Drug Profile

Alpelisib - Novartis Oncology

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

Latest Information Update: 03 Jun 2025

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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

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

30 May 2025 Novartis Pharmaceuticals plans to initiate a phase II trial for Growth Disorder (In adolescents, In adults, In children, In the elderly) (PO) (NCT06997588)
28 Mar 2025 No recent reports of development identified for phase-I development in Growth-disorders(In volunteers) in United Kingdom (PO, Tablet)
02 Jan 2025 Chemical structure information added.

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