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AMXT 1501

Drug Profile

AMXT 1501

Alternative Names: AMX-513; AMX513 dicaprate; AMXT 1501 dicaprate; AMXT-1501

Latest Information Update: 08 Oct 2025

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At a glance

  • Originator Aminex Therapeutics
  • Class Antineoplastics; Small molecules
  • Mechanism of Action Polyamine uptake inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Neuroblastoma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Solid tumours
  • Phase 0 Glioma

Most Recent Events

  • 08 Oct 2025 Aminex plans a clinical trial for Malignant melanoma and Breast cancer (Metastatic disease, Combination therapy)
  • 02 Oct 2025 AMXT 1501 receives Orphan Drug status for Neuroblastoma (Combination therapy) in USA
  • 24 Dec 2024 Aminex Therapeutics terminates a phase I/II trial in Solid tumours (Combination therapy, Late-stage disease, Inoperable/Unresectable, In children, In adolescents, In the elderly, In adults, Metastatic disease, Second-line therapy or greater) in USA and Australia (PO) because DFMO required reformulation from IV to capsule to maintain safety (NCT05500508)

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