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Clinical trial register · European Union · CTIS

Clinical Trials in Poland

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 — 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 12445 total CTIS records — a stated recency window, not the full historical archive. Synced 19 Sep 2026, 04:26 UTC
2500
Shown in this register
most recently authorised
12,445
Total on CTIS
full historical archive
745
Phase III
within the shown window
Top member states
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524
Narrow the registerReset
Phase
Phase I 558 Phase I/II 214 Phase II 726 Phase III 745 Phase IV 257
Lead sponsor
AstraZeneca AB 60 Assistance Publique Hopitaux De Paris 49 Merck Sharp & Dohme LLC 48 Pfizer Inc. 45 Novo Nordisk A/S 42
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
581 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
Solid tumor Study for Long term Treatment of Cancer Patients Who Have Participated in BMS-Parent Studies Investigating Adagrasib (BMS-986503)
2025-524905-34-00Solid tumor
Bristol-Myers Squibb Services Unlimited Company
Neoplasms
Greece, Hungary, Poland, Belgium, Spain, Netherlands, Germany, France, Portugal, Italy, Romania
25/08/2026
Phase III
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)
2025-524928-21-00Pancreatic Adenocarcinoma
Revolution Medicines Inc.
Neoplasms
Sweden, Spain, France, Poland, Italy, Norway, Belgium, Germany, Czechia, Austria, Netherlands, Denmark
24/08/2026
Phase III
A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (both in Combination with the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women with HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)
2025-524846-85-00​​HR-positive, HER2-negative, inoperable locally advanced o…
Laboratorios Farmaceuticos Rovi S.A.
Neoplasms
Romania, Spain, Bulgaria, Czechia, Latvia, Poland, Croatia, Slovakia
21/08/2026
Phase III
A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera
2025-524669-25-00Polycythemia Vera
Deciphera Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Austria, Czechia, Italy, Portugal, Germany, France, Hungary, Spain, Poland
21/08/2026
Phase III
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)
2025-524934-24-00Neoplasms, Gastrointestinal Stromal
Glaxosmithkline Research & Development Limited
Neoplasms
Italy, Portugal, Germany, Sweden, Poland, Romania, Finland, Greece, Norway, Spain, Netherlands, France, Hungary
21/08/2026
Phase III
A Randomized, Open-Label Phase 3 Study of Azenosertib Versus Investigator’s Choice of Chemotherapy in Platinum-Resistant High-Grade Serous Ovarian, Primary Peritoneal, or Fallopian Tube Cancers Positive for Cyclin E1 Protein Expression
2025-524641-27-00High-Grade Serous Ovarian, Fallopian Tube, or Primary Perit…
K-Group Beta Inc.
Neoplasms
Germany, Spain, Italy, Belgium, Poland, France, Ireland
21/08/2026
Phase II
A Randomized, Double-Blind, Phase 2 Trial Evaluating the Efficacy, Safety and Tolerability of Primary Cardioprotection with Dapagliflozin in Patients with Newly Diagnosed Multiple Myeloma Undergoing Autologous Hematopoietic Stem Cell Transplantation
2026-525418-67-00Multiple Myeloma
Instytut Hematologii I Transfuzjologii
Hemic and Lymphatic Diseases
Poland
21/08/2026
Phase III
A Phase 3, Randomized, Open-Label Study of Linvoseltamab Versus Daratumumab in Participants with Smoldering Multiple Myeloma at High Risk of Developing Multiple Myeloma
2025-523252-31-00High Risk Smoldering Multiple Myeloma (HR-SMM)
Regeneron Pharmaceuticals Inc.
Neoplasms
Italy, Spain, Poland, France, Norway, Greece, Germany
20/08/2026
Phase II
J2S-MC-GZMS: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants with IBS-D
2025-524973-17-00Irritable Bowel Syndrome Diarrhea
Eli Lilly & Co.
Digestive System Diseases
Germany, Poland, Spain, Belgium
20/08/2026
Phase III
JS2-MC-GZMI: A Phase 3, Multicenter, Randomized, Double-Blind, Parallel-Arm Study to Investigate the Efficacy and Safety of Adjunctive Treatment with Brenipatide in Delaying Time to Relapse Compared with Placebo in Adult Participants with Major Depressive Disorder (RENEW-MDD- 2)
2025-522310-24-00Depressive Disorder, Major
Eli Lilly & Co.
Mental Disorders
Poland, Greece, Spain, Germany
19/08/2026
Phase I/II
A Phase 1/2 Trial of TER-2013 in Patients with Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
2025-525036-34-00Solid Tumours
Terremoto Biosciences Inc.
Neoplasms
Spain, Ireland, Hungary, Romania, France, Portugal, Belgium, Poland
18/08/2026
Phase III
