Clinical Trials in Czechia 2026 - 58 Recent EU Authorisations

Phase III Nutritional and Metabolic Diseases Authorised 04/09/2026

Efficacy and safety of zenagamtide s.c. once weekly compared to insulin glargine s.c. once daily in participants with type 2 diabetes and increased cardiovascular risk inadequately controlled on 1–3 oral glucose-lowering medications (AMBITION 7)

Type 2 diabetes (T2D) and increased cardiovascular (CV) risk not in adequate glycaemic control on 1–3 marketed oral glucose lowering medications.

Novo Nordisk A/S

110 participants planned

Germany · Czechia

2026-525209-11-00 on CTIS ↗

Phase III Immune System Diseases Authorised 02/09/2026

A parallel group, Phase 3, randomized, open-label, 2-arm study to demonstrate the superiority of belumosudil versus best available therapy (BAT) in participants at least 12 years of age with chronic graft versus host disease (cGVHD) refractory to or recurrent after 2 to 5 prior lines of systemic therapy

Immune system diseases

Sanofi-Aventis Recherche & Developpement

263 participants planned

Belgium · Czechia · Hungary · Sweden · Lithuania · Croatia · Netherlands · Slovakia · Poland · Norway · France · Italy · Bulgaria · Germany · Slovenia · Estonia · Portugal · Greece · Denmark

2026-525913-30-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 01/09/2026

A multicenter, prospective, randomized, placebo and non-surgical standard of care (NSSOC) controlled study, performed to evaluate the safety and efficacy of EscharEx and its placebo (gel vehicle) compared to NSSOC in participants with Venous Leg Ulcers (VLU)

Venous Leg Ulcer (VLU)

Mediwound Ltd.

35 participants planned

Czechia · Slovakia

2026-526070-16-00 on CTIS ↗

Phase II Hemic and Lymphatic Diseases Authorised 31/08/2026

HOVON 168: Epcoritamab in Addition to R-Mini-CHOP Compared to R-Mini-CHOP in Elderly, Frail or Unfit Patients with Diffuse Large B-cell Lymphoma

Diffuse large B-cell lymphoma (DLBCL)

Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting

261 participants planned

Czechia · Denmark · Croatia · Spain · Sweden · Finland · Portugal · Ireland · Netherlands · Norway

2025-524230-25-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 26/08/2026

A Phase 2a, proof-of-concept, multicenter, double-blind, randomized, placebo-controlled, parallel-group trial to assess the efficacy and safety of ACT-777991 in adults with non-segmental vitiligo

Non-segmental vitiligo

Idorsia Pharmaceuticals Ltd.

24 participants planned

Czechia · Poland

2025-524865-25-00 on CTIS ↗

Phase II Immune system processes Authorised 25/08/2026

A Phase 2b, Randomized, Multicenter, Double-Blind, Dose-Finding, Active-Controlled Study of Siplizumab (TCD601) Compared to Rabbit Anti-Thymocyte Globulin in Renal Transplant Recipients Requiring Induction Therapy and Receiving Standard of Care Immunosuppression with Tacrolimus, Mycophenolic Acid and Corticosteroids (MODERNIZE 1)

Renal Transplantation

Nefro Avillion Clinical Development LLC

27 participants planned

Czechia · Spain · Portugal · Austria

2026-525646-29-00 on CTIS ↗

Phase I Not possible to specify Authorised 25/08/2026

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.

No medical condition

Adamed Pharma S.A.

60 participants planned

Czechia

2026-527468-34-00 on CTIS ↗

Phase II Skin and Connective Tissue Diseases Authorised 25/08/2026

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

Atopic Dermatitis (AD)

Apollo Therapeutics Limited

138 participants planned

Hungary · Czechia · Germany · Bulgaria · Poland · Spain

2026-525673-39-00 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 25/08/2026

Bioavailability Comparison of Valsartan 320 mg Tablets (Test vs. Reference Product)

Not applicable (submitted trial is a BE study in healthy participants)

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

34 participants planned

Czechia

2026-527569-31-00 on CTIS ↗

Phase III Neoplasms Authorised 24/08/2026

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)

Pancreatic Adenocarcinoma

Revolution Medicines Inc.

281 participants planned

Sweden · Spain · France · Poland · Italy · Norway · Belgium · Germany · Czechia · Austria · Netherlands · Denmark

2025-524928-21-00 on CTIS ↗

Phase III Neoplasms Authorised 21/08/2026

A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (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)

HR-positive, HER2-negative, inoperable locally advanced or metastatic breast cancer

Laboratorios Farmaceuticos Rovi S.A.

