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Updated 06 Jul 2026 · EMA CTIS official data

Clinical Trials in Denmark

← All EU trials

The most recently authorised clinical trials across the European Union - drawn live from the European Medicines Agency's Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation. Searchable by country, phase, sponsor and condition.

77
Recent authorisations
34
Phase III trials
Denmark
Selected country
Phase II Mental Disorders Authorised 03/07/2026
The Acute and Long-term Impact of Support in Psilocybin Therapy for Depression: The Psilocybin Setting Trial (PSISET)
Depression
Kobenhavns Universitet, Koebenhavns Universitet · 180 participants
📍 Denmark
2025-522961-31-01 on CTIS ↗
Phase I Female Urogenital Diseases and Pregnancy Complications Authorised 03/07/2026
Calcium Electroporation for Urinary Bladder Tumors: A First-in-Human Feasibility, Safety, and Early Response Trial - The CALCIFER Trial
Bladder cancer, Bladder tumors, Urothelial cancer, Urothelial tumors
Region Sjaelland · 20 participants
📍 Denmark
2026-526388-39-00 on CTIS ↗
Phase I/II Nervous System Diseases Authorised 01/07/2026
The headache- and migraine-inducing effects of apremilast in women with migraine without aura
Migraine without aura
Syddansk Universitet (University of Southern Denmark) · 14 participants
📍 Denmark
2026-525987-16-00 on CTIS ↗
Phase III Neoplasms Authorised 01/07/2026
A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)
Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)
Genmab A/S · 189 participants
📍 Finland · Belgium · France · Denmark · Austria · Germany · Italy · Czechia · Norway
2025-522167-15-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 30/06/2026
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 128 participants
📍 Greece · France · Italy · Belgium · Denmark · Germany · Czechia · Portugal · Austria
2025-521769-29-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 30/06/2026
A Phase 2/3 Study to Characterize and Evaluate the Efficacy, Safety, and Tolerability of hu14.18K322A Treatment Given in Combination with Chemotherapy in Participants with High-Risk Neuroblastoma
Participants with relapsed HRNB and participants with HRNB refractory to treatment The clinical trial will recruit participants aged ≥18 months to <18 years, and therefore all participants will be minors at the time of consent.
Renaissance Pharma Limited · 56 participants
📍 France · Denmark · Ireland · Germany
2025-524397-42-00 on CTIS ↗
Phase IV Mental Disorders Authorised 29/06/2026
Unprescribing the Pill to Reassess Symptom and Cognitive Recovery in Depression (UNPRESCRIB-D)
Major Depressive Disorder
Region Hovedstaden · 106 participants
📍 Denmark
2026-526314-90-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 28/06/2026
Self-Assessment Method for Statin side-effects Or Nocebo 2
Cardiovascular diseases
Copenhagen University Hospital, Region Hovedstaden · 160 participants
📍 Denmark
2025-524955-30-01 on CTIS ↗
Phase III Neoplasms Authorised 26/06/2026
A Randomized, Double-Blind, Phase 3 Study of Chemotherapy With or Without INCB161734 in Previously Untreated, KRAS G12D-Mutated Metastatic Pancreatic Ductal Adenocarcinoma (DAWN-303)
Pancreatic Ductal Adenocarcinoma
Incyte Corp. · 205 participants
📍 Poland · Italy · Netherlands · Sweden · Denmark · Finland · Spain · France · Belgium · Norway · Austria
2025-525009-18-00 on CTIS ↗
Phase IV Hemic and Lymphatic Diseases Authorised 25/06/2026
A multicentre, adaptive, randomised, multidomain, platform trial for dose optimization in the treatment of adult patients with haematological diseases (BLOOD-dose): core protocol
Haematological diseases; any disorder that primarily affects the blood, bone marrow, the lymphatic system and/or blood-forming organs.
Region Hovedstaden · 200 participants
📍 Denmark
2026-525658-13-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 25/06/2026
Evaluating the effect of inhaled levodopa (Inbrija®) for early morning off in Parkinson’s disease
parkinson's disease
Region Hovedstaden · 22 participants
📍 Denmark
2026-526465-18-00 on CTIS ↗
Phase II Nervous System Diseases Authorised 23/06/2026
A Phase IIb, Non-Profit, Open-label Trial for the Intrathecal Administration of AAV9/AP4M1 for Hereditary Spastic Paraplegia Type 50 (SPG50).
