Clinical trial register · European Union · CTIS

Clinical Trials in Ireland, 2026

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 2557 most recently authorised of 12637 total CTIS records — a stated recency window, not the full historical archive. Synced 16 Oct 2026, 03:17 UTC

2557

Shown in this register

most recently authorised

12,637

Total on CTIS

full historical archive

779

Phase III

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Top member states

Spain 1071 France 924 Germany 907 Italy 776 Poland 609 Netherlands 560

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Phase

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Member state

All 28 states

Trials with a site in Ireland

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase III

A Phase 3b/4, Multicenter, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm, Long-Term Study to Evaluate the Safety and Efficacy of Saroglitazar Magnesium on Clinical Outcomes in Participants with Primary Biliary Cholangitis (PBC)

2025-524067-20-00Primary Biliary Cholangitis (PBC)

DrugSaroglitazar Magnesium

Zydus Therapeutics Inc.

Digestive System Diseases

Ireland, Greece, Estonia, Netherlands, Bulgaria, Slovakia, Poland, Latvia, Croatia, Spain, France, Italy

05/10/2026

Phase III

A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Effect of Mitapivat on Transfusion Burden in Subjects With Sickle Cell Disease

2026-526778-18-00Anemia in subjects with sickle cell disease (SCD)

DrugMitapivat

Agios Pharmaceuticals Inc.

Hemic and Lymphatic Diseases

Italy, France, Belgium, Ireland

28/09/2026

Phase I/II

ROSETTA RCC-208: A Phase 1/2 Open-label, Multi-center, Randomized Study of Pumitamig Alone or in Combination with Ipilimumab or Cabozantinib in Participants with Advanced Renal Cell Carcinoma (RCC)

2026-527163-15-00Advanced Renal Cell Carcinoma

DrugsCabozantinib·Ipilimumab

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Ireland, Romania, Italy, Spain, Czechia, Finland, France, Germany

24/09/2026

Phase III

A Randomized, Open-label, Phase 3 Study of Rina-S ± Bevacizumab Versus Investigator's Choice of Platinum-Based Chemotherapy ± Bevacizumab as 2L Treatment in Participants With Recurrent Platinum-Sensitive Ovarian Cancer

2025-524202-15-00Recurrent Platinum-Sensitive Ovarian Cancer

DrugsPegfilgrastim·Doxorubicin·Paclitaxel·Bevacizumab

Genmab A/S

Neoplasms

Czechia, Netherlands, Lithuania, Ireland, Finland, Hungary, Spain, Greece, Italy, France, Germany, Poland

18/09/2026

Phase III

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

2025-523857-32-00Spinal Muscular Atrophy

DrugSalanersen

Biogen Idec Research Limited

Nervous System Diseases

Portugal, Italy, Belgium, Croatia, Hungary, Germany, Ireland, France, Norway, Poland

31/08/2026

Phase II

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

2025-524230-25-00Diffuse large B-cell lymphoma (DLBCL)

DrugsEpcoritamab·Rituximab

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Hemic and Lymphatic Diseases

Czechia, Denmark, Croatia, Spain, Sweden, Finland, Portugal, Ireland, Netherlands, Belgium, Norway

31/08/2026

Phase III

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

2025-524263-21-01Resected Stage II-III Kirsten rat sarcoma virus oncogene ho…

DrugsDivarasib·Nivolumab·Pembrolizumab

F. Hoffmann-La Roche AG

Neoplasms

France, Spain, Austria, Greece, Portugal, Ireland, Belgium, Italy, Poland, Germany, Netherlands

28/08/2026

Phase II

C6461010 - An Interventional, Open-Label, Phase 2 Study to Investigate the Safety and Efficacy of PF-08634404 Monotherapy or in Combination in Adult Participants with Early-Stage Resectable or Locally Advanced Unresectable Non-Small Cell Lung Cancer

2025-524825-42-00Early-Stage Resectable or Locally Advanced Unresectable Non…

DrugsPF-08634404·Pemetrexed·Paclitaxel·Carboplatin

Pfizer Inc.

Neoplasms

Spain, France, Italy, Ireland, Germany, Poland

26/08/2026

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…

DrugsTopotecan·Doxorubicin·Gemcitabine·Paclitaxel

K-Group Beta Inc.

Neoplasms

Germany, Spain, Italy, Belgium, Poland, France, Ireland

21/08/2026

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

DrugsImlunestrant·Fulvestrant

Terremoto Biosciences Inc.

