Drug Profile

Alpelisib - Novartis Oncology

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

Latest Information Update: 07 Jul 2026

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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

01 Jul 2026 Novartis Pharmaceuticals plans a phase II trial for Breast cancer (Second-line therapy or greater) in January 2027 (PO) (NCT07679269)
03 Apr 2026 Novartis Pharmaceuticals terminates a phase-III clinical trials in Triple-negative-breast-cancer (Late-stage disease, Combination therapy, Second-line therapy or greater) in USA, Argentina, Australia, Austria, Brazil, Bulgaria, China, Colombia, Croatia, France, Germany, Hungary, India, Israel, Italy, Malaysia, Mexico, Norway, Peru, Poland, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Turkey and United Kingdom following a strategic decision to halt recruitment due to persistently slow enrollment (NCT04251533)
18 Mar 2026 Radius Health Inc. has been acquired and merged into Paratek Pharmaceuticals

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