regdanvimab   Click here for help

GtoPdb Ligand ID: 11332

Synonyms: CT-P-59 | CT-P59 | Regkirona®
Approved drug
regdanvimab is an approved drug (South Korea & EMA (2021))
Compound class: Antibody
Comment: Regdanvimab (CT-P59) is a recombinant monoclonal antibody against the surface spike protein of SARS-CoV-2 [1]. It was developed by Celltrion. Regdanvimab inhibits SARS-CoV-2 infection via steric hindrance of its binding to human ACE2.
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Summary of Clinical Use Click here for help
Regdanvimab (CT-P59) was progressed to clinical evaluation for COVID-19 [2]. The first marketing authorisation for regdanvimab was issued in South Korea in September 2021 [3], under which it was approved for use to treat patients >50 years, with mild COVID-19 symptoms and with at least one underlying medical condition, or for those with moderate symptoms. The EMA approved its use in November 2021, based on results from NCT04602000. The EMA authorisation indicates regdanvimab for the treatment of patients with confirmed COVID-19, who do not require supplemental oxygen therapy, but who are at increased risk of progressing to severe disease.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT04525079 To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P59 in Healthy Subjects Phase 1 Interventional Celltrion
NCT04602000 To Evaluate the Safety and Efficacy of CT-P59 in Patients With Mild to Moderate Syptoms of Severe Acute Respiratory Syndrome COVID-19 Phase 2/Phase 3 Interventional Celltrion
NCT04593641 This is a Phase 1 Study to Evaluate the Safety,Tolerability and Virology of CT P59 in Patients With Mild Symptoms of Symptoms of Coronavirus Disease (COVID-19) Phase 1 Interventional Celltrion
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