CSL-346 is under clinical development by CSL 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 CSL-346’s likelihood of approval (LoA) and phase transition for Diabetic Nephropathy took place on 07 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 07 Nov 2022 increased CSL-346’s LoA and PTSR for Lipid Disorders.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their CSL-346 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

CSL-346 overview

CSL-346 (VEGF-B antagonist) is under development for the treatment of diabetic nephropathy or other conditions associated with aberrant lipid metabolism. The drug candidate is administered by subcutaneous and intravenous injection. CSL-346 is a version of the 2H10 antibody. It is a monoclonal antibody that antagonizes VEGF-B. It was also under development for breast carcinomas, survival of new vessels in the eye.

CSL overview

CSL discovers, develops, manufactures, commercializes and distributes biopharmaceuticals and related products. Its portfolio encompasses plasma-derived products for the treatment of hemophilia, hereditary angioedema, von Willebrand disease, inherited primary and secondary immune deficiencies, respiratory disease, neurological disorders and protein-based medicines for treating serious human illnesses. The company also provides products for the prevention of hemolytic disease in newborns, infection in solid organ transplant recipients and to treat specific infections for victims of trauma and burns. CSL markets an array of vaccines, anti-venoms and pharmaceutical products of various other manufacturers. The company sells its products in Australia, Germany, Switzerland, the US, the UK and other countries. CSL is headquartered in Parkville, Victoria, Australia.

Quick View CSL-346 LOA Data

Report Segments
  • Innovator
Drug Name
  • CSL-346
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Metabolic Disorders
  • Oncology
  • Ophthalmology
Key Developers
  • Sponsor Company: CSL
  • Originator: CSL Innovation
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.