Clinical Trials in Sweden 2026 - 39 Recent EU Authorisations

📍 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 IV Musculoskeletal Diseases Authorised 22/06/2026

Sample Collection Study to Monitor the Risk of Malignancy Due to Insertional Oncogenesis in Early Onset Patients with Metachromatic Leukodystrophy Treated with OTL-200 in the Clinical Development Program

Metachromatic leukodystrophy
Orchard Therapeutics (Europe) Limited · 29 participants

📍 Netherlands · Germany · Italy · Sweden · France

2025-522275-28-00 on CTIS ↗

Phase II Nervous System Diseases Authorised 18/06/2026

A randomized, double-blind, placebo-controlled, 104-week proof-of-concept study to evaluate the efficacy of intravenous prasinezumab in participants with Parkinson's disease carrying a severe mutation in the GBA gene (prevent cognitive decline in GBA-associated PD)

PARKINSON’S DISEASE
Universitaetsklinikum Tuebingen AöR · 110 participants

📍 Spain · Germany · Italy · Sweden · France · Luxembourg

2024-513496-40-00 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 I/II Respiratory Tract Diseases Authorised 08/06/2026

TSRA196-AAT-201: A Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose Expansion, and Single Repeat Dose Study of TSRA-196 in Adults With the PiZZ Genotype Who Have Lung and/or Liver Disease Associated with Severe Alpha-1 Antitrypsin Deficiency

Lung and/or Liver Disease Associated with Alpha-1 Antitrypsin Deficiency (AATD)
Tessera Therapeutics Inc. · 25 participants

📍 Ireland · Sweden · Netherlands

2025-523497-16-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 08/06/2026

A randomized, multiple ascending doses, clinical trial to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of CV-01 after double-blind, placebo-controlled multiple oral administrations for 2 weeks in healthy volunteers, and multiple oral administrations open-label for 2 weeks in a cohort of participants with drug resistant epilepsy

Drug resistant epilepsy
Angelini Pharma Italia Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. Enunciabile Anche Angelini Pharma Italia S.p.A. Angelini Pharma S.p.A. A.C.R.A.F. S.p.A. Acraf S.p.A. Angelini S.p.A. aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. · 36 participants

📍 Sweden

2026-525478-21-00 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 II Mental Disorders Authorised 05/06/2026

Long-term outcomes and safety of repeated rituximab treatment in psychotic disorders – RITS-LONG

Schizophrenia spectrum disorder (SSD)
Region Oerebro Laen · 122 participants

📍 Sweden

2026-525324-26-00 on CTIS ↗

Phase III Diagnosis Authorised 03/06/2026

Prognostic Performance of Quantitative Myocardial Perfusion Imaging Using H2[15O] Positron Emission Tomography in Coronary Artery Disease - The AQUA COR trial

Cardiovascular disease
Vaestra Goetalandsregionen · 40000 participants

📍 Sweden

2024-518706-41-01 on CTIS ↗

Phase III Nervous System Diseases Authorised 03/06/2026

Montelukast as disease modifying treatment in mild-moderate Parkinson’s disease, an open-label, phase II extension trial (MONTPARK_OLE)

Parkinson's Disease
Karolinska University Hospital · 98 participants

📍 Sweden

2026-525906-37-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 02/06/2026

A Randomized Open Label Trial Exploring the Soluble and Imaging Biomarker Dynamic Responses to Tolebrutinib Compared to Rituximab Treatment in Patients with Multiple Sclerosis (MS)

Multiple Sclerosis
Region Stockholm – SLSO · 60 participants

📍 Sweden

2025-523892-50-00 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 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 IV Neoplasms Authorised 22/05/2026

Comparing intraoperative indocyanine green fluorescence imaging with standard clinical assessment for flap perfusion in head and neck reconstruction: A randomised controlled Trial (VISION Trial)

Head and neck cancer
Region Skane · 244 participants

📍 Sweden

2025-524710-29-00 on CTIS ↗

Phase III Neoplasms Authorised 22/05/2026

ROSETTA Lung-201: A Randomized, Multicenter, Open-label Phase 3 study of Pumitamig Monotherapy Compared to Durvalumab in Participants with Unresectable Stage III NSCLC Without Progression After Platinum-based Concurrent Chemoradiation Therapy

Unresectable Stage III non-small cell lung cancer without progression
Bristol-Myers Squibb Services Unlimited Company · 279 participants

📍 France · Ireland · Germany · Greece · Bulgaria · Spain · Netherlands · Italy · Sweden · Romania · Hungary · Belgium · Austria · Poland

2025-523576-23-00 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 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 15/05/2026

ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%

Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants

📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia

2025-523586-18-00 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 III Neoplasms Authorised 12/05/2026

DAREON®-Lung-1: A Phase III multi-center, open-label, randomised trial of intravenous obrixtamig in combination with atezolizumab, carboplatin, and etoposide vs. atezolizumab, carboplatin, and etoposide as first-line treatment in patients with extensive-stage small cell lung cancer.

small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 295 participants

📍 Czechia · Sweden · Poland · Netherlands · Greece · Latvia · Finland · Norway · Belgium · Austria · Portugal · Romania · Italy · Estonia · France · Ireland · Germany · Spain · Bulgaria · Hungary

2025-520565-51-00 on CTIS ↗

Phase II Therapeutics Authorised 11/05/2026

Evaluation of hANP for prevention of acute kidney injury after cardiac surgery: A two-part randomized controlled trial with open-label extension in children aged 0–12 months.

Acute kidney injury (AKI) occurring in newborns and infants after cardiac surgery with cardiopulmonary bypass. The study targets early postoperative renal dysfunction and fluid imbalance in this high-risk population.
Vaestra Goetalandsregionen · 100 participants

📍 Sweden

2025-524069-26-00 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 I Respiratory Tract Diseases Authorised 28/04/2026

A randomised, open-label, single-centre, drug-drug-interaction trial to evaluate the impact of carboxylesterase 2 (CES2)- and CYP3A4-inhibition on the pharmacokinetics of buloxibutid in healthy volunteers

Idiopathic pulmonary fibrosis
Vicore Pharma AB · 24 participants

📍 Sweden

2026-526135-18-00 on CTIS ↗

Phase III Neoplasms Authorised 28/04/2026

CIRCULATE III - Tailoring the decision for adjuvant chemotherapy using circulating tumour DNA, in patients with stage III colorectal cancer

Stage III colorectal cancer
Unicancer · 300 participants

📍 France · Sweden

2025-521045-24-00 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 II Mental Disorders Authorised 24/04/2026

Prevention of Sexual Offending with Cognitive Behavioral Therapy Alone Versus Therapy Combined with Testosterone Suppression – the PREVENT-MED randomized clinical trial

Paraphilic disorder, Compulsive sexual behavior disorder
Vaestra Goetalandsregionen · 180 participants

📍 Sweden

2024-518120-68-01 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) plus Zanubrutinib (BGB-3111) Compared with Venetoclax plus Acalabrutinib in Patients with Previously Untreated Chronic Lymphocytic Leukemia

treatment-naive Chronic Lymphocytic Leukemia
BeOne Medicines I GmbH · 186 participants

📍 Netherlands · Poland · Italy · Germany · Spain · Romania · Czechia · France · Sweden

2025-524366-21-00 on CTIS ↗

Phase III Neoplasms Authorised 20/04/2026

A Phase 3, Randomized, Open-label Study of Sacituzumab Tirumotecan (MK-2870) Versus Investigator’s Choice of Non-platinum Chemotherapy in Participants with Pretreated Locally Advanced/Metastatic Urothelial Carcinoma

Locally advanced/metastatic urothelial carcinoma
Merck Sharp & Dohme LLC · 265 participants

📍 Netherlands · Greece · Italy · Germany · Spain · Belgium · Sweden · France

2024-520014-22-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 20/04/2026

C0371017 - A PHASE 3, NON-INVESTIGATIONAL PRODUCT, MULTI COUNTRY COHORT STUDY TO DESCRIBE THE LONG-TERM SAFETY AND EFFECTIVENESS OF A PRIOR SINGLE-DOSE TREATMENT WITH INVESTIGATIVE GIROCTOCOGENE FITELPARVOVEC OR FIDANACOGENE ELAPARVOVEC IN PARTICIPANTS WITH HEMOPHILIA A OR HEMOPHILIA B, RESPECTIVELY

hemophilia A, severe to moderately severe hemophilia B (FIX:C ≤ 2%)
Pfizer Inc. · 31 participants

📍 Italy · Germany · France · Spain · Sweden · Greece

2025-523660-21-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/04/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants with Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis
Ferrer Internacional S.A., Prilenia Therapeutics B.V. · 420 participants

📍 Belgium · Netherlands · Poland · France · Germany · Ireland · Italy · Sweden · Spain

2025-524002-16-00 on CTIS ↗

Phase I Respiratory Tract Diseases Authorised 17/04/2026

A Phase 1 Study of AIR-001 in Adults with AATD.

Alpha-1 Antitrypsin Deficiency
Airna Corp. · 19 participants

📍 Sweden · Ireland · Spain · Netherlands · Portugal · Germany

2025-523558-14-00 on CTIS ↗