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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: 22 May 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

  • 22 May 2026 Celcuity plans for a phase III VIKTORIA-2 trial expansion for HER2-negative-breast-cancer (Combination therapy, First-line therapy, Late-stage disease, Metastatic disease, Inoperable/unresectable) (IV)
  • 15 May 2026 Celcuity announces intention to submit sNDA to US FDA for HER2-negative-breast-cancer in USA in the Q3 of 2026
  • 15 May 2026 Celcuity announces intention to submit VIKTORIA-1 data to other regulatory authorities outside the US

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