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Gedatolisib - Celcuity

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Drug Profile

Gedatolisib - Celcuity

Alternative Names: PF-05212384; PF-5212384; PKI-587

Latest Information Update: 02 Sep 2025

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At a glance

  • Originator Wyeth
  • Developer Celcuity; Pfizer
  • Class Antineoplastics; Morpholines; Piperidines; Small molecules; Triazines; Urea compounds
  • Mechanism of Action 1 Phosphatidylinositol 3 kinase inhibitors; MTOR protein inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III HER2 negative breast cancer
  • Phase I/II Prostate cancer
  • Discontinued Acute myeloid leukaemia; Colorectal cancer; Endometrial cancer; Non-small cell lung cancer; Solid tumours

Most Recent Events

  • 27 Aug 2025 Celcuity plans a rolling NDA submission to the US FDA for gedatolisib in September 2025
  • 27 Aug 2025 US FDA agrees to accept NDA for Gedatolisib for HER2-negative-breast-cancer for review under the Real-Time Oncology Review program
  • 14 Aug 2025 Celcuity announces intention to submit NDA to US FDA for HER2-negative-breast-cancer in the fourth quarter of 2025

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