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PM 54

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Drug Profile

PM 54

Alternative Names: PM-54

Latest Information Update: 31 Dec 2025

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At a glance

  • Originator PharmaMar
  • Class Antineoplastics
  • Mechanism of Action Apoptosis stimulants; RNA polymerase II 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

Most Recent Events

  • 18 Dec 2025 US FDA approves IND application for PM 54 in Solid tumours
  • 18 Dec 2025 PharmaMar plans a phase I/II trial for Solid tumours, including Malignant melanoma, Endometrial cancer, Neuroendocrine tumours and Mesothelioma (Combination therapy, Late-stage disease) in USA (IV)
  • 14 Oct 2025 PM 54 is still in phase-I clinical trials in Solid tumours (Late-stage disease, Second-line therapy or greater, Monotherapy) in Belgium, USA and Spain (IV) (NCT05841563) (PharmaMar pipeline; October 2025)

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