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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
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
1018 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
Randomised, crossover bioequivalence clinical trial of memantine 20 mg capsules versus memantine 20 mg film-coated tablets, after a single oral dose administration to healthy volunteers under fasting conditions.
2025-523808-75-00Alzheimerโ€™s disease
Laboratorios Alter S.A.
Mental Disorders
Spain
09/10/2025
Phase I
Bioequivalence clinical trial of two formulations of linagliptin
2025-523384-37-00Healthy volunteers
Laboratorios Normon S.A.
Not possible to specify
Spain
08/10/2025
Phase II
C4921003 - A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of an Oral Branched-Chain Ketoacid Dehydrogenase Kinase Inhibitor, PF-07328948 in Adults with Heart Failure (BRANCH-HF)
2024-518438-94-00Heart failure
Pfizer Inc.
Cardiovascular Diseases
France, Spain, Bulgaria, Poland, Hungary, Czechia
08/10/2025
Phase III
SGLT2 INHIBITION FOR CARDIOVASCULAR ENDPOINT REDUCTION IN HYPERTENSION
2025-520794-39-00Arterial Hypertension
Universitaetsklinikum Schleswig-Holstein AรถR
Cardiovascular Diseases
Germany, Slovenia, Spain, Austria, Portugal, Italy
08/10/2025
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 III
A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Deucravacitinib in Adolescent Subjects (12 years to less than 18 years) with Moderate to Severe Plaque Psoriasis
2023-506296-97-00Moderate to Severe Plaque Psoriasis
Bristol-Myers Squibb Services Unlimited Company
Immune System Diseases
Germany, Romania, Italy, Belgium, Poland, Hungary, Spain
08/10/2025
Phase III
ETOP 27-23 ARCH โ€“ A randomised phase III trial of adjuvant cemiplimab in patients with resected stage IIA-IIIB NSCLC who have not received prior adjuvant chemotherapy.
2024-519901-36-00Patients with resected stage IIA-IIIB non-small cell lung cโ€ฆ
ETOP IBCSG Partners Foundation
Neoplasms
France, Estonia, Spain, Austria, Italy, Germany, Ireland
08/10/2025
Phase I
Dose Escalation Study with Bispecific Antibodies in Adult Patients with Lupus Nephritis
2024-518288-37-00Lupus Nephritis
Regeneron Pharmaceuticals Inc.
Immune System Diseases
Spain, France, Germany
07/10/2025
Phase III
A multi-center, open-label, single-arm study to evaluate the efficacy and safety of oral rilzabrutinib in adults with immune thrombocytopenia (ITP) who failed first-line treatment
2025-522070-36-00immune thrombocytopenia (ITP)
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
France, Spain, Italy, Germany, Czechia, Poland, Hungary, Austria, Norway
07/10/2025
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 III
Open Label Extension Clinical Trial of Vormatrigine in Adult Patients with Epilepsy.
2025-521640-38-00Focal onset seizures or primary generalized tonic-clonic seโ€ฆ
Praxis Precision Medicines Inc.
Nervous System Diseases
Germany, Spain, Poland, Italy
06/10/2025
Phase III
A Phase 3b open-label, randomised study of IPX203 in subjects with advanced Parkinsonโ€™s disease and motor fluctuations - ADIP study
2025-521772-57-00Motor fluctuations in advanced Parkinsonโ€™s disease
Zambon Biotech S.A.
Nervous System Diseases
Spain, Italy, Poland
06/10/2025
Phase III
A Randomized, Placebo-Controlled, Double-Blind, Multi-Center Phase 3 Study of Zipalertinib Plus Adjuvant Chemotherapy Versus Placebo Plus Adjuvant Chemotherapy in Stage IB-IIIA NSCLC Patients with Uncommon EGFR Mutations Following Complete Tumor Resection (REZILIENT4)
2025-521775-31-00Stage IB-IIIA NSCLC Patients with uncommon EGFR Mutations
Taiho Oncology Inc.
Neoplasms
Germany, Poland, Spain, France, Belgium, Italy, Greece, Romania, Netherlands
06/10/2025
Phase III
A Prospective, Open-Label, Randomized, Interventional Study to Evaluate the Efficacy and Tolerability of Sucrosomialยฎ Iron vs Ferric Maltol in Iron Deficient Women
2025-522004-24-00iron deficient
Pharmanutra S.p.A.