97 participants planned

Romania · Spain · Bulgaria · Czechia · Latvia · Poland · Croatia · Slovakia

2025-524846-85-00 on CTIS ↗

Phase III Hemic and Lymphatic Diseases Authorised 21/08/2026

A Phase 3 Randomized, Double-blind, Placebo-controlled Global Study of Sapablursen in Polycythemia Vera

Polycythemia Vera

Deciphera Pharmaceuticals Inc.

106 participants planned

Austria · Czechia · Italy · Portugal · Germany · France · Hungary · Spain · Poland

2025-524669-25-00 on CTIS ↗

Phase III Eye Diseases Authorised 17/08/2026

A Randomized, Double-masked, Comparative Clinical Study Evaluating the Efficacy, Safety, and Immunogenicity of ABP 938 8 mg Versus EYLEA® HD (Aflibercept) Delivered via Intravitreal Injection in Participants with Neovascular Age-related Macular Degeneration

Neovascular Age-related Macular Degeneration (nAMD)

Amgen Inc.

255 participants planned

Slovakia · Latvia · Czechia · Poland · Spain · Hungary · Lithuania

2025-523500-72-00 on CTIS ↗

Phase II Cardiovascular Diseases Authorised 14/08/2026

A Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety, and tolerability of CRD-4730 in patients with heart failure with reduced ejection fraction (HFREF) (CALIBRATE-HF)

heart failure

Cardurion Pharmaceuticals Inc.

369 participants planned

Latvia · Slovakia · Lithuania · Hungary · Italy · Netherlands · Spain · Poland · Bulgaria · Czechia

2025-525033-31-00 on CTIS ↗

Phase I Female Urogenital Diseases and Pregnancy Complications Authorised 14/08/2026

Bioequivalence of Estradiol 10 mcg Vaginal Tablets in Healthy Women Participants.

Not applicable (submitted trial is a bioavailability trial in healthy participants).

Laboratorios Leon Farma S.A.

48 participants planned

Czechia

2026-526477-42-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 14/08/2026

A Phase 2 Randomized Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Three Doses of Frevecitinib (KN-002) in Patients with Severe Asthma not Adequately Controlled with Medium to High Dose ICS/LABA Therapy (PANAIRAMA)

Severe asthma

Kinaset Therapeutics Inc.

350 participants planned

Czechia · Bulgaria · Romania · Hungary · Germany · Poland · Greece

2023-509125-41-00 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 12/08/2026

Bioavailability Comparison of Finerenone 20 mg Tablets (Test vs. Comparator Product).

Comparative bioavailability study under fasting conditions.

ZAKLADY FARMACEUTYCZNE POLPHARMA S.A.

52 participants planned

Czechia

2026-527382-30-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 10/08/2026

Bioequivalence study 3 to compare pharmacokinetics of Parkinson´s disease drugs in healthy volunteers

Parkinson's desease

Orion Corporation

40 participants planned

Czechia

2026-525450-11-00 on CTIS ↗

Phase III Hormonal diseases Authorised 07/08/2026

A Phase 3, Randomized, Double-Masked, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves’ Disease Inadequately Controlled With Antithyroid Drugs

Graves' Disease (GD)

Argenx

145 participants planned

Italy · Czechia · Spain · Denmark · Belgium · Romania · Latvia · France · Germany · Greece · Sweden · Poland · Lithuania · Bulgaria

2025-523333-26-00 on CTIS ↗

Phase I Hormonal diseases Authorised 05/08/2026

An open label, randomized, single-dose, two-treatment, two-sequence, two-period, cross-over pilot comparative bioavailability study comparing Empagliflozin and Metformin f.c. tabs (12.5+1000) mg, VIANEX S.A., Greece versus Synjardy 12.5 mg/1,000 mg film-coated tablets, Boehringer Ingelheim International GmbH, Germany, in healthy male and female volunteers under fasting conditions.

treatment of diabetes

Vianex S.A.

