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GDC 4198

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Drug Profile

GDC 4198

Alternative Names: GDC-4198; RGT-419B

Latest Information Update: 12 Oct 2025

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At a glance

  • Originator Regor Therapeutics
  • Developer Genentech; Regor Therapeutics
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Cyclin-dependent kinase 2 inhibitors; Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 6 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 HER2 negative breast cancer
  • Phase I Solid tumours

Most Recent Events

  • 12 Oct 2025 GDC 4198 is still in phase I trial for HER2-negative-breast-cancer (Combination therapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (PO, Capsule) (NCT05304962)
  • 12 Oct 2025 GDC 4198 is still in phase I trial for HER2-negative-breast-cancer (Monotherapy, Inoperable/Unresectable, Late-stage disease, Metastatic disease) in USA (PO, Capsule) (NCT05304962)
  • 25 Sep 2025 Phase-I/II clinical trials in HER2-negative-breast-cancer (Late-stage disease, Metastatic disease, Second-line therapy or greater, Combination therapy) in USA (PO) (NCT07100106)

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