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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 โ€” 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 โ€” 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
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270 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
A Global Phase 2b, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Ninerafaxstat in Patients with Symptomatic Non Obstructive Hypertrophic Cardiomyopathy โ€“ FORTITUDE-HCM
2024-515125-28-00Non-obstructive hypertrophic cardiomyopathy
Imbria Pharmaceuticals Inc.
Cardiovascular Diseases
Austria, Germany, Belgium, France, Portugal, Spain, Netherlands, Italy, Poland
20/11/2025
Phase II
Phase 2, Randomized, Double-Blind, Placebo-controlled, Parallel-Group, Multicenter Study to Evaluate the Safety and Efficacy of Tarperprumig in Adult Participants with Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
2025-521706-17-00Anti-neutrophil cytoplasmic antibody (ANCA)-associated vascโ€ฆ
Alexion Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Spain, France, Italy, Germany, Poland
17/11/2025
Phase II
A phase II, randomized, open-label, national, multicenter study evaluating the efficacy and safety of the combination of atezolizumab and bevacizumab as neoadjuvant plus adjuvant treatment in hepatocellular carcinoma (ASPIRE)
2025-521459-22-00Patients with resectable hepatocellular carcinoma (amenableโ€ฆ
Fundacio De Recerca Clinic Barcelona-Institut Dโ€™Investigacions Biomediques August Pi I Sunyer
Neoplasms
Spain
17/11/2025
Phase II
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, PHASE 2B TRIAL TO ASSESS THE EFFICACY, SAFETY, AND TOLERABILITY OF AEF0217 FOR 24 WEEKS IN ADULTS AND OLDER ADOLESCENTS WITH DOWN SYNDROME
2025-521013-10-00Treatment of behavioural and cognitive impairments in Down โ€ฆ
Aelis Farma
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Spain, Italy, France
17/11/2025
Phase II
A Randomized, Double-Blinded, Placebo-Controlled, Dose-Finding, Adaptive Trial to Evaluate the Safety, Tolerability, and Efficacy of TAK-360 in Participants with Narcolepsy without Cataplexy (NT2)
2024-517711-70-01Narcolepsy without Cataplexy (NT2)
Takeda Development Center Americas Inc.
Nervous System Diseases
Spain, Italy, France
14/11/2025
Phase II
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Atopic Dermatitis who Participated in Previous Afimkibart Clinical Trials
2025-520771-59-00Atopic Dermatitis
F. Hoffmann-La Roche AG
Skin and Connective Tissue Diseases
Italy, Poland, Germany, Spain, France
13/11/2025
Phase II
A Phase 2, open-label, multicenter study to evaluate efficacy and safety of zanidatamab for the treatment of participants with previously treated HER2-expressing solid tumors (DiscovHER PAN-206)
2024-516551-41-00Patients with HER2-expressing solid tumors
Jazz Pharmaceuticals Ireland Limited
Neoplasms
Spain, France
13/11/2025
Phase II
A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
2025-521737-91-00Neoplasm malignant with KRAS G12C mutation
Merck Sharp & Dohme LLC
Neoplasms
Norway, Spain, Sweden, Italy, Denmark, France, Poland, Germany, Greece
12/11/2025
Phase II
Efficacy of Tuvusertib in Recurrent IDH mutant Astrocytoma with ATRX mutation, a phase II prospective trial.
2025-521843-19-00IDH1/2-mutated, ATRX-mutated and p53-mutated astrocytoma
Grupo Espanol De Investigacion En Neurooncologia
Neoplasms
Spain
11/11/2025
Phase II
Phase 2 Platform Trial to Assess the Efficacy and Safety of Long-acting Antibodies as Single Agents and in Combinations for Moderately to Severely Active Ulcerative Colitis
2025-521242-26-00Moderately to Severely Active Ulcerative Colitis
Spyre Therapeutics Inc.
Digestive System Diseases
Belgium, Hungary, Lithuania, Netherlands, Croatia, Czechia, Bulgaria, Romania, Spain, France, Austria, Italy, Greece, Poland, Germany, Slovakia
10/11/2025
Phase II
A phase 2, Multicenter Study of TILs Treatment in Germ Cell tumors: the ARES Study
2025-522427-10-00Germ Cell Tumors refractory to salvage chemotherapy
Fundacio Institut D'Investigacio Biomedica De Bellvitge IDIBELL
Neoplasms
Spain
04/11/2025
Phase II
Efficacy and safety assessment of T1695 ophthalmic suspension, versus Ciclosporin ophthalmic emulsion, in participants with moderate to severe Vernal Keratoconjunctivitis (VKC)
2025-521567-12-00Vernal Keratoconjunctivitis (VKC)
Laboratoires Thea
Eye Diseases
Spain, Italy, Bulgaria, France, Greece
04/11/2025
Phase II
A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa
2025-521293-34-00Moderate-to-severe hidradenitis suppurativa
Almirall S.A.
