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LAE 001

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Drug Profile

LAE 001

Alternative Names: CFG-920; LAE-201; LAE001

Latest Information Update: 29 May 2024

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At a glance

  • Originator Novartis
  • Developer Laekna Therapeutics; Novartis
  • Class Antineoplastics; Chlorinated hydrocarbons; Imidazolines; Pyridines; Small molecules
  • Mechanism of Action Aldosterone synthase inhibitors; Steroid 17-alpha-hydroxylase 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 I/II Prostate cancer

Most Recent Events

  • 24 May 2024 US FDA approves IND application for phase-III trial for LAE 001 in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease, Second-line therapy or greater)
  • 30 Mar 2024 Laekna completes a phase I/II trial in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease) in South Korea and USA (PO) (NCT04060394)
  • 21 Feb 2024 Laekna Therapeutics suspends a phase I/II trial in Prostate cancer (Metastatic disease, Hormone refractory) in China (PO) due to change in clinical development plan (NCT03843918)

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