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Updated 14 Sep 2026 · EMA CTIS official data

Clinical Trials in Norway

← 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.

35
Recent authorisations
19
Phase III trials
Norway
Selected country
Showing 35 trials
Phase IV Therapeutics Authorised 02/09/2026

ACTOR – AUC Control of Tacrolimus in Organ Recipients

Kidney transplantation
Oslo Universitetssykehus HF
24 participants planned
Norway
2026-527107-22-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 02/09/2026

Reduced-dose versus full-dose systemic thrombolysis for high-risk pulmonary embolism: a multicentre, randomised, open-label, blinded-endpoint trial

Pulmonary embolism
Vaestra Goetalandsregionen, University Of Gothenburg
280 participants planned
Denmark · Sweden · Norway
2024-515904-37-00 on CTIS ↗
Phase III Immune System Diseases Authorised 02/09/2026

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

Immune system diseases
Sanofi-Aventis Recherche & Developpement
338 participants planned
Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Austria · Norway · France · Italy · Bulgaria · Spain · Germany · Romania · Slovenia · Estonia · Portugal · Greece · Denmark
2026-525913-30-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 31/08/2026

A Phase 3, Randomized, Double-Blinded Study to Evaluate the Safety and Efficacy of Salanersen (BIIB115) After Onasemnogene Abeparvovec Treatment in Infants with Genetically Diagnosed Spinal Muscular Atrophy

Spinal Muscular Atrophy
Biogen Idec Research Limited
24 participants planned
Portugal · Italy · Belgium · Croatia · Hungary · Germany · Ireland · France · Norway · Poland
2025-523857-32-00 on CTIS ↗
Phase II Hemic and Lymphatic Diseases Authorised 31/08/2026

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL)
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
276 participants planned
Czechia · Denmark · Croatia · Spain · Sweden · Finland · Portugal · Ireland · Netherlands · Belgium · Norway
2025-524230-25-00 on CTIS ↗
Phase III Neoplasms Authorised 24/08/2026

A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Investigator Choice of Chemotherapy (modified FOLFIRINOX or Gemcitabine plus Nab-paclitaxel) with or without Zoldonrasib (RMC-9805) as First-line Treatment in Patients with Metastatic KRAS G12D-mutated Pancreatic Adenocarcinoma (RASolute 305)

Pancreatic Adenocarcinoma
Revolution Medicines Inc.
281 participants planned
Sweden · Spain · France · Poland · Italy · Norway · Belgium · Germany · Czechia · Austria · Netherlands · Denmark
2025-524928-21-00 on CTIS ↗
Phase III Neoplasms Authorised 21/08/2026

A Phase 3, Randomized, Multicenter, Open-Label Study of Velzatinib (GSK6042981) versus Imatinib in Participants with Previously Untreated Metastatic and/or Unresectable Gastrointestinal Stromal Tumors (GIST)

Neoplasms, Gastrointestinal Stromal
Glaxosmithkline Research & Development Limited
302 participants planned
Italy · Portugal · Germany · Sweden · Poland · Romania · Finland · Greece · Norway · Spain · Netherlands · France · Hungary
2025-524934-24-00 on CTIS ↗
Phase III Neoplasms Authorised 20/08/2026

A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma

High Risk Smoldering Multiple Myeloma (HR-SMM)
Regeneron Pharmaceuticals Inc.
108 participants planned
Italy · Spain · Poland · France · Norway · Greece · Germany
2025-523252-31-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 20/08/2026

Effects of Menopausal Hormone Therapy on QTc in Genetically Confirmed Long QT Syndrome: A Prospective Randomized Sequential Crossover Study with Long-Term Observational Follow-Up (LQTS-HER)

Long QT syndrome
Oslo Universitetssykehus HF
15 participants planned
Norway
2026-526442-28-00 on CTIS ↗
Phase III Neoplasms Authorised 17/08/2026

Durvalumab after concurrent platinum/etoposide chemotherapy and high-dose twice-daily thoracic radiotherapy in limited stage small cell lung cancer – an open label, randomized phase III trial (DAHRTS)

Small-cell lung cancer, limited stage
Norges Teknisk-Naturvitenskapelige Universitet NTNU
426 participants planned
Denmark · Finland · Estonia · Germany · Lithuania · Sweden · Norway · Netherlands
2026-525513-31-00 on CTIS ↗
Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Systemic sclerosis
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
179 participants planned
Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania
2025-523884-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease
Janssen Cilag International
194 participants planned
Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece
2026-525922-39-00 on CTIS ↗
Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis
Janssen Cilag International
302 participants planned
France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal
2026-525923-26-00 on CTIS ↗
Phase IV Cardiovascular Diseases Authorised 28/07/2026

STRategiEs for Antiplatelet Management foLlowIng acute coroNary syndromE (STREAMLINE)

ischemic heart disease
Instituto De Investigacion Sanitaria Fundacion Jimenez Diaz
3500 participants planned
Spain · Norway
2026-525933-22-00 on CTIS ↗
Phase II Neoplasms Authorised 27/07/2026

A Cancer Research UK Phase II trial of CY-101 given via intratumoural administration in locally advanced or metastatic adrenocortical carcinoma (CLARITY)

LOCALLY ADVANCED OR METASTATIC ADRENOCORTICAL CARCINOMA
Cancer Research UK
26 participants planned
Spain · France · Germany · Norway
2025-522757-19-00 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 24/07/2026

