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ARCT-021 Dose 1
ARCT-021 Dose 1 is a mRNA vaccine Biologic drug developed by Arcturus Therapeutics, Inc.. It is currently in Phase 2 development for COVID-19.
ARCT-021 is a mRNA-based vaccine.
ARCT-021 Dose 1 is an investigational vaccine being studied for its safety and tolerability in healthy adult subjects with SARS-CoV-2, COVID-19, SARS-CoV-2 Infection, Corona Virus Infection, and Covid19. The study, titled "Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects," is a Phase 1/2 randomized, double-blinded, placebo-controlled, ascending dose study.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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-021 Dose 1 |
|---|---|
| Sponsor | Arcturus Therapeutics, Inc. |
| Drug class | mRNA vaccine |
| Modality | Biologic |
| Therapeutic area | Infectious Diseases |
| Phase | Phase 2 |
Mechanism of action
It works by encoding for a specific antigen, which is then produced by the host cells to stimulate an immune response.
Approved indications
- COVID-19
Common side effects
- Injection site pain
- Fatigue
- Headache
Key clinical trials
- A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults (PHASE1, PHASE2)
- A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults (PHASE2)
- Open Label Extension Study to Assess the Safety and Long-Term Immunogenicity of ARCT-021 (PHASE2)
- Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects (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-021 Dose 1 CI brief — competitive landscape report
- ARCT-021 Dose 1 updates RSS · CI watch RSS
- Arcturus Therapeutics, Inc. portfolio CI
Frequently asked questions about ARCT-021 Dose 1
What is ARCT-021 Dose 1?
How does ARCT-021 Dose 1 work?
What is ARCT-021 Dose 1 used for?
Who makes ARCT-021 Dose 1?
What drug class is ARCT-021 Dose 1 in?
What development phase is ARCT-021 Dose 1 in?
What are the side effects of ARCT-021 Dose 1?
Related
- Drug class: All mRNA vaccine drugs
- Manufacturer: Arcturus Therapeutics, Inc. — full pipeline
- Therapeutic area: All drugs in Infectious Diseases
- Indication: Drugs for COVID-19
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing