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Melphalan drug delivery system - Delcath Systems

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Drug Profile

Melphalan drug delivery system - Delcath Systems

Alternative Names: CHEMOSAT; CHEMOSAT® Hepatic Delivery System for Melphalan; CS-PHP-Melphalan; Generation Two CHEMOSAT Delivery System for Melphalan; Hepzato Kit; HEPZATO-KIT; Melblez Kit; melphalan hydrochloride for injection/hepatic delivery system; Melphalan/HDS; Melphalan/Hepatic Delivery System

Latest Information Update: 28 Aug 2025

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At a glance

  • Originator Yale University School of Medicine
  • Developer Delcath Systems; Leiden University Medical Center
  • Class Antineoplastics; Aromatic amino acids; Myeloablative agonists; Nitrogen mustard compounds; Small molecules
  • Mechanism of Action Alkylating agents; DNA damage stimulants; Immunosuppressants
  • Orphan Drug Status

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

    Yes - Liver cancer; Neuroendocrine tumours; Cholangiocarcinoma; Malignant melanoma; Uveal melanoma; Multiple myeloma
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Liver metastases
  • Phase II/III Cholangiocarcinoma
  • Phase II Liver cancer

Most Recent Events

  • 05 Aug 2025 Phase-II clinical trials in Liver metastases (Combination therapy, Late-stage disease, Second-line therapy or greater) in USA (Intrahepatic) (NCT06607458)
  • 28 Apr 2025 US FDA completes its 30-day review of the IND application for melphalan drug delivery system in Breast cancer for a phase II trial in USA
  • 28 Apr 2025 Delcath Systems plans a phase II trial in HER2-negative breast cancer (Metastatic disease, Combination therapy, Second-line therapy or greater) in USA, Europe (Intrahepatic), in the fourth quarter of 2025

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