Heriditary spastic paraplegia (SPG50)
Rigshospitalet, Elpida Therapeutics SPC · 2 participants
📍 Denmark
2025-524481-15-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 22/06/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants
📍 Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece
2025-524322-18-00 on CTIS ↗
Phase II Musculoskeletal Diseases Authorised 22/06/2026
A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study to Evaluate the Safety and Efficacy of AGA2115 in Adults with Type I, III, or IV Osteogenesis Imperfecta (OI)
Osteogenesis Imperfecta
Angitia Inc. Ltd. · 40 participants
📍 Netherlands · France · Denmark
2025-522951-24-00 on CTIS ↗
Phase II Musculoskeletal Diseases Authorised 22/06/2026
A Phase 2, Randomized, Double-blind, Placebo-controlled Crossover Study Evaluating the Efficacy and Safety of LTG-321 in Patients with Osteoarthritis of the Knee
Osteoarthritis of the knee
Latigo Biotherapeutics Inc. · 180 participants
📍 Denmark
2026-525966-22-00 on CTIS ↗
Phase I Nutritional and Metabolic Diseases Authorised 17/06/2026
A phase 1 first-in-human study of a phenylalanine-binding polymer (phelimin) in healthy volunteers and adult, classical PKU patients
Phenylketonuria
Mipsalus ApS · 7 participants
📍 Denmark
2024-519121-38-01 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 17/06/2026
IM0271016: An Open-label, Multi-center, Long-term Extension Study to Evaluate the Long-term Safety and Tolerability of Admilparant in Participants with Pulmonary Fibrosis
Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
Bristol-Myers Squibb Services Unlimited Company · 318 participants
📍 Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany
2025-522373-10-00 on CTIS ↗
Phase I Neoplasms Authorised 16/06/2026
A Phase 1, Open-Label, Multicenter Study of INCA036873 in Participants With Advanced Solid Tumors and Hematological Malignancies
Hematological malignancies, Advanced solid tumors
Incyte Corp. · 150 participants
📍 Italy · Belgium · Denmark
2025-523130-11-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 15/06/2026
An Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of BBP-418 (Ribitol) in Participants with Limb-Girdle Muscular Dystrophy 2I/R9 (LGMD2I/R9)
Limb Girdle Muscular Dystrophy (LGMD) Type 2I
ML Bio Solutions Inc. · 35 participants
📍 Germany · Denmark · Netherlands · Italy · Norway
2025-524371-23-00 on CTIS ↗
Phase II Neoplasms Authorised 15/06/2026
A Phase II, Open-label, Multicenter Study Testing Teclistamab in Combination with Pomalidomide Administered in Alternative Fashion in Participants with RRMM, who Received 1 - 3 Prior Lines of Therapy, Including Lenalidomide and Anti-CD38 Therapy
Multiple myeloma (RRMM)
Odense University Hospital · 50 participants
📍 Finland · Denmark · Estonia · Norway
2025-522114-23-00 on CTIS ↗
Phase III Neoplasms Authorised 12/06/2026
A Phase 2/3, Randomized, Open-Label, Comparison Study of MK-1045 Versus Blinatumomab in Participants With Relapsed or Refractory CD19+ B-Cell Acute Lymphoblastic Leukemia (B-ALL)
​Relapsed/refractory B-cell Acute Lymphoblastic Leukemia​
Merck Sharp & Dohme LLC · 109 participants
📍 Greece · Netherlands · Sweden · France · Italy · Spain · Denmark
2025-522267-15-00 on CTIS ↗
Phase IV Musculoskeletal Diseases Authorised 12/06/2026
BEAT Fatigue – Benefit of Elevated Administration of Thiamine for Fatigue in Rheumatoid Arthritis: A randomized, double-blind, placebo-controlled trial
Fatigue in rheumatoid arthritis patients
Odense University Hospital · 150 participants
📍 Denmark
2024-519268-41-00 on CTIS ↗
Phase I Neoplasms Authorised 10/06/2026
A clinical trial to learn about the effects of JFI447 and how it shows up in scans compared to FFG233 in people with solid tumors
Patients with metastatic PDAC, NSCLC, HR+/HER2- ductal and lobular BC, TNBC, CRC or STS.
