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TOS 358

Drug Profile

TOS 358

Alternative Names: TOS-358

Latest Information Update: 12 Apr 2023

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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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase I Solid tumours
  • Research Cancer; CNS cancer; Colorectal cancer; Haematological malignancies; Lung cancer

Most Recent Events

  • 10 Apr 2023 US FDA approves IND application for TOS 358 in Solid tumours, before February 2023
  • 15 Feb 2023 Phase-I clinical trials in Solid tumours (Metastatic disease, Late-stage disease, Recurrent, Second-line therapy or greater) in USA (PO) (NCT05683418)
  • 23 Feb 2022 Early research in Lung cancer, CNS cancer, Cancer (RAS mutant, Oncogenic mutant multiple cancers), Hematological malignancies and Colorectal cancer in USA (unspecified route) as of February 2022 (Totus Medicines pipeline; February 2022)
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