Tagraxofusp is under clinical development by A. Menarini Industrie Farmaceutiche Riunite and currently in the Phase I, 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 Tagraxofusp’s likelihood of approval (LoA) and phase transition for Myelofibrosis took place on 04 Mar 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 Tagraxofusp Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tagraxofusp overview

Tagraxofusp (Elzonris) acts as an immunosuppresant. It is formulated as injectable solution and concentrate for solution for intravenous route of administration. Elzonris is indicated for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adults and in pediatric patients 2 years and older with both treatment-naïve and previously-treated blastic plasmacytoid dendritic cell neoplasm.

Tagraxofusp (SL-401) is under development for the treatment of  blastic plasmacytoid dendritic cell neoplasm, hematologic malignancies including blastic plasmacytoid dendritic cell neoplasm (BPDCN), relapsed/refractory myelofobrosis (MF), acute myeloid leukemia (AML), relapsed/refractory chronic myelomonocytic leukemia (CMML), myelodysplastic syndrome (MDS), multiple myeloma and other disorders include systemic mastocytosis (SM), advanced symptomatic primary eosinophilic disorder (PED), systemic sclerosis, and hypereosinophilic syndrome. The drug candidate is administered through intravenous route as infusion. It is a diphtheria toxin (DT)-IL3 fusion protein. It acts by targeting the IL-3R and is developed based on StemScreen technology. The drug candidate was under development for the treatment of T-cell acute lymphoblastic leukemia (T-ALL), mantle cell lymphoma, Hodgkin’s lymphoma.

A. Menarini Industrie Farmaceutiche Riunite overview

A. Menarini Industrie Farmaceutiche Riunite (Menarini), formerly Farmacia Internazionale, is a biopharmaceutical company that undertakes the research, development and manufacture of several pharmaceutical products in various dosage forms. The company’s products portfolio is focused on a several therapeutic and wellness areas, including allergy, andrology, ant infective areas, cardiovascular areas, gastrointestinal disorders, gynecology and women’s wellness, respiratory areas, rheumatology, osteoporosis, dermatology and personal care, energy supplements and multivitamins, among others. Menarini operates through its manufacturing sites, and research and development centers and has a presence across Europe and Asia, Africa, and Central and South America. It distributes products across various countries worldwide through partners and distributors. Menarini is headquartered in Florence, Italy.

Quick View Tagraxofusp LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tagraxofusp
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Gastrointestinal
  • Hematological Disorders
  • Immunology
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

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.