Melphalan flufenamide hydrochloride is a Peptide owned by Oncopeptides, and is involved in 4 clinical trials, of which 3 were completed, and 1 is planned.

Melphalan flufenamide (Mel-flufen, J-1) acts as DNA synthesis inhibitor. The drug candidate is a prodrug of melphalan that consists of a dipeptide bound to melphalan. It is activated by aminopeptidase N in the cytoplasm. The drug candidate is a bifunctional alkylating agent which reacts with an atom on each of the two DNA strands to produce a cross-link that covalently links the two strands of the DNA double helix. The cross-links prevent cells from replicating effectively and can eventually lead to cell death.

The revenue for Melphalan flufenamide hydrochloride is expected to reach a total of $1.4bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Melphalan flufenamide hydrochloride NPV Report.

Melphalan flufenamide hydrochloride was originated by Karolinska Institute and is currently owned by Oncopeptides.

Melphalan flufenamide hydrochloride Overview

Melphalan flufenamide hydrochloride (Pepaxto / Pepaxti) is a peptide conjugate alkylating drug acts as an antineoplastic agent. It is formulated as lyophilized powder for solution for intravenous route of administration. It is indicated to treat relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

Melphalan flufenamide (Mel-flufen, J-1) is under development for the treatment of relapsed or refractory multiple myeloma, acute myelocytic leukemia and relapsed diffuse large B-cell lymphoma. The drug candidate is administered through intravenous route. It is a prodrug of melphalan that consists of a dipeptide bound to melphalan.

It was also under development for solid tumors such as non-small cell lung cancer, ovarian cancer, small-cell lung cancer, high-dose setting in conjunction with bone marrow transplantation in newly diagnosed multiple myeloma, breast cancer, malignant mesothelioma, Non-Hodgkin's lymphoma, urothelial cancer, amyloidosis and bladder cancer.

Oncopeptides Overview

Oncopeptides is a pharmaceutical company, It focusses on therapies to treat hematological diseases. Its lead product includes Melflufen, a peptide drug conjugate, which is used to treat hematological cancer and relapsed and refractory multiple myeloma. The company is also carrying on clinical studies for developing an OPD5 product, which is used to treat relapsed and refractory multiple myeloma (myeloablative conditioning regimen). Oncopeptides utilize a peptide-drug conjugate (PDC) technology platform to deliver cytotoxic activity to the cancer cells and safeguard the healthy cells. The company has operations in the US and Sweden. Oncopeptides is headquartered in Stockholm, Sweden.

The company reported revenues of (Swedish Krona) SEK118.3 million for the fiscal year ended December 2021 (FY2021). The operating loss of the company was SEK1,420.9 million in FY2021, compared to an operating loss of SEK1,591.3 million in FY2020. The net loss of the company was SEK1,430.3 million in FY2021, compared to a net loss of SEK1,594.7 million in FY2020.

Quick View – Melphalan flufenamide hydrochloride

Report Segments
  • Innovator (NME)
Drug Name
  • Melphalan flufenamide hydrochloride
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.