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Melphalan flufenamide - Oncopeptides

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Drug Profile

Melphalan flufenamide - Oncopeptides

Alternative Names: CK-1535; J 1; Mel-flufen; Melphalan flufenamide hydrochloride - Oncopeptides; Melphalan-prodrug-Oncopeptides; Pepaxti; PEPAXTO; Ygalo

Latest Information Update: 29 Aug 2026

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At a glance

  • Originator Oncopeptides
  • Class Amides; Amines; Antineoplastics; Chlorinated hydrocarbons; Esters; Fluorobenzenes; Peptide drug conjugates
  • Mechanism of Action Alkylating agents
  • Orphan Drug Status

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

    Yes - Multiple myeloma
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Multiple myeloma
  • Phase I/II Amyloid light-chain amyloidosis
  • Phase I Glioblastoma
  • No development reported Acute myeloid leukaemia; Breast cancer; Diffuse large B cell lymphoma
  • Discontinued Cancer

Most Recent Events

  • 17 Jun 2026 Phase-I clinical trials in Glioblastoma (Recurrent) in Norway (IV) (CTIS2026-525543-32-00)
  • 15 May 2026 Oncopeptides plans a phase I pharmacokinetics trial for Glioblastoma (Recurrent) in Norway (Parenteral) in June 2026 (CTIS2026-525543-32-00)
  • 28 Jun 2025 No recent reports of development identified for preclinical development in Acute-myeloid-leukaemia(Second-line therapy or greater) in Sweden (Parenteral)

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