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: None *
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:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count: 4
Highest Development Phases
Phase 3: Multiple Myeloma
Phase 2: Amyloidosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2018-002761-19 | P2 |
Active, not recruiting |
Amyloidosis |
2023-02-15 |
|
| Anchor Trial | P2 |
Completed |
Multiple Myeloma |
2022-02-02 |
|
| PORT study | P2 |
Completed |
Multiple Myeloma |
2022-01-10 |
|
| OCEAN | P3 |
Active, not recruiting |
Multiple Myeloma |
2020-11-17 |