Hemic and Lymphatic Diseases
Spain
06/10/2025
Phase III
A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01).
2024-519654-37-00Recurrent or Metastatic Head and Neck Squamous Cell Carcinoโ€ฆ
Bicara Therapeutics Inc.
Neoplasms
Belgium, Austria, Italy, Poland, Spain, Germany, Czechia, Ireland, Greece, France, Portugal
06/10/2025
Phase III
Transdermal testosterone pretreatment in poor responders with androgen receptor polymorphism undergoing ICSI: A Randomized Clinical Investigation.
2024-510596-37-01low ovarian reserve according to Bologna criteria and carriโ€ฆ
Instituto Bernabeu S.L.
Female Urogenital Diseases and Pregnancy Complications
Spain
06/10/2025
Phase II
A Phase 2, Randomized, Blinded, Placebo-Controlled Trial Investigating the Efficacy and Safety of Visugromab plus Nivolumab with or without Docetaxel versus Docetaxel Monotherapy in Second-Line Treatment of Participants with Metastatic Non-Squamous Non-Small Cell Lung Cancer (GDFATHER-NSCLC-02)
2024-516794-70-00Metastatic non-squamous non-small cell lung cancer
CatalYm GmbH
Neoplasms
Spain, Italy, Germany, Poland, Romania
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 III
A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan in Combination with Pembrolizumab Versus Platinum-based Chemotherapy in Combination with Pembrolizumab, as First-line Therapy in Participants with Locally Advanced Unresectable or Metastatic HER2-overexpressing and PD-L1 TPS <50% Non-squamous Non-small Cell Lung Cancer. (DESTINY-Lung06)
2024-515658-26-00Unresectable or Metastatic HER2 overexpressing and PD-L1 TPโ€ฆ
Daiichi Sankyo Inc.
Neoplasms
France, Belgium, Germany, Portugal, Italy, Greece, Romania, Spain, Poland
06/10/2025
Phase III
C4951063: An interventional efficacy and safety, Phase 3, double-blind, parallel group study to investigate intermittent prevention of Menstrual Migraine with Rimegepant compared with placebo in women participants 18 to 45 years of age
2024-517121-10-00Menstrual Migraine
Pfizer Inc.
Nervous System Diseases
Netherlands, Italy, Poland, Denmark, Germany, Spain
06/10/2025
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impactof Maridebart Cafraglutide on Cardiovascular Outcomes in Participants with Atherosclerotic Cardiovascular Disease and Overweight or Obesity (MARITIME-CV)
2024-516652-18-00Atherosclerotic cardiovascular disease (ASCVD) and obesity โ€ฆ
Amgen Inc.
Cardiovascular Diseases
Slovakia, Denmark, Portugal, Czechia, Poland, Greece, Bulgaria, France, Spain, Sweden, Finland, Belgium, Romania, Germany, Hungary, Netherlands, Italy, Austria
06/10/2025
Phase I
EAST-1 (ERAP-inhibition in Axial Spondyloarthritis Trial-1)
2025-521315-39-00Axial spondyloarthritis
Grey Wolf Therapeutics Limited
Hemic and Lymphatic Diseases
Belgium, Germany, Netherlands, Spain, Poland
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 IV
A biomarker enrichment trial of anti-EGFR agents in patients with advanced colorectal cancer (aCRC) with wild-type RAS and right primary tumour location (right-PTL) - ARIEL-ENGIC 04 EU trial
2025-521209-42-00advanced colorectal cancer with wild-type RAS and right priโ€ฆ
Fondazione GONO G.I.
Neoplasms
Italy, Germany, Spain
06/10/2025
Phase IV
Randomized clinical trial to assess the efficacy and safety of a strategy for primary prevention of cardiovascular disease in patients with inflammatory rheumatic diseases based on the use of carotid ultrasound.