18 participants planned

Czechia

2026-526397-17-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 04/08/2026

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron Compared with Placebo in Adults with Type 2 Diabetes Mellitus on Background Insulin (Eluminate-3)

type 2 diabetes mellitus

AstraZeneca AB

200 participants planned

Poland · Germany · Bulgaria · Czechia

2025-523935-20-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 03/08/2026

A Randomized, Double-blind, Parallel-group Phase III Study to Evaluate the Efficacy, Safety, and Tolerability of Elecoglipron and Dapagliflozin in Combination, Compared with Elecoglipron Alone and Dapagliflozin Alone, in Adults with Type 2 Diabetes Mellitus (Eluminate-5)

type 2 diabetes mellitus

AstraZeneca AB

360 participants planned

Slovakia · Poland · Czechia · Germany · Hungary · Greece · Denmark

2025-523941-81-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 03/08/2026

A double-blind, randomised, placebo-controlled trial evaluating the efficacy and safety of oral nerandomilast treatment in patients with systemic sclerosis (SSc)

Systemic sclerosis

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

179 participants planned

Denmark · Hungary · Sweden · Netherlands · Germany · Belgium · France · Greece · Norway · Finland · Czechia · Portugal · Bulgaria · Spain · Austria · Romania · Croatia · Poland · Estonia · Italy · Lithuania

2025-523884-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease

Moderately to Severely Active Crohn’s Disease

Janssen Cilag International

194 participants planned

Norway · Romania · Austria · Italy · Slovakia · Germany · Hungary · Netherlands · Belgium · France · Portugal · Czechia · Poland · Spain · Greece

2026-525922-39-00 on CTIS ↗

Phase III Immune System Diseases Authorised 03/08/2026

A Phase 3 Randomized, Double-blind, and Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of JNJ-78934804 in Participants with Moderately to Severely Active Ulcerative Colitis

Moderately to Severely Active Ulcerative Colitis

Janssen Cilag International

302 participants planned

France · Bulgaria · Romania · Slovakia · Norway · Denmark · Greece · Italy · Austria · Poland · Netherlands · Czechia · Germany · Belgium · Spain · Hungary · Portugal

2026-525923-26-00 on CTIS ↗

Phase I Nervous System Diseases Authorised 30/07/2026

Bioequivalence of Tramadol retard 200 mg Prolonged-Release Tablets in Healthy Participants Under Fasting Conditions

Not applicable (submitted trial is a bioavailability trial in healthy participants).

Laboratorios Cinfa S.A.

36 participants planned

Czechia

2026-525836-41-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 30/07/2026

J3L-MC-EZEJ: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Lepodisiran to Investigate the Effect on Coronary Plaque in Adults With Elevated Lp(a) Who Have Established Atherosclerotic Cardiovascular Disease or Are at Risk for a First Cardiovascular Event

Lipoprotein(a), Atherosclerosis, Cardiovascular Diseases

Eli Lilly & Co.

145 participants planned

Hungary · Czechia · Spain · Netherlands

2025-524858-34-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 29/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo controlled, Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Cardiovascular Outcomes in Participants with HFpEF and HFmrEF (Elevate-HF)

Heart failure with preserved ejection fraction (HFpEF) and heart failure with mildly reduced ejection fraction (HFmrEF); on background SGLT2i.

AstraZeneca AB

2343 participants planned

Spain · Hungary · Germany · Poland · Italy · Bulgaria · Netherlands · Austria · Romania · Sweden · France · Greece · Slovakia · Czechia

2026-526304-79-00 on CTIS ↗

Phase III Nutritional and Metabolic Diseases Authorised 27/07/2026

A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Participants with obesity with or without type 2 diabetes

Novo Nordisk A/S

1140 participants planned

Greece · Portugal · France · Slovakia · Bulgaria · Netherlands · Romania · Italy · Austria · Poland · Hungary · Spain · Czechia · Belgium

2025-522488-14-00 on CTIS ↗

Phase III Cardiovascular Diseases Authorised 24/07/2026

A Phase III, Randomized, Double-blind, Parallel-group, Placebo-controlled Multicenter Study to Evaluate the Effect of Elecoglipron in Reducing Renal Outcomes and Mortality in Participants with Chronic Kidney Disease (Elevate-CKD)

Chronic kidney disease (CKD) in adults, with specified ranges of eGFR and albuminuria (UACR), irrespective of T2DM status; background SGLT2i dapagliflozin 10 mg as GDMT.

AstraZeneca AB

1600 participants planned

Czechia · Italy · Hungary · Romania · Bulgaria · Sweden · Denmark · Poland · Spain · Norway · Finland · Greece · France · Germany

2025-523994-41-00 on CTIS ↗

Phase III Hormonal diseases Authorised 23/07/2026

A Phase 3b, Open-Label Study of Crinecerfont to Evaluate Androgen Reduction and Related Outcomes in Adults With Classic Congenital Adrenal Hyperplasia

Classic Congenital Adrenal Hyperplasia (CAH)

Neurocrine Biosciences Inc.

