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Melphalan flufenamide

Alternative Names: melphalan flufenamide, melflufen, pepaxto
Clinical Status: Active
Latest Update: 2025-04-01
Latest Update Note: Clinical Trial Update

Product Description

Melphalan flufenamide (melflufen, Pepaxto®) is a peptide conjugated alkylating drug developed by Oncopeptides for the treatment of multiple myeloma (MM) and amyloid light-chain amyloidosis. It is an ethyl ester of a lipophilic dipeptide consisting of melphalan and para-fluoro-L-phenylalanine.  (Sourced from: https://pubmed.ncbi.nlm.nih.gov/33961277/)

Mechanisms of Action: Alkylating Agent

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Intravenous

FDA Designation: *

Approval Status: Not Approved

Approved Countries: Belgium | Croatia | Czech | European Medicines Agency | Finland | Greece | Hungary | Iceland | Ireland | Italy | Lithuania | Poland | Portugal | Slovakia | Sweden | United States

Approved Indications: None

Known Adverse Events: None

Company: Oncopeptides AB
Company Location:
Company CEO:
Additional Commercial Interests: None

Clinical Description

Countries in Clinic:

Active Clinical Trial Count: 1

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Multiple Myeloma

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

OCEAN

P3

Completed

Multiple Myeloma

2023-02-03

2025-05-06

Primary Completion Date|Study Completion Date|Treatments|Trial Status