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الإدارة المركزية للمستحضرات الحيوية والمبتكرة والدراسات الإكلينيكية

ملخص التقيم العلمي والفني للتجارب السريرية لهيئة الدواء المصرية ٢٠٢٦

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
Efficacy and Safety of Induction Therapy with RO7790121 in Patients with Moderately to Severely
Active Crohn's Disease

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

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