Peringatan Keamanan

Single doses of up to 8000mg of ragdanvimab have been administered to patients in clinical trials without evidence of dose-limiting toxicities.L39140 In the event of a suspected overdose, employ general supportive measures as clinically indicated.

Regdanvimab

DB16405

biotech approved investigational

Deskripsi

Regdanvimab (CT-P59) is a recombinant human IgG1 monoclonal antibody directed at the receptor binding domain (RBD) of the SARS-CoV-2 spike protein.L39140 It blocks the interaction between viral spike proteins and angiotensin-converting enzyme 2 (ACE2) that allows for viral entry into the cell, thereby inhibiting the virus' ability to replicate. Trials investigating the use of regdanvimab as a therapeutic candidate for the treatment of COVID-19 began in mid-2020.A235830,A241995 It received its first full approval in South Korea in September 2021,A241995 followed by the EU in November 2021.L39130

Struktur Molekul 2D

Struktur tidak tersedia

Peta Jejaring Molekuler
Legenda: ObatTargetGenEnzim(Panah → menunjukkan arah efek / relasi)TransporterCarrier

Profil Farmakokinetik

Waktu Paruh (Half-Life) The mean terminal half-life of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 17 days.[L39140]
Volume Distribusi The steady-state apparent volume of distribution following intravenous administration of regdanvimab 40 mg/kg in patients with COVID-19 was 83 mL/kg.[L39140]
Klirens (Clearance) The mean clearance of regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 was 0.20 mL/hr/kg.[L39140]

Absorpsi

The mean Cmax and AUC0-infof regdanvimab following intravenous administration of 40 mg/kg to patients with COVID-19 were 1017 µg/mL and 182095 ?g?h/ml, respectively.L39140,L39155

Metabolisme

As regdanvimab is a recombinant IgG1 antibody, it is likely to be degraded into smaller peptides and amino acids in the same way as endogenous IgG1.L39140

Rute Eliminasi

Regdanvimab is likely to be eliminated via normal immunoglobulin degradation pathways.L39140

Interaksi Obat

1 Data
Imlifidase The therapeutic efficacy of Regdanvimab can be decreased when used in combination with Imlifidase.

Target Protein

Spike glycoprotein S

Referensi & Sumber

Synthesis reference: Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, Jeong JH, Kim M, Kim JI, Kim P, Bae JS, Shim EY, Lee MS, Kim MS, Noh H, Park GS, Park JS, Son D, An Y, Lee JN, Kwon KS, Lee JY, Lee H, Yang JS, Kim KC, Kim SS, Woo HM, Kim JW, Park MS, Yu KM, Kim SM, Kim EH, Park SJ, Jeong ST, Yu CH, Song Y, Gu SH, Oh H, Koo BS, Hong JJ, Ryu CM, Park WB, Oh MD, Choi YK, Lee SY: A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun. 2021 Jan 12;12(1):288. doi: 10.1038/s41467-020-20602-5.
Artikel (PubMed)
  • PMID: 33319649
    Tuccori M, Ferraro S, Convertino I, Cappello E, Valdiserra G, Blandizzi C, Maggi F, Focosi D: Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline. MAbs. 2020 Jan-Dec;12(1):1854149. doi: 10.1080/19420862.2020.1854149.
  • PMID: 33436577
    Kim C, Ryu DK, Lee J, Kim YI, Seo JM, Kim YG, Jeong JH, Kim M, Kim JI, Kim P, Bae JS, Shim EY, Lee MS, Kim MS, Noh H, Park GS, Park JS, Son D, An Y, Lee JN, Kwon KS, Lee JY, Lee H, Yang JS, Kim KC, Kim SS, Woo HM, Kim JW, Park MS, Yu KM, Kim SM, Kim EH, Park SJ, Jeong ST, Yu CH, Song Y, Gu SH, Oh H, Koo BS, Hong JJ, Ryu CM, Park WB, Oh MD, Choi YK, Lee SY: A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun. 2021 Jan 12;12(1):288. doi: 10.1038/s41467-020-20602-5.
  • PMID: 34724174
    Syed YY: Regdanvimab: First Approval. Drugs. 2021 Nov 1. pii: 10.1007/s40265-021-01626-7. doi: 10.1007/s40265-021-01626-7.

Contoh Produk & Brand

Produk: 1 • International brands: 1
Produk
  • Regkirona
    Injection, solution, concentrate • 60 mg/ml • Intravenous • EU • Approved
International Brands
  • Regkirona — Celltrion Healthcare

Sekuens Gen/Protein (FASTA)

Sekuens dimuat saat dibutuhkan agar halaman tetap ringan.
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