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Synonyms: CT-P-59 | CT-P59 | Regkirona®
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.
Ligand Activity Visualisation ChartsThese are box plot that provide a unique visualisation, summarising all the activity data for a ligand taken from ChEMBL and GtoPdb across multiple targets and species. Click on a plot to see the median, interquartile range, low and high data points. A value of zero indicates that no data are available. A separate chart is created for each target, and where possible the algorithm tries to merge ChEMBL and GtoPdb targets by matching them on name and UniProt accession, for each available species. However, please note that inconsistency in naming of targets may lead to data for the same target being reported across multiple charts. ✖ |
| No information available. |
Summary of Clinical Use  |
| 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 | ||
| External links |
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For extended ADME data see the following: European Medicines Agency (EMA) |
