Drug intelligence / Profile preview

CT-P63

Development stage
Phase 3
Lead developer
Celltrion
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics
Administration
Intravenous, Inhalation
01

Overview

CT-P63 is a monoclonal antibody developed to target the spike receptor binding domain (RBD) of SARS-CoV-2, the virus responsible for COVID-19. It acts as a neutralizing antibody, broadly inhibiting multiple variants of SARS-CoV-2, including Beta, Delta, and Omicron. Preclinical studies demonstrated potent *in vitro* and *in vivo* neutralization activity against these variants. In animal models, CT-P63 significantly reduced viral titers in the respiratory tract and eliminated detectable infectious virus from the lungs. Clinical trials have shown that CT-P63 is safe and well-tolerated with dose-proportional pharmacokinetics following intravenous administration. A nebulized formulation has also been developed to enable self-administration by patients; this version not only neutralizes but also traps viruses in airway mucus for rapid clearance from the lungs via natural mucociliary mechanisms[2][3][4][5]. The drug is being investigated primarily as a treatment for COVID-19 infection.

02

Targets

RBD (SARS-CoV-2 spike receptor-binding domain)

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