Drug Profile


Alternative Names: BYL-719; NVP-BYL-719

Latest Information Update: 12 Oct 2017

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At a glance

  • Originator Novartis
  • Developer Columbia University; H. Lee Moffitt Cancer Center and Research Institute; Memorial Sloan-Kettering Cancer Center; Northwestern University; Novartis; Novartis Oncology; Peter MacCallum Cancer Centre; University Health Network
  • Class Amides; Antineoplastics; Dicarboxylic acids; Fluorine compounds; Pyridines; Pyrrolidines; Small molecules; Thiazoles
  • Mechanism of Action Phosphatidylinositol 3 kinase alpha inhibitors
  • 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 Breast cancer
  • Phase II Non-small cell lung cancer
  • Phase I/II Colorectal cancer; Head and neck cancer; Multiple myeloma; Oesophageal cancer
  • Phase I Gastric cancer; Gastrointestinal stromal tumours; Pancreatic cancer; Rectal cancer; Uveal melanoma
  • Discontinued Solid tumours

Most Recent Events

  • 12 Sep 2017 Safety and efficacy data from a phase I trial in Solid tumours presented at the 42nd European Society for Medical Oncology Congress (ESMO-2017)
  • 15 Aug 2017 Array BioPharma completes a phase I/II trial in Solid tumours (Combination therapy, Late-stage disease) in Italy, USA, Australia, France, Spain, United Kingdom and Switzerland (PO) (NCT01449058)
  • 08 Jul 2017 Novartis completes a phase II trial in Breast cancer (Combination therapy, Neoadjuvant therapy) in US, Austria, Australia, Belgium, Canada, Germany, Netherlands, Hong Kong, Italy and Spain (NCT01923168)
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