ملخص التقيم العلمي والفني للتجارب السريرية لهيئة الدواء المصرية 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 |
| 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 |