Neoplasms

Spain, Ireland, Hungary, Romania, France, Portugal, Belgium, Poland

18/08/2026

Phase III

4TAZPower: A Phase 3b/4, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Trial to Evaluate the Efficacy and Safety of Daily Subcutaneous Injections of Elamipretide in Patients with Genetically Confirmed Barth Syndrome

2025-523837-25-00Barth Syndrome

DrugElamipretide

Stealth Biotherapeutics Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Ireland, Netherlands, France, Italy

27/07/2026

Phase III

An Open-Label, Phase 3 Study to Evaluate the Efficacy and Safety of Salanersen (BIIB115) in Participants Aged 15-60 Years With Spinal Muscular Atrophy Who Are Either Treatment-Naïve or Have Previously Been Treated With Risdiplam

2025-524054-34-00Spinal Muscular Atrophy

DrugSalanersen

Biogen Idec Research Limited

Nervous System Diseases

Finland, Spain, Italy, Poland, Ireland, Germany, France

24/07/2026

Phase II

A Phase 2, Multicenter, Randomized, Double-blind, Placebocontrolled Study, to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Intrathecally Administered Mivelsiran in Adult Participants with Early-Stage Down Syndrome-Associated Alzheimer’s Disease (DS-AD)

2025-523390-42-00Early-Stage Down Syndrome-Associated Alzheimer’s Disease (D…

DrugMivelsiran

Alnylam Pharmaceuticals Inc.

Nervous System Diseases

Italy, Netherlands, Spain, Germany, Ireland

22/07/2026

Phase III

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

2025-522227-99-00Huntington’s Disease

DrugVotoplam

Novartis Pharma AG

Nervous System Diseases

Norway, Poland, Spain, Sweden, Bulgaria, Netherlands, Finland, Portugal, Austria, Italy, Greece, Ireland, Czechia, France, Romania, Belgium, Germany, Denmark, Slovakia, Hungary

20/07/2026

Phase III

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

2025-524463-20-00Asthma

DrugsDopamine·Depemokimab

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Ireland, Spain, Germany, Czechia, Bulgaria, France, Belgium, Romania, Italy

14/07/2026

Phase II

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

2025-524285-18-00Advanced and/or Metastatic Solid Tumors with Homozygous MTA…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Belgium, Ireland, Germany, Norway, Italy, France, Spain

07/07/2026

Phase I

A Phase 1 Study of TORL-1-23 in Advanced Cancer

2024-517189-40-00Advanced Cancer

Torl Biotherapeutics LLC

Neoplasms

Ireland

06/07/2026

Phase III

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

2025-524397-42-00Participants with relapsed HRNB and participants with HRNB…

DrugsTemozolomide·Irinotecan

Renaissance Pharma Limited

Nervous System Diseases

France, Spain, Denmark, Ireland, Germany

30/06/2026

Phase I/II

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

2025-524623-50-00Solid Tumors

DrugsElironrasib·RMC-9805·Erbitux·Ivonescimab

Revolution Medicines Inc.

Neoplasms

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

29/06/2026

Phase III

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

2025-522373-10-00Progressive pulmonary fibrosis and Idiopathic pulmonary fib…

DrugAdmilparant

Bristol-Myers Squibb Services Unlimited Company

Respiratory Tract Diseases

Finland, Portugal, Hungary, Ireland, Poland, Greece, France, Belgium, Denmark, Italy, Spain, Netherlands, Austria, Germany

17/06/2026

Phase I/II

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

2025-523497-16-00Lung and/or Liver Disease Associated with Alpha-1 Antitryps…

Tessera Therapeutics Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Ireland, Sweden, Netherlands

08/06/2026

Phase I/II

A Phase 1/2, Multicenter, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamic, and Antitumor Activity of CR-001 in Adult Participants with Locally Advanced or Metastatic Solid Tumors.

2025-523590-42-00Locally Advanced or Metastatic Solid Tumors

Crescent Biopharma Inc.

Neoplasms

Spain, Ireland, Italy, France, Romania

02/06/2026

Phase III

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

2025-522435-33-00Hemophilia A

F. Hoffmann-La Roche AG

Hemic and Lymphatic Diseases

Hungary, Spain, Ireland, Poland, Austria, Germany, Denmark, Belgium, Netherlands, Italy, France

01/06/2026

Phase II

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

2025-523400-72-00Cystic fibrosis

Vertex Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Spain, Sweden, Germany, Italy, Belgium, Czechia, Ireland, Portugal, Netherlands, France, Denmark

29/05/2026

Phase III

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of GB-0895 Adjunctive Therapy in Adults and Adolescents with Severe Uncontrolled Asthma

2025-524040-35-00Severe uncontrolled asthma

Generate Biomedicines Inc.