2025-521086-28-00CHRONIC INFLAMMATORY RHEUMATIC DISEASE: rheumatoid arthritiโ€ฆ
Instituto De Investigacion Marques De Valdecilla
Cardiovascular Diseases
Spain
03/10/2025
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 II randomized clinical trial of Tarlatamab as maintenance treatment after sequential chemo-radiotherapy vs sequential chemo-radiotherapy as standard treatment for limited stage SCLC patients not eligible for concurrent chemo-radiotherapy. MERLIN GECP 24/01
2024-515201-26-00Small cell lung cancer (SCLC)
Fundacion GECP
Neoplasms
Spain
02/10/2025
Phase III
A Phase 3, Multicenter, Prospective, Randomized, Open-label Efficacy and Safety Study of Intravenous Brincidofovir versus Intravenous Cidofovir for Treatment of Adenovirus Infection in Pediatric and Adult Subjects After Allogeneic Hematopoietic Cell Transplantation (allo HCT)
2025-521903-28-00Adenovirus viremia
Symbio Pharmaceuticals Ltd.
Virus Diseases
Germany, Italy, France, Spain, Portugal
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 I/II
An open-label, Phase 1/2, multicenter study of belumosudil in children aged 1 to <18 years requiring systemic treatment for active moderate-to-severe chronic graft versus host disease (cGVHD).
2024-511508-18-00Chronic graft versus host disease.
Sanofi-Aventis Recherche & Developpement
Immune System Diseases
France, Italy, Belgium, Spain, Netherlands, Germany
30/09/2025
Phase I
Phase 1b Study of Tarlatamab in Combination with YL201 with or without Anti-PD-L1 in Subjects with Extensive Stage Small Cell Lung Cancer (DeLLphi-310)
2024-515903-21-00Extensive Stage Small Cell Lung Cancer (ES-SCLC)
Amgen Inc.
Neoplasms
France, Germany, Spain, Greece, Hungary, Italy
30/09/2025
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
A Randomized Double-Blind Placebo-Controlled Cross-Over Trial of the Safety, Tolerability, and Efficacy of PN6047 HCl in Peripheral Neuropathic Pain Characterized by Mechanical Allodynia
2024-517304-12-00Mechanical allodynia
Pharmnovo AB
Nervous System Diseases
Spain, Czechia
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 III
A Phase III, Randomised, Open-Label, Sponsor-Blinded, Multicenter Study of Rilvegostomig in Combination with Bevacizumab with or without Tremelimumab as First-line Treatment in Patients With Advanced Hepatocellular Carcinoma (ARTEMIDE-HCC01)
2024-518210-81-00Advanced Hepatocellular Carcinoma
AstraZeneca AB
Neoplasms
Italy, Germany, France, Poland, Spain, Netherlands
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 IV
A randomized, double-blind, placebo-controlled study to evaluate the effect of dupilumab on airway inflammation through assessments of mucus plugging and other lung imaging parameters in patients with chronic obstructive pulmonary disease (AEOLUS)
2025-521268-37-00Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
Respiratory Tract Diseases
Netherlands, Hungary, France, Germany, Austria, Spain, Poland, Sweden, Italy, Denmark
29/09/2025
Phase III
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physicianโ€™s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
2025-520582-51-00Hormone receptor positive breast cancer
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, France, Italy, Spain, Hungary, Germany
29/09/2025
Phase I
A Study of LY4175408 in Participants With Advanced or Metastatic Solid Tumors.
2025-521916-20-00Cancer
Eli Lilly & Co.
Neoplasms
Spain, France
29/09/2025
Phase I/II
A Multicenter, Randomized, Open-Label, Phase 1b/2 Trial of Valemetostat Tosylate Plus Pembrolizumab vs Pembrolizumab Alone in Participants with Advanced or Metastatic Non-small Cell Lung Cancer whose Tumors Express PD-L1 with Tumor Proportion Score โ‰ฅ50% Without Actionable Genomic Alterations
2024-519671-26-00Advanced or Metastatic Non-Small Cell Lung Cancer
Daiichi Sankyo Inc.
Neoplasms
Spain, France, Italy
29/09/2025
Phase III
Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)
2025-521627-78-00Neoplasms, Lung
Glaxosmithkline Research & Development Limited
Neoplasms
Hungary, France, Portugal, Greece, Sweden, Ireland, Poland, Bulgaria, Romania, Finland, Italy, Germany, Spain
29/09/2025
Phase III
APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)
2024-520407-27-00X-Linked Protoporphyria (XLP), Erythropoietic Protoporphyriโ€ฆ
Disc Medicine Inc.
Nutritional and Metabolic Diseases
Germany, Ireland, Spain, France, Norway, Netherlands, Sweden, Belgium, Italy
29/09/2025
Phase III
A Global Phase 3 Open-Label Extension Study to Assess the Long-Term Safety, Tolerability, and Efficacy of Intravenous AOC 1001 for the Treatment of Myotonic Dystrophy Type 1
2025-520766-22-00Myotonic Dystrophy Type 1
Avidity Biosciences Inc.
