Enasidenib

Drug Profile

Enasidenib

Alternative Names: AG 221; CC-90007; IDH2 inhibitor - Agios/Celgene

Latest Information Update: 25 Mar 2017

Price : $50

At a glance

  • Originator Agios Pharmaceuticals
  • Developer Agios Pharmaceuticals; Celgene Corporation
  • Class Antineoplastics; Propanols; Pyridines; Small molecules; Triazines
  • Mechanism of Action Isocitrate dehydrogenase 2 inhibitors
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia
  • 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

  • Preregistration Acute myeloid leukaemia
  • Phase I/II Solid tumours
  • Phase I Haematological malignancies

Most Recent Events

  • 01 Mar 2017 FDA assigns PDUFA action date of 30/08/2017 for Enasidenib for Acute myeloid leukaemia
  • 30 Jan 2017 Phase-I/II clinical trials in Acute myeloid leukaemia (Combination therapy, First-line therapy, Newly diagnosed) in United Kingdom, South Korea, Italy, Netherlands, Australia, Canada (PO) (NCT02677922)
  • 09 Jan 2017 Preregistration for Acute myeloid leukaemia (In the elderly, Late-stage disease, Second-line therapy or greater) in USA (PO) in December 2016
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