Drugs / GX-19N
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04915989 | Feb 2021 → Apr 2022 | COVID-19 | Genexine, Inc. | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04715997 | Dec 2020 → Apr 2022 | COVID-19 | Genexine, Inc. | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT05067946 | Oct 2021 → Oct 2022 | COVID-19 | Genexine, Inc. | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-07-09 | PT Kalbe Farma Tbk | Regulatory GET BPOM APPROVAL, KALBE IMPLEMENT CLINICAL TRIAL co.id ↗
PT Kalbe Farma Tbk (“Kalbe”) has received approval from the Food and Drug Supervisory Agency (“BPOM”) to conduct a phase 2b/3 clinical trial for the COVID-19 GX-19N vaccine in Indonesia. |
| 2021-07-07 | Genexine, Inc. | Regulatory COVID-19 vaccine GX-19N, phase 2/3 IND approved at Indonesia. genexine.com ↗
Genexine(KQ095700) announced their COVID-19 vaccine GX-19N’s phase 2/3 IND is approved by Indonesian FDA, BPOM(BPOM; Badan Pengawas Obat dan Makanan). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-30 | Genexine, Inc. | Genexine plans to develop GX-19N as booster vaccine genexine.com ↗ |
| 2021-07-09 | PT Kalbe Farma Tbk | GET BPOM APPROVAL, KALBE IMPLEMENT CLINICAL TRIAL co.id ↗ |
| 2021-07-07 | Genexine, Inc. | COVID-19 vaccine GX-19N, phase 2/3 IND approved at Indonesia. genexine.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GX-19N | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05067946 ↗ |
| Modality | Vaccine | “BACKGROUND: We assessed the safety and immunogenicity of two recombinant DNA vaccines for COVID-19: GX-19 containing plasmid DNA encoding the SARS-CoV-2 spike protein, and...” PMID 35156068 ↗ Feb 2022 |
| Route | Intramuscular | “The vaccines were delivered intramuscularly using an electroporator.” PMID 35156068 ↗ Feb 2022 |