PRX OTCAlternative Names: PRX-OTC
Latest Information Update: 02 Dec 2016
At a glance
- Originator PhaseRx
- 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.
On Fast track
Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.
- New Molecular Entity Yes
Highest Development Phases
- Preclinical Inborn urea cycle disorders
Most Recent Events
- 28 Nov 2016 PRX OTC receives Orphan Drug status for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) in USA
- 28 Nov 2016 PhaseRx plans to file an IND application with the US FDA in USA for Inborn urea cycle disorders (ornithine transcarbamylase deficiency) by the end of 2017
- 08 Nov 2016 Preclinical pharmacodynamics and adverse events data released by PhaseRx