Drugs / EA-2353
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05392751 | Jun 2022 → Apr 2024 | retinitis pigmentosa | Endogena Therapeutics, Inc | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2024-09-19 | Endogena Therapeutics, Inc | Results First data showing preliminary evidence of efficacy were presented at the Retinal Cell and Gene Therapy Innovation Summit organized by the Foundation Fighting Blindness endogena.com ↗
First data showing preliminary evidence of efficacy were presented at the Retinal Cell and Gene Therapy Innovation Summit organized by the Foundation Fighting Blindness |
| 2023-04-05 | Endogena Therapeutics, Inc | Results Endogena Therapeutics Completes Dose Escalation in the Phase 1/2a Clinical Trial of EA-2353 for the Treatment of Retinitis Pigmentosa endogena.com ↗
No clinically relevant or dose-limiting adverse events were identified after repeated intravitreal injections. |
| 2023-02-06 | Endogena Therapeutics, Inc | Regulatory Endogena Therapeutics Receives US FDA Fast Track Designation for EA-2353 for the Treatment of Retinitis Pigmentosa endogena.com ↗ |
| 2022-06-04 | Endogena Therapeutics, Inc | Regulatory FDA grants orphan drug designation for Endogena’s lead program targeting retinitis pigmentosa endogena.com ↗
Endogena Therapeutics Inc., which discovers and develops endogenous regenerative medicines, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for its EA-2353 ophthalmic suspension targeting retinitis pigmentosa, a rare condition that causes slow and progressive loss of vision. |
All press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-09-19 | Endogena Therapeutics, Inc | First data showing preliminary evidence of efficacy were presented at the Retinal Cell and Gene Therapy Innovation Summit organized by the Foundation Fighting Blindness endogena.com ↗ |
| 2023-05-04 | Endogena Therapeutics, Inc | Endogena Therapeutics Completes Enrollment Ahead of Schedule in its Phase 1/2a Trial of EA-2353 for Retinitis Pigmentosa endogena.com ↗ |
| 2023-04-05 | Endogena Therapeutics, Inc | Endogena Therapeutics Completes Dose Escalation in the Phase 1/2a Clinical Trial of EA-2353 for the Treatment of Retinitis Pigmentosa endogena.com ↗ |
| 2023-02-06 | Endogena Therapeutics, Inc | Endogena Therapeutics Receives US FDA Fast Track Designation for EA-2353 for the Treatment of Retinitis Pigmentosa endogena.com ↗ |
| 2022-06-04 | Endogena Therapeutics, Inc | FDA grants orphan drug designation for Endogena’s lead program targeting retinitis pigmentosa endogena.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EA-2353 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05392751 ↗ |
| Route | Intravitreal | “Unilateral intravitreal injections (IVT) will be administered into the subject's Study Eye” NCT05392751 ↗ |