Rusfertide acetate is under clinical development by Protagonist Therapeutics and currently in the Phase II and 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 Rusfertide acetate’s likelihood of approval (LoA) and phase transition for Polycythemia Vera took place on 06 Jun 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.

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

Rusfertide acetate overview

PTG-300 is under development for the treatment of iron overload related indications including polycythemia vera and hereditary hemochromatosis. It is a hepcidin mimetic. It is injected through subcutaneous route. The drug candidate is developed based on VectrixTM technology platform.

It was also under development for beta-thalassemia and myelodysplastic syndromes.

Protagonist Therapeutics overview

Protagonist Therapeutics (Protagonist) is a clinical-stage biopharmaceutical company that discovers and develops orally stable peptides as targeted therapies. The company through its proprietary technology platform develops structurally novel oral or injectable peptides for protein-protein interaction targets. Protagonist’s peptides specifically target biological pathways that are also targeted by currently marketed injectable antibody drugs. Protagonist’ product candidates are intended for the treatment of inflammatory bowel disease and other gastrointestinal diseases and hematological disorders. The company has its operations in the US and Australia. Protagonist is headquartered in Milpitas, California, the US.

Quick View Rusfertide acetate LOA Data

Report Segments
  • Innovator
Drug Name
  • Rusfertide acetate
Administration Pathway
  • Intramuscular
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Genetic Disorders
  • Hematological Disorders
  • 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.