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SIL 204

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Drug Profile

SIL 204

Alternative Names: KRASG12D-LODER; siG12D-LODER; SIL-204

Latest Information Update: 04 Dec 2025

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At a glance

  • Originator Silenseed
  • Developer Silexion Therapeutics
  • Class Antineoplastics; Small interfering RNA
  • Mechanism of Action KRAS protein expression inhibitors; RNA interference
  • 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 II Pancreatic cancer
  • Preclinical Colorectal cancer; Lung cancer

Most Recent Events

  • 02 Dec 2025 Silexion Therapeutics announced that it has received positive formal written Scientific Advice from the German Federal Institute for Drugs and Medical Devices (BfArM) regarding the proposed design of the planned phase II/III clinical trial for SIL204
  • 12 Nov 2025 Silexion Therapeutics announces intention to submit the regulatory application for the clinical trial of SIL 204 in Germany in the first quarter of 2026
  • 30 Sep 2025 Silexion Therapeutics announces intention to submit the regulatory application to the Israel Ministry of Health for the clinical trial of SIL 204 in Pancreatic cancer (Late-stage disease) in Q4 2025.

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