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Updated 06 Jul 2026 · EMA CTIS official data

Clinical Trials in Portugal

← All EU trials

The most recently authorised clinical trials across the European Union - drawn live from the European Medicines Agency's Clinical Trials Information System (CTIS), the single register for every trial run under the EU Clinical Trials Regulation. Searchable by country, phase, sponsor and condition.

36
Recent authorisations
24
Phase III trials
Portugal
Selected country
Phase III Respiratory Tract Diseases Authorised 30/06/2026
A Long-term Open-Label Extension Study of Treprostinil Palmitil Inhalation Powder for Treatment of Pulmonary Hypertension Associated with Interstitial Lung Disease
Pulmonary Hypertension Associated with Interstitial Lung Disease
Insmed Inc. · 128 participants
📍 Greece · France · Italy · Belgium · Denmark · Germany · Czechia · Portugal · Austria
2025-521769-29-00 on CTIS ↗
Phase I/II Nervous System Diseases Authorised 30/06/2026
Phase 1-2, Open-Label, Single and Multiple Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intrathecally-Administered ION337 in Patients with Dravet Syndrome
Dravet Syndrome
Ionis Pharmaceuticals Inc. · 10 participants
📍 France · Belgium · Portugal · Germany
2025-523835-20-00 on CTIS ↗
Phase III Neoplasms Authorised 29/06/2026
AndroMETa-CRC-560: An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) plus Bevacizumab in Subjects with Refractory Metastatic Colorectal Cancer
Colorectal Cancer
AbbVie Deutschland GmbH & Co. KG · 138 participants
📍 Greece · Portugal · Belgium
2025-521712-19-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 22/06/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Non-Active Secondary Progressive Multiple Sclerosis
Non-active Secondary Progressive Multiple Sclerosis (SPMS)
Zenas Biopharma (USA) LLC · 467 participants
📍 Germany · Bulgaria · Netherlands · Sweden · Portugal · Croatia · Italy · Austria · Spain · Poland · France · Denmark · Hungary · Romania · Estonia · Slovakia · Belgium · Czechia · Norway · Lithuania · Greece
2025-524322-18-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 17/06/2026
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
Progressive pulmonary fibrosis and Idiopathic pulmonary fibrosis
Bristol-Myers Squibb Services Unlimited Company · 318 participants
📍 Finland · Portugal · Hungary · Ireland · Poland · Greece · France · Belgium · Denmark · Italy · Spain · Netherlands · Austria · Germany
2025-522373-10-00 on CTIS ↗
Phase II Digestive System Diseases Authorised 10/06/2026
J6E-MC-KWAM: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Development Program to Evaluate the Efficacy and Safety of LY4268989 (MORF-057) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis (EMERALD-3)
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe, Ulcerative Colitis (UC)
Eli Lilly & Co. · 104 participants
📍 Latvia · Portugal · Greece · France · Czechia · Italy · Poland · Slovakia · Hungary · Croatia · Lithuania
2025-524404-29-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 08/06/2026
A Phase 2b/3, Randomized, Double-Blinded, Placebo Controlled Study ChecKing the Efficacy and Safety of ATAciguat to Slow the Progression of VaLvular DYsfunction in Participants with Moderate Calcific Aortic Valve STenosis (KATALYST-AV)
Moderate Calcific Aortic Valve Stenosis (CAVS)
Kardigan Inc. · 496 participants
📍 Norway · Czechia · Portugal · Austria · Poland · France · Spain
2025-522176-86-01 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 08/06/2026
A prospective, open-label, non-randomized, multicentre trial to assess the safety and PD of Cangrelor as procedural platelet inhibitor in paediatric subjects from birth to <18 years of age undergoing diagnostic and/or therapeutic percutaneous vascular procedures for management of congenital heart disease
Congenital Heart Disease
Chiesi Farmaceutici S.p.A. · 48 participants
📍 Netherlands · Germany · Portugal · Austria
2025-523109-14-00 on CTIS ↗
Phase III Eye Diseases Authorised 05/06/2026
