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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 — 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 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 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 Clear sponsor filter
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
48 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase II
KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations
2025-521939-36-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …
Merck Sharp & Dohme LLC
Neoplasms
Italy, Poland, Spain, Finland, Netherlands, Greece
24/02/2026
Phase III
A Phase 2/3, Randomized, Active-Controlled, Open-Label (Phase 2) and Double-Blind (Phase 3) Study to Evaluate the Antiretroviral Activity, Safety, and Tolerability of Islatravir (ISL) and Ulonivirine (ULO) Once Weekly Compared With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) Once Daily in Treatment-Naïve Adult Participants Living With HIV 1
2025-522519-40-00HIV
Merck Sharp & Dohme LLC
Virus Diseases
France, Spain
16/02/2026
Phase I/II
A Phase 1/2 Open-Label Rolling-Arm Umbrella Platform Study of Investigational Agents in Combination With Enfortumab Vedotin Plus Pembrolizumab as First-Line Treatment in Participants With Locally Advanced or Metastatic Urothelial Carcinoma: KEYMAKER-U04–Substudy 04D
2025-522253-19-00Urothelial carcinoma
Merck Sharp & Dohme LLC
Neoplasms
Netherlands, France, Spain
03/02/2026
Phase I
A clinical study of MK-1045 in people with lupus or rheumatoid arthritis (MK-1045-004)
2025-523412-36-00Systemic lupus erythematosus, Rheumatoid arthritis
Merck Sharp & Dohme LLC
Immune System Diseases
Italy, Belgium, Romania
02/02/2026
Phase III
An Operationally Seamless Phase 2/3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Enlicitide Decanoate in Pediatric Participants with Heterozygous Familial Hypercholesterolemia
2024-519068-42-00​Heterozygous Familial Hypercholesterolemia​ in pediatric p…
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Germany, Spain, Belgium, Czechia, Norway, France, Poland, Netherlands, Italy, Finland
26/01/2026
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 I/II
A Clinical study of MK-4716 in people with certain solid tumors (MK-4716-001)
2025-522495-84-00Cancer – Solid Tumors : 1L NSCLC and all other advanced or …
Merck Sharp & Dohme LLC
Neoplasms
Spain
23/12/2025
Phase I/II
Phase 1/2 Study of Intravesical MK-3120 in BCG-Naïve or BCG-Exposed High-Risk Non-muscle Invasive Bladder Cancer
2025-520467-40-00High-risk non-muscle invasive bladder cancer (NMIBC) with c…
Merck Sharp & Dohme LLC
Neoplasms
Belgium, Greece, Austria, Spain, Norway, Netherlands, Italy, France
22/12/2025
Phase III
An Open-label Long-term Follow-up Study to Evaluate the Effects of Sotatercept When Added to Background Pulmonary Arterial Hypertension (PAH) Therapy for the Treatment of PAH (MK-7962-038)
2025-521970-33-00​​Pulmonary Arterial Hypertension (PAH)
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Czechia, Germany, Sweden, Greece, Croatia, Belgium, Poland, Spain, Portugal, Italy, Denmark, France, Netherlands
01/12/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084 in Combination With Subcutaneous Pembrolizumab and Berahyaluronidase alfa (MK-3475A) Versus MK-3475A in Combination With Pemetrexed/Platinum (Carboplatin or Cisplatin) Chemotherapy as First-line Treatment of Participants With KRAS G12C-Mutant, Advanced or Metastatic Nonsquamous NSCLC (KANDLELIT-007)
2024-514500-14-00Participants with KRAS G12C-Mutant, Advanced or Metastatic …
Merck Sharp & Dohme LLC
Neoplasms
Germany, Italy, France, Poland, Spain, Hungary, Romania, Greece, Austria, Netherlands, Belgium
27/11/2025
Phase III
