Drug Type AAV based gene therapy |
Synonyms AAV-RPGR, AAV5-hRKp.RPGR, Bota-vec + [9] |
Target |
Mechanism RPGR gene transference, Gene transference |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationFast Track (US), Orphan Drug (US), Orphan Drug (EU), PRIME (EU), Breakthrough Therapy (CN) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
X-linked retinitis pigmentosa | Phase 3 | US | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | BE | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | CA | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | DK | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | FR | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | IL | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | IT | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | NL | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | ES | 04 Dec 2020 | |
X-linked retinitis pigmentosa | Phase 3 | CH | 04 Dec 2020 |
Phase 1/2 | 45 | bxicautpmg(itrtnrypuw) = 3 SAEs were observed in the dose-escalation phase of the study (n=10; one retinal tear and one panuveitis in the low dose cohort) wowxyauvcj (codmgoygiy ) | Positive | 28 Jun 2022 | |||
Phase 1/2 | - | AAV5-RPGR gene therapy | zjdkberbzz(iudyhcefrw) = ojojxagmdq rnylzukcby (abzhqgvpdd ) | - | 01 May 2022 |