Last reviewed 2026-05-18 · How we verify

ARCT-154

Arcturus Therapeutics, Inc. · Phase 1 active Biologic Quality 40/100

ARCT-154 is a mRNA vaccine Biologic drug developed by Arcturus Therapeutics, Inc.. It is currently in Phase 1 development.

Self-amplifying mRNA vaccine encoding SARS-CoV-2 spike protein that replicates within cells to produce sustained antigen expression.

Likelihood of approval

9.6% vs 9.6% industry baseline

If approved by FDA: likely 2033–2036

Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 1 → approval rate +9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2033–2036	—
EMA	EU	2034–2037	+0.7 yr
MHRA	GB	2034–2037	+0.7 yr
Health Canada	CA	2034–2038	+0.9 yr
TGA	AU	2034–2038	+1.2 yr
PMDA	JP	2034–2038	+1.5 yr
NMPA	CN	2035–2039	+2.3 yr
MFDS	KR	2034–2038	+1.4 yr
CDSCO	IN	2034–2039	+1.8 yr
ANVISA	BR	2035–2039	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	ARCT-154
Sponsor	Arcturus Therapeutics, Inc.
Drug class	mRNA vaccine
Modality	Biologic
Phase	Phase 1

Mechanism of action

ARCT-154 utilizes self-amplifying RNA (saRNA) technology that encodes both the SARS-CoV-2 spike protein antigen and viral replication machinery. Once delivered into cells, the saRNA replicates itself to produce higher levels of the spike protein antigen, potentially enabling lower vaccine doses while generating robust immune responses.

Approved indications

Common side effects

No common side effects on file.

Key clinical trials

The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) (PHASE2, PHASE3)
A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults (PHASE1, PHASE2)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

ARCT-154 CI brief — competitive landscape report
ARCT-154 updates RSS · CI watch RSS
Arcturus Therapeutics, Inc. portfolio CI

Frequently asked questions about ARCT-154

What is ARCT-154?

ARCT-154 is a mRNA vaccine drug developed by Arcturus Therapeutics, Inc..

How does ARCT-154 work?

Self-amplifying mRNA vaccine encoding SARS-CoV-2 spike protein that replicates within cells to produce sustained antigen expression.

Who makes ARCT-154?

ARCT-154 is developed by Arcturus Therapeutics, Inc. (see full Arcturus Therapeutics, Inc. pipeline at /company/arcturus-therapeutics-inc).

What drug class is ARCT-154 in?

ARCT-154 belongs to the mRNA vaccine class. See all mRNA vaccine drugs at /class/mrna-vaccine.

What development phase is ARCT-154 in?

ARCT-154 is in Phase 1.

Drug class: All mRNA vaccine drugs
Manufacturer: Arcturus Therapeutics, Inc. — full pipeline

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing