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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: 28 Jun 2025

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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
  • No development reported Acute myeloid leukaemia; Breast cancer; Diffuse large B cell lymphoma
  • Discontinued Cancer

Most Recent Events

  • 28 Jun 2025 No recent reports of development identified for preclinical development in Acute-myeloid-leukaemia(Second-line therapy or greater) in Sweden (Parenteral)
  • 28 Jun 2025 No recent reports of development identified for preclinical development in Diffuse large B cell lymphoma(Second-line therapy or greater) in Sweden (Parenteral)
  • 04 Sep 2024 Oncopeptides enters into an exclusive distribution agreement with Veld Pharmaceuticals and Slavpharma to commercialize melphalan flufenamide in Africa and Eurasia

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