EDA-CT Application(s) Assessment Summary Publication Report (CT-ASPR) 2026
| Protocol ID/Number |
Protocol Title |
Product Name/Dosage Form |
Marketing Authorization Holder (MAH) |
Publish Date |
| CNTO1959CRD3005 |
A Phase 3, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Guselkumab in Participants with Fistulizing, Perianal Crohn’s Disease |
Guselkumab |
Janssen Scientific and Medical Affairs |
01/07/2026 |
| CNBG2020003SQ |
Multicenter, Randomized, Double Blind, Parallel Placebo Controlled, Phase III Clinical Trial to Evaluate the Protective Efficacy, Safety and immunogenicity of Inactivated SARS-CoV-2 Vaccines in Healthy Population Aged 18 years old and above |
Inactivated SARS-CoV-2 Vaccines |
China National Biotec Group Company Limited (CNBG) Wuhan Institute of Biological Products Co., Ltd. (WIBP) (A subsidiary institute under CNBG)
Beijing Institute of Biological Products Co., Ltd. (BIBP) (A subsidiary institute under CNBG)
|
28/06/2026 |
| 01-Sputnik-Light-2021 |
A Phase III, Randomized, Double Blind, Placebo-Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik Light Vector Vaccine in Adults in the SARS-CoV-2 Infection Prophylactic Treatment |
Sputnik Light Vector Vaccine |
-The Global Sponsor: Human Vaccine LLC |
28/06/2026 |
|
|
A Phase III, Randomized, Open-Label, Sponsor-Blinded, Multicenter Study of Durvalumab in Combination with Tremelimumab ± Lenvatinib Given Concurrently with Transarterial Chemoembolization (TACE) Compared to TACE Alone in Patients with Locoregional Hepatocellular Carcinoma |
Durvalumab |
AstraZeneca |
22/06/2026 |
|
Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study of Durvalumab Monotherapy or in Combination with Bevacizumab as Adjuvant Therapy in Patients with Hepatocellular Carcinoma Who Are at High Risk of Recurrence After Curative Hepatic Resection or Ablation |
Durvalumab |
AstraZeneca |
21/06/2026 | |
| GBT2104-131 (C5361001) |
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Safety and Efficacy of Inclacumab in Participants with Sickle Cell Disease Experiencing Vaso-occlusive Crises |
Inclacumab |
Global Blood Therapeutics, Inc. “GBT”, a wholly owned subsidiary of Pfizer Inc. |
18/05/2026 |
| COVID_VACC_1 |
Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated SARS-CoV-2 Vaccine Against COVID-19 in Healthy Adults. |
Inactivated SARS-CoV-2 Vaccine |
National Research Centre (NRC) |
12/5/2026 |
| DAY101-002 |
A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients with Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) |
Tovorafenib |
Day One Biopharmaceuticals, Inc. (Day One) |
11/5/2026 |
| M20-465 |
A Phase 3 Multicenter, Randomized, Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lutikizumab in Adult and Adolescent Subjects with Moderate to Severe Hidradenitis Suppurativa |
Lutikizumab |
Abbvie |
05/05/2026 |
| MOM-M281-006 |
Efficacy and Safety of M281 in Adults with Warm Autoimmune Hemolytic Anemia: A Multicenter, Randomized, Double-blind, Placebo-controlled Study with a Long-term Open-label Extension |
M281 |
Janssen Research & Development, LLC |
30/04/2026 |
| SPHINX22122020 |
Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of SARS CoV-2 Infection (COVID-19) |
EgyVax Vaccine |
EVA PHARMA, Veterinary Serum & Vaccine Research Institute (VSVRI), the Supreme Council of University Hospitals, and the Ministry of Higher Education and Scientific Research |
26/04/2026 |
| MO42541 (Imbrave) |
A Phase III, Open-Label, Randomized Study of Atezolizumab with Lenvatinib or Sorafenib Versus Lenvatinib or Sorafenib alone in Hepatocellular Carcinoma Previously Treated with Atezolizumab and Bevacizumab |
Atezolizumab | F. Hoffmann-La Roche Ltd | 22/04/2026 |
| START24042025 |
Adhesion and Safety of Rotigexole Compared to Neupro®: A Non-Inferiority Open-Labelled Crossover Randomized Controlled Trial |
Rotigexole | EVA Pharma, Egypt | 21/04/2026 |
| MN39159 “Consonance study” |
An open Label, Single-arm, 4-year study to evaluate effectiveness and safety of Ocrelizumab treatment in patients with progressive multiple sclerosis |
MN39159 | F. Hoffmann-La-Roche Ltd | 15/04/2026 |
| GA45332 |
A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the |
RO7790121 | F. Hoffmann-La-Roche Ltd | 30/3/2026 |
| NN7535-7822 (FLORAL) |
An Open-Label, Multi-Centre, Rollover Study to Characterise Long-Term Safety and Efficacy of Etavopivat in Adults, Adolescents and Children who Have Sickle Cell Disease or Thalassemia and Have Completed a Treatment Period in an Etavopivat Study |
Etavopivat Film-coated tablet | Novo Nordisk A/S | 09/03/2026 |
| GA45331 |
A Phase III, Multicenter, Double blind , Placebo -controlled, treat through study to assess the efficacy and safety of Induction and Maintenance Therapy with RO7790121in patients with Moderately to severely active Crohn's disease |
RO7790121 | F. Hoffmann-La-Roche Ltd | 01/03/2026 |