Novartis Pharma AG · 22 participants
📍 Denmark
2025-523665-24-00 on CTIS ↗
Phase III Neoplasms Authorised 08/06/2026
A Randomized, Open-Label, Phase 3 Study of ZL-1310, a DLL3 Antibody Drug Conjugate (ADC), Compared to Investigator’s Choice Therapy in Participants with Relapsed Small Cell Lung Cancer
Small Cell Lung Cancer (SCLC)
Zai Lab (US) LLC · 234 participants
📍 Belgium · Czechia · Germany · Denmark · Greece · Netherlands · Poland · Spain · Austria · Italy · France
2025-522818-23-00 on CTIS ↗
Phase II Neoplasms Authorised 08/06/2026
An open-label, non-randomized, single center, single dose, exploratory phase II trial of FG001 (an imaging agent) in combination with transoral robotic surgery for oropharyngeal squamous cell carcinoma and neck dissection surgery for oral squamous cell carcinoma with regional lymph node metastases
Oral Squamous Cell Carcinoma with neck metastases, Oropharyngeal Squamous Cell Carcinoma
Rigshospitalet · 40 participants
📍 Denmark
2025-522845-23-00 on CTIS ↗
Phase IV Virus Diseases Authorised 08/06/2026
Measles-mumps-rubella vaccine (MMR) at 6 months of age: Long-term follow-up
Prevention of measles, mumps, and rubella by vaccination
Rigshospitalet · 1000 participants
📍 Denmark
2026-526160-21-00 on CTIS ↗
Phase I Neoplasms Authorised 08/06/2026
A study to learn more about how safe BAY 3771249 is and how well it works in people with advanced or metastatic colorectal cancer that has a KRAS G12D mutation
adenocarcinoma of the colon or rectum
Bayer Consumer Care AG · 49 participants
📍 Finland · Spain · Sweden · Italy · Denmark · Netherlands · Belgium
2025-523648-11-00 on CTIS ↗
Phase I/II Neoplasms Authorised 08/06/2026
KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments
Locally advanced or metastatic KRAS G12C-mutated non-small cell lung cancer; advanced solid tumors harboring the KRAS G12C mutation.
Novartis Pharma AG · 31 participants
📍 Spain · Italy · France · Denmark · Belgium
2025-523537-26-00 on CTIS ↗
Phase III Eye Diseases Authorised 05/06/2026
A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 250 participants
📍 Austria · Slovakia · Portugal · Czechia · Hungary · Spain · France · Denmark · Italy · Croatia
2025-524894-17-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 04/06/2026
Pulmonary Embolism & Anticoagulation Evaluation in Cancer Patient - PEACE
Incidental Subsegmental Pulmonary Embolism in cancer patients
Region Hovedstaden · 234 participants
📍 Denmark
2025-524110-28-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026
A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS FACTOR VIII PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A WITHOUT INHIBITORS
Hemophilia A Without Inhibitors
F. Hoffmann-La Roche AG · 42 participants
📍 France · Austria · Poland · Netherlands · Spain · Denmark · Italy · Germany · Hungary
2025-522434-32-00 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 01/06/2026
A MULTICENTER, RANDOMIZED, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, PHARMACOKINETICS AND PHARMACODYNAMICS OF NXT007 PROPHYLAXIS VERSUS EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA A
Hemophilia A
F. Hoffmann-La Roche AG · 124 participants
📍 Hungary · Spain · Ireland · Poland · Austria · Germany · Denmark · Belgium · Netherlands · Italy · France
2025-522435-33-00 on CTIS ↗
Phase III Digestive System Diseases Authorised 29/05/2026
COPE-CP: The effect of Celecoxib on pain, quality of life, use of opioids, and inflammation in patients suffering from chronic pancreatitis: a multicenter randomized placebo-controlled, double-blinded clinical trial
Chronic pancreatitis
Odense University Hospital · 80 participants
📍 Denmark
2025-522956-25-00 on CTIS ↗
Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 29/05/2026
A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX‑828/Deutivacaftor With and Without Tezacaftor in Subjects Aged 18 Years and Older With Cystic Fibrosis
Cystic fibrosis
Vertex Pharmaceuticals Inc. · 80 participants
📍 Spain · Sweden · Germany · Italy · Belgium · Czechia · Ireland · Portugal · Netherlands · France · Denmark
2025-523400-72-00 on CTIS ↗
Phase IV Respiratory Tract Diseases Authorised 28/05/2026
