KML-001 is under clinical development by Komipharm International and currently in the Phase II 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 KML-001’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 31 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their KML-001 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

KML-001 overview

KML-001(sodium metaarsenite) is under development for the treatment of solid tumors including breast cancer, colorectal cancer, refractory non-Hodgkin lymphoma, metastatic biliary tract cancer, lung cancer metastatic to the brain, hepatocellular carcinoma, bile duct cancer (cholangiocarcinoma), glioblastoma multiforme (GBM), non-small cell lung cancer, lung cancer and malignant glioma. It is administered through oral route.The drug candidate is an arsenic compound. It was also under development for the treatment of colorectal, bone metastasis, transitional cell cancer, germ cell tumors, ovarian cancer, acute myelocytic leukemia, pancreatic cancer ,prostate cancer, esophageal cancer.

Komipharm International overview

Komipharm International (Komipharm) provides pharmaceutical and animal health products. The company’s product pipeline includes PAX-1-001, a non-opioid drug candidate designed to treat cancer pain; PAX-1-002 for treating brain cancer; PAX-1-004 against gallbladder, prostate cancer and multiple myeloma; KML001 an oral drug used for the treatment of prostate, solid, biliary tract, lung and liver cancer and malignant lymphoma; PAX-1-003, to treat lung to brain metastases, head and neck cancer, metastatic melanoma, osteosarcoma and soft tissue cancer. It also develops vaccines and medical products for treating fever, pain, skin problems and other diseases in animals. Komipharm works in partnership with other pharmaceutical companies worldwide to develop its pipeline products. The company operates production facilities in Australia, the US and South Korea. Komipharm is headquartered in Siheung, South Korea

Quick View KML-001 LOA Data

Report Segments
  • Innovator
Drug Name
  • KML-001
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.