Clinical Trials in Sweden 2026 - 52 Recent EU Authorisations

Phase III Reproductive and Urinary Physiological Phenomena Authorised 10/09/2026

SCARP-DIAL (SGLT2i for CARdiovascular Protection in DIALysis)

Chronic dialysis, Cardiovascular disease

Karolinska University Hospital

1000 participants planned

Sweden

2026-526075-35-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 02/09/2026

First-in-human evaluation of [11C]UCB-1A as imaging marker for synaptic vesicle glycoprotein 2C (SV2C): a PET study in healthy volunteers and participants with Parkinson’s disease

Parkinson's disease

Karolinska Institutet

40 participants planned

Sweden

2026-526848-13-00 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 Neoplasms Authorised 01/09/2026

A Phase III Open-Label, Randomised, Multicentre Study of Consolidation with a Single Administration of AZD0120, a Dual-Targeting Autologous Chimeric Antigen Receptor T-cell (CAR T) Therapy Directed Against BCMA and CD19, Compared with Continuous Standard Therapy in Participants with NDMM Who Are Ineligible to Receive ASCT as Initial Therapy (DURGA-5).

Newly Diagnosed Multiple Myeloma

AstraZeneca AB

234 participants planned

Poland · Italy · Denmark · France · Sweden · Germany · Spain

2025-524014-29-00 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 II Neoplasms Authorised 25/08/2026

Phase 2 Randomized, Double-blind, Placebo-controlled Study Evaluating the Prophylactic Use of Tocilizumab to Prevent Cytokine Release Syndrome With Ramantamig Administration in Participants With Relapsed/Refractory Multiple Myeloma

Relapsed/Refractory Multiple Myeloma

Janssen Cilag International

123 participants planned

Sweden · Spain · Greece · Portugal · France · Hungary

2025-524793-42-00 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 Cardiovascular Diseases Authorised 21/08/2026

A 52-week multicenter, randomized, parallel-group trial in overweight people investigating lifestyle changes, mushroom supplementation and bupropion to reduce adiposity and cardiometabolic risk

Overweight or class I obesity (BMI 25.0–34.9 kg/m²), with or without cardiometabolic risk factors (hypertension, hyperlipidemia, and/or prediabetes).

Uppsala University

250 participants planned

Sweden

2026-527136-13-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 18/08/2026

A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants with CAD

Coronary artery disease

Ribocure Pharmaceuticals AB

200 participants planned

Sweden · Poland

2026-525901-10-00 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 II Nervous System Diseases Authorised 14/08/2026

An Exploratory Phase 2 Multicenter, Double-blind, Randomized, Placebo controlled, Parallel Group Study to Investigate the Safety, Tolerability, and Efficacy of TML-6 in Early Alzheimer’s Disease

Early Alzheimer’s Disease

Merry Life Biomedical Co. Ltd.

70 participants planned

Sweden

2026-525539-18-00 on CTIS ↗

Phase I/II Nutritional and Metabolic Diseases Authorised 13/08/2026

A two-part, randomised, double-blind, placebo-controlled, parallel-group, 12week trial investigating the safety, tolerability, pharmacokinetics and efficacy of XEN-D0501 in obese participants

Obesity

Pila Pharma AB

46 participants planned

Sweden

2026-525869-42-00 on CTIS ↗

Phase II Male Urogenital Diseases Authorised 12/08/2026

A phase II, single arm two-phase, clinical study of individually adapted systemic radioligand therapy with 177Lu-PSMA I&T for patients with metastatic, castration-resistant prostate cancer

Prostate cancer

Region Uppsala

80 participants planned

Sweden

2026-527110-23-00 on CTIS ↗

Phase IV Digestive System Diseases Authorised 11/08/2026

Patient-Controlled Anesthesia for endoscopic Procedural Sedation – PCAPS study

Adenoma

Karolinska Institutet

175 participants planned

Sweden

2025-524859-31-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 10/08/2026

Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity

Overweight and obesity

Novo Nordisk A/S

315 participants planned

Netherlands · Belgium · Greece · Poland · Spain · Denmark · France · Bulgaria · Sweden