A Phase 3, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of rozanolixizumab in adult participants with ocular myasthenia gravis
2025-524756-54-00Ocular Myasthenia Gravis
UCB Biopharma
Immune System Diseases
Hungary, Greece, Italy, Spain, Germany, Poland, France
18/08/2026
Phase II
A Randomized, Double-Blind, Placebo-Controlled Phase II Trial to Evaluate Safety, and Pharmacodynamics of Repeated Subcutaneously Administered RBD1119 in Participants with CAD
2026-525901-10-00Coronary artery disease
Ribocure Pharmaceuticals AB
Cardiovascular Diseases
Sweden, Poland
18/08/2026
Phase II
A Phase II, Randomized, Open-label, Multi-center Study of AK104 in Combination with Lenvatinib versus Lenvatinib in Participants with Advanced Hepatocellular Carcinoma Who Have Progressed on Atezolizumab and Bevacizumab
2025-524591-30-00Hepatocellular Carcinoma
Akeso Biopharma Co. Ltd.
Neoplasms
Poland, France, Spain, Italy
18/08/2026
Phase III
A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered via Intravitreal Injection in Participants with Neovascular Age-related Macular Degeneration
2025-523500-72-00Neovascular Age-related Macular Degeneration (nAMD)
Amgen Inc.
Eye Diseases
Slovakia, Latvia, Czechia, Poland, Spain, Hungary, Lithuania
17/08/2026
Phase III
C4931007 - A PHASE 3, RANDOMIZED, DOUBLE-BLIND TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS
2025-523447-35-02Pneumoccoccal Immunisation
Pfizer Inc.
Bacterial Infections and Mycoses
Spain, Finland, Poland, Germany, Greece, Hungary, Italy
17/08/2026
Phase III
A Phase III, Randomized, Open-label Trial of BNT324 Versus Docetaxel With Prednisone/Prednisolone in Metastatic Castration-resistant Prostate Cancer
2025-524445-27-00Metastatic castration-resistant prostate cancer (mCRPC)
BioNTech SE
Male Urogenital Diseases
Belgium, Spain, Italy, Poland, Germany, Hungary
17/08/2026
Phase I
A Two-part study to learn the amount of polymyxin E1 in the body over time formed after a single inhaled dose of colistimethate sodium (CMS) in healthy adults (Part 1) and after single inhaled and vein-infused doses of CMS in adults with non‑cystic fibrosis bronchiectasis (NCFB) (Part 2)
2025-524324-22-00Non-cystic fibrosis bronchiectasis
Zambon S.p.A.
Respiratory Tract Diseases
Belgium, Poland, Bulgaria
17/08/2026
Phase II
A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)
2025-525033-31-00heart failure
Cardurion Pharmaceuticals Inc.
Cardiovascular Diseases
Latvia, Slovakia, Lithuania, Hungary, Italy, Netherlands, Spain, Poland, Bulgaria, Czechia
14/08/2026
Phase II
A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)
2023-509125-41-00Severe asthma
Kinaset Therapeutics Inc.
Respiratory Tract Diseases
Czechia, Bulgaria, Romania, Hungary, Germany, Poland, Greece
14/08/2026
Phase III
SERAFA-1: A Single arm, Open label, Multicentre, Phase IIIb Study Of Camizestrant plus Ribociclib in 1st line Treatment of ER-positive, HER2-negative Advanced Breast Cancer Patients
2025-523444-12-00Breast Cancer
AstraZeneca AB
Neoplasms
Poland, Spain, France, Germany, Italy
13/08/2026
Phase III
Prognostic value assessment of PSMA-T4 examination in the group of patients with triple-negative breast cancer (TNBC) qualified to radical therapy
2025-525110-29-01triple-negative breast cancer
Narodowe Centrum Badan Jadrowych
Neoplasms
Poland
12/08/2026
Phase II
Evaluation of the efficacy, safety, and tolerability of lutetium-177-labeled PSMA ligand in patients with progression of adenoid cystic carcinoma originating from the salivary glands - an open, non-commercial clinical trial
2026-525776-26-00adenoid cystic carcinoma of the salivary glands
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Otorhinolaryngologic Diseases
Poland
12/08/2026
Phase III
Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity
2025-524626-18-00Overweight and obesity
Novo Nordisk A/S
Nutritional and Metabolic Diseases
Netherlands, Belgium, Greece, Poland, Spain, Denmark, France, Bulgaria, Sweden
10/08/2026
Phase III
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
2025-523333-26-00Graves' Disease (GD)
Argenx
Hormonal diseases
Italy, Czechia, Spain, Denmark, Belgium, Romania, Latvia, France, Germany, Greece, Sweden, Poland, Lithuania, Bulgaria
07/08/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 19 September 2026. https://priyalifescience.com/clinical-trials-europe/country/poland

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Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See the Ireland, UK or USA registers. For approved medicines, see the EMA Approvals Tracker.