A randomized double-masked, multicenter, 3-arm, pivotal Phase 2/3 study to evaluate the efficacy and safety of intravitreal (IVT) EYE201/MK-8748 compared to aflibercept (2 mg) in participants with neovascular age-related macular degeneration (NVAMD)
Neovascular age-related macular degeneration (NVAMD)
Eyebiotech Limited · 250 participants
📍 Austria · Slovakia · Portugal · Czechia · Hungary · Spain · France · Denmark · Italy · Croatia
2025-524894-17-00 on CTIS ↗
Phase II Congenital, Hereditary, and Neonatal Diseases and Abnormalities Authorised 29/05/2026
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
Cystic fibrosis
Vertex Pharmaceuticals Inc. · 80 participants
📍 Spain · Sweden · Germany · Italy · Belgium · Czechia · Ireland · Portugal · Netherlands · France · Denmark
2025-523400-72-00 on CTIS ↗
Phase II Mental Disorders Authorised 27/05/2026
An Open-Label Study to Assess the Long-Term Safety and Tolerability of ML-007C-MA in Adult Participants with Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Hallucinations and Delusions Associated with Alzheimer’s Disease Psychosis
Maplight Therapeutics Inc. · 85 participants
📍 Italy · Poland · Czechia · Portugal · Bulgaria · France · Slovakia · Romania · Hungary
2025-521757-16-00 on CTIS ↗
Phase IV Female Urogenital Diseases and Pregnancy Complications Authorised 22/05/2026
Exogenous progesterone as ovulation trigger – a pilot study
Infertility
Instituto Valenciano De Infertilidade Clinica De Reproducao Assistida Lda. · 10 participants
📍 Portugal
2025-523850-15-00 on CTIS ↗
Phase III Immune System Diseases Authorised 20/05/2026
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
Hidradenitis Suppurativa (HS)
Novartis Pharma AG · 307 participants
📍 Portugal · Greece · Germany · Hungary · France · Spain · Bulgaria · Slovakia · Poland · Czechia · Belgium · Italy
2025-523259-72-00 on CTIS ↗
Phase III Neoplasms Authorised 19/05/2026
Phase III Randomized, International, Open-Label Clinical Trial of Treatment Intensification with Docetaxel plus Apalutamide in Patients with Metastatic Hormone-Sensitive Prostate Cancer Who Did Not Achieve a Deep PSA Response After Initial Treatment with Apalutamide: REINFORCE Trial
Metastatic hormone-sensitive prostate cancer
Alianza Multidisciplinar Para La Investigacion De Los Tumores Genitourinarios Guard · 292 participants
📍 Spain · Germany · France · Portugal · Italy
2025-524408-30-01 on CTIS ↗
Phase III Hemic and Lymphatic Diseases Authorised 19/05/2026
A Phase 3 prospective randomised clinical trial of VMX-C001 vs usual pharmacological care in patients receiving a FXa direct oral anticoagulant (FXa DOAC) who require urgent surgery or other invasive procedure that is associated with a high risk of bleeding, with or without planned administration of heparin (EQUILIBRIX-S)
Patients on Factor Xa inhibitor treatment needing an urgent intervention associated with a high risk of bleeding
VarmX B.V. · 443 participants
📍 Belgium · Germany · Italy · France · Czechia · Bulgaria · Hungary · Spain · Netherlands · Poland · Austria · Estonia · Romania · Portugal · Lithuania
2025-521632-12-00 on CTIS ↗
Phase II Nutritional and Metabolic Diseases Authorised 19/05/2026
PODOMOUNT-Basket, a Phase II, multicentre, randomised, 2-arm parallel-group, double-blind, placebo-controlled basket trial to assess safety, tolerability, PK, and efficacy of BI 764198 in four proteinuric kidney diseases
Proteinuric kidney diseases
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 66 participants
📍 Portugal · Greece · Italy · Poland · Estonia · Slovakia · Sweden · Denmark · Belgium · Norway · Romania · France · Spain · Germany · Netherlands · Croatia
2025-523425-17-00 on CTIS ↗
Phase III Bacterial Infections and Mycoses Authorised 19/05/2026
Multicentre, randomised, double-blind, placebo-controlled clinical trial to confirm the efficacy, safety, and clinical impact of the mucosal bacterial therapeutic vaccine MV140 in women with non-complicated recurrent urinary tract infections (rUTIs).
Recurrent Non-Complicated Urinary Tract Infections (rUTIs).
