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AMXT 1501

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Drug Profile

AMXT 1501

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

Latest Information Update: 30 Mar 2026

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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; Diffuse intrinsic pontine glioma
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Solid tumours
  • Phase 0 Glioma

Most Recent Events

  • 12 Mar 2026 AMXT 1501 receives Orphan Drug status for Diffuse intrinsic pontine glioma (Combination therapy) in USA
  • 02 Mar 2026 Phase-I/II clinical trials in Solid tumours (Combination therapy, In children, In adolescents, In adults) in USA (PO) (NCT06465199)
  • 18 Dec 2025 Aminex Therapeutics initiates enrolment in a phase Ib/II trial for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease, Inoperable/Unresectable, Second-line therapy or greater, In adults, In the elderly) in USA (PO, Tablet) (NCT07287917)

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