Skin and Connective Tissue Diseases
Germany, Italy, Ireland, Poland, Spain, France
03/11/2025
Phase II
A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 years of Age and Older With Bronchiectasis and Chronic Pseudomonas aeruginosa Colonization
2025-523009-14-00Bronchiectasis with chronic pseudomonas aeruginosa colonizaโ€ฆ
AstraZeneca AB
Respiratory Tract Diseases
Netherlands, Italy, Greece, Denmark, Belgium, Spain, France, Germany
31/10/2025
Phase II
A Phase 2, Parallel-arm, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of BFB759 in Patients with Atopic Dermatitis (COMPASS 2-AD)
2025-521624-30-00Atopic dermatitis
Bluefin Biomedicine Inc.
Immune System Diseases
Poland, Bulgaria, Germany, Czechia, Spain
31/10/2025
Phase II
DECISION ON OPTIMAL COMBINATORIAL THERAPIES IN IMMUNE-MEDIATED INFLAMMATORY DISEASES (IMIDS) USING SYSTEMS APPROACHES
2024-518011-19-01Psoriatic Arthritis, Rheumatoid Arthritis
Cardiff University
Immune System Diseases
Spain
30/10/2025
Phase II
A Phase 2, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of ALXN2030 in Adult Patients with Antibody-Mediated Rejection after Kidney Transplantation
2024-517498-25-00Antibody-Mediated Rejection after Kidney Transplantation
Alexion Pharmaceuticals Inc.
Pathological Conditions, Signs and Symptoms
Spain
28/10/2025
Phase II
An open-label phase II trial to evaluate the clinical efficacy, safety and tolerability of MAS825 in pediatric and adult participants with Stillโ€™s disease
2024-520208-25-00Stillโ€™s disease
Novartis Pharma AG
Immune System Diseases
Italy, Netherlands, Spain, France, Germany
28/10/2025
Phase II
A Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
2024-517614-14-00Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Immunovant Sciences GmbH
Immune System Diseases
Austria, Hungary, Slovenia, Greece, Denmark, Ireland, Finland, Estonia, Spain, Slovakia, Netherlands, Poland, Norway, Italy, Portugal, Belgium, Germany, Romania, Bulgaria
28/10/2025
Phase II
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
2025-521745-25-00Rheumatoid Arthritis
Merck Sharp & Dohme LLC
Immune System Diseases
Poland, Spain, Germany
27/10/2025
Phase II
An open-label randomised, phase II trial of Datopotamab deruxtecan plus Durvalumab versus Datopotamab deruxtecan in patients with PDL1-negative metastatic triple-negative breast cancer
2024-519913-76-00PDL1-negative metastatic triple-negative breast cancer
Queen Mary University Of London
Neoplasms
Spain, Germany
23/10/2025
Phase II
A Multi-Center, Single Arm, Open-Label Extension Study to Evaluate the Long-term Safety and Efficacy of GSK4527226 [AL101] in Participants with Early Alzheimerโ€™s Disease.
2025-521107-42-00Alzheimer's Disease
Glaxosmithkline Research & Development Limited
Nervous System Diseases
Sweden, Norway, Italy, France, Spain, Finland, Netherlands, Germany
23/10/2025
Phase II
A Phase 2, Open-label, Multi-cohort Study to Assess the Efficacy and Safety of ASP5541 in Participants with Advanced Prostate Cancer
2024-517653-27-00Prostate Cancer
Astellas Pharma Global Development Inc.
Neoplasms
Italy, Poland, Spain, France, Germany
22/10/2025
Phase II
A Phase 2, Double-Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Apitegromab in Subjects <2 Years Old With Spinal Muscular Atrophy (SMA) (OPAL)
2024-520130-29-00Spinal Muscular Atrophy
Scholar Rock Inc.
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Belgium, France, Italy, Spain, Netherlands
21/10/2025
Phase II
Blomia tropicalis allergen extract. Determination of the vivo histamine equivalent prick test units
2024-515169-33-00Allergy to Blomia tropicalis
Inmunotek S.L.
Immune System Diseases
Spain
20/10/2025
Phase II
EPIK-P4: A Phase II single arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
2024-519960-42-00PIK3CA-Related Overgrowth Spectrum (PROS)
Novartis Pharma AG
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Italy, Netherlands, Belgium, Spain, Austria, Germany, France
20/10/2025
Phase II
EFfIcacy and Tolerability of FIXed duration teclistamab and talquetamab FOR FRAIL patients with newly diagnosed multiple myeloma (2 cohort study) - the EMN 37 FITFIX FOR FRAIL trial
2024-520433-76-00Newly Diagnosed Multiple Myeloma
European Myeloma Network B.V., Emn Trial Office S.r.l. Impresa Sociale
Neoplasms
Norway, Italy, Spain, Netherlands
20/10/2025
Phase II
A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Patients With Graves' Disease
2025-521920-31-00Gravesโ€™ Disease
Immunovant Sciences GmbH
Immune System Diseases
Italy, Poland, Greece, Germany, Netherlands, Czechia, Spain, Latvia, Bulgaria
17/10/2025
Phase II
A Phase 2, Randomized, Open-Label Study Of Axatilimab Versus Best Available Therapy in Pediatric Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy (AGAVE-256)
2025-521849-25-00Chronic Graft-Versus-Host Disease
Incyte Corp.
Immune System Diseases
Spain, Belgium, Germany, Italy
17/10/2025
Phase II
A phase 2, two-part study to assess the safety, antiviral biomarker responses, and efficacy of inhaled SNG001 for the treatment of patients with a confirmed respiratory virus infection undergoing invasive mechanical ventilation
2024-520375-27-00Lower respiratory tract viral infections
Synairgen Research Limited
Virus Diseases
Netherlands, France, Spain, Belgium
15/10/2025
Phase II
A double-blind, randomised, placebo-controlled, parallel group, Phase IIa trial to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of BI 765423 administered intravenously with or without standard of care in patients with idiopathic pulmonary fibrosis
2025-520658-12-00Idiopathic Pulmonary Fibrosis (IPF)
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
Respiratory Tract Diseases
Germany, Italy, Spain, Belgium
09/10/2025
Phase II
A Phase 2 Multicenter, Open-Label Study Evaluating the Efficacy and Safety of TYRA-300 in Participants with FGFR3 Altered Low Grade, Intermediate Risk Non-Muscle Invasive Bladder Cancer (SURF302)
2025-521277-14-00Non-muscle invasive bladder cancer (NMIBC)
Tyra Biosciences Inc.
Neoplasms
Italy, Spain, France
08/10/2025
Phase II
A Phase 2, Multicenter, Open-Label Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants with Active SLE (Including Lupus Nephritis) with Inadequate Response to Glucocorticoids and at Least 2 Immunosuppressants (Breakfree-SLE)
2024-519278-37-00Systemic Lupus Erythematosus, Lupus Nephritis
Celgene Corp.
Immune System Diseases
France, Spain, Portugal, Germany, Belgium, Poland, Italy, Denmark, Austria
06/10/2025
Phase II
A Phase 2a double blind, randomized, parallel arm, placebo-controlled trial to investigate the effects of two dose levels of CIT-013 on disease activity in patients with Hidradenitis Suppurativa (HS)
2025-521684-12-00Hidradenitis Suppurativa
Citryll B.V.
Skin and Connective Tissue Diseases
Netherlands, Germany, Poland, Spain
06/10/2025
Phase II
A Phase 1b/2 Open-Label, Multicenter Study of RMC-9805 with or without RMC-6236, in Combination with Other Anticancer Agents, in Patients with RAS G12D-Mutated Non-Small Cell Lung Cancer (NSCLC) โ€“ Subprotocol C
2025-521147-21-00Lung Cancer
Revolution Medicines Inc.
Respiratory Tract Diseases
Germany, Austria, France, Netherlands, Czechia, Greece, Italy, Spain, Denmark
06/10/2025
Phase II
Upfront trastuzumab-deruxtecan plus capecitabine and bevacizumab for patients with HER2 positive metastatic colorectal cancer: the CHIMERA trial
2024-519479-24-00metastatic colorectal cancer
Fondazione GONO G.I.
Neoplasms
Germany, France, Italy, Spain
02/10/2025
Phase II
A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)
2025-521278-32-00Idiopathic Pulmonary Fibrosis (IPF)
Mediar Therapeutics Inc.
Immune System Diseases
Croatia, Ireland, Netherlands, Spain, France, Belgium
01/10/2025
Phase II
A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants with Early Alzheimer's Disease
2024-519190-19-00Alzheimerโ€™s Disease
Merck Sharp & Dohme LLC
Nervous System Diseases
Spain, Belgium, Netherlands
30/09/2025
Phase II
Phase II, Placebo-controlled trial of Cannabidiol for the treatment of alcohol dependence (PLACONCANALDE)
2023-504439-42-01alcohol dependence
Hospital Universitario 12 De Octubre
Behavioral Disciplines and Activities
Spain
30/09/2025
Phase II
Phase II study of lurbinectedin and irinotecan in adult and young adult patients with advanced desmoplastic small round cell tumor (DSRCT)
2024-519261-21-00Desmoplastic small round cell tumor
Italian Sarcoma Group
Neoplasms
Spain, Italy
30/09/2025
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Parallel group, Placebo-controlled, Dose Range Finding Study to Evaluate the Efficacy, Safety, and Tolerability of Nebulized CSL787 in Adults (18 to 85 years) with Non-cystic Fibrosis Bronchiectasis
2024-518821-13-00Non-cystic Fibrosis Bronchiectasis
CSL Behring LLC
Respiratory Tract Diseases
Spain, Belgium, Germany, Greece, Denmark, Netherlands, Hungary, Italy, France, Poland
26/09/2025
Phase II
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
2025-521519-37-00IgA Nephropathy (IgAN); Berger Disease; Renal and Urinary Dโ€ฆ
Vera Therapeutics Inc.