Respiratory Tract Diseases

Italy, Slovakia, Spain, Ireland, Belgium, France, Estonia

26/05/2026

Phase II

Safety and efficacy of T10430 eye drops in controlling paediatric myopia progression

2025-521563-13-01Paediatric myopia

Laboratoires Thea

Eye Diseases

Ireland, Austria

22/05/2026

Phase III

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

2025-523576-23-00Unresectable Stage III non-small cell lung cancer without p…

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

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

22/05/2026

Phase III

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.

2025-520565-51-00small cell lung cancer

DrugsObrixtamig·Tocilizumab·Atezolizumab·Carboplatin

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Neoplasms

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

12/05/2026

Phase III

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

2025-522255-25-00Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neop…

Eli Lilly & Co.

Neoplasms

Netherlands, Hungary, France, Austria, Poland, Italy, Denmark, Romania, Greece, Norway, Czechia, Belgium, Spain, Ireland, Germany

11/05/2026

Phase III

An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.

2024-520218-23-00Pulmonary Arterial Hypertension

Inhibikase Therapeutics Inc.

Cardiovascular Diseases

Spain, Poland, Italy, Belgium, Latvia, Denmark, Czechia, Germany, France, Netherlands, Portugal, Ireland, Austria, Greece, Lithuania

28/04/2026

Phase III

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)

2023-508047-40-00Ovarian cancer

Merck Sharp & Dohme LLC

Neoplasms

Norway, Ireland, Spain, Greece, France, Poland, Denmark, Austria, Hungary, Belgium, Czechia, Finland, Germany, Italy, Sweden

28/04/2026

Phase III

A Phase 3, Parallel-group Treatment, Blinded, Randomized, Placebo-controlled Study to Assess the Efficacy and Safety of Pegtibatinase Administered Subcutaneously in Addition to Standard of Care in Participants with Classical Homocystinuria due to Cystathionine Beta Synthase Deficiency (HARMONY)

2023-504135-40-00Classical Homocystinuria

Travere Therapeutics Inc.

Nutritional and Metabolic Diseases

Belgium, Ireland, Spain, Italy, Germany, France, Portugal, Poland

27/04/2026

Phase II

The MAVRiC Study: A Phase II Study of Disease Risk Mutation-guided Finite Duration Acalabrutinib plus Venetoclax for Relapse in CLL/SLL after First-line Finite covalent BTKi plus BCL2i combination, with or without Obinutuzumab

2024-518858-17-00Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CL…

DrugsAcalabrutinib·Venetoclax

AstraZeneca AB

Neoplasms

Italy, Austria, Spain, Ireland, Czechia, Poland

27/04/2026

Phase II

A Phase 2, Multicenter, Randomized, Placebo-controlled, Double-blind Study of the Efficacy and Safety of Vamifeport in Adult Subjects with HFE-related Hereditary Hemochromatosis (FERROCLEAR Study)

2025-523793-16-00Homeostatic iron regulator gene-related hereditary hemochro…

CSL Behring LLC

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Austria, Poland, Spain, Germany, France, Ireland, Romania, Belgium, Italy, Czechia, Netherlands

20/04/2026

Phase III

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

2025-524002-16-00Amyotrophic Lateral Sclerosis

Ferrer Internacional S.A., Prilenia Therapeutics B.V.

Nervous System Diseases

Belgium, Netherlands, Poland, France, Germany, Ireland, Italy, Sweden, Spain

20/04/2026

Phase III

A Phase 3, Randomized, Open-Label Study of INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum Resistant Ovarian Cancer With Cyclin E1 Overexpression (MAESTRA 2)

2025-522748-42-00Ovarian cancer

DrugsTopotecan·Doxorubicin·Gemcitabine·Paclitaxel

Incyte Corp.

Neoplasms

Ireland, Poland, France, Netherlands, Spain, Italy, Germany, Belgium

17/04/2026

Phase I

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

2025-523558-14-00Alpha-1 Antitrypsin Deficiency

Airna Corp.

Respiratory Tract Diseases

Sweden, Ireland, Spain, Netherlands, Portugal, Germany

17/04/2026

Phase III

A Phase 3, Multicenter, Open-Label, Randomized Trial to Compare the Efficacy and Safety of Elritercept versus Epoetin Alfa for the Treatment of Anemia Due to IPSS-R Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes in ESA-naïve Adult Participants Who Require Red Blood Cell Transfusions

2025-523544-12-00Myelodysplastic neoplasms/syndromes (MDS)

Takeda Development Center Americas Inc.