2025-524626-18-00 on CTIS ↗

Phase III Hormonal diseases Authorised 07/08/2026

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

Graves' Disease (GD)

Argenx

145 participants planned

Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria

2025-523333-26-00 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 Mental Disorders Authorised 29/07/2026

B-HAPPI: Bipolar disorder and high-dose adjunctive pramipexole for anhedonic depression – a phase III, double-blind, randomized controlled trial

Bipolar disorder

Region Skane

186 participants planned

Sweden

2026-526383-20-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.

AstraZeneca AB

2343 participants planned

Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia

2026-526304-79-00 on CTIS ↗

Phase I/II Neoplasms Authorised 28/07/2026

Melanoma-TBK1-inhibitor enhanced Immuno Therapy with Checkpoint Inhibitors: a Phase IB/II Trial in Unresectable Stage III or Stage IV Cutaneous Melanoma

Unresectable Stage III or Stage IV Cutaneous Melanoma

Karolinska University Hospital

105 participants planned

Sweden

2026-526821-16-00 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 Hormonal diseases Authorised 23/07/2026

A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia

Classic Congenital Adrenal Hyperplasia (CAH)

Neurocrine Biosciences Inc.

71 participants planned

Czechia · Germany · Sweden · Portugal · Romania · Bulgaria · Italy · Austria · Spain

2025-524282-24-00 on CTIS ↗

Phase III Not possible to specify Authorised 23/07/2026

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

No medical condition

Chemo Research S.L.

1550 participants planned

Sweden · Czechia · Spain · Hungary · Poland · Finland · Romania

2026-525727-24-00 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 II Cardiovascular Diseases Authorised 20/07/2026

A Phase IIb, randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of concomitant use of eplontersen and ALXN2220 compared with eplontersen and placebo in adult participants with transthyretin-mediated amyloid cardiomyopathy (ATTR-CM).

Transthyretin-Mediated Amyloid Cardiomyopathy (ATTR-CM)

AstraZeneca AB

158 participants planned

Germany · Italy · Spain · France · Sweden

2025-523908-75-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 20/07/2026

A placebo-controlled comparability study to compare two presentations of cagrilintide for weight management in participants with overweight or obesity

Participants with overweight or obesity

Novo Nordisk A/S

171 participants planned

Sweden · Greece · Hungary · Portugal

2025-524249-29-00 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 Female Urogenital Diseases and Pregnancy Complications Authorised 17/07/2026

Paracervical block with ropivacaine for pain relief in second trimester medical abortion - a double blind placebo controlled randomized trial

abortion

Karolinska Institutet

132 participants planned

Sweden

2025-524599-52-03 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 16/07/2026

A double-blind, randomised, placebo-controlled first-in-human/Phase Ib trial to investigate safety, tolerability, pharmacokinetics, and preliminary efficacy of single and multiple doses of TIR-C 2% cutaneous emulsion in adults with mild to moderate atopic dermatitis

Atopic dermatitis

Pharmability AB

52 participants planned

Sweden

2026-526343-35-00 on CTIS ↗

Phase II Not possible to specify Authorised 15/07/2026

COLOVERT – Conversion therapy in colorectal cancer with peritoneal metastases not amenable to upfront cytoreductive surgery and HIPEC: a phase II “pick-the-winner” open-label randomized trial

Colorectal cancer with peritoneal metastases

Uppsala University Hospital

60 participants planned

Sweden

2026-526122-41-00 on CTIS ↗

Phase I/II Hemic and Lymphatic Diseases Authorised 14/07/2026

FLAsH-IV-AML: A phase I/II multi-center study to assess the tolerability and efficacy of the addition of hydroxyurea to salvage treatment with fludarabine, ara-C, idarubicin and venetoclax for adults with relapsed or refractory acute myeloid leukemia

