Givinostat hydrochloride is under clinical development by Italfarmaco and currently in Pre-Registration for Duchenne Muscular Dystrophy. According to GlobalData, Pre-Registration drugs for Duchenne Muscular Dystrophy have an 83% phase transition success rate (PTSR) indication benchmark for progressing into Marketed. GlobalData’s report assesses how Givinostat hydrochloride’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 hydrochloride 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 licenses medicinal products. The company’s product portfolio includes antithrombotics, antihypertensive drugs, vitamin and mineral supplements, peripheral vasodilators and antineoplastic drugs, 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, the US and Brazil. Italfarmaco is headquartered in Milan, Lombardia, Italy.

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

This content was updated on 18 March 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.