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TOS 358

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Drug Profile

TOS 358

Alternative Names: TOS-358

Latest Information Update: 12 Jan 2026

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At a glance

  • Originator Totus Medicines
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Phosphatidylinositol 3 kinase alpha 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 Solid tumours
  • Clinical Phase Unknown Breast cancer
  • Research Cancer; CNS cancer; Colorectal cancer; Haematological malignancies; Lung cancer

Most Recent Events

  • 06 Jan 2026 Clinical trials in Breast cancer (Combination therapy, Metastatic disease) (unspecified route)
  • 13 Sep 2024 Efficacy, safety and pharmacokinetics data from a phase-I clinical trials in Solid tumours presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)
  • 10 Apr 2023 US FDA approves IND application for TOS 358 in Solid tumours, before February 2023

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