Givinostat is under clinical development by Italfarmaco 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 Givinostat’s likelihood of approval (LoA) and phase transition for Duchenne Muscular Dystrophy took place on 20 Oct 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 Givinostat Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Givinostat overview

Givinostat is under development for the treatment of myeloproliferative diseases including essential thrombocythemia, post-polycythemia vera myelofibrosis (PPV-MF),post-essential thrombocythemia myelofibrosis, polycythemia vera, post-essential thrombocythemia myelofibrosis, Becker muscular dystrophy and Duchenne muscular dystrophy in ambulant children. It is administered through the oral route as an oral suspension and hard gelatin capsule. Givinostat is a histone deacetylase inhibitor. It was also under development for the treatment of Crohn's disease, chronic lymphocytic leukemia and relapsed and refractory multiple myeloma, systemic juvenile idiopathic arthritis (SJIA), systemic cryptococcosis and Hodgkin lymphoma. It is a hydroxamate.

Italfarmaco overview

Italfarmaco, a subsidiary of Italfarmaco Holding SpA, is a pharmaceutical and chemical company that develops, manufactures, commercializes, and licences medicinal products. The company’s products portfolio comprises antithrombotics, antihypertensive drugs, Vitamin and mineral supplements, peripheral vasodilators, antineoplastic drugs, antianemics, among others across the therapeutic areas of cardiovascular, osteoporosis, inflammation, gynecology, immuno-oncologic, neurology, and osteoporosis. It also undertakes research and development projects in the areas of inflammation, muscular and nervous degeneration, oncology, and others. Italfarmaco operates manufacturing plants in Frosinone, Italy; Camacari Brazil; and Malta. The company markets products in Switzerland, Spain, Portugal, Greece, Russia, Turkey, Chile, Peru, Morocco, United States, and Brazil. Italfarmaco is headquartered in Milan, Italy.

Quick View Givinostat LOA Data

Report Segments
  • Innovator
Drug Name
  • Givinostat
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Genetic Disorders
  • Infectious Disease
  • Musculoskeletal 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.