71 participants planned

Czechia · Germany · Sweden · Portugal · Romania · Bulgaria · Italy · Austria · Spain

2025-524282-24-00 on CTIS ↗

Phase III Not possible to specify Authorised 23/07/2026

Prospective, multicentre, open-label, single arm trial on contraceptive efficacy, safety and tolerability of LPRI-CF113 (Drospirenone 4 mg + 2.8 mg) during 13 cycles.

No medical condition

Chemo Research S.L.

1550 participants planned

Sweden · Czechia · Spain · Hungary · Poland · Finland · Romania

2026-525727-24-00 on CTIS ↗

Phase III Digestive System Diseases Authorised 21/07/2026

A Phase III, Multicentre, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Elafibranor in Adult Participants with Primary Sclerosing Cholangitis

Primary Sclerosing Cholangitis

Ipsen Bioscience Inc.

127 participants planned

Spain · Sweden · Germany · Romania · Finland · Portugal · Austria · Italy · Denmark · Czechia · France · Netherlands · Poland · Belgium · Norway

2026-525242-29-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 20/07/2026

A randomized, placebo-controlled, double-blind Phase 3 study to evaluate the efficacy, safety and tolerability of votoplam in participants with Huntington’s Disease

Huntington’s Disease

Novartis Pharma AG

368 participants planned

Norway · Poland · Spain · Sweden · Bulgaria · Netherlands · Finland · Portugal · Austria · Italy · Greece · Ireland · Czechia · France · Romania · Belgium · Germany · Denmark · Slovakia · Hungary

2025-522227-99-00 on CTIS ↗

Phase II Digestive System Diseases Authorised 16/07/2026

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Confirm Efficacy and Safety of MH002 and to Assess the Effect of Dose in Patients With Mild-to-Moderate Ulcerative Colitis Insufficiently Controlled With 5-Aminosalicylic Acid

Ulcerative Colitis

Microbial Resource Management Health

109 participants planned

Czechia · Poland · Italy

2025-524682-24-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 14/07/2026

The MODIFY Study: A Phase 3b/4 randomized, double-blind, placebo-controlled, multicentre study evaluating the impact of early intervention with depemokimab on exacerbation rate, clinical remission, lung function decline, and safety in adults and adolescents with at risk Type 2 asthma, conducted up to 156 weeks.

Asthma

Glaxosmithkline Research & Development Limited

229 participants planned

Ireland · Spain · Germany · Czechia · Bulgaria · France · Belgium · Romania · Italy

2025-524463-20-00 on CTIS ↗

Phase I/II Neoplasms Authorised 13/07/2026

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Multiple Myeloma (MM), Multiple Myeloma (MM)

AbbVie Deutschland GmbH & Co. KG

88 participants planned

Germany · Poland · Czechia · Belgium · France · Greece · Sweden · Portugal · Italy

2025-525105-20-00 on CTIS ↗

Phase III Nervous System Diseases Authorised 07/07/2026

An Open-Label, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Xembify versus Gamunex-C in Participants with Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)

Grifols Therapeutics LLC

20 participants planned

Romania · Czechia · Poland

2025-522165-30-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 07/07/2026

A study to evaluate the dose-exposure, safety, and exploratory efficacy of nerandomilast in children and adolescents from 2 years to less than 18 years of age with fibrosing interstitial lung disease (Part A: double-blind, placebo-controlled in children from 6 to less than 18 years of age and open-label active treatment in children from 2 to less than 6 years of age), followed by an open-label phase with active treatment (Part B)

Fibrosing interstitial lung disease

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

20 participants planned

Belgium · Greece · Germany · France · Finland · Spain · Czechia · Poland · Italy · Netherlands · Denmark · Portugal

2025-523369-32-00 on CTIS ↗

Phase III Neoplasms Authorised 07/07/2026

A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Cevostamab in Combination with Pomalidomide and Dexamethasone Versus Standard of Care in Patients with Multiple Myeloma who Have Received One to Three Prior Lines of Therapy

Multiple Myeloma

F. Hoffmann-La Roche AG

133 participants planned

France · Germany · Italy · Greece · Denmark · Czechia · Spain · Poland

2025-524028-23-00 on CTIS ↗

Phase III Respiratory Tract Diseases Authorised 06/07/2026

A Phase 2b/Phase 3, randomized, double-blind, placebo-controlled, multicenter study, to investigate the efficacy and safety of lunsekimig in adult participants with inadequately controlled chronic obstructive pulmonary disease (COPD) characterized by an eosinophilic phenotype