Hemic and Lymphatic Diseases

France, Belgium, Germany, Italy, Bulgaria, Ireland, Lithuania, Norway, Romania, Hungary, Spain, Greece, Poland, Netherlands

17/04/2026

Phase I/II

Phase 1/2A Study of OTP-01, a Dual Paratopic PD-1/VEGFR2 Antibody, in Patients with Advanced Solid Tumors

2025-524111-37-00advanced solid tumors

Ottimo Pharma Limited

Neoplasms

Ireland, Spain, Portugal

14/04/2026

Phase II

TREAT-EC (Tirzepatide in the treatment of endometrial cancer) - a clinical trial

2025-523877-40-00Endometrial adenocarcinoma

DrugsLevonorgestrel·Tirzepatide

University College Dublin

Neoplasms

Ireland

02/04/2026

Phase III

Randomised, Open-label, Phase III Study of AZD5335 Versus Mirvetuximab Soravtansine in FRα-high and AZD5335 Versus Investigator’s Choice Chemotherapy in FRα-low Expressing High-grade Platinum-resistant Epithelial Ovarian Cancer Patients (TREVI-OC-01)

2025-520466-22-00Advanced Platinum-resistant Epithelial Ovarian Cancer

AstraZeneca AB

Pathological Conditions, Signs and Symptoms

Ireland, Greece, Czechia, France, Sweden, Belgium, Denmark, Spain, Italy, Germany

27/03/2026

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Proof of Concept (POC) Study Evaluating the Safety, Tolerability, and Efficacy of Nintedanib Solution for Inhalation (AP02) in Participants with Idiopathic Pulmonary Fibrosis (IPF) (AURA-IPF)

2025-523431-19-00Idiopathic Pulmonary Fibrosis (IPF)

Avalyn Pharma Inc.

Respiratory Tract Diseases

Germany, Italy, Spain, Ireland

26/03/2026

Phase I

Phase 1 trial of valemetostat and darolutamide in mCRPC

2025-522512-16-00Metastatic Castration Resistant Prostate Cancer (mCRPC)

Daiichi Sankyo Inc.

Neoplasms

Ireland, Spain, France

18/03/2026

Phase III

A prospective, open-label, randomized, multicenter phase-III trial to evaluate the efficacy of pirtobrutinib and epcoritamab compared with R-(mini)-CHOP for treatment of patients with Richter Transformation - CLLRT2

2024-513445-37-00previously untreated RT, irrespective of risk factors and d…

DrugsEpcoritamab·Pirtobrutinib·Prednisolone·Vincristine

University Of Cologne

Neoplasms

Austria, Germany, Denmark, Ireland, Netherlands, Italy

18/03/2026

Phase I/II

A Phase 1/2 Trial of RPTR-1-201, a T Cell Receptor Bispecific Therapy, in Advanced Solid Tumors

2025-524010-28-00Advanced Solid Tumor

Repertoire Immune Medicines Inc.

Neoplasms

Spain, Ireland, Portugal, France

17/03/2026

Phase I

Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors

2025-523686-15-00Advanced or Metastatic Solid Tumors

Olema Pharmaceuticals Inc.

Neoplasms

Ireland, Spain, France

17/03/2026

Phase II

A phase 2b, randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of Usnoflast administered to adult subjects with Amyotrophic Lateral Sclerosis (ALS)

2025-522580-15-00Amyotrophic Lateral Sclerosis (ALS)

Zydus Therapeutics Inc.

Nervous System Diseases

Spain, Germany, Sweden, Ireland, Poland, Italy, Belgium, France, Netherlands

12/03/2026

Phase III

A randomized, double-blind, placebo-controlled Phase III study to evaluate the efficacy and safety of remibrutinib in patients with secondary progressive multiple sclerosis

2025-521546-23-00Secondary progressive multiple sclerosis

Novartis Pharma AG

Nervous System Diseases

Denmark, Slovenia, Netherlands, Portugal, Ireland, Sweden, Croatia, Greece, Germany, Latvia, Czechia, Spain, Romania, Belgium, Austria, Lithuania, Slovakia, Poland, Estonia, Bulgaria, France, Italy, Hungary, Finland, Norway

03/03/2026

Phase II

POSITRON - PsilOcybin with pSychologIcal supporT foR cOcaiNe: a randomised controlled pilot feasibility trial of psilocybin with psychological support for cocaine use disorder

2024-515147-32-02Cocaine addiction

Trinity College Dublin

Mental Disorders

Ireland

27/02/2026

Phase III

Studying Treatments in patients receiving androgen deprivation therapy (ADT) for Metastatic Prostate Cancer: Evaluation of Drug and radiation Efficacy: A 2nd multi-arm multi-stage randomised controlled trial (STAMPEDE2)

2025-522145-21-00Metastatic hormone sensitive prostate cancer

University College London

Neoplasms

Ireland, Germany, Spain

25/02/2026

Phase III

TRITON-PN: A Phase 3, Global, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Hereditary Transthyretin-Mediated Amyloidosis with Polyneuropathy (hATTR-PN)

2025-522544-40-00Hereditary transthyretin-mediated amyloidosis with polyneur…

Alnylam Pharmaceuticals Inc.

