with certain solid tumors (MK-4716-001)
2025-522495-84-00Cancer – Solid Tumors : 1L NSCLC and all other advanced or …
Merck Sharp & Dohme LLC
Neoplasms
Spain
23/12/2025
Phase I
C5951001- A Phase 1 Study of PF-08046876 in Participants with Advanced Solid Tumors.
2025-521729-33-00advanced solid tumors
Pfizer Inc.
Neoplasms
Spain
23/12/2025
Phase I/II
An Open-Label, Phase I/II First-in-Human, Dose Escalation, Dose Optimisation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, Immunogenicity and Antitumour Activity of IPN60300 as Single Agent in Adult Participants with Locally Advanced or Metastatic Solid Tumours.
2025-522139-33-00Advanced or metastatic solid tumours
Ipsen Pharma
Neoplasms
France, Spain
23/12/2025
Phase II
A Phase 2b, Randomized, Blinded Trial Investigating the Efficacy and Safety of Visugromab in combination with Nivolumab and Lenvatinib compared to Double Placebo and Lenvatinib in Participants with Unresectable or Metastatic Hepatocellular Carcinoma and Compensated Liver Function (Child-Pugh A) after Failure of First-Line Treatment that Included an Anti-PD-(L)1 Compound (GDFATHER-HCC-01)
2025-520675-86-00Unresectable or Metastatic Hepatocellular Carcinoma and Com…
CatalYm GmbH
Neoplasms
Germany, France, Italy, Spain
23/12/2025
Phase III
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Intravenous Prasinezumab in Participants with Early-Stage Parkinson’s Disease
2025-522683-32-00Early-Stage Parkinson’s Disease (PD)
F. Hoffmann-La Roche AG
Nervous System Diseases
France, Austria, Portugal, Netherlands, Poland, Germany, Spain, Denmark, Italy
23/12/2025
Phase II
PHASE II STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CAMIZESTRANT PLUS RIBOCICLIB IN PATIENTS WITH HORMONE RECEPTOR-POSITIVE (HR+) BREAST CANCER​ (THE CADILLAC STUDY)
2024-520027-88-00Patients with hormone receptor-positive (HR+) breast cancer
Medica Scientia Innovation Research S.L.
Neoplasms
Spain, Germany
23/12/2025
Phase I/II
Phase 1b/2 Dose-Ranging Study of the Safety, PK, PD & Efficacy of the Activin Signaling Inhibitor HS235 vs placebo added to background therapy in PAH (SEASIde)
2025-523010-89-00Pulmonary arterial hypertension
35Pharma Inc.
Cardiovascular Diseases
Hungary, Spain, Poland, Germany, Czechia
23/12/2025
Phase II
A randomized, double-blind, placebo-controlled, dose-ranging Phase 2 study of brivekimig followed by a maintenance period in participants with moderate to severe hidradenitis suppurativa
2025-522333-61-00Hidradenitis suppurativa
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
Poland, Hungary, Netherlands, Germany, Czechia, Spain, France, Italy, Greece
22/12/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 25 September 2026. https://priyalifescience.com/clinical-trials-europe/country/spain?page=7

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,490 trial records at the last sync on 25 Sep 2026, 03:16 UTC; this register shows the 2,500 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 1,016 of those trials with a site in Spain.

How many recently authorised EU trials have a site in Spain?

1,016 of the 2,500 most recently authorised trials in this register list a site in Spain; 422 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

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.