Product Description
Arcturus is on track to initiate a Phase 1 H5N1 pandemic flu study in Q4. The clinical study is funded by BARDA and designed to enroll approximately 200 healthy adults in the United States. This vaccine, named ARCT-2304, utilizes the Company's proprietary STARR® self-amplifying mRNA and LUNAR® delivery technologies. (Sourced from: https://ir.arcturusrx.com/news-releases/news-release-details/arcturus-therapeutics-announces-second-quarter-2024-financial)
Mechanisms of Action: Vaccine
Novel Mechanism: No
Modality: Vaccine
Route of Administration: Intramuscular
FDA Designation: Fast Track - Influenza, Human *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Arcturus Therapeutics
Company Location: Western America
Company CEO: Joseph E. Payne
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: United States
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Arcturus Therapeutics announced they will present P1 Influenza, Human results in YE25 for ARCT-2304
Highest Development Phases
Phase 1: Influenza, Human
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06602531 |
ARCT-2304-01 | P1 |
Active, not recruiting |
Influenza, Human |
2025-06-13 |
50% |
2025-10-23 |
Primary Completion Date|Primary Endpoints|Start Date |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
11/10/2025 |
News Article |
Arcturus Therapeutics Announces Third Quarter 2025 Financial Update and Pipeline Progress |
|
08/11/2025 |
News Article |
Arcturus Therapeutics Announces Second Quarter 2025 Financial Update and Pipeline Progress |
|
05/12/2025 |
News Article |
Arcturus Therapeutics Announces First Quarter 2025 Financial Update and Pipeline Progress |
|
04/10/2025 |
News Article |
Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1 |