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Alpelisib - Novartis Oncology

Drug Profile

Alpelisib - Novartis Oncology

Alternative Names: Alpericive - Novartis Oncology; BYL-719; NVP-BYL-719; Piqray

Latest Information Update: 13 Oct 2021

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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; Novartis; Novartis Oncology; University Health Network
  • Class Amides; Antineoplastics; 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.

    Yes - Growth disorders
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Breast cancer
  • Phase III Head and neck cancer; Ovarian cancer
  • Phase II Growth disorders
  • Discontinued Gastric cancer; Gastrointestinal stromal tumours; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Pancreatic cancer; Rectal cancer; Solid tumours; Uveal melanoma

Most Recent Events

  • 27 Sep 2021 Phase-III clinical trials in Breast cancer (Second-line therapy or greater, Combination therapy, Metastatic disease) in Germany, Hungary (PO) (NCT05038735) (EudraCT2021-001966-39)
  • 09 Sep 2021 Novartis Pharmaceuticals plans the phase III EPIK-B5 trial for Breast Cancer (Combination therapy, Late-stage disease, Second-line therapy or greater) in October 2021 (PO) (NCT05038735)
  • 28 Jul 2021 Novartis plans the phase II EPIK-3 trial in Growth disorders (In adults, In adolescents, In children, In elderly) in September 2021 (NCT04980833)
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