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate Coadministered With Rosuvastatin in Adults With Hyperlipidemia
2025-521495-54-00Hyperlipidemia
Merck Sharp & Dohme LLC
Cardiovascular Diseases
Spain, Hungary
19/11/2025
Phase I
A clinical study of MK-6050 in healthy people (MK-6050-001)
2025-523861-58-00Hidradenitis suppurativa
Merck Sharp & Dohme LLC
Immune System Diseases
Belgium
12/11/2025
Phase II
A Phase 2, Open-Label, Multicenter, Tumor-agnostic Study of MK-1084 as Monotherapy and in Combination with Cetuximab, in Participants with KRAS G12C-Mutant, Advanced Solid Tumors (KANDLELIT-014)
2025-521737-91-00Neoplasm malignant with KRAS G12C mutation
Merck Sharp & Dohme LLC
Neoplasms
Norway, Spain, Sweden, Italy, Denmark, France, Poland, Germany, Greece
12/11/2025
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 Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Radiographic Axial Spondyloarthritis (Ankylosing Spondylitis)
2025-521059-21-00Radiographic axial spondyloarthritis (as known as ankylosin…
Merck Sharp & Dohme LLC
Musculoskeletal Diseases
Netherlands, Germany, Poland
30/10/2025
Phase II
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Rheumatoid Arthritis
2025-521745-25-00Rheumatoid Arthritis
Merck Sharp & Dohme LLC
Immune System Diseases
Poland, Spain, Germany
27/10/2025
Phase I
A clinical study of MK-4082 in healthy people (MK-4082-001)
2025-522100-25-00Weight management
Merck Sharp & Dohme LLC
Nutritional and Metabolic Diseases
Belgium
08/10/2025
Phase III
A Phase 3, Randomized, Active-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of MK-8527 Oral Once-Monthly as HIV-1 Preexposure Prophylaxis
2025-520610-58-00HIV-1 prevention
Merck Sharp & Dohme LLC
Virus Diseases
France
03/10/2025
Phase II
A Phase 2 Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study to Evaluate the Efficacy and Safety of MK-2214 in Participants with Early Alzheimer's Disease
2024-519190-19-00Alzheimer’s Disease
Merck Sharp & Dohme LLC
Nervous System Diseases
Spain, Belgium, Netherlands
30/09/2025
Phase III
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy versus Treatment of Physician’s Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04)
2025-520582-51-00Hormone receptor positive breast cancer
Merck Sharp & Dohme LLC
Neoplasms
Greece, Poland, France, Italy, Spain, Hungary, Germany
29/09/2025
Phase III
A Phase 3, Randomized, Open-label, Multicenter Clinical Study to Evaluate the Safety and Efficacy of MK-1084, Cetuximab, and mFOLFOX6 versus mFOLFOX6 With or Without Bevacizumab as First-line Treatment of Participants With KRAS G12C-mutant, Locally Advanced Unresectable or Metastatic Colorectal Cancer (KANDLELIT-012).
2024-517232-22-00KRAS G12C-mutant, Locally Advanced Unresectable or Metastat…
Merck Sharp & Dohme LLC
Neoplasms
Poland, Spain, Netherlands, Italy, Finland, Romania, France, Germany, Hungary
17/09/2025
Phase III
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants with Moderately to Severely Active Crohn’s Disease
2024-518296-56-00Crohn’s Disease
Merck Sharp & Dohme LLC
Digestive System Diseases
Spain, Austria, Lithuania, France, Belgium, Germany, Sweden, Czechia, Finland, Croatia, Latvia, Portugal, Netherlands, Italy, Denmark, Slovakia, Romania, Poland, Ireland, Hungary, Greece
03/09/2025
Phase III
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk Early-Stage Triple-Negative Breast Cancer (TNBC) or Hormone Receptor-low positive/HER2-negative Breast Cancer
2024-520190-12-00Breast Cancer: triple negative breast cancer (TNBC) and hor…
Merck Sharp & Dohme LLC
Neoplasms
France, Sweden, Poland, Spain, Finland, Portugal, Belgium, Czechia, Germany, Greece, Hungary, Italy, Romania, Norway
27/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. 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.