Givinostat 8.86 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Oral suspension

Available Strengths: 8.86 mg/mL

Reference Brands: Duvyzat (USA/EU)

Category: Neurology

Givinostat is a histone deacetylase (HDAC) inhibitor which works by inhibiting class I and II HDAC enzymes, reducing inflammation, muscle degeneration and fibrosis in patients with Duchenne muscular dystrophy. It is indicated for patients aged 6 years and older with DMD, regardless of specific genetic variant. The medication is given as a twice daily oral suspension with food, and requires monitoring of blood counts and triglycerides due to risks of thrombocytopenia and hypertriglyceridaemia.

Product Description:

Givinostat is an oral histone deacetylase inhibitor for Duchenne muscular dystrophy. In dystrophic muscle, loss of dystrophin disrupts nitric oxide signalling, which leaves HDAC activity abnormally high and drives inflammation, fibrosis and fat replacement of muscle. Inhibiting HDAC aims to slow that degeneration, and it does so independently of the patient's specific mutation — unlike exon-skipping therapies, which only work for particular deletions.

It is taken twice daily as an oral suspension, dosed by body weight, alongside corticosteroids, in ambulant boys aged six and over. In the pivotal trial it slowed decline in a timed stair-climb compared with placebo; the effect was modest, and outcomes beyond the trial period are still being established. Thrombocytopenia is the main dose-limiting adverse effect, so platelet counts are monitored and the dose is reduced if they fall. Raised triglycerides, diarrhoea and QT prolongation also need watching.

Sourcing notes. Originator product, with no generic. Approved in the US in 2024 and conditionally authorised in the EU in 2025, which means continued authorisation depends on further data being provided. Registration elsewhere is limited, so most supply outside those regions is named-patient import. The suspension needs dose-accurate dispensing by weight, and supply comes with the originator's patient support arrangements.