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ARCT-2301

Development stage
Unknown
Lead developer
CSL Seqirus
Modality
mRNA Therapeutics → RNA Therapeutics → Nucleic Acid Therapeutics, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

ARCT-2301 is a self-amplifying mRNA (sa-mRNA) vaccine, also known as a replicon vaccine, developed by Arcturus Therapeutics in partnership with CSL Seqirus. It is designed to protect against COVID-19 by encoding the SARS-CoV-2 spike protein. The sa-mRNA technology incorporates a viral replicase that allows the mRNA to self-replicate within host cells, leading to sustained antigen expression and potentially requiring lower doses than conventional mRNA vaccines. ARCT-2301 is a bivalent formulation and has been updated to target variants such as Omicron JN.1. In August 2025, Meiji Seika Pharma received manufacturing and marketing approval for the JN.1-targeted version of the vaccine in Japan, with plans for commercial supply to begin in late 2025.

Brand names
KOSTAIVE
Other names
KOSTAIVE Bivalentself-amplifying mRNA COVID-19 vaccinesa-mRNA COVID-19 vaccinereplicon COVID-19 vaccine
02

Targets

SARS-CoV-2 spike

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