A Phase 4, Multicenter, Double-blind, Study to Investigate the Efficacy, Safety, and Tolerability of 3 Active Doses of Respreeza® / Zemaira® Weekly Intravenous Infusions Administered over 3 Years as Longterm Maintenance Therapy in Adult Subjects with Emphysema Related to Alpha1 Antitrypsin Deficiency
Alpha1-proteinase inhibitor deficiency, Alpha1 antitrypsin deficiency, Emphysema
CSL Behring LLC · 33 participants
📍 Denmark
2025-522964-33-00 on CTIS ↗
Phase II Immune System Diseases Authorised 27/05/2026
An Extension Study to Evaluate the Long-Term Safety and Efficacy of Afimkibart (RO7790121) in Patients with Rheumatoid Arthritis who Participated in Previous Afimkibart Clinical Trials
moderate to severe rheumatoid arthritis (RA)
F. Hoffmann-La Roche AG · 46 participants
📍 Italy · Spain · Germany · France · Denmark · Poland · Belgium
2025-523579-47-00 on CTIS ↗
Phase III Immune System Diseases Authorised 27/05/2026
A Phase 3b, Multicenter, Randomized, Open-Label, Active-Controlled Study to Compare the Efficacy and Safety of Guselkumab versus Risankizumab in the Treatment of Participants with Moderately to Severely Active Crohn’s Disease
Moderately to Severely Active Crohn’s Disease
Janssen Cilag International · 302 participants
📍 Slovakia · Germany · Denmark · France · Spain · Italy · Netherlands · Belgium · Poland · Sweden · Austria · Czechia · Hungary
2025-521590-13-00 on CTIS ↗
Phase I/II Neoplasms Authorised 26/05/2026
LIGHTBEAM-U01 Substudy 01D: A Phase 1b/2 Substudy to Evaluate the Safety and Efficacy of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors
Neoplasm malignant
Merck Sharp & Dohme LLC · 21 participants
📍 France · Spain · Sweden · Germany · Italy · Belgium · Denmark
2025-522339-32-00 on CTIS ↗
Phase I Musculoskeletal Diseases Authorised 26/05/2026
First-in-human study to assess the safety and feasibility of intra-articular administration of allogeneic engineered gingival fibroblasts (aeGF) in participants with knee osteoarthritis.
Knee osteoarthritis
Scarcell Therapeutics · 10 participants
📍 Denmark
2026-525604-99-00 on CTIS ↗
Phase IV Bacterial Infections and Mycoses Authorised 22/05/2026
A randomized, placebo-controlled, blinded, parallel-group clinical trial to assess the efficacy of N-acetylcysteine in adults with acute infections or sepsis and evidence of liver dysfunction: the IMPACT-NAC trial
Acute infection, Sepsis
Region Hovedstaden · 360 participants
📍 Denmark
2026-525895-25-00 on CTIS ↗
Phase I/II Neoplasms Authorised 22/05/2026
A 2-part phase 1/2 open-label trial evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of ODM-212 in combination with anti-cancer therapy in participants with advanced solid tumours
Neoplasms benign malignant and unspecified (incl. cysts and polyps)
Orion Corporation · 85 participants
📍 Finland · Denmark · Spain · France
2025-524620-22-00 on CTIS ↗
Phase II Metabolism Authorised 21/05/2026
An open-label, single-arm extension study to evaluate the long-term safety, tolerability, and efficacy of KL1333 (napazimone) in patients with primary mitochondrial disease
Adult patients with primary mitochondrial disease
Pharming Technologies B.V. · 117 participants
📍 Belgium · Germany · Czechia · Spain · Denmark · Italy · France
2025-524367-20-00 on CTIS ↗
Phase I Neoplasms Authorised 21/05/2026
First time in human (FTIH) study to investigate the safety and preliminary activity of GSK5533524 alone or in combination in adult participants with advanced solid tumors
Neoplasms
Glaxosmithkline Research & Development Limited · 52 participants
📍 Spain · Denmark · Finland · France
2025-524165-25-00 on CTIS ↗
Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026
PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases
Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants
📍 Portugal · Greece · Italy · Poland · Estonia · Slovakia · Sweden · Denmark · Belgium · Norway · Romania · France · Spain · Germany · Netherlands · Croatia
2025-523425-17-00 on CTIS ↗
Phase III Neoplasms Authorised 19/05/2026
A Randomized, Double-Blind, Phase 3 Study of Standard-of-Care Chemotherapy and Bevacizumab With or Without INCA33890 in the First-Line Treatment of Metastatic Microsatellite Stable Colorectal Cancer
