Drug Profile

PRX OTC

Alternative Names: PRX-OTC

Latest Information Update: 04 Sep 2023

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At a glance

Originator PhaseRx
Class Enzymes
Mechanism of Action Enzyme replacements

Orphan Drug Status

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

Yes - Inborn urea cycle disorders
New Molecular Entity Yes

Highest Development Phases

Discontinued Inborn urea cycle disorders

Most Recent Events

04 Sep 2023 Discontinued - Preclinical for Inborn urea cycle disorders in USA (unspecified route)
28 Aug 2020 No recent reports of development identified for preclinical development in Inborn-urea-cycle-disorders in USA
25 Apr 2017 The European Medicines Agency's Committee for Orphan Medicinal Products issues a positive opinion recommending Orphan Drug status for PRX OTC for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) in European Union

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