Musculoskeletal Diseases
France, Denmark, Spain, Italy, Germany, Netherlands
29/09/2025
Phase III
A Phase 3b Extension Study to Evaluate the Long-Term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohnโ€™s Disease
2023-508804-39-00Ulcerative Colitis or Crohnโ€™s Disease
Takeda Development Center Americas Inc.
Digestive System Diseases
Spain, Ireland, Portugal, Poland, Belgium, Netherlands, Bulgaria, Romania, Italy, Denmark
29/09/2025
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 I
CITY
2024-520294-13-00Cutaneous T-cell lymphomas (CTCL)
Assistance Publique Hopitaux De Paris
Skin and Connective Tissue Diseases
Spain, France
26/09/2025
Phase I
A Phase I Study of BMS-986497 alone or in combination with Azacitidine (Aza) and Azacitidine plus Venetoclax (AZA+VEN) in relapsed or refractory (R/R) AML or MDS
2024-519537-29-00Acute Myeloid Leukemia and Myelodysplastic Syndrome
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
France, Spain
26/09/2025
Phase III
A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
2024-517131-52-00Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lympโ€ฆ
BeOne Medicines AG
Neoplasms
France, Sweden, Czechia, Austria, Belgium, Germany, Denmark, Spain, Netherlands, Italy, Ireland, Poland
26/09/2025
Phase I/II
A phase 1/2, open label, multicenter clinical trial investigating the safety, tolerability, pharmacokinetics, and antineoplastic activity of S095035 (MAT2A inhibitor) as a single agent and in combination in adult participants with advanced or metastatic solid tumors with homozygous deletion of MTAP
2025-521249-25-00MTAP-deleted advanced or metastatic solid tumors
Institut De Recherches Internationales Servier IRIS
Neoplasms
Denmark, Italy, Germany, Spain, France
26/09/2025
Phase III
A 52 week, randomized, double-blind, double dummy multinational, multicenter, active controlled, 2-arm parallel group trial comparing CHF 5993 100/6/12.5 ยตg pMDI (fixed combination of extrafine Beclomethasone Dipropionate plus Formoterol Fumarate plus Glycopyrronium Bromide) to Seretideยฎ Evohalerยฎ 125/25 ยตg pMDI (fixed combination of fluticasone propionate / salmeterol xinafoate) in adolescent subjects with asthma uncontrolled on medium doses of inhaled corticosteroids in combination with long acting รŸ2 agonists.
2024-514248-95-00Uncontrolled Asthma
Chiesi Farmaceutici S.p.A.
Respiratory Tract Diseases
Italy, Germany, Spain
26/09/2025
Phase I
A PHASE 1/1B, OPEN-LABEL, MULTICENTER, FIRST-IN-HUMAN DOSE ESCALATION AND DOSE EXPANSION STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS, AND ANTI-TUMOR ACTIVITY OF VVD-159642 AS A SINGLE AGENT AND IN COMBINATION IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
2025-522148-42-00Advanced Solid Tumours
Vividion Therapeutics Inc.
Neoplasms
Spain
26/09/2025
Phase III
A multi-centre, single-arm study to demonstrate the efficacy of bone marrow allogeneic mesenchymal cells combined with biomaterial (combined ATMP) for bone healing in delayed union and non-union after long bone fractures (OrthoAlloUnion).
2025-520841-60-00Delayed consolidation or non-union long bone fracture
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda
Musculoskeletal Diseases
Spain, Italy, France, Germany
26/09/2025
Phase I
A Study to Test How Safe, Effective and How the Body Responds to the Combination of Mosunetuzumab and Pirtobrutinib Together to Treat Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma
2024-514152-32-00Relapsed or Refractory Chronic Lymphocytic Leukemia (R/R CLโ€ฆ
F. Hoffmann-La Roche AG
Neoplasms
France, Spain, Poland
25/09/2025
Phase II
A Randomized, Double-Blind, Active-Controlled Multicenter Phase 2 Study Evaluating the Efficacy and Safety of ALG-000184 Compared with Tenofovir Disoproxil Fumarate in Untreated HBeAg-Positive and HBeAg-Negative Adult Subjects with Chronic Hepatitis B Virus Infection (B-SUPREME)
2025-521178-33-00Chronic Hepatitis B Virus Infection
Aligos Therapeutics Inc.
