Drugs / ARCT-2304
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06602531 | Dec 2024 → Jun 2025 | influenza | Arcturus Therapeutics, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-04-10 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1 arcturusrx.com ↗
Arcturus Therapeutics Holdings Inc. (the “Company”, “Arcturus”, Nasdaq: ARCT), a commercial messenger RNA medicine company focused on the development of infectious disease vaccines and opportunities within liver and respiratory rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for the self-amplifying mRNA (sa-mRNA) vaccine candidate, ARCT-2304, designed for active immunization to protect against disease caused by influenza A H5N1 subtype contained in the vaccine. |
| 2024-11-11 | Arcturus Therapeutics, Inc. | Regulatory Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial arcturusrx.com ↗
the U.S. Food and Drug Administration (FDA) has issued a “Study Can Proceed” notification |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-04-10 | Arcturus Therapeutics, Inc. | Arcturus Therapeutics Receives U.S. FDA Fast Track Designation for the STARR® mRNA Vaccine Candidate ARCT-2304 for Pandemic Influenza A Virus H5N1 arcturusrx.com ↗ |
| 2024-11-11 | Arcturus Therapeutics, Inc. | Arcturus Therapeutics Receives Clearance from FDA to Begin H5N1 Pandemic Flu Vaccine Clinical Trial arcturusrx.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ARCT-2304 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06602531 ↗ |
| Modality | Messenger RNA (mRNA) | “self-amplifying mRNA pandemic influenza (H5N1) vaccine” NCT06602531 ↗ |
| Route | Intramuscular | “administered as a 2-dose vaccination series as an intramuscular (IM) injection” NCT06602531 ↗ |