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Italy, Greece, Spain, Sweden, Ireland, Cyprus, Portugal, Germany

20/02/2026

Phase I

Single-centre clinical trial investigating the safety and tolerability of increasing multiple doses of nebulised SS0331 in healthy participants

2025-523530-30-00Treatment and post exposure prevention of respiratory tract…

Softox Defense Solutions AS

Bacterial Infections and Mycoses

Ireland

20/02/2026

Phase III

Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab versus Placebo in Patients with Cancer-associated Cachexia

2025-523533-25-00Cancer-associated Cachexia

CatalYm GmbH

Nutritional and Metabolic Diseases

France, Czechia, Romania, Italy, Germany, Poland, Spain, Bulgaria, Norway, Ireland, Netherlands

13/02/2026

Phase III

HELIOS: An Open-Label, Long-Term Study to Investigate the Safety, Tolerability, and Efficacy of DISC-1459 (Bitopertin) in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP).

2025-523275-27-00Erythropoietic Protoporphyria (EPP), X-Linked Protoporphyri…

Disc Medicine Inc.

Nutritional and Metabolic Diseases

Italy, France, Ireland, Belgium, Sweden, Germany, Netherlands, Norway, Spain

12/02/2026

Phase III

An Open-label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety/Tolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients with Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg/kg/week and 120 mg/kg/week Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)

2025-522792-29-00Alpha-1 Antitrypsin Deficiency

DrugIVIG

Grifols Therapeutics LLC

Respiratory Tract Diseases

Poland, Denmark, Netherlands, Ireland, Sweden, Spain, Portugal, Germany, France

27/01/2026

Phase I

A Phase 1 Study for ZW251 in Participants with Solid Tumors.

2025-523088-39-00Advanced Solid Tumors

Zymeworks Bc Inc.

Neoplasms

Portugal, Ireland, Spain

15/01/2026

Phase I

A trial to learn how safe AZD5335 is and if a drug called itraconazole changes how AZD5335 moves through the body over time in adults with ovarian, peritoneal, or fallopian tube cancer

2025-522731-34-00Ovarian cancer Primary peritoneal cancer Fallopian tube can…

AstraZeneca AB

Neoplasms

Spain, Ireland, Portugal

15/01/2026

Phase III

HOVON 181 AML: Bleximenib or Placebo in Combination with Standard Induction and Consolidation Therapy followed by Maintenance for the Treatment of Patients with Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a double-blind phase 3 study

2025-522767-15-00Acute Myeloid Leukemia

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

Neoplasms

Belgium, Netherlands, Germany, Austria, Denmark, Estonia, Finland, Ireland, Italy, Lithuania, Spain, Sweden, Norway, Poland

15/01/2026

Phase III

A Phase 3, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab With or Without Bevacizumab Compared With Standard of Care as Firstline Maintenance Treatment for Participants With Persistent, Recurrent, or Newly Diagnosed Metastatic Cervical Cancer With PD-L1 CPS Greater Than or Equal to 1 (TroFuse-036/GOG-3123/ENGOT-cx22)

2025-521514-26-00Persistent, Recurrent, or Newly Diagnosed Metastatic Cervic…

Merck Sharp & Dohme LLC

Neoplasms

Greece, Ireland, France, Belgium, Czechia, Hungary, Austria, Spain, Sweden, Germany, Poland, Denmark, Italy

14/01/2026

Phase III

IZABRIGHT-BLADDER01: A Randomized, Open-label, Phase 2/3 trial of Izalontamab Brengitecan versus platinum-based chemotherapy for metastatic urothelial cancer in participants with disease progression on or after an immunotherapy-based treatment

2025-522400-24-00Metastatic urothelial cancer

Bristol-Myers Squibb Services Unlimited Company

Male Urogenital Diseases

Ireland, Belgium, Germany, Italy, Norway, Spain, Austria, Sweden, France, Romania, Czechia

19/12/2025

Phase II

A Phase 1/2 Study to Evaluate STK-012 as a Single Agent and in Combination Therapy in Subjects with Front-line Advanced NSCLC and Other Selected Indications

2025-522632-14-00Non-small cell lung cancer (NSCLC)

Synthekine Inc.

Neoplasms

Ireland, Poland, Spain, Italy

19/12/2025

Phase III

A Phase 2b/3 Adaptive, Randomized, Active controlled Study Evaluating the Efficacy, Safety, and Tolerability of Povetacicept Versus Calcineurin Inhibitor in the Treatment of Primary Membranous Nephropathy

2025-521661-27-00Primary Membranous Nephropathy

Vertex Pharmaceuticals Inc.

Immune System Diseases

Hungary, Ireland, Czechia, Italy, Spain, Germany, Netherlands

12/12/2025

Phase III

A Prospective, Multicenter, Open-label, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of Prophylactic VGA039 in Adolescent and Adult Patients with von Willebrand Disease (VIVID-6)

2025-522056-10-01von Willebrand Disease

Vega Therapeutics Inc.

Hemic and Lymphatic Diseases

Austria, Italy, Ireland, Germany, Finland

08/12/2025

Phase III

A Randomized, Phase 2/3 Study Comparing Navlimetostat (BMS-986504) in Combination With Nab-Paclitaxel and Gemcitabine versus Placebo in Combination With Nab-Paclitaxel and Gemcitabine in Participants with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Harboring Homozygous MTAP Deletion

2025-522598-12-00Untreated Metastatic Pancreatic Ductal Adenocarcinoma

Bristol-Myers Squibb Services Unlimited Company

Neoplasms

Czechia, Austria, Belgium, Ireland, Spain, Germany, Romania, Netherlands, Slovakia, Greece, Poland, Italy, Denmark, France, Sweden

28/11/2025

Phase III

A randomized, double-blind, placebo-controlled, parallel-group, multicenter study of the efficacy and safety of depemokimab in adult participants with COPD with Type 2 inflammation.

2024-520418-22-00Chronic Obstructive Pulmonary Disease

Glaxosmithkline Research & Development Limited

Respiratory Tract Diseases

Slovakia, Denmark, France, Sweden, Ireland, Belgium, Netherlands, Spain, Croatia, Germany, Poland, Hungary, Norway, Portugal

24/11/2025

Phase III

A Phase 3 Open-label Randomized Study Assessing the Efficacy and Safety of RLY-2608 + Fulvestrant Versus Capivasertib + Fulvestrant as Treatment for PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) Locally Advanced or Metastatic Breast Cancer Following Recurrence or Progression On or After Treatment with a CDK4/6 Inhibitor

2025-523083-21-00PIK3CA-mutant Hormone Receptor Positive, Human Epidermal Gr…

Relay Therapeutics Inc.

Neoplasms

Hungary, Spain, Italy, Belgium, Netherlands, Austria, Germany, Greece, Czechia, Denmark, Poland, Bulgaria, Portugal, France, Ireland, Romania

11/11/2025

Phase III

A Phase 3, Randomized, Open-label Study of Belzutifan + Zanzalintinib Versus Cabozantinib in Participants with Advanced RCC who Experienced Disease Recurrence During or After Prior Adjuvant Anti-PD-1/L1 Therapy (LITESPARK-033)

2024-517136-21-00Renal Cell Carcinoma

Merck Sharp & Dohme LLC

Neoplasms

Greece, Germany, France, Italy, Croatia, Denmark, Czechia, Austria, Belgium, Ireland, Spain, Poland

10/11/2025

Phase II

A Seamless Phase 2a/2b, Randomized, Double-Blind, Placebo- and Active-Controlled, Multiple-Arm, Multiple-Stage, Adaptive Study Evaluating the Efficacy and Safety of LAD191 in Adults With Moderate-to-Severe Hidradenitis Suppurativa

2025-521293-34-00Moderate-to-severe hidradenitis suppurativa

DrugAdalimumab

Almirall S.A.

Skin and Connective Tissue Diseases

Germany, Italy, Ireland, Poland, Spain, France

03/11/2025

Phase II

A Phase 2b, Multi-center, Randomized, Double-blind, Placebo controlled Study of IMVT-1402 Treatment in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

2024-517614-14-00Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Immunovant Sciences GmbH

Immune System Diseases

Austria, Hungary, Slovenia, Greece, Denmark, Ireland, Finland, Estonia, Spain, Slovakia, Netherlands, Poland, Norway, Italy, Portugal, Belgium, Germany, Romania, Bulgaria

28/10/2025

Phase III

A Phase 3, Open-Label, Multicenter, Extension Study of Acoramidis in Patients with Newly Diagnosed Variant Transthyretin Amyloid Cardiomyopathy (ACT-EARLY OLE)

2024-513676-18-00Transthyretin Amyloidosis

DrugAcoramidis

Eidos Therapeutics Inc.