Metastatic Microsatellite Stable Colorectal Cancer
Incyte Corp. · 292 participants
📍 Poland · France · Denmark · Norway · Spain · Germany · Belgium · Netherlands · Austria · Italy
2025-523735-19-00 on CTIS ↗
Phase II Neoplasms Authorised 18/05/2026
TAILOR-PANC: Molecularly Tailored Therapy versus Standard Care in Advanced Pancreatic Cancer (DPCG-02)
Advanced pancreatic cancer
Region Hovedstaden · 1200 participants
📍 Denmark
2025-522431-34-00 on CTIS ↗
Phase II Neoplasms Authorised 18/05/2026
A Phase 2 Study to Evaluate the Safety and Efficacy of Telisotuzumab Adizutecan for the Treatment of Subjects with Locally Advanced or Metastatic Solid Tumors that Harbor MET Amplification
Locally Advanced or Metastatic Solid Tumours that harbour MET Amplification gene
AbbVie Deutschland GmbH & Co. KG · 29 participants
📍 Spain · France · Denmark
2024-518871-74-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 18/05/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants
📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary
2025-524316-11-00 on CTIS ↗
Phase III Neoplasms Authorised 13/05/2026
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
advanced or metastatic extrapulmonary neuroendocrine carcinoma
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 144 participants
📍 Portugal · Spain · Poland · Sweden · Italy · Czechia · France · Netherlands · Finland · Denmark · Austria · Germany · Belgium · Norway
2025-523869-22-00 on CTIS ↗
Phase II Therapeutics Authorised 13/05/2026
SCARFREE-001: A Phase 2 Dose-Finding and Proof-of-Concept Study of Intradermal Verteporfin for Scar Prevention in Open and Closed Surgical Wounds
Scar formation following surgical wounds
Odense University Hospital · 12 participants
📍 Denmark
2025-525083-14-00 on CTIS ↗
Phase I Nutritional and Metabolic Diseases Authorised 11/05/2026
A research study to see how NNC0487-0111 affects the body’s energy use after a weight loss in adults living with obesity, compared to a low-calorie diet or placebo
Obesity
Novo Nordisk A/S · 120 participants
📍 Netherlands · Denmark
2025-522744-40-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 11/05/2026
The GranStone Trial - Prevention of Kidney Stones due to Paraffin Oil Induced Granuloma
Paraffin Oil Induced Granulomatous Disease
Region Hovedstaden · 100 participants
📍 Denmark
2026-525608-85-00 on CTIS ↗
Phase I Nervous System Diseases Authorised 11/05/2026
A Study to Assess the Safety of RG6496 in Huntington’s Disease Gene Expansion Carriers with the Selected Genetic Variant (POINT-HD)
Huntington’s Disease Gene Expansion Carriers
F. Hoffmann-La Roche AG · 43 participants
📍 Italy · Poland · Denmark · Germany · Portugal · Spain
2025-520631-17-00 on CTIS ↗
Phase III Neoplasms Authorised 11/05/2026
J5E-MC-JZXB - FRAmework-01: A Two-Part Phase 3 Study of Sofetabart Mipitecan (LY4170156) versus Chemotherapy or Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer, and Sofetabart Mipitecan plus Bevacizumab versus Platinum-Based Chemotherapy plus Bevacizumab in Platinum-Sensitive Ovarian Cancer
Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Peritoneal Neoplasms
Eli Lilly & Co. · 486 participants
📍 Netherlands · Hungary · France · Austria · Poland · Italy · Denmark · Romania · Greece · Norway · Czechia · Belgium · Spain · Ireland · Germany
2025-522255-25-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 11/05/2026
A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies
Chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement · 146 participants
📍 Germany · Netherlands · Portugal · Denmark · Sweden · Finland · France · Spain · Austria · Italy · Hungary · Romania · Belgium · Czechia · Poland
2025-522983-33-00 on CTIS ↗
Phase II Neoplasms Authorised 07/05/2026
Neoadjuvant Immunotherapy and Organ-sparing Treatment in Patients with Stage I-III dMMR Colon Cancer: A National, Multicentre, Personalised, Phase II Study (RESET C2)
Localised dMMR Colon Cancer
Region Sjaelland · 152 participants
📍 Denmark
2026-525214-62-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 06/05/2026
