Givinostat is under clinical development by Italfarmaco and currently in Phase II for Myelofibrosis. According to GlobalData, Phase II drugs for Myelofibrosis have a 43% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Givinostat’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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 includes antithrombotics, antihypertensive drugs, vitamin and mineral supplements, peripheral vasodilators, antineoplastic drugs, antianemics, among others. Italfarmaco offers products in the 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. The company 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, Lombardia, Italy.

For a complete picture of Givinostat’s drug-specific PTSR and LoA scores, buy the report here.


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.