|
Synonyms: crovalimab-akkz | Piasky® | RG-6107 | RG6107 | Senkai® (China) | SKY59
crovalimab is an approved drug (China NMPA, FDA & EMA (2024))
Compound class:
Antibody
Comment: Crovalimab (SKY59/RG6107) is a long-acting anti-C5 recycling monoclonal antibody [2,6]. The antibody is engineered to bind C5 in a pH-dependent manner. It binds strongly to C5 in the plasma, but in the acidic conditions within the endosome the antibody-C5 immune complex dissociates. The free antibody is re-cycled and can bind more plasma C5, to provide sustained complement inhibition. The C5 released in the endosome is trafficked to the lysosome for degradation. Crovalimab is proposed as a treatment for complement-mediated disorders such as paroxysmal nocturnal hemoglobinuria (PNH) [5] and Lupus nephritis.
|
| No information available. |
Summary of Clinical Use  |
| Crovalimab was advanced to clinical studies to evaluate efficacy as a treament for complement-mediated diseases. It was first approved in China in February 2024, to treat paroxysmal nocturnal hemoglobinuria (PNH) [1]. FDA approval for this indication followed in June 2024. |
| Clinical Trials | |||||
| Clinical Trial ID | Title | Type | Source | Comment | References |
| NCT05075824 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Crovalimab as Adjunct Treatment in Prevention of Vaso-Occlusive Episodes (VOE) in Sickle Cell Disease (SCD) | Phase 2 Interventional | Hoffmann-La Roche | ||
| NCT04958265 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS) | Phase 3 Interventional | Hoffmann-La Roche | ||
| NCT04654468 | A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibition | Phase 3 Interventional | Hoffmann-La Roche | 3 | |
| NCT04434092 | A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. | Phase 3 Interventional | Hoffmann-La Roche | 3-4 | |
