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Gedatolisib - Celcuity

Drug Profile

Gedatolisib - Celcuity

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

Latest Information Update: 26 Feb 2024

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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 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 Feb 2024 Phase-I/II clinical trials in Prostate cancer (Combination therapy, Inoperable/Unresectable, Metastatic disease, Second-line Therapy or greater, Hormone refractory) in France (IV) (NCT06190899)
  • 06 Dec 2023 Pharmacodynamics data from a preclinical trial in Breast cancer released by Celcuity
  • 05 Dec 2023 Efficacy and adverse events data from a phase I/II trial in Breast cancer presented at the 46th Annual San Antonio Breast Cancer Symposium (SABCS-2023)
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