Melphalan hydrochloride is under clinical development by Delcath Systems and currently in the Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Melphalan hydrochloride’s likelihood of approval (LoA) and phase transition for Ocular Melanoma took place on 28 Jan 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Melphalan hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Melphalan hydrochloride overview

Melphalan hydrochloride in combination with chemosaturation therapy is under development for the treatment of colorectal cancer, ocular melanoma metastatic to the liver and liver metastasis of uveal melanoma. The drug is administered by intrahepatic arterial infusion. The drug candidate was also under development for hepatocellular carcinoma, unresectable sarcoma of the extremity, adenocarcinomas of gastrointestinal origin, neuroendocrine tumors, cutaneous melanoma metastatic to the liver. It was also under development for the treatment of intra hepatic cholangiocarcinoma.

Delcath Systems overview

Delcath Systems (Delcath) specializes in developing percutaneous hepatic perfusion technologies to treat primary and metastatic liver cancers. Its patented drug delivery platform delivers ultra-high doses of chemotherapeutic agents to the liver while preventing them from entering the patient’s bloodstream. The company’s lead product is Melphalan Hydrochloride for Injection for use with the proprietary Delcath Hepatic Delivery System (HEPZATO KIT) to administer high-dose chemotherapy to the liver. The company sells its proprietary system to deliver and filter melphalan hydrochloride in Europe under the trade name, Delcath Chemosat Hepatic Delivery System for Melphalan (Chemosat). Delcath is headquartered in New York, the US.

Quick View Melphalan hydrochloride LOA Data

Report Segments
  • Innovator
Drug Name
  • Melphalan hydrochloride
Administration Pathway
  • Intrahepatic
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase III

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

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.