A randomised active-controlled trial to assess the safety and pharmacodynamics of two blinded doses of vortosiran and open-label apixaban in patients with non-valvular atrial fibrillation

non-valvular atrial fibrillation
Ribocure Pharmaceuticals AB
150 participants planned
Norway · Denmark · Poland · Sweden
2026-525417-31-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 24/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.
AstraZeneca AB
1600 participants planned
Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany
2025-523994-41-00 on CTIS ↗
Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis
Ipsen Bioscience Inc.
127 participants planned
Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway
2026-525242-29-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease
Novartis Pharma AG
368 participants planned
Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary
2025-522227-99-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 20/07/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1

Narcolepsy Type 1
Alkermes Inc.
116 participants planned
Sweden · Finland · Belgium · Spain · Austria · Netherlands · France · Norway · Germany · Italy · Poland
2025-524711-36-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 20/07/2026

Phase 3 Single-Arm Open-Label Study to Evaluate the Efficacy and Safety of Zodasiran in Adolescent Subjects (age 12 to <18 years) with Homozygous Familial Hypercholesterolemia (SPRUCE)

Homozygous Familial Hypercholesterolemia (HoFH)
Arrowhead Pharmaceuticals Inc.
9 participants planned
Netherlands · Denmark · Norway · Sweden · Poland
2025-523662-24-00 on CTIS ↗
Phase III Digestive System Diseases Authorised 14/07/2026

RASolute 303: A Phase 3 Global, Multicenter, Open-label, Randomized, 3-Arm Study of Daraxonrasib Monotherapy or Daraxonrasib Plus Gemcitabine and Nab-paclitaxel versus Gemcitabine and Nab-paclitaxel as a First-Line Treatment for Patients with Metastatic Pancreatic Adenocarcinoma

Metastatic Pancreatic Adenocarcinoma
Revolution Medicines Inc.
337 participants planned
Poland · Belgium · Norway · Sweden · Austria · Germany · Denmark · Netherlands · France · Italy · Spain
2025-525088-34-00 on CTIS ↗
Phase II Immune System Diseases Authorised 13/07/2026

Inducing durable immunological control of HIV-1 through administration of long-acting broadly neutralizing antibodies and low-dose anti-PD-1 – a randomized, double-blinded, placebo-controlled trial (the IDUNN trial)

HIV-1 disease
Region Midtjylland
60 participants planned
Sweden · Norway · Denmark · Iceland
2025-523725-17-00 on CTIS ↗
Phase II Neoplasms Authorised 07/07/2026

A Phase 2 Open-Label, Multi-Center Study of BMS-986504 as Monotherapy and in Combination with Other Agents in Participants with Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion

Advanced and/or Metastatic Solid Tumors with Homozygous MTAP Deletion
Bristol-Myers Squibb Services Unlimited Company
123 participants planned
Belgium · Ireland · Germany · Norway · Italy · France · Spain
2025-524285-18-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases
Sanofi-Aventis Recherche & Developpement
550 participants planned
Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain
2024-518213-25-00 on CTIS ↗
Phase II Neoplasms Authorised 03/07/2026

Individualized Intrathecal Chemotherapy Based on Measurement of Brain Fluid Clearance in Pediatric Patients

Acute lymphoblastic leukemia and lymphoma
Oslo University Hospital HF
50 participants planned
Norway
2025-522453-20-00 on CTIS ↗
Phase II Psychological Phenomena Authorised 03/07/2026

A Randomized, Delayed-Treatment Controlled, Phase 2 Pilot Study of Manualized MDMA-Assisted Therapy for Young Adults with Chronic Treatment-Resistant Major Depressive Disorder

Major Depressive Disorder
Ostfold Hospital Trust
16 participants planned
Norway
2024-520319-42-01 on CTIS ↗
Phase II Cardiovascular Diseases Authorised 01/07/2026

High-dose Insulin Euglycemic Therapy in Non-Toxic Acute Cardiogenic Shock.

Non-toxic acute cardiogenic shock
Oslo Universitetssykehus HF
20 participants planned
Norway
2025-523858-13-01 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
257 participants planned
Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland
2025-522167-15-00 on CTIS ↗
Phase IV Musculoskeletal Diseases Authorised 23/06/2026

Treatment strategies for juvenile idiopathic arthritis patients with sustained inactive disease: A phase 4, multicentre, randomised trial comparing maintenance versus tapered TNF alpha inhibitor monotherapy - the Treat-JIA trial

Juvenil Idiopatic Arthritis
Oslo Universitetssykehus HF
90 participants planned
Norway
2026-525611-13-00 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
486 participants planned
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 Eye Diseases Authorised 22/06/2026

Pain Relief at Screening for Retinopathy of Prematurity - The PROPER study

Retinopathy of prematurity
St. Olavs Hospital HF
33 participants planned
Norway
2023-507975-23-01 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 planned
Germany · Denmark · Netherlands · Italy · Norway
2025-524371-23-00 on CTIS ↗
Phase II Hemic and Lymphatic Diseases Authorised 15/06/2026

A single arm single center exploratory observational phase II study, aimed to detect long term changes in volume of port-wine macrocheilia and color of port-wine stain in patients undergoing surgery and laser therapy during sirolimus treatment. Quality of life and efficacy and safety of sirolimus will be assessed.

Vascular malfomation
Oslo University Hospital HF
20 participants planned
Norway
2024-511937-37-01 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 planned
Finland · Denmark · Estonia · Norway
2025-522114-23-00 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/norway (Accessed: 14 September 2026).

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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. See who's running these trials in our Company Directory, or compare pay across these markets in the EU Salary Guide.