Alpelisib

Drug Profile

Alpelisib

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

Latest Information Update: 09 Dec 2016

Price : $50

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.

    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 Breast cancer
  • Phase II Non-small cell lung cancer
  • Phase I/II Colorectal cancer; Head and neck cancer; Multiple myeloma; Oesophageal cancer; Solid tumours
  • Phase I Gastric cancer; Gastrointestinal stromal tumours; Pancreatic cancer; Rectal cancer; Uveal melanoma

Most Recent Events

  • 29 Nov 2016 Novartis Pharmaceuticals terminates a phase-I/II trial in Head and neck cancer (Combination therapy, Late-stage disease) in USA, Canada, Australia, France, Netherlands, Hong Kong, South Korea, Singapore and Taiwan due to sponsor decision (slow recruitment) (NCT01602315)
  • 07 Oct 2016 Adverse events data from a phase I trial in Solid tumours presented at the 41st European Society for Medical Oncology Congress (ESMO-2016)
  • 30 Jun 2016 Novartis completes a phase Ib/II trial for Oesophageal cancer (oesophageal squamous cell carcinoma; second-line or greater therapy, combination therapy) in Spain (NCT01822613)
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