Respiratory tract diseases

Sanofi-Aventis Recherche & Developpement

550 participants planned

Germany · Romania · Greece · Norway · Netherlands · Poland · Lithuania · Czechia · Slovakia · Spain

2024-518213-25-00 on CTIS ↗

Phase I Cardiovascular Diseases Authorised 02/07/2026

Bioequivalence Study of Dapagliflozin 10 mg

Not applicable (submitted trial is a BE study in healthy participants)

Vipharm S.A.

40 participants planned

Czechia

2026-526840-10-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

"A Phase 3 Randomized Study Comparing JNJ-79635322 versus Teclistamab in Participants with Relapsed or Refractory Multiple Myeloma after 1 to 3 Prior Lines of Therapy, Including an Anti-CD38 Antibody and Lenalidomide"

Relapsed or Refractory Multiple Myeloma

Janssen Cilag International

206 participants planned

Poland · Spain · Czechia · France · Italy · Germany · Greece

2025-523815-12-00 on CTIS ↗

Phase II Respiratory Tract Diseases Authorised 01/07/2026

A Phase II, Randomized, Double-blind, 3-Period Cross-over, Dose‑ranging Study to Assess the Efficacy and Safety of Glycopyrronium (GP) versus Placebo in Participants of 4 to Less than 12 Years of Age with Asthma Receiving Background Budesonide and Formoterol Fumarate (BFF) (FAROS)

Asthma

AstraZeneca AB

35 participants planned

Czechia · Poland · Hungary

2025-524914-26-00 on CTIS ↗

Phase III Neoplasms Authorised 01/07/2026

A Randomized, Open-Label, Phase 3 Study of Rinatabart Sesutecan (Rina-S) Plus Standard of Care Versus Standard of Care as Maintenance Treatment After 2L PlatinumBased Doublet Chemotherapy in Participants With Recurrent Platinum-Sensitive Ovarian Cancer (PSOC)

Ovarian Cancer Platinum-Sensitive Ovarian Cancer (PSOC)

Genmab A/S

257 participants planned

Finland · Belgium · Hungary · France · Denmark · Austria · Germany · Italy · Spain · Czechia · Norway · Poland

2025-522167-15-00 on CTIS ↗

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.

165 participants planned

Greece · France · Italy · Belgium · Denmark · Germany · Poland · Czechia · Portugal · Austria · Spain · Romania

2025-521769-29-00 on CTIS ↗

Phase III Skin and Connective Tissue Diseases Authorised 29/06/2026

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Parallel Study to Evaluate the Efficacy and Safety of Enpatoran in Participants with Active Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease Receiving Standard of Care

Cutaneous Manifestations of Lupus Erythematosus With or Without Systemic Disease

Merck Healthcare KGaA

57 participants planned

Germany · Romania · France · Bulgaria · Belgium · Spain · Poland · Greece · Italy · Czechia

2025-524855-30-00 on CTIS ↗

Phase III Female Urogenital Diseases and Pregnancy Complications Authorised 29/06/2026

A Randomized Phase III Study to Investigate the Efficacy and Safety of Alpha1H as a Neoadjuvant Therapy in Participants with Low- to Intermediate-Risk/Low-Grade Papillary Non-Muscle Invasive Bladder Cancer

Non-Muscle Invasive Papillary Bladder Cancer

Hamlet BioPharma AB

169 participants planned

Czechia

2026-525531-16-00 on CTIS ↗

Phase III Musculoskeletal Diseases Authorised 23/06/2026

Multicenter Interventional Study Somatrogon Impact on Outcomes in Naive Small for Gestational Age or Idiopathic Short Stature paediatric patients compared with daily growth hormone

Small for gestational age (SGA) and idiopathic short stature (ISS)

Schneider Children's Medical Center Of Israel

95 participants planned

Greece · Poland · France · Czechia

2025-523832-38-00 on CTIS ↗

Phase III Immune System Diseases Authorised 22/06/2026

A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema

Hereditary Angioedema

Adarx Pharmaceuticals Inc.

45 participants planned

Poland · Italy · Hungary · France · Austria · Czechia · Belgium · Spain · Bulgaria · Germany · Croatia

2025-521353-16-00 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

486 participants planned

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 II Digestive System Diseases Authorised 16/06/2026