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Clinical trial register · European Union · CTIS

Recently authorised EU trials

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 โ€” 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 โ€” a stated recency window, not the full historical archive. Synced 20 Sep 2026, 03:17 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 register
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
2500 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
A Phase 1 Trial to Evaluate the Safety, PK, and PD of AX-0811 in Healthy Participants
2026-526764-21-00Cholestatic disease
ProQR Therapeutics VIII B.V.
Digestive System Diseases
Belgium
25/08/2026
Phase I
The pivotal bioequivalence study comparing the test product to the reference product, which belongs to the group of medicines used for lowering levels of cholesterol in the blood.
2026-527468-34-00No medical condition
Adamed Pharma S.A.
Not possible to specify
Czechia
25/08/2026
Phase II
A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Camoteskimab in Adults with Moderate-to-Severe Atopic Dermatitis
2026-525673-39-00Atopic Dermatitis (AD)
Apollo Therapeutics Limited
Skin and Connective Tissue Diseases
Hungary, Czechia, Germany, Bulgaria, Poland, Spain
25/08/2026
Phase I
Bioavailability Comparison of Valsartan 320 mg Tablets (Test vs. Reference Product)
2026-527569-31-00Not applicable (submitted trial is a BE study in healthy paโ€ฆ
ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.
Cardiovascular Diseases
Czechia
25/08/2026
Phase II
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
2025-524793-42-00Relapsed/Refractory Multiple Myeloma
Janssen Cilag International
Neoplasms
Sweden, Spain, Greece, Portugal, France, Hungary
25/08/2026
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 IV
Piperacillin/tazobactam or ampicillin and gentamicin for empirical treatment of community acquired infection: A randomised clinical trial (PAGER)
2026-526131-20-00Urosepsis, Infection of unknown origin, Pyelonephritis, Cysโ€ฆ
Region Hovedstaden
Bacterial Infections and Mycoses
Denmark
25/08/2026
Phase I
A Phase 1 Study of TT125-802 as Monotherapy and in Combination with Pomalidomide and Dexamethasone in Participants with Multiple Myeloma
2025-523536-39-00Relapsed and Refractory Multiple Myeloma
TOLREMO therapeutics AG
Neoplasms
Italy, Spain
24/08/2026
Phase I/II
A combined phase I/IIa trial to investigate the safety and pharmacokinetics of StaphAcute in healthy participants and patients with Staphylococcus aureus bacteremia - StaphAcute
2024-511586-10-01Phase IIa: patients with methicillin susceptible (MSSA) or โ€ฆ
University Of Cologne
Bacterial Infections and Mycoses
Germany
24/08/2026
Phase I
Proof of cOncept Study demonStrating the potential substitutIon of suBcutaneous Injection of recombinant human insulin by subLIngual administration of S.L.I.Mยฎ-Formulations in TYpe-I DIABEtic PaTiEntS
2025-524539-38-01Patients with diabete type 1 under pump
Sublin B.V.
Nutritional and Metabolic Diseases
France
24/08/2026
Phase III
A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Etifoxine Monotherapy in The Treatment of Adjustment Disorder with Anxiety (ADWA)
2025-524287-38-00Treatment of adjustment disorder with anxiety (ADWA).
Biocodex
Nervous System Diseases
Bulgaria, France, Czechia
24/08/2026
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 IV
Adalimumab Treatment for Patients with Hidradenitis Suppurativa at high risk of Progressing to Severe Disease: An Unblinded Randomized, Controlled Trial
2025-522505-37-00Hidradenitis suppurativa
Gentofte Hospital
Skin and Connective Tissue Diseases
Denmark
24/08/2026
Phase I/II
A Prospective Diagnostic Trial of Al[ยนโธF]F-NOTA-folate PET in Patients with Suspected Cardiac Sarcoidosis or Infective Endocarditis and Healthy Volunteers (FOL-CARD)
2026-526655-59-00Cardiac Sarcoidosis, Infective endocarditis
Turku University Hospital
Cardiovascular Diseases
Finland
24/08/2026
Phase III
Evaluation of the efficacy and safety of photodynamic therapy with BF-200 ALA (Ameluzยฎ) in immunosuppressed patients with actinic keratoses and superficial basal cell carcinoma at any location.
2026-526649-85-00Immunosuppressed patients with premalignant and malignant sโ€ฆ
Dra. Elena Gonzรกlez Guerra
Skin and Connective Tissue Diseases
Spain
24/08/2026
Phase II
A Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, and Potential Antiseizure Activity of Adjunctive OV329 Therapy in Adults with Drug-Resistant Focal Epilepsy
2026-525896-23-00Focal epilepsy
Ovid Therapeutics Inc.
Nervous System Diseases
Netherlands
21/08/2026
Phase III
FOSFOLD - Fosfomycin trometamol compared with another active antibiotic relay therapy for the treatment of acute Escherichia coli pyelonephritis in elderly women: a randomized, multicenter, non-inferiority trial
2025-521663-13-00Women aged 75 years or older presenting with E. coli pyelonโ€ฆ
Assistance Publique Hopitaux De Paris
Female Urogenital Diseases and Pregnancy Complications
France
21/08/2026
Phase III
Surgery versus intra-lesional sclerosis with polidocanol (Aetoxisclerol) in labial venous malformations in children and adults: a randomized controlled trial - SASOV
2025-521374-34-00superficial labial venous malformation
Centre Hospitalier Regional Universitaire De Tours
Cardiovascular Diseases
France
21/08/2026
Phase III
A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femaraยฎ (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)
2025-524846-85-00โ€‹โ€‹HR-positive, HER2-negative, inoperable locally advanced oโ€ฆ
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 Multicenter, Randomized, Double-Blind, 2-Treatment Arm Study to Assess Comparative Pharmacokinetics, Efficacy, Safety and Immunogenicity Between Intravenous AVT32-DRL_PB and Keytrudaยฎ as an Adjuvant Treatment in Participants with Stage IIB/C-III Melanoma Following Complete Resection
2025-525093-11-00Stage IIB/C-III Melanoma
Alvotech Swiss AG
Neoplasms
Romania, Spain
21/08/2026
Phase I
A randomized, double-blind, placebo-controlled clinical trial to investigate the human monoclonal antibody NG004 in acute, incomplete cervical spinal cord injury (SCI) patients
2026-526089-26-00Acute Incomplete Cervical Spinal Cord Injury
NovaGo Therapeutics AG
Nervous System Diseases
Germany
21/08/2026
Phase I/II
A multicenter, non-therapeutic, interventional, long-term follow-up clinical trial to evaluate the safety of autologous PRAME-directed TCR T cell therapy IMA203 or IMA203CD8 in patients with previously treated, advanced and/or metastatic solid tumors
2026-525827-25-00Solid tumors
Immatics US Inc.
Neoplasms
Germany
21/08/2026
Phase III
A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study Evaluating the Efficacy, Pharmacokinetics, and Safety of Mitapivat in Pediatric Subjects With ฮฑ- or ฮฒ-Nonโ€“Transfusion-Dependent Thalassemia (ENERGIZEKids)
2025-524706-15-00Non-Transfusion-Dependent Alpha- or Beta-Thalassemia
Agios Pharmaceuticals Inc.
Hemic and Lymphatic Diseases
Italy, Greece
21/08/2026
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Priya Life Science (2026). EU Clinical Trials Register (CTIS). Derived from the EMA Clinical Trials Information System. Retrieved 20 September 2026. https://priyalifescience.com/clinical-trials-europe

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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.