Ornithine phenylacetate

Drug Profile

Ornithine phenylacetate

Alternative Names: L-Ornithine phenylacetate; OCR-002; OP; Ornithine hydrochloride/sodium phenylacetate; Sodium phenylacetate/ornithine hydrochloride; UCL-L1V

Latest Information Update: 10 Mar 2017

Price : $50

At a glance

  • Originator University College London
  • Developer Ocera Therapeutics
  • Class Basic amino acids; Diamino amino acids; Esters; Hepatoprotectants; Neuroprotectants; Phenylacetates; Small molecules
  • Mechanism of Action Aminohydrolase modulators; Ammonia scavengers; NF-kappa B modulators; Nitric oxide synthase modulators
  • Orphan Drug Status

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

    Yes - Hepatic encephalopathy; Liver failure
  • 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.

    Hepatic encephalopathy
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II/III Hepatic encephalopathy
  • Phase II Liver failure

Most Recent Events

  • 10 Mar 2017 Ocera Therapeutics announces intention to meet with the US FDA to discuss phase III development plan for Ornithine phenylacetate in the third quarter of 2017
  • 08 Mar 2017 Updated efficacy data from a phase IIb STOP-HE trial in Hepatic encephalopathy released by Ocera Therapeutics
  • 30 Jan 2017 Top-line efficacy and safety data from a phase IIb STOP-HE trial in Hepatic encephalopathy released by Ocera Therapeutics
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