Virus Diseases
Spain, Italy, Bulgaria, Romania, France
24/09/2025
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 III
EASi-PROTKTโ„ข - 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 II
A Phase 2b, Multicenter, Randomized, Double-blinded, Placebo-controlled, Parallel-group, Dose-finding Study to Evaluate the Efficacy and Safety of IMG-007 in Adult Participants with Moderate-to-Severe Atopic Dermatitis
2024-520117-50-00Atopic Dermatitis
Inmagene LLC
Immune System Diseases
Czechia, Spain, Germany, Hungary, Poland
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-negaโ€ฆ
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 I
A research study looking at how different doses of study medicine (Inno8) work in the body of people with haemophilia A
2025-520490-38-00Haemophilia A with or without inhibitors. Proposed indicatiโ€ฆ
Novo Nordisk A/S
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Poland, Spain, Austria, Italy, Germany, Belgium, France, Portugal, Sweden
22/09/2025
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 I
A Study to assess the Safety, Tolerability and effect of RO7673396 when used alone as well as with other cancer medications in participants with Advanced Solid Tumors
2024-519622-20-00Advanced Solid Tumors Harboring RAS Mutation(S)
F. Hoffmann-La Roche AG
Neoplasms
Germany, Netherlands, Spain, Denmark, France, Belgium
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 I
An exploratory study to investigate the impact on the viral reservoir of adding a broadly neutralizing antibody with or without an attachment inhibitor to an integrase inhibitor-based antiretroviral therapy regimen in adults living with HIV (ENTRANCE)
2025-520629-19-00HIV Infections
Viiv Healthcare UK Limited
Virus Diseases
Netherlands, Spain, Belgium, Denmark
22/09/2025
Phase I
A study to test a new immunotherapy, ABX-001, alone and in combination with the marketed drug, pembrolizumab, for the treatment of tumors previously treated with other therapies.
2024-512403-39-01Advanced Solid Tumors Who Are Beyond Standard of Care
Abalos Therapeutics GmbH
Neoplasms
Spain, Germany
22/09/2025
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 (LIBTAYOยฎ) 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 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 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 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 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 Metastatโ€ฆ
Merck Sharp & Dohme LLC
Neoplasms
Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary
17/09/2025
Phase II
A Phase 2b, non-randomized, controlled, open-label, extension study to evaluate the persistence of immune response of the adjuvanted RSVPreF3 vaccine and the safety and immunogenicity following revaccination in lung and kidney transplant recipients (โ‰ฅ18 years of age)
2024-519730-23-00Respiratory Syncytial Virus Infections
GlaxoSmithKline Biologicals
Respiratory Tract Diseases
Italy, Germany, Spain
16/09/2025
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 kโ€ฆ
Takeda Development Center Americas Inc.
Immune System Diseases
Spain, Czechia, Austria, Hungary, Germany, Norway, Slovenia, France, Sweden, Netherlands, Poland, Italy
16/09/2025
Phase I/II
A Phase 1/2, Single-arm, Open-Label Trial to Evaluate the Safety and Efficacy of Nadofaragene Firadenovec Instilled to the Renal Pelvis in Adult Subjects with Low-Grade Upper Tract Urothelial Carcinoma (LG-UTUC)
2024-514360-70-00Low-grade upper track urothelial carcinoma (LG-UTUC)
Ferring Pharmaceuticals A/S
Female Urogenital Diseases and Pregnancy Complications
Spain, France, Netherlands
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 I
An Open Label Study to Assess the Effect of Patient Use and Robustness on Tiotropium Bromide Spray 2.5ฮผg, Soft Mist Inhaler device
2025-522412-16-00Chronic obstructive pulmonary disease
Laboratorios Liconsa S.A.
Respiratory Tract Diseases
Spain
16/09/2025
Phase I/II
A Phase 1/2, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study to Assess the Safety, Pharmacokinetics, and Efficacy of AMG 732 in Healthy Subjects and Subjects with Moderate-to-Severe Active Thyroid Eye Disease
2024-514110-12-00Thyroid Eye Disease
Amgen Inc.
