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Alpelisib - Novartis Oncology

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Drug Profile

Alpelisib - Novartis Oncology

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

Latest Information Update: 06 Feb 2024

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At a glance

  • Originator Novartis
  • Developer Columbia University; H. Lee Moffitt Cancer Center and Research Institute; Kura Oncology; Memorial Sloan-Kettering Cancer Center; Novartis; Novartis Oncology; Peter MacCallum Cancer Centre; 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 HER2 negative breast cancer
  • Registered Growth disorders
  • Phase III Head and neck cancer; HER2 positive breast cancer; Triple negative breast cancer
  • Phase II/III Lymphatic disorders
  • Phase II Breast cancer
  • Discontinued Gastric cancer; Gastrointestinal stromal tumours; Multiple myeloma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Pancreatic cancer; Rectal cancer; Solid tumours; Uveal melanoma

Most Recent Events

  • 06 Feb 2024 Novartis plans to file regulatory application for Lymphatic disorders in or after 2027 (Novartis pipeline, February 2024)
  • 31 Dec 2023 Discontinued - Phase-I for Ovarian cancer (Combination therapy, Second-line therapy or greater) in Finland (PO)
  • 31 Dec 2023 Discontinued - Phase-I for Ovarian cancer (Combination therapy, Second-line therapy or greater) in USA (PO)
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