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Roxadustat - FibroGen

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Drug Profile

Roxadustat - FibroGen

Alternative Names: ASP 1517; AZD 9941; EVRENZO; Evrenzo; FG-4592

Latest Information Update: 21 May 2025

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At a glance

  • Originator FibroGen
  • Developer Astellas Pharma; AstraZeneca; FibroGen
  • Class Amides; Antianaemics; Carboxylic acids; Isoquinolines; Small molecules
  • Mechanism of Action 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Anaemia
  • Preregistration Chemotherapy-induced anaemia
  • Discontinued Sickle cell anaemia

Most Recent Events

  • 12 May 2025 FibroGen anticipates receiving feedback from the FDA regarding the potential phase III development program in Q3 2025
  • 12 May 2025 FibroGen plans a phase III trial for Anemia in lower-risk myelodysplastic syndromes (LR-MDS)
  • 20 Feb 2025 FibroGen plans type C meeting with the US FDA to determine next development steps for roxadustat in the US, in the second quarter of 2025

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