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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 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 Clear sponsor filter
Member state
Spain 1023 France 890 Germany 861 Italy 742 Poland 581 Netherlands 524 Belgium 426 Czechia 327
All 28 states
42 of 2500 shown studies
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Phase
Study
Lead sponsor
Area
Member states
Decision
Phase I
A Phase I, open-label, non-randomized study to assess the absorption, distribution, metabolism and excretion (ADME) and pharmacokinetics of LTP001 following a single oral dose of [14C]LTP001 in healthy male participants
2025-524172-29-00Healthy volunteers
Novartis Pharma AG
Not possible to specify
Netherlands
06/03/2026
Phase I/II
A phase Ib/II open-label, multi-center study of the DNA protein kinase inhibitor AMO959 with lutetium (177Lu) vipivotide tetraxetan (AAA617) in combination with an androgen receptor pathway inhibitor (ARPI) in adult participants with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
2025-521859-23-00PSMA-positive mCRPC with prior exposure to at least one pri…
Novartis Pharma AG
Neoplasms
Germany, France, Spain, Italy
05/03/2026
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 III
A randomized, double-blind, placebo-controlled study to evaluate efficacy and safety of early in hospital initiation of inclisiran treatment in patients with acute coronary syndromes: Victorion – RIDES
2025-521670-34-00Acute coronary syndrome (ST-elevation myocardial infarction…
Novartis Pharma AG
Cardiovascular Diseases
Germany, Hungary, Poland, France, Spain
16/02/2026
Phase I
A phase I open-label, multi-center study to evaluate the safety, tolerability, dosimetry, and preliminary activity of [177Lu]Lu-DFC413 and safety and imaging properties of [68Ga]Ga-NNS309 in patients with solid tumors
2025-521702-18-00Locally advanced unresectable or metastatic soft tissue sar…
Novartis Pharma AG
Neoplasms
Germany, Portugal, France, Spain, Denmark
16/02/2026
Phase I
A Participant- and Investigator--Blinded, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants with Chronic Kidney Disease
2025-520978-18-00Chronic Kidney Disease
Novartis Pharma AG
Female Urogenital Diseases and Pregnancy Complications
Germany, Romania
10/02/2026
Phase II
A multicenter, randomized, participant- and investigator -blinded, placebo-controlled, phase 2a study to assess the efficacy, safety and tolerability of GIA632 in adult participants with moderate to severe atopic dermatitis
2025-521503-43-00Atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
France, Germany, Poland, Czechia, Bulgaria
14/01/2026
Phase II
A multi- center, randomized, double-blind, placebo-controlled parallel–group, dose-finding study to evaluate efficacy, safety, and tolerability of DII235 in adults with elevated Lipoprotein(a)
2025-521912-21-00Cardiovascular risk reduction in participants with elevated…
Novartis Pharma AG
Cardiovascular Diseases
Germany
13/01/2026
Phase I/II
TulmiSTAR-02: A two-part Phase I dose escalation study of tulmimetostat (DZR123) in combination with darolutamide or abiraterone followed by open-label, randomized, Phase II dose expansion study to assess the safety and efficacy of tulmimetostat in combination with darolutamide versus darolutamide alone in patients with metastatic hormone-sensitive prostate cancer
2025-521873-15-00Metastatic hormone-sensitive prostate cancer
Novartis Pharma AG
Neoplasms
Hungary, Spain, Italy, Germany, France
18/12/2025
Phase II
Exploratory Study of Ianalumab in Adults with Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) who Have Previously Benefited from Ianalumab (VAY RE-HIT)
2024-518231-11-00Immune thrombocytopenia (ITP) Warm autoimmune hemolytic an…
Novartis Pharma AG
Hemic and Lymphatic Diseases
Germany, Czechia, Belgium, Spain, Italy, Bulgaria, Romania, France, Hungary
08/12/2025
Phase I/II
TulmiSTAR-01: A two-part, Phase I dose escalation and expansion followed by a randomized, open-label multicenter, Phase II study to assess the safety and efficacy of the combination of tulmimetostat (DZR123) and JSB462 (luxdegalutamide) vs standard of care in patients with progressive metastatic castrate resistant prostate cancer
2025-521880-10-00Metastatic castrate resistant prostate cancer (mCRPC)
Novartis Pharma AG
Neoplasms
Italy, Germany, Poland, France, Denmark, Spain
01/12/2025
Phase II
A randomized, placebo-controlled, participant- and investigator-blinded study to evaluate the efficacy in reducing atrial fibrillation burden (AFB) as well as the safety, tolerability, and pharmacokinetics of oral PKN605 in participants with atrial fibrillation
2025-520518-79-00Atrial Fibrillation
Novartis Pharma AG
Cardiovascular Diseases
Netherlands, Germany
17/11/2025
Phase II
An open-label phase II trial to evaluate the clinical efficacy, safety and tolerability of MAS825 in pediatric and adult participants with Still’s disease
2024-520208-25-00Still’s disease
Novartis Pharma AG
Immune System Diseases
Italy, Netherlands, Spain, France, Germany
28/10/2025
Phase II
EPIK-P4: A Phase II single arm study to assess the efficacy, safety and pharmacokinetics of alpelisib (BYL719) in pediatric and adult patients with PIK3CA-related overgrowth spectrum (PROS)
2024-519960-42-00PIK3CA-Related Overgrowth Spectrum (PROS)
Novartis Pharma AG
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Italy, Netherlands, Belgium, Spain, Austria, Germany, France
20/10/2025
Phase II
A multicenter, randomized, double-blind, placebo-controlled, Phase II platform study to assess the efficacy and safety of investigational compound(s) in patients with moderate to severe atopic dermatitis
2024-519081-49-00Moderate to severe atopic dermatitis
Novartis Pharma AG
Skin and Connective Tissue Diseases
Czechia, Netherlands, Poland, Germany, Spain, Hungary, France, Italy, Slovakia
22/09/2025
Phase II
A Phase II, randomized, open-label, multi-center study of JSB462 in combination with lutetium (177Lu) vipivotide tetraxetan in adult male patients with PSMA-positive metastatic castration resistant prostate cancer (mCRPC)
2024-520155-24-00Metastatic castration resistant prostate cancer (mCRPC)
Novartis Pharma AG
Neoplasms
Netherlands, Austria, Germany, Italy, France, Czechia, Spain
17/09/2025
Phase II
LuMIERE: A Phase 1/2, Multicenter, Open label, Non randomized Study to Investigate Safety and Tolerability, Pharmacokinetics, Dosimetry, and Preliminary Activity of [177Lu]Lu FAP 2286 in Participants with an Advanced Solid Tumor
2023-508995-12-01Metastatic Breast Carcinoma (BC), Recurrent or metastatic n…
Novartis Pharma AG
Neoplasms
Italy, Spain, Belgium, France
26/08/2025
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Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 19 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.