Drug Profile


Alternative Names: BPI 2358; NPI 2358

Latest Information Update: 10 Jul 2017

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At a glance

  • Originator Nereus Pharmaceuticals
  • Developer BeyondSpring Pharmaceuticals; National Cancer Institute (USA); Nereus Pharmaceuticals; University of Washington
  • Class Antineoplastics; Imidazoles; Piperazines; Small molecules
  • Mechanism of Action Guanine nucleotide exchange factor stimulants; Mitosis inhibitors; Tubulin polymerisation inhibitors; Vascular disrupting agents
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Non-small cell lung cancer
  • Phase II/III Neutropenia
  • Phase I Solid tumours
  • Preclinical Glioblastoma
  • Research Brain cancer

Most Recent Events

  • 06 Jul 2017 BeyondSpring announces intention to submit a NDA to the US FDA and CFDA in 2019
  • 06 Jul 2017 The China Food and Drug Administration approves IND application for two phase II/III trials (BPI-2358-105 and BPI-2358-106) in Neutropaenia (Prevention, Chemotherapy-induced) in China
  • 01 Jun 2017 BeyondSpring submits an IND application for the phase II/III BPI-2358-106 trial in Neutropaenia (Prevention, Chemotherapy-induced) with the China Food and Drug Administration in China
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