Adults (≥ 18 years of age) with relapsed or refractory acute myeloid leukemia (R/R AML)

Karolinska University Hospital

26 participants planned

Sweden

2026-526961-76-00 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 I/II Neoplasms Authorised 13/07/2026

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Multiple Myeloma (MM), Multiple Myeloma (MM)

AbbVie Deutschland GmbH & Co. KG

88 participants planned

Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 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 III Neoplasms Authorised 08/07/2026

Fight Osteosarcoma Through European Research evolving study platform from diagnosis to relapse (FOSTER evolving study platform)

Osteosarcoma

Institut Gustave Roussy

508 participants planned

Sweden · Poland · Denmark · Finland · Netherlands · Italy · France · Spain

2023-505575-69-01 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 08/07/2026

HMBeacon: A Phase 2, Randomized, Double-blind Study of the Safety, Tolerability, Efficacy, and Pharmacodynamics of Multiple Dose ALN-6400 in Female Patients with Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)

Von Willebrand Disease (VWD) and Heavy Menstrual Bleeding (HMB)

Alnylam Pharmaceuticals Inc.

5 participants planned

Netherlands · Sweden · Germany

2025-524967-19-00 on CTIS ↗

Phase I Digestive System Diseases Authorised 07/07/2026

A clinical trial comparing how the body takes up budesonide from different forms of medicine when taken by mouth with or without food.

Acute eosinophilic esophagitis

Dr. Falk Pharma GmbH

50 participants planned

Sweden

2025-522686-29-00 on CTIS ↗

Phase III Eye Diseases Authorised 07/07/2026

Multicenter, randomized, double-blind, parallel-group clinical study comparing RD03/2016 (levoFloxacin and ketorolac trometAmol) eye drops vs Leviosa® (levofloxacin and dexamethaSone 21-phosphaTe) eye drops for 7 days for the prevention and treatment of inflammation and prevention of infection associated with cataract surgery in adults. (FAST 7)

Cataract

Ntc S.r.l.

536 participants planned

Spain · Poland · Greece · Sweden · Italy

2026-525594-39-00 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

613 participants planned

Denmark · Sweden · Poland · Estonia · Portugal · Latvia · Spain · Hungary · Germany · Finland · Italy · Belgium · France

2024-518016-39-00 on CTIS ↗

Phase I Skin and Connective Tissue Diseases Authorised 30/06/2026

A double-blind, prospective, randomised, placebo-controlled, single-centre, proof-of-principle trial in healthy volunteers to investigate safety, local tolerability, pharmacokinetics, and pharmacodynamics of Asacaine after topical administration on skin exposed to ultraviolet B radiation

Topical pain

Auxesis Pharma Holding AB (publ)

12 participants planned

Sweden

2026-526022-41-00 on CTIS ↗

Phase I/II Neoplasms Authorised 29/06/2026

A Phase 1/2 Open-Label, Multicenter Study of RAS(ON) inhibitors in Combination with Ivonescimab with or without Other Anti-Cancer Agents in Patients with Solid Tumors

Solid Tumors

Revolution Medicines Inc.

252 participants planned

France · Poland · Ireland · Spain · Greece · Germany · Italy · Sweden · Belgium

2025-524623-50-00 on CTIS ↗

Phase IV Cardiovascular Diseases Authorised 26/06/2026

Short and long-term Hemodynamic and Physiological Effects of Mavacamten in Obstructive Hypertrophic Cardiomyopathy

Obstructive Hypertrophic Cardiomyopathy

Region Skane

40 participants planned

Sweden

2025-524722-17-00 on CTIS ↗

Phase IV Respiratory Tract Diseases Authorised 24/06/2026

Morphine for resting breathlessness in severe illness and palliative care (MORE-B): a randomized clinical trial

Serious, chronic, life-limiting disease

Region Skane

40 participants planned

Sweden

2026-525838-32-00 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 IV Musculoskeletal Diseases Authorised 22/06/2026