Colchicine Assessment of Low-grade Inflammation and Biomarker Response in Atherosclerosis with Targeted Evaluation
Ischemic Heart Disease, Coronary Artery Disease, Chronic Coronary Artery Syndrome
Region Hovedstaden · 70 participants
📍 Denmark
2026-525547-32-01 on CTIS ↗
Phase III Immune System Diseases Authorised 05/05/2026
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Janssen Cilag International · 271 participants
📍 Denmark · Hungary · Portugal · Italy · Norway · Greece · Slovakia · Czechia · France · Poland · Bulgaria · Germany · Spain · Romania · Finland
2025-523552-31-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 04/05/2026
Efficacy and safety of NNC0487-0111 s.c. once-weekly in participants with obesity (AMAZE 1)
Obesity
Novo Nordisk A/S · 270 participants
📍 Denmark · France · Germany · Belgium
2024-520440-42-00 on CTIS ↗
Phase III Neoplasms Authorised 04/05/2026
A Phase 3, Randomized, Double-blind, Study of Belzutifan + Zanzalintinib Versus Belzutifan + Placebo in Participants with Advanced RCC who have progressed on or after both PD-1/L1 and VEGF-TKI therapies in sequence or in combination (LITESPARK-034)
Renal Cell Carcinoma
Merck Sharp & Dohme LLC · 311 participants
📍 Denmark · Spain · Netherlands · Germany · France · Czechia · Poland · Italy · Greece
2024-516993-31-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 28/04/2026
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.
Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc. · 94 participants
📍 Spain · Poland · Italy · Belgium · Latvia · Denmark · Czechia · Germany · France · Netherlands · Portugal · Ireland · Greece
2024-520218-23-00 on CTIS ↗
Phase III Neoplasms Authorised 28/04/2026
A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)
Renal Cell Carcinoma, hepatocellular carcinoma, nonMSI-H/dMMR colorectal cancer, pancreatic ductal adenocarcinoma, biliary tract cancer, non-MSIH/dMMR endometrial cancer, esophageal squamous cell carcinoma, Advanced Pheochromocytoma/Paraganglioma, Pancreatic Neuroendocrine Tumor, von Hippel-Lindau (VHL)Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor, Advanced Solid Tumors With HIF-2α related Genetic Alterations
Merck Sharp & Dohme LLC · 37 participants
📍 Czechia · Spain · Poland · Belgium · Finland · Germany · France · Netherlands · Hungary · Denmark
2025-524160-38-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 28/04/2026
A Phase 3, Randomized, Double-Blind, 48-Week Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of DYNE-101 Administered to Participants with Myotonic Dystrophy Type 1
Myotonic Dystrophy Type 1
Dyne Therapeutics Inc. · 72 participants
📍 Netherlands · Spain · Italy · Denmark · Germany · Belgium · France
2025-522957-20-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026
Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
Obesity and T2D
Novo Nordisk A/S · 157 participants
📍 Slovakia · Austria · Spain · Romania · Portugal · Italy · Denmark · Belgium · Sweden · Poland · Netherlands · Croatia · Hungary · Bulgaria
2023-509176-42-00 on CTIS ↗
Phase III Anesthesia and Analgesia Authorised 28/04/2026
A randomized, open-label, Phase III trial to assess the efficacy and safety of BupiZenge compared to lidocaine for pain associated with oral mucositis in head and neck cancer
Head and neck cancer, Oral mucositis
OncoZenge AB · 150 participants
📍 Germany · Denmark · Norway · Sweden
2025-524386-24-00 on CTIS ↗
Phase III Neoplasms Authorised 28/04/2026
A Phase 3, Randomized, Open-label, Multicenter Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) Maintenance Treatment With or Without Bevacizumab Versus Standard of Care in Participants With Newly Diagnosed Advanced HRD-Negative Ovarian Cancer Following First-line Platinum-based Chemotherapy (TroFuse-021/ENGOTov85/ GOG-3102)
Ovarian cancer
Merck Sharp & Dohme LLC · 349 participants
📍 Norway · Ireland · Spain · Greece · France · Poland · Denmark · Austria · Hungary · Belgium · Czechia · Finland · Germany · Italy · Sweden
2023-508047-40-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/04/2026
Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).