Pathological Conditions, Signs and Symptoms
Spain, Poland
24/09/2025
Phase II
A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis
2024-519081-49-00Moderate to severe atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
Czechia, Netherlands, Poland, Germany, Spain, Hungary, France, Italy, Slovakia
22/09/2025
Phase II
A Multicentre, Parallel-group, Phase IIb, Randomised, Double blind, Placebo-controlled, 3-Arm, 24-Week Study to Evaluate the Efficacy and Safety of AZD6793 Tablets in Adult Participants with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (PRESTO).
2025-520473-40-00Moderate to Very Severe Chronic Obstructive Pulmonary Diseaโ€ฆ
AstraZeneca AB
Respiratory Tract Diseases
Spain, Greece, Bulgaria, Germany, Denmark, Hungary, Italy, Poland
22/09/2025
Phase II
A Phase 2, Open-Label, Multicenter Study of Zoldonrasib(RMC-9805) in Previously Treated Patients with RAS G12DMutant Non-Small Cell Lung Cancer (NSCLC) โ€“ Subprotocol D
2025-521681-10-00Lung Cancer
Revolution Medicines Inc.
Respiratory Tract Diseases
Germany, Greece, Netherlands, Czechia, France, Austria, Denmark, Spain, Italy
22/09/2025
Phase II
Standardized Dermatophagoides mix (D. pteronyssinus + D. farinae) in TBU/ml in liquid formulation for sublingual immunotherapy: Phase II, randomized dose determination clinical trial.
2025-521522-15-00Allergic rhinitis/rhinoconjunctivitis caused by dust mite aโ€ฆ
Asac Pharmaceutical Inmunology S.A., Advanced Outcomes Research S.L.
Immune System Diseases
Spain
17/09/2025
Phase II
A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
2024-520155-24-00Metastatic castration resistant prostate cancer (mCRPC)
Novartis Pharma AG
Neoplasms
Netherlands, Austria, Germany, Italy, France, Czechia, Spain
17/09/2025
Phase II
A Phase 2, Multicenter, Platform Study of Targeted Therapies for the Treatment of Adult Subjects with Moderately to Severely Active Rheumatoid Arthritis.
2025-520721-21-00Rheumatoid Arthritis
AbbVie Deutschland GmbH & Co. KG
Immune System Diseases
Germany, Czechia, Hungary, Spain, Poland, Slovakia
12/09/2025
Phase II
Phase II Study Of Tarlatamab Alone Or In Combination With Chemotherapy In Advanced Neuroendocrine Carcinomas Of The Digestive System Or Unknown Primary Origin
2024-514327-42-00Advanced neuroendocrine carcinomas (NECs) of the digestive โ€ฆ
Grupo Espanol De Tumores Neuroendocrinos
Neoplasms
Spain, France
10/09/2025
Phase II
A Phase 2b Randomized, Double-blind, Placebo-controlled, Parallel-Group Study to Assess Efficacy and Safety of Verekitug (UPB-101) in Participants with Moderate-to-Severe Chronic Obstructive Pulmonary Disease (COPD)
2025-520488-42-00Moderate-to-Severe Chronic Obstructive Pulmonary Disease (Cโ€ฆ
Upstream Bio Inc.
Respiratory Tract Diseases
Romania, Lithuania, Hungary, Spain, Bulgaria, Ireland, Germany, Latvia, Czechia, Poland, Slovakia
09/09/2025
Phase II
Phase 2 Study of Zelenectide Pevedotin in Participants with Previously-Treated NECTIN4 Amplified Advanced or Metastatic Non-small Cell Lung Cancer
2025-521115-40-00Advanced or Metastatic Non-small Cell Lung Cancer
Bicycletx Limited
Neoplasms
Italy, Spain, France, Germany
09/09/2025
Phase II
A Phase 2 Study to Evaluate the Safety and Efficacy of Atacicept in Multiple Autoimmune Glomerular Diseases (PIONEER)
2024-518465-10-00Multiple Autoimmune Glomerular Diseases
Vera Therapeutics Inc.
Pathological Conditions, Signs and Symptoms
Germany, France, Italy, Spain, Poland, Belgium
08/09/2025
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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=3

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