Roxadustat

Drug Profile

Roxadustat

Alternative Names: ASP 1517; FG-4592

Latest Information Update: 06 Mar 2017

Price : $50

At a glance

  • Originator FibroGen
  • Developer Astellas Pharma; AstraZeneca; FibroGen
  • Class Amides; Antianaemics; Carboxylic acids; Isoquinolines; Small molecules
  • Mechanism of Action Basic helix loop helix transcription factor modulators; Hypoxia-inducible factor-proline dioxygenase inhibitors
  • 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.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Anaemia
  • Discontinued Sickle cell anaemia

Most Recent Events

  • 30 Jan 2017 AstraZeneca announces intention to submit NDA to China FDA in 2017
  • 30 Jan 2017 Clinical Trial Application (CTA) for roxadustat is under review by China FDA
  • 30 Jan 2017 Positive topline efficacy data from two phase III trials in Anaemia released by FibroGen
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