imdevimab   Click here for help

GtoPdb Ligand ID: 11328

Synonyms: REGN-10987 | REGN10987 | Ronapreve® (imdevimab + casirivimab)
Approved drug
imdevimab is an approved drug (Japan and UK MHRA (2021))
Compound class: Antibody
Comment: Imdevimab is a fully human monoclonal antibody against the surface spike protein of SARS-CoV-2 [1-2]. It is a virus neutralising mAb that was developed by Regeneron.
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Summary of Clinical Use Click here for help
In clinical evaluation as a cocktail (REGN-COV2) with REGN10933 (casirivimab) for COVID-19. Phase 3 as of November 2020. These two mAbs have non-overlapping epitopes on the SARS-CoV-2 spike protein. In late November 2020 the FDA granted REGN-COV2 emergency use authorization (EUA) for the treatment of mild to moderate COVID-19 in adults and pediatric patients who have had a positive test result and who are in a recognised group at high risk of progressing to severe disease. This EUA does not authorise REGN-COV2 use in hospitalised COVID-19 patients, or in those already receiving oxygen therapy for COVID-19. The EUA was granted, based on data coming from clinical trial NCT04617535.
In July 2021, the Japanese Ministry of Health, Labour and Welfare approved this antibody cocktail, now known by the trade name Ronapreve based on results from NCT04425629 (REGN-COV 2067) [3]. The UK's MHRA approved Ronapreve in August 2021 based on data from the RECOVERY trial (NCT04381936).
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT04452318 Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay Phase 3 Interventional Regeneron Pharmaceuticals
NCT04425629 Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19 Phase 2/Phase 3 Interventional Regeneron Pharmaceuticals
NCT04381936 Randomised Evaluation of COVID-19 Therapy Phase 2/Phase 3 Interventional University of Oxford