Inmunotek S.L. · 252 participants
📍 Portugal
2025-524377-16-00 on CTIS ↗
Phase III Nervous System Diseases Authorised 18/05/2026
A Phase 3, Randomized, Double-blind, Efficacy and Safety Study Comparing Orelabrutinib to Placebo in Patients With Primary Progressive Multiple Sclerosis
Primary Progressive Multiple Sclerosis (PPMS)
Zenas Biopharma (USA) LLC · 398 participants
📍 Italy · Finland · Bulgaria · Greece · Belgium · Estonia · Portugal · Spain · Germany · France · Czechia · Slovakia · Romania · Croatia · Poland · Austria · Netherlands · Denmark · Sweden · Hungary
2025-524316-11-00 on CTIS ↗
Phase III Neoplasms Authorised 15/05/2026
ROSETTA Lung-202: A Randomized, Double-Blind, Phase 3 Study of Pumitamig Monotherapy Compared to Pembrolizumab as First-line Treatment in Participants with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with PD-L1 ≥ 50%
Non-Small Cell Lung Cancer
Bristol-Myers Squibb Services Unlimited Company · 265 participants
📍 Portugal · Norway · Sweden · Bulgaria · France · Belgium · Austria · Germany · Finland · Poland · Romania · Netherlands · Spain · Italy · Hungary · Czechia
2025-523586-18-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 15/05/2026
Efficacy and safety of NNC0487-0111 s.c. once-weekly compared to semaglutide s.c. once-weekly in participants with overweight or obesity, and type 2 diabetes (AMAZE 8)
Participants with overweight or obesity, and type 2 diabetes
Novo Nordisk A/S · 440 participants
📍 Germany · Croatia · Portugal · Hungary · Bulgaria · Romania · Poland
2024-520446-31-00 on CTIS ↗
Phase III Neoplasms Authorised 13/05/2026
A Phase III, multi-center, open-label, randomised, controlled trial of intravenous obrixtamig in combination with carboplatin and etoposide vs. carboplatin and etoposide as first-line therapy in DLL3-positive patients with unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinomas.
advanced or metastatic extrapulmonary neuroendocrine carcinoma
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 144 participants
📍 Portugal · Spain · Poland · Sweden · Italy · Czechia · France · Netherlands · Finland · Denmark · Austria · Germany · Belgium · Norway
2025-523869-22-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 12/05/2026
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
severe uncontrolled asthma
Generate Biomedicines Inc. · 271 participants
📍 Latvia · Hungary · Bulgaria · Romania · Portugal · Netherlands · Croatia · Germany · Greece · Czechia
2025-521950-41-00 on CTIS ↗
Phase III Neoplasms Authorised 12/05/2026
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.
small cell lung cancer
Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A. · 295 participants
📍 Czechia · Sweden · Poland · Netherlands · Greece · Latvia · Finland · Norway · Belgium · Austria · Portugal · Romania · Italy · Estonia · France · Ireland · Germany · Spain · Bulgaria · Hungary
2025-520565-51-00 on CTIS ↗
Phase III Musculoskeletal Diseases Authorised 12/05/2026
A Phase 3, Multicenter, Long-Term Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Zasocitinib (TAK-279) in Subjects With Active Psoriatic Arthritis Who are Either Biologic DMARD-Naïve or Biologic DMARD-Experienced, Including Those With Inadequate Response to Biologic DMARDs
Psoriatic Arthritis
Takeda Development Center Americas Inc. · 638 participants
📍 Germany · Belgium · Spain · Czechia · Croatia · Portugal · Poland · Latvia · Bulgaria · France · Estonia · Hungary · Italy
2025-522586-30-00 on CTIS ↗
Phase I Nervous System Diseases Authorised 11/05/2026
A Study to Assess the Safety of RG6496 in Huntington’s Disease Gene Expansion Carriers with the Selected Genetic Variant (POINT-HD)
Huntington’s Disease Gene Expansion Carriers
F. Hoffmann-La Roche AG · 43 participants
📍 Italy · Poland · Denmark · Germany · Portugal · Spain
2025-520631-17-00 on CTIS ↗
Phase III Respiratory Tract Diseases Authorised 11/05/2026
A double-blinded extension study to evaluate the long-term safety and tolerability of itepekimab in adult participants with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) who participated in either EFC18418 or EFC18419 clinical studies
Chronic rhinosinusitis with nasal polyps
Sanofi-Aventis Recherche & Developpement · 146 participants
📍 Germany · Netherlands · Portugal · Denmark · Sweden · Finland · France · Spain · Austria · Italy · Hungary · Romania · Belgium · Czechia · Poland
2025-522983-33-00 on CTIS ↗
Phase III Immune System Diseases Authorised 05/05/2026
A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Nipocalimab in Adults with Moderate to Severe Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
Janssen Cilag International · 271 participants
📍 Denmark · Hungary · Portugal · Italy · Norway · Greece · Slovakia · Czechia · France · Poland · Bulgaria · Germany · Spain · Romania · Finland
2025-523552-31-00 on CTIS ↗
Phase III Cardiovascular Diseases Authorised 28/04/2026
An Adaptive, 2-Part, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of IKT-001 in Pulmonary Arterial Hypertension.