Cardiovascular Diseases

Germany, Portugal, Netherlands, France, Spain, Italy, Ireland, Belgium, Sweden, Denmark, Greece

22/10/2025

Phase III

A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB AND PEMBROLIZUMAB VERSUS PEMBROLIZUMAB AND PEMETREXED AND CARBOPLATIN OR CISPLATIN IN PATIENTS WITH PREVIOUSLY UNTREATED, KRAS G12C-MUTATED, ADVANCED OR METASTATIC NON-SQUAMOUS NON-SMALL CELL LUNG CANCER

2024-518365-10-00Previously Untreated Advanced or Metastatic Non-Squamous No…

F. Hoffmann-La Roche AG

Neoplasms

Ireland, Greece, Hungary, Netherlands, France, Denmark, Germany, Poland, Italy, Portugal, Spain, Belgium

21/10/2025

Phase III

A Phase 3, Double-Blind, Placebo-Controlled, Randomized Study to Assess the Safety of Epicutaneous Immunotherapy with DBV712 250 µg in 1-through 3-year-old Children with Peanut Allergy

2025-521697-34-00Peanut allergy

Dbv Technologies

Immune System Diseases

Spain, France, Netherlands, Ireland

20/10/2025

Phase III

TRITON-CM: A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nucresiran in Patients with Transthyretin-Mediated Amyloidosis with Cardiomyopathy (ATTR amyloidosis with cardiomyopathy)

2024-519917-72-00Transthyretin Amyloidosis with Cardiomyopathy (ATTR Amyloid…

Alnylam Pharmaceuticals Inc.

Cardiovascular Diseases

France, Germany, Italy, Greece, Belgium, Portugal, Netherlands, Austria, Sweden, Denmark, Spain, Czechia, Hungary, Ireland, Romania, Norway, Poland, Slovakia

14/10/2025

Phase I

A multi-part, adaptive, Phase 1, first time in human study in healthy participants and participants with atopic dermatitis (AD) to assess the safety, tolerability, pharmacokinetics (PK) of single ascending (SAD), multiple ascending doses (MAD) and selected dose of SYX-5219 (AD Participants)

2025-522216-17-00Atopic Dermatitis

Sitryx Therapeutics Limited

Skin and Connective Tissue Diseases

Germany, Bulgaria, Ireland, Denmark

09/10/2025

Phase III

ETOP 27-23 ARCH – A randomised phase III trial of adjuvant cemiplimab in patients with resected stage IIA-IIIB NSCLC who have not received prior adjuvant chemotherapy.

2024-519901-36-00Patients with resected stage IIA-IIIB non-small cell lung c…

ETOP IBCSG Partners Foundation

Neoplasms

France, Estonia, Spain, Austria, Italy, Germany, Ireland

08/10/2025

Phase III

A Multicenter, Randomized, Double-blind, Phase 2/3 Study of Ficerafusp Alfa (BCA101) or Placebo in Combination with Pembrolizumab for First-Line Treatment of PD-L1-positive, Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (FORTIFI-HN01).

2024-519654-37-00Recurrent or Metastatic Head and Neck Squamous Cell Carcino…

Bicara Therapeutics Inc.

Neoplasms

Belgium, Austria, Italy, Poland, Spain, Germany, Czechia, Ireland, Greece, France, Portugal

06/10/2025

Phase II

A Phase 2 Randomized, Double-blind, Placebo-Controlled Study of the Safety and Efficacy of MTX-463 in Participants with Idiopathic Pulmonary Fibrosis (IPF)

2025-521278-32-00Idiopathic Pulmonary Fibrosis (IPF)

Mediar Therapeutics Inc.

Immune System Diseases

Croatia, Ireland, Netherlands, Spain, France, Belgium

01/10/2025

Phase III

Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), compared with Topotecan in Participants with Relapsed Small Cell Lung Cancer (SCLC)

2025-521627-78-00Neoplasms, Lung

Glaxosmithkline Research & Development Limited

Neoplasms

Hungary, France, Portugal, Greece, Sweden, Ireland, Poland, Bulgaria, Romania, Finland, Italy, Germany, Spain

29/09/2025

Phase III

APOLLO: A Randomized, Double-Blind, Placebo-Controlled Study of Bitopertin to Evaluate the Efficacy, Safety, and Tolerability in Participants with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

2024-520407-27-00X-Linked Protoporphyria (XLP), Erythropoietic Protoporphyri…

Disc Medicine Inc.

Nutritional and Metabolic Diseases

Germany, Ireland, Spain, France, Norway, Netherlands, Sweden, Belgium, Italy

29/09/2025

Phase III

A Phase 3b Extension Study to Evaluate the Long-Term Safety of Vedolizumab Subcutaneous in Pediatric Subjects With Ulcerative Colitis or Crohn’s Disease

2023-508804-39-00Ulcerative Colitis or Crohn’s Disease

Takeda Development Center Americas Inc.

