Clinical trial register · European Union · CTIS

EU Clinical Trials Tracker

Name: EU clinical trials authorised under CTIS
Creator: Priya Life Science
License: https://www.ema.europa.eu/en/about-us/legal-notice

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 2556 most recently authorised of 12777 total CTIS records — a stated recency window, not the full historical archive. Synced 06 Nov 2026, 03:17 UTC

2556

Shown in this register

most recently authorised

12,777

Total on CTIS

full historical archive

789

Phase III

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Top member states

Spain 1075 France 930 Germany 898 Italy 778 Poland 619 Netherlands 547

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Trials in this register

Phase

Study

Lead sponsor

Area

Member states

Decision

Phase II

A Phase IIb multicenter, randomized, double-blind, placebo-controlled, dose-range study to assess the efficacy and safety of GIA632 in participants with moderate to severe cutaneous lichen planus, followed by an extension period

2025-522300-25-00Cutaneous lichen planus

DrugGIA632

Novartis Pharma AG

Immune System Diseases

Italy, Germany, Spain, France

02/11/2026

Phase III

A 52-week multi-center, randomized, double-blind, placebo- controlled phase 3 study to evaluate the efficacy, safety and tolerability of remibrutinib in adult participants with severe chronic pruritus of unknown origin (CPUO)

2025-524497-41-00Chronic Pruritus of Unknown Origin (CPUO)

DrugsPimecrolimus·Remibrutinib·Tacrolimus

Novartis Pharma AG

Immune System Diseases

Germany, Austria, Poland, Spain, Italy, France

23/10/2026

Phase I

A clinical trial to learn about the safety of HJB647 in people with uncontrolled hypertension

2026-526540-12-00Uncontrolled Hypertension

Novartis Pharma AG

Cardiovascular Diseases

Germany

23/10/2026

Phase II

A randomized, double-blind, placebo-controlled, multicenter Phase 2a/b study assessing the efficacy, safety and tolerability of DDY391 in participants with Sjögren's Disease

2025-524513-92-00Sjögren's Disease

Novartis Pharma AG

Immune System Diseases

Portugal, Bulgaria, Belgium, Spain, Denmark, France, Slovakia, Poland, Hungary, Italy, Netherlands, Germany, Austria

15/10/2026

Phase II

An open label, multi-center alpelisib roll-over study to assess long-term safety in participants who have completed a Novartis sponsored alpelisib (BYL719) study and are judged by the Investigator to benefit from continued treatment with alpelisib.

2026-525890-38-00• PROS (PIK3CA‑Related Overgrowth Spectrum) and, • Breast N…

DrugsAlpelisib·Fulvestrant

Novartis Pharma AG

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

France, Italy, Bulgaria, Slovakia, Finland, Spain

12/10/2026

Phase III

An open-label, single-arm, multicenter roll-over extension program (REP) to characterize the long-term safety and tolerability of iptacopan (LNP023) in patients who have completed a clinical trial (parent study) in the iptacopan pediatric program.

2026-525677-39-00Paroxysmal Nocturnal Hemoglobinuria (PNH) and IgA nephropat…

DrugIptacopan

Novartis Pharma AG

Immune System Diseases

Italy

06/10/2026

Phase III

A randomized, double-blind, placebo-controlled, 2-arm multicenter Phase III study to assess the efficacy and safety of ianalumab in participants with Sjogren's disease with high symptom burden (THALASSA)

2025-522271-29-00Sjögren's disease

DrugsTenofovir Alafenamide·Entecavir·Ianalumab

Novartis Pharma AG

Immune System Diseases

Austria, Portugal, Slovakia, Italy, Poland, Hungary, Spain, Czechia, France, Netherlands, Germany

05/10/2026

Phase I

A phase I study of [177Lu]Lu-DWJ155 and [68Ga]Ga-DWJ155 in patients with solid tumors

2024-518348-19-00Advanced Breast cancer (HER2+, HR+/HER2-negative or TNBC), …

Novartis Pharma AG

Neoplasms

France, Italy, Spain, Portugal, Germany, Belgium

29/09/2026

Phase I

A clinical trial to learn about the effects of IEV407 when given alone or with endocrine therapy in people with advanced breast cancer

2025-522707-26-00Advanced HR+/HER- breast cancer

Novartis Pharma AG

Neoplasms

Germany, France, Netherlands, Spain, Italy

15/09/2026

Phase II

A multicenter, randomized, double-blind, placebo- controlled Phase 2 study to investigate the efficacy, safety and tolerability of remibrutinib (LOU064) in adult patients with Papulopustular Rosacea (PPR)

2025-524496-23-00Papulopustular Rosacea (PPR)

Novartis Pharma AG

Skin and Connective Tissue Diseases

Bulgaria, Spain, France, Italy, Germany

14/09/2026

Phase I

A clinical trial to learn about the effects of 225Ac-ETN029 in people with advanced solid tumors

2024-519111-34-00Small Cell Lung Cancer (SCLC), Neuroendocrine Prostate Canc…

Novartis Pharma AG

Neoplasms

France, Spain, Italy, Germany

08/09/2026

Phase I

A clinical trial to learn about the effects of INR731 alone or with an androgen receptor pathway inhibitor (ARPI) in men with prostate cancer

2025-524080-20-00Metastatic castration resistant prostate cancer

Novartis Pharma AG

Neoplasms

France, Italy, Spain, Germany

17/08/2026

Phase III

A single-arm, multicenter, phase III study to assess efficacy, pharmacokinetics, safety and tolerability of atrasentan in pediatric patients of 2 to <18 years of age with primary immunoglobulin A nephropathy (IgAN)

2025-522824-29-00Primary IgAN

Novartis Pharma AG

Immune system processes

France, Spain

10/08/2026

Phase II

A Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study of YMI024 to assess efficacy in reducing inflammatory markers, safety, and tolerability in adults with stable coronary artery disease and elevated hsCRP

2026-525974-21-00Chronic Kidney Disease, Heart Failure, Coronary Artery dise…

Novartis Pharma AG

Cardiovascular Diseases

Germany

05/08/2026

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

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 I

A clinical trial to learn about the effects of JFI447 and how it shows up in scans compared to FFG233 in people with solid tumors

2025-523665-24-00Patients with metastatic PDAC, NSCLC, HR+/HER2- ductal and …

Novartis Pharma AG

Neoplasms

Denmark

10/06/2026

Phase II

A multicenter, randomized, double-blind, placebo-controlled, dose-ranging Phase IIb study to assess the efficacy and safety of GIA632 in adult participants with non-segmental vitiligo followed by an extension period

2025-522301-37-00Nonsegmental vitiligo

Novartis Pharma AG

Skin and Connective Tissue Diseases

Germany, Spain, Netherlands, France, Italy

08/06/2026

Phase I/II

KontRASt-R: An open-label, multi-center, rollover study for participants who have been previously enrolled into a Novartis-sponsored opnurasib (JDQ443) study and are continuing to benefit from opnurasib as a single agent or in combination with other study treatments

2025-523537-26-00Locally advanced or metastatic KRAS G12C-mutated non-small …

Novartis Pharma AG

Neoplasms

Spain, Italy, France, Denmark, Belgium

08/06/2026

Phase III

A double-dummy, double-blind, randomized, active controlled, two-way cross-over study with 12-week treatment duration per period, to evaluate the efficacy and safety of QVM149 (indacaterol acetate / glycopyrronium bromide / mometasone furoate) compared to salmeterol xinafoate/fluticasone propionate in children from 12 years to less than 18 years of age with asthma.

2022-502365-26-00Asthma

DrugSalbutamol

Novartis Pharma AG

Respiratory Tract Diseases

Poland, France, Slovakia, Spain, Hungary, Germany, Romania

01/06/2026

Phase III

A Phase 3, Randomized, Double-Blind, Active-Control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients with Myelofibrosis who are JAK inhibitor naive

2025-523555-66-00Myelofibrosis

DrugsPelabresib·Ruxolitinib

Novartis Pharma AG

Neoplasms

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

29/05/2026

Phase I/II

A Phase I/II open label study of DJI136, a DLL3-targeted CAR-T therapy, in adult patients with ES-SCLC

2025-523276-23-00Extensive stage small cell lung cancer

DrugsBendamustine·Tocilizumab·Fludarabine·Cyclophosphamide

Novartis Pharma AG

Neoplasms

Spain, France

27/05/2026

Phase III

An open-label, multi-center protocol for patients who have completed a previous Novartis sponsored remibrutinib study and are judged by the investigator to benefit from continued treatment with remibrutinib

2025-524078-40-00Chronic Spontaneous Urticaria

Novartis Pharma AG

Skin and Connective Tissue Diseases

Germany, Spain, France, Poland, Bulgaria, Czechia

20/05/2026

Phase III

A double-blind, double-dummy, parallel group, multicenter Phase 3 extension study evaluating the long-term safety and efficacy of 2 doses of remibrutinib in adult participants with moderate to severe hidradenitis suppurativa

2025-523259-72-00Hidradenitis Suppurativa (HS)

Novartis Pharma AG

Immune System Diseases

Portugal, Greece, Germany, Hungary, France, Spain, Bulgaria, Slovakia, Poland, Czechia, Belgium, Italy, Denmark

20/05/2026

Phase II

A phase II, multicenter, open-label, single arm study to evaluate the safety and efficacy of asciminib in pediatric participants newly diagnosed or previously treated with Philadelphia positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) with or without known T315I mutation

2025-522138-29-00Philadelphia positive Chronic Myeloid leukemia in Chronic P…

Novartis Pharma AG

Neoplasms

Spain, France, Germany, Poland, Italy, Netherlands, Greece, Hungary

18/05/2026

Phase II

A randomized, double masked, placebo-controlled, multicenter, dose-range finding study to assess the efficacy and safety of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration

2025-523704-77-00Geographic atrophy secondary to age-related macular degener…

Novartis Pharma AG

Eye Diseases

Bulgaria, Romania, Germany, Czechia, Spain, Poland, Italy, Hungary, France

04/05/2026

Phase III

A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy

2024-519638-22-00IgA nephropathy

Novartis Pharma AG

Immune System Diseases

Belgium, France, Czechia, Croatia, Greece, Germany, Italy, Spain

04/05/2026

Phase II

A Phase 2a, Randomized, Participant- and Investigator blinded, Parallel-group, Placebo-controlled, Multicenter Study to Assess the Safety, Tolerability, and Treatment Response of GXV813 in Hospitalized Adults with DSM-5 Schizophrenia (STAR-1)

2025-524058-32-00Schizophrenia

Novartis Pharma AG

Mental Disorders

Bulgaria

29/04/2026

Phase I/II

A multi-center, open-label, phase I/II study to evaluate the safety and efficacy of asciminib with chemotherapy followed by blinatumomab in pediatric, adolescent, and young adult patients with relapsed or refractory BCR::ABL1-positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)

2025-522019-40-00relapsed or refractory BCR::ABL1-positive (Philadelphia pos…

DrugsAsciminib·Hydrocortisone·Blinatumomab·Cytarabine

Novartis Pharma AG

Neoplasms

Italy, Spain, Germany, Netherlands, France, Denmark, Czechia

27/04/2026

Phase III

A Phase III, randomized, placebo-controlled, parallel group, double-blind study to evaluate the efficacy and safety of NIO752 in participants with Progressive Supranuclear Palsy followed by an Open Label Extension

2025-523481-24-00Participants with Progressive Supranuclear Palsy Richardson…

Novartis Pharma AG

Nervous System Diseases

Netherlands, Germany, Spain, Italy, France, Belgium

21/04/2026

Phase I/II

An open-label, multi-center, phase I/II study of GVV858 as a single agent and in combination with endocrine therapy in patients with advanced hormone receptor positive, HER2-negative breast cancer and other advanced solid tumors

2025-521911-38-00Advanced HR+/HER- breast cancer

DrugsLeuprorelin Acetate·Goserelin·Letrozole·Fulvestrant

Novartis Pharma AG

Neoplasms

Italy, Germany, France, Czechia, Denmark, Spain

16/04/2026

Phase I

A clinical trial to learn about the effects of DAK539 on the blood levels of repaglinide, midazolam, drospirenone, and ethinyl estradiol in people with advanced cancer

2025-521000-22-00Patients with advanced malignancies

Novartis Pharma AG

Neoplasms

Spain, Italy, France

14/04/2026

Phase I

A clinical trial to learn how liver function affects the blood levels of DAK539 in people with advanced cancer

2025-521001-40-00Advanced Malignancies and Hepatic Impairment

Novartis Pharma AG

Neoplasms

Spain, France, Italy

09/04/2026

Phase II

An open-label, uncontrolled, multicenter study to assess the effect of zigakibart treatment on histologic, circulating, and excreted markers of kidney disease and dysfunction in adult patients with IgA nephropathy

2024-519699-24-00IgA nephropathy

Novartis Pharma AG

Immune System Diseases

Czechia, Germany, Spain, Italy, Poland

17/03/2026

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

Cite this view

Priya Life Science (2026). EU Clinical Trials Register (CTIS), filtered. Derived from the EMA Clinical Trials Information System. Retrieved 6 November 2026. https://priyalifescience.com/clinical-trials-europe

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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 12,777 trial records at the last sync on 06 Nov 2026, 03:17 UTC; this register shows the 2,556 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 47 of those trials that match the filters currently applied.

How many clinical trials does CTIS hold?

CTIS held 12,777 trial records at the last sync. Of the 2,556 most recently authorised trials shown in this register, 789 are Phase III, and 47 match the filters currently applied. Trials are counted by authorisation, not by recruitment status, which CTIS does not publish in the same form as ClinicalTrials.gov.

Summary by phase

Trials by phase, 47 trials
Phase	Trials	Share
Phase II	16	34%
Phase III	13	27.7%
Phase I	11	23.4%
Phase I/II	7	14.9%

Most active sponsors

Lead sponsors with the most trials
Lead sponsor	Trials
Novartis Pharma AG	47

Member states with the most trials

Member states by number of trials with a site there
Member state	Trials
France	37
Germany	37
Spain	37
Italy	32
Poland	15
Netherlands	14
Czechia	13
Belgium	11
Bulgaria	11
Hungary	11

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Browse trials by member state

Spain (1075) France (930) Germany (898) Italy (778) Poland (619) Netherlands (547) Belgium (455) Czechia (341) Denmark (319) Hungary (254) Greece (237) Austria (219) Romania (219) Bulgaria (218) Sweden (200)

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Browse trials by condition

Advanced solid tumors (23) Atopic Dermatitis (19) Non-Small Cell Lung Cancer (15) Obesity (14) Parkinson’s disease (14) Multiple sclerosis (13) Rheumatoid arthritis (13) Breast Cancer (11) Ulcerative colitis (11) Prostate Cancer (10)

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.