Drug Profile

OPGx 003

Alternative Names: OPGx-003; OPGx-NMNAT1

Latest Information Update: 22 Mar 2023

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At a glance

Originator Massachusetts Eye and Ear
Developer Opus Genetics
Class Eye disorder therapies; Gene therapies
Mechanism of Action Gene transference; NMNAT1 protein replacements

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

No
New Molecular Entity No

Highest Development Phases

Preclinical Leber congenital amaurosis

Most Recent Events

21 Mar 2023 Opus Genetics anticipates to file an IND application for OPGx 003 program in 2025 (Opus Genetics pipeline, March 2023)
22 Sep 2022 Opus Genetics plans a phase I/II trial for Leber congenital amaurosis in USA in 2024 (Opus Genetics pipeline, September 2022)
01 Sep 2022 Opus Genetics plans to request a pre-IND meeting with the US FDA in 2022

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