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 Jan 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

  • 05 Jan 2017 Pharmacokinetics data from a phase I trial in Hepatic encephalopathy released by Ocera Therapeutics
  • 05 Jan 2017 Ocera Therapeutics completes the phase II STOP-HE trial for Hepatic encephalopathy (in patients with acute liver cirrhosis) in Australia, Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Russia, Spain, USA (NCT01966419)
  • 07 Dec 2016 Ocera Therapeutics completes enrolment in the phase II STOP-HE trial for Hepatic encephalopathy (in patients with acute liver cirrhosis) in USA, Australia, Austria, Belgium, Bulgaria, Canada, Czech Republic, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Russia and Spain (NCT01966419)
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