Drugs / CodaVax-RSV
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT04919109 | Mar 2023 → Jun 2025 | respiratory syncytial virus infectious disease | Codagenix, Inc | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT04295070 | Jul 2020 → Mar 2021 | respiratory syncytial virus infectious disease | Codagenix, Inc | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2022-11-02 | Codagenix, Inc | Regulatory Codagenix Receives FDA Fast Track Designation for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax™-RSV codagenix.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CodaVax™-RSV, an intranasal, live-attenuated vaccine candidate, for the prevention of respiratory syncytial virus (RSV). |
| 2022-06-01 | Codagenix, Inc | Regulatory Codagenix Receives FDA Clearance of Investigational New Drug Application for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax™-RSV codagenix.com ↗
With this FDA clearance, the company plans to initiate a Phase 1 study of vaccine safety and immunogenicity against RSV in healthy children aged six months to five years. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2022-11-02 | Codagenix, Inc | Codagenix Receives FDA Fast Track Designation for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax™-RSV codagenix.com ↗ |
| 2022-06-01 | Codagenix, Inc | Codagenix Receives FDA Clearance of Investigational New Drug Application for Live-Attenuated, Intranasal RSV Vaccine Candidate CodaVax™-RSV codagenix.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CodaVax-RSV | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04295070 ↗ |
| Modality | Vaccine | “Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper” NCT04295070 ↗ |
| Route | Intranasal | “delivered intranasally via dropper” NCT04295070 ↗ |