Pulmonary Arterial Hypertension
Inhibikase Therapeutics Inc. · 94 participants
📍 Spain · Poland · Italy · Belgium · Latvia · Denmark · Czechia · Germany · France · Netherlands · Portugal · Ireland · Greece
2024-520218-23-00 on CTIS ↗
Phase III Neoplasms Authorised 28/04/2026
A two-part, seamless, multicenter, RANDOMIZED, open-label, ADAPTIVE Phase ii/III STUDY OF THE BLOOD-BRAIN barrier PENETRANT RO7771950 versus Tucatinib, both in combination with trastuzumab and capecitabine, in patients with Pretreated unresectable locally advanced or metastatic HER2-positive breast cancer, with or without central nervous system metastases
Pretreated Unresectable Locally Advanced or Metastatic human epidermal growth factor receptor 2 (HER2)-Positive Breast Cancer, with or without Central Nervous System (CNS) Metastases
F. Hoffmann-La Roche AG · 237 participants
📍 Belgium · France · Italy · Austria · Romania · Poland · Portugal · Czechia · Germany · Spain · Hungary
2025-524498-17-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 28/04/2026
Efficacy, safety and pharmacokinetics of cagrilintide s.c. 2.4 mg as monotherapy and in combination with semaglutide s.c. 2.4 mg (CagriSema) once weekly for weight management in children and adolescents with overweight or obesity
Obesity and T2D
Novo Nordisk A/S · 157 participants
📍 Slovakia · Austria · Spain · Romania · Portugal · Italy · Denmark · Belgium · Sweden · Poland · Netherlands · Croatia · Hungary · Bulgaria
2023-509176-42-00 on CTIS ↗
Phase III Nutritional and Metabolic Diseases Authorised 27/04/2026
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)
Classical Homocystinuria
Travere Therapeutics Inc. · 22 participants
📍 Belgium · Ireland · Spain · Italy · Germany · France · Portugal · Poland
2023-504135-40-00 on CTIS ↗
Phase II Respiratory Tract Diseases Authorised 27/04/2026
A Phase IIb, multicentre, randomised, doubleblind, placebocontrolled, three-arm parallel-group study to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab), with an optional 24-week doubleblind, placebocontrolled extension phase in participants with idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF)
Chiesi Farmaceutici S.p.A. · 103 participants
📍 Belgium · Germany · Italy · Czechia · Bulgaria · Netherlands · France · Portugal · Poland · Spain · Romania
2024-514246-37-00 on CTIS ↗
Phase I Not possible to specify Authorised 22/04/2026
Single-Dose Study in Healthy Participants to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg Under Fasting Conditions, and to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg Under Fasting versus Fed Conditions.
No medical condition.
Institut De Recherches Internationales Servier IRIS · 24 participants
📍 Portugal
2026-526040-13-00 on CTIS ↗
Phase II Hormonal diseases Authorised 21/04/2026
Protocol Title: Efficacy and safety of once-weekly subcutaneous NNC0662-0419 in participants with type 2 diabetes – a dose-finding study
type 2 diabetes
Novo Nordisk A/S · 145 participants
📍 Spain · Hungary · Portugal · Poland · Slovakia · Croatia
2025-523260-20-00 on CTIS ↗
Phase I Not possible to specify Authorised 20/04/2026
Multiple-Dose Study in Healthy Participants Under Fasting Conditions to Evaluate the Bioequivalence of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide SR 1.5 mg and to Compare the Bioavailability of One Film-Coated Mini-Tablet of Indapamide SR 1.5 mg versus One Film-Coated Tablet of Indapamide IR 2.5 mg.
No medical condition.
Institut De Recherches Internationales Servier IRIS · 48 participants
📍 Portugal
2026-525823-26-00 on CTIS ↗
Phase I Respiratory Tract Diseases Authorised 17/04/2026
A Phase 1 Study of AIR-001 in Adults with AATD.
Alpha-1 Antitrypsin Deficiency
Airna Corp. · 19 participants
📍 Sweden · Ireland · Spain · Netherlands · Portugal · Germany
2025-523558-14-00 on CTIS ↗
No trials match your search.
Cite this page

Priya Life Science (2026). EU Clinical Trials Tracker. Available at: https://priyalifescience.com/clinical-trials-europe/country/portugal (Accessed: 6 July 2026).

Source: Clinical Trials Information System (CTIS), European Medicines Agency - trials authorised under the EU Clinical Trials Regulation (Regulation 536/2014), showing the most recent EU authorisation decisions, refreshed daily. Listing here is informational and not medical advice; eligibility is determined by each study team. Looking for Irish sites? See our Ireland Clinical Trials Tracker. For approved medicines, see the EMA Approvals Tracker.