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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: 27 Feb 2026

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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; MTORC1 protein inhibitors; MTORC2 protein inhibitors; Proto-oncogene protein c-akt 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

  • Preregistration 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

  • 11 Feb 2026 Pfizer suspends a phase I trial in Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in USA (IV) due to pending funding and drug supply (NCT03065062)
  • 27 Jan 2026 Planned Prescription Drug User Fee Act (PDUFA) date for HER2-negative-breast-cancer (Late-stage disease, Combination therapy, Metastatic disease, Second-line therapy or greater) in USA (IV) is 2026-07-17
  • 20 Jan 2026 Celcuity plans to launch the gedatolisib for HER2-negative-breast-cancer

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