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Alpelisib

Phase 3

NOVARTIS AG (NVSEF)

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Phase 3

Development Phase

1

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

Upcoming Catalysts

What are catalysts?

Jan '27

NVSEFPhase 2$269.0B

Alpelisib Phase 2 Est. Readout

Alpelisib• Breast Neoplasms69

Jan 2027~ConfirmedSTALE

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Competitive Landscape

3 competitors in Breast Neoplasms

SNYepidoxorubicine, ciclophosphamide, methotrexate, fluorouracile

ATOS(Z)-endoxifen

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Drug Information

Target Indication

Breast Neoplasms

Clinical Trial

Last updated: 4/10/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMAPending

Vijoice

Treatment of patients with severe manifestations of PIK3CA-related overgrowth spectrum

Orphan

EMA7/15/2026

Vijoice

Treatment of adult and paediatric patients aged 2 years and older with severe or life-threatening manifestations of PIK3CA-related overgrowth spectrum (PROS)

OrphanConditional

EMA7/27/2020

Piqray

Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1).

Drug Science

Mechanism of action & safety profile

Developer

NVSEF

NOVARTIS AG

Biotechnology•North America•NASDAQ

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