Obesity
Novo Nordisk A/S · 325 participants
📍 Belgium · Germany · Bulgaria · France · Spain · Denmark · Italy · Netherlands
2025-523804-62-00 on CTIS ↗
Phase IV Immune System Diseases Authorised 27/04/2026
A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
severely active ulcerative colitis (US) and CD (Crohn’s disease)
Eli Lilly & Co. · 16 participants
📍 Spain · Denmark · Germany · Italy · Poland
2025-522362-78-00 on CTIS ↗
Phase II Nervous System Diseases Authorised 27/04/2026
Methylphenidate for Early Awakening in Coma (MEAWAKE)
Coma due to acute brain injury
Rigshospitalet · 324 participants
📍 Austria · Denmark · Germany · France
2025-524937-19-00 on CTIS ↗
Phase I/II Respiratory Tract Diseases Authorised 27/04/2026
Study of IBI3009 alone or in combination with other therapies for extensive-stage small cell lung cancer
Extensive-Stage Small Cell Lung Cancer
Fortvita Biologics (USA) Inc. · 30 participants
📍 Poland · Denmark · Spain
2025-523972-21-00 on CTIS ↗
Phase I/II Neoplasms Authorised 27/04/2026
A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)
relapsed or refractory BCR::ABL1-positive (Philadelphia positive, Ph+) or BCR::ABL1-like (Ph-like) acute lymphoblastic leukemia (ALL)
Novartis Pharma AG · 21 participants
📍 Italy · Spain · Germany · Netherlands · France · Denmark · Czechia
2025-522019-40-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 24/04/2026
Infusion of Furosemide to Improve Diuretic Efficiency in Acute Heart Failure (INFUSE-AHF)
Acute heart failure with volume overload
Region Midtjylland · 436 participants
📍 Denmark
2025-523589-26-00 on CTIS ↗
Phase I/II Neoplasms Authorised 21/04/2026
A Phase 1/2, Open-label Study of Oral S241656 (BDTX-4933) as Monotherapy and in Combination with Other Anti-Cancer Therapies in Patients with KRAS, BRAF and Other Selected RAS/MAPK Mutation-Positive Malignancies
Malignancies with Documented KRAS, BRAF and Other Selected RAS/MAPK Mutations
Institut De Recherches Internationales Servier IRIS · 105 participants
📍 France · Spain · Denmark · Italy
2025-523474-16-00 on CTIS ↗
Phase III Neoplasms Authorised 20/04/2026
J4G-MC-JZVD - FORAGER-2: A Phase 3, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Vepugratinib Combined with Enfortumab Vedotin and Pembrolizumab in Adults with Untreated Locally Advanced or Metastatic Urothelial Carcinoma with an FGFR3 Genetic Alteration.
Urinary Bladder Neoplasms, Neoplasm Metastasis, Carcinoma, Transitional Cell
Eli Lilly & Co. · 197 participants
📍 Italy · Poland · Denmark · Czechia · France · Hungary · Germany · Netherlands · Spain
2025-522855-25-00 on CTIS ↗
Phase IV Hormonal diseases Authorised 20/04/2026
Impact of treatment with TransCon PTH on Quality of Life, cognitive function, brain structure, and cerebral capillary bloodflow in patients with hypoparathyroidism
Hypoparathyroidism
Region Midtjylland · 40 participants
📍 Denmark
2025-523930-14-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 17/04/2026
Efficacy and safety of NNC0487-0111 compared to placebo on morbidity and mortality in people with heart failure with preserved or mildly reduced ejection fraction and obesity (HF-POLARIS).
HFpEF or HFmrEF and obesity
Novo Nordisk A/S · 1992 participants
📍 Denmark · Greece · Bulgaria · Italy · Netherlands · Spain · Poland · Czechia · Germany · France
2025-523717-29-00 on CTIS ↗
Phase I/II Neoplasms Authorised 16/04/2026
An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors
Advanced HR+/HER- breast cancer
Novartis Pharma AG · 55 participants
📍 Italy · Germany · France · Czechia · Denmark · Spain
2025-521911-38-00 on CTIS ↗
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Cite this page

Priya Life Science (2026). EU Clinical Trials Tracker. Available at: https://priyalifescience.com/clinical-trials-europe/country/denmark (Accessed: 6 July 2026).

Source: Clinical Trials Information System (CTIS), European Medicines Agency - trials authorised under the EU Clinical Trials Regulation (Regulation 536/2014), showing the most recent EU authorisation decisions, refreshed daily. Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See our Ireland Clinical Trials Tracker. For approved medicines, see the EMA Approvals Tracker.