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Gedatolisib

Learn how gedatolisib is changing the breast cancer landscape.

What is gedatolisib and what sets it apart

Gedatolisib, a potential first-in-class pan-phosphatidylinositol 3-kinase (PI3K)/mammalian target of rapamycin (mTOR) inhibitor, could address resistance mechanisms to standard endocrine therapies in hormone receptor (HR)-positive/human epidermal growth factor receptor 2 (HER2)-negative breast cancer due to its ability to target all four class I PI3K isoforms (α, β, γ, δ) as well as mTOR.

This broader pathway inhibition could also improve efficacy and treat a greater patient population over isoform-specific PI3K inhibitors. Phase 3 results showed potentially “practice-changing” effects on outcomes compared with current studies.

About gedatolisib

  • Company: Celcuity
  • Type: Pan-PI3K/mTOR inhibitor
  • Usage: Intravenous administration (once weekly for 3 weeks in a 28-day treatment cycle) to treat HR-positive/HER2-negative metastatic breast cancer
    Also being evaluated for metastatic castration-resistant prostate cancer (mCRPC)
  • When will gedatolisib be available?
    Expected launch 2026: European Union, United States

Gedatolisib sales and success forecasts

$1.08bn
expected sales in the G7 markets in 2031
91%
probability of success for gedatolisib in the United States

[The safety profile and improvement in PFS in the VIKTORIA-1 trial] offer potentially paradigm-shifting results for HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.

Igor Gorbatchevsky, MD Celcuity Chief Medical Officer

Source: Celcuity, 2025

Drugs in the 2026 list

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