Eye Diseases
France, Spain, Italy, Poland, Germany, Greece
15/09/2025
Phase IV
A Single-arm, Open-label Phase 4 Study of Nirogacestat in Adult Premenopausal Females with Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
2024-515215-21-00DESMOID TUMOURS/AGGRESSIVE FIBROMATOSIS (DT/AF)
Springworks Therapeutics Inc.
Skin and Connective Tissue Diseases
Netherlands, Italy, Spain, Belgium, Germany
15/09/2025
Phase I
A Phase 1 Study of ATV-1601, in Patients with Advanced Cancer that have AKT1 E17K Mutations
2025-521480-12-00Advanced solid tumors, Breast Cancer
Atavistik Bio Inc.
Neoplasms
Belgium, Italy, Spain, France
15/09/2025
Phase I
A Phase 1 Study of NDI-219216 in Patients with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair
2025-522774-36-00Advanced solid tumors
Nimbus Wadjet Inc.
Neoplasms
Spain, Portugal, France, Ireland
15/09/2025
Phase I
A Study of LY4050784 in Participants With Advanced or Metastatic Solid Tumors
2024-519727-18-00Metastatic Solid Tumor Advanced Solid Tumor Non-small Cell โ€ฆ
Eli Lilly & Co.
Neoplasms
Spain, Germany, France
15/09/2025
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 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 I
A Phase 1/1b Study of IAM1363 in HER2 Cancers
2024-519188-17-00Relapsed/refractory malignancy with documented diagnosis ofโ€ฆ
Iambic Therapeutics Inc.
Neoplasms
Spain, France, Ireland, Italy, Netherlands
11/09/2025
Phase IV
Early treatment of Atrial fibrillation for Stroke prevention Trial in acute STROKE (EAST-STROKE)
2025-521260-35-00acute ischemic stroke and atrial fibrillation (AF)
University Medical Center Hamburg-Eppendorf
Cardiovascular Diseases
Spain, Germany, Netherlands
11/09/2025
Phase II
A randomized, open label, multicenter, Phase 2 study to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivoยฎ in combination with mFOLFOX6 and bevacizumab versus standard of care for first-line treatment of non-MSI-H/dMMR, PD-L1 positive advanced colorectal cancer.
2024-519590-19-00PD-L1 positive advanced colorectal cancer
Ono Pharmaceutical Co. Ltd.
Neoplasms
Spain, France, Italy
10/09/2025
Phase II
A phase 2, multi-center study consisting of a randomized, placebo-controlled period, followed by an open-label extension period to assess the efficacy, safety, and tolerability of tibulizumab in adults with hidradenitis suppurativa
2024-519736-17-00Hidradenitis Suppurativa
Zura Bio Inc.
Immune System Diseases
Poland, Germany, Spain, Hungary
10/09/2025
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 IV
Optimising TREATment for severe Gram-Negative Bacterial infections.
2025-521476-65-00Severe Gram-Negative Bacterial infections
Fundacion Para La Gestion De La Investigacion En Salud De Sevilla
Bacterial Infections and Mycoses
Spain
09/09/2025
Phase I
A Study to Assess Adverse Events and Change in Disease Activity of Intravenously (IV) Infused ABBV-324 in Compared to Oral Lenvatinib Capsules in Adult Participants With Hepatocellular Cancer (HCC) or Squamous-Cell Non-Small Cell Lung Cancer (LUSC)
2024-518012-39-00Squamous-Cell Non-Small Cell Lung Cancer, Hepatocellular Caโ€ฆ
AbbVie Deutschland GmbH & Co. KG
Neoplasms
Spain
09/09/2025
Phase IV
Low Intervention, Open, Multicentric, Phase IV Exploratory Clinical Trial to evaluate new biomarkers for the diagnosis and treatment monitoring of tuberculosis
2025-522235-34-00Bacterial pneumonia patients, Pulmonary tuberculosis patienโ€ฆ
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Bacterial Infections and Mycoses
Spain
09/09/2025
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 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 II
Phase II randomized clinical trial for evaluating the safety and feasibility of fecal microbiota transplant (FMT) in stage II-III non-small cell lung cancer (NSCLC) patients, using immune checkpoint inhibitors (ICI) responders as donors. MIGRANT GECP 24/02
2025-521251-24-00Non-Small cell lung cancer (NSCLC)
Fundacion GECP
Neoplasms
Spain
08/09/2025
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=10

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