Drugs / OpCT-001
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT06789445 | Mar 2025 → Oct 2029 expected | Usher syndrome, cone-rod dystrophy, retinitis pigmentosa | BlueRock Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-01-22 | BlueRock Therapeutics | Regulatory FDA grants Orphan Drug Designation to BlueRock Therapeutics’ investigational cell therapy OpCT-001 bluerocktx.com ↗ |
| 2026-01-22 | Bayer | Regulatory FDA grants Orphan Drug Designation to BlueRock Therapeutics’ investigational cell therapy OpCT-001 bayer.com ↗ |
| 2025-02-27 | BlueRock Therapeutics | Regulatory BlueRock Therapeutics receives FDA Fast Track Designation for OpCT-001 for the treatment of primary photoreceptor diseases bluerocktx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. |
| 2025-02-27 | Bayer | Regulatory BlueRock Therapeutics receives FDA Fast Track Designation for OpCT-001 for the treatment of primary photoreceptor diseases bayer.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. |
| 2024-09-03 | BlueRock Therapeutics | Regulatory BlueRock Therapeutics announces FDA clearance of IND application for investigational iPSC-derived cell therapy OpCT-001 for the treatment of primary photoreceptor diseases bluerocktx.com ↗
today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. |
| 2024-09-03 | Bayer | Regulatory BlueRock Therapeutics announces FDA clearance of IND application for investigational iPSC-derived cell therapy OpCT-001 for the treatment of primary photoreceptor diseases bayer.com ↗
BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned, independently operated subsidiary of Bayer AG, today announced the clearance of its Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. |
All press releases naming this drug 11 releases
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 | OpCT-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06789445 ↗ |
| Modality | Cell therapy | “Cell therapy product composed of photoreceptor precursor cells derived from human induced pluripotent stem cells (iPSCs).” NCT06789445 ↗ |
| Route | Other | “OpCT-001 dose level 1 will be administered via subretinal injection.” NCT06789445 ↗ |