Digestive System Diseases

Spain, Ireland, Portugal, Poland, Belgium, Netherlands, Bulgaria, Romania, Italy, Denmark

29/09/2025

Phase III

A Phase 3 Randomized, Open-Label, Multicenter Study of Sonrotoclax Plus Anti-CD20 Antibody Therapies Versus Venetoclax Plus Rituximab in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

2024-517131-52-00Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymp…

BeOne Medicines AG

Neoplasms

France, Sweden, Czechia, Austria, Belgium, Germany, Denmark, Spain, Netherlands, Italy, Ireland, Poland

26/09/2025

Phase III

EASi-PROTKT™ - A Phase III double-blind, randomised, parallel-group superiority trial to evaluate efficacy and safety of the combined use of oral vicadrostat (BI 690517) and empagliflozin compared with placebo and empagliflozin in participants with type 2 diabetes, hypertension and established cardiovascular disease

2025-521188-11-00cardiovascular disease, hypertension, Type 2 diabetes

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Cardiovascular Diseases

Lithuania, Netherlands, Ireland, Romania, France, Hungary, Finland, Latvia, Austria, Germany, Greece, Italy, Sweden, Denmark, Czechia, Belgium, Slovakia, Croatia, Spain, Norway, Bulgaria, Poland, Portugal

24/09/2025

Phase III

OPTIMA YOUNG : Optimal Personalized Treatment of early breast cancer using Multi-parameter Analysis : focus on YOUNGer women

2024-519655-28-00Premenopausal patients with high-risk HR-positive/HER2-nega…

DrugsLeuprorelin Acetate·Goserelin·Elacestrant·Tamoxifen

Unicancer

Neoplasms

Poland, France, Italy, Greece, Spain, Ireland, Belgium

23/09/2025

Phase III

A Double-blind, Randomized,Placebo-controlled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)

2025-520554-11-00Cardiovascular Disease

Amgen Inc.

Cardiovascular Diseases

Spain, Hungary, Portugal, Greece, Germany, Italy, Austria, Ireland, Romania, Slovakia, Netherlands, Czechia, Bulgaria, Denmark, France, Poland, Belgium

22/09/2025

Phase I

A Phase 1 Study of NDI-219216 in Patients with Advanced Solid Tumors with and without Microsatellite Instability and/or Deficient Mismatch Repair

2025-522774-36-00Advanced solid tumors

Nimbus Wadjet Inc.

Neoplasms

Spain, Portugal, France, Ireland

15/09/2025

Phase I

ACUMEN: Phase I Dose Escalation and Cohort Expansion study to affirm the safety of pharmacological doses of a novel formulation of intravenous melatonin in babies with hypoxic-ischaemic encephalopathy (HIE) to augment therapeutic hypothermia (HT) treatment; to reduce the incidence and severity of disability in babies with moderate-severe HIE.

2025-520538-49-00Moderate-Severe Hypoxic-Ischaemic Encephalopathy (HIE)

University College London

Nervous System Diseases

Ireland

12/09/2025

Phase I

A Phase 1/1b Study of IAM1363 in HER2 Cancers

2024-519188-17-00Relapsed/refractory malignancy with documented diagnosis of…

Iambic Therapeutics Inc.

Neoplasms

Spain, France, Ireland, Italy, Netherlands

11/09/2025

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 16 October 2026. https://priyalifescience.com/clinical-trials-europe/country/ireland

Query this register directly

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About this register

This register is built from the EU Clinical Trials Information System (CTIS), run by the European Medicines Agency: the single register for every trial authorised under the EU Clinical Trials Regulation (536/2014). CTIS held 12,637 trial records at the last sync on 16 Oct 2026, 03:17 UTC; this register shows the 2,557 most recently authorised of them, a stated recency window rather than the full archive. The list can be downloaded as CSV or JSON.

This page shows the 87 of those trials with a site in Ireland.

How many recently authorised EU trials have a site in Ireland?

87 of the 2,557 most recently authorised trials in this register list a site in Ireland; 53 of them are Phase III. Trials are counted by authorisation on CTIS, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase (Ireland), 87 trials
Phase	Trials	Share
Phase III	53	60.9%
Phase II	16	18.4%
Phase I	11	12.6%
Phase I/II	7	8%

Most active sponsors

Lead sponsors with the most trials (Ireland)
Lead sponsor	Trials
Bristol-Myers Squibb Services Unlimited Company	6
Alnylam Pharmaceuticals Inc.	3
AstraZeneca AB	3
F. Hoffmann-La Roche AG	3
Glaxosmithkline Research & Development Limited	3
Merck Sharp & Dohme LLC	3
Biogen Idec Research Limited	2
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.	2
Disc Medicine Inc.	2
Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting	2

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.