Ularitide

Drug Profile

Ularitide

Alternative Names: ANF-95-126; ANP 95126; Atrial natriuretic factor (95-126); Atrial natriuretic factor prohormone (95-126); Atriopeptin (95-126); CDD 95-126; CDD ANP 95-126; ESP-305; Ularitide acetate; Urodilatin

Latest Information Update: 28 Apr 2016

Price : $50

At a glance

  • Originator CardioPep Pharma; University of Heidelberg
  • Developer Cardiorentis; PDL BioPharma
  • Class Amino acids; Natriuretic peptides
  • Mechanism of Action Atrial peptide agonists; Diuretics
  • Orphan Drug Status

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

    No
  • 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.

    Acute heart failure
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute heart failure
  • Discontinued Asthma; Kidney disorders

Most Recent Events

  • 01 Mar 2016 Cardiorentis completes the TRUE-AHF trial in (Acute heart failure in USA, Argentina, Belgium, Brazil,Chile, Canada, Germany, Israel, France, Poland, Romania, Serbia, Switzerland, Turkey, Sweden, Czech Republic, Spain, Latvia, Lithuania, Estonia, Italy, Finland, the Netherlands and Hungary (NCT01661634)
  • 15 Dec 2015 Ularitide receives Fast Track designation for Acute heart failure [IV,Infusion] in USA
  • 22 May 2015 Cardiorentis completes enrolment in the phase III trial for Acute heart failure in USA, Argentina, Belgium, Brazil,Chile, Canada, Germany, Israel, France, Poland, Romania, Serbia, Switzerland, Turkey, Sweden, Czech Republic, Spain, Latvia, Lithuania, Estonia, Italy, Finland, the Netherlands and Hungary
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