Givinostat

Givinostat
Clinical data
Trade names	Duvyzat
AHFS/Drugs.com	Monograph
MedlinePlus	a624025
License data	US DailyMed: Givinostat;
Routes of; administration	By mouth
Drug class	Histone deacetylase inhibitor
ATC code	M09AX14 (WHO) ;
Legal status
Legal status	US: ℞-only; EU: Rx-only;
Identifiers
	IUPAC name {6-[(diethylamino)methyl]naphthalen-2-yl}methyl [4-(hydroxycarbamoyl)phenyl]carbamate;
CAS Number	497833-27-9 ;
PubChem CID	9804992;
IUPHAR/BPS	7490;
DrugBank	DB12645;
ChemSpider	7980752 ;
UNII	5P60F84FBH;
KEGG	D12742;
ChEBI	CHEBI:94187;
ChEMBL	ChEMBL1213492;
PDB ligand	QCM (PDBe, RCSB PDB);
CompTox Dashboard (EPA)	DTXSID70198049 ;
ECHA InfoCard	100.258.524
Chemical and physical data
Formula	C24H27N3O4
Molar mass	421.497 g·mol−1
3D model (JSmol)	Interactive image;
	SMILES O=C(OCc2cc1ccc(cc1cc2)CN(CC)CC)Nc3ccc(cc3)C(=O)NO;
	InChI InChI=1S/C24H27N3O4/c1-3-27(4-2)15-17-5-7-21-14-18(6-8-20(21)13-17)16-31-24(29)25-22-11-9-19(10-12-22)23(28)26-30/h5-14,30H,3-4,15-16H2,1-2H3,(H,25,29)(H,26,28) ; Key:YALNUENQHAQXEA-UHFFFAOYSA-N ;
	(what is this?) (verify)

Givinostat, sold under the brand name Duvyzat is a medication used for the treatment of Duchenne muscular dystrophy.^[1]^[4] It is a histone deacetylase inhibitor with potential anti-inflammatory, anti-angiogenic, and antineoplastic activities.^[5] It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation and loss of muscle.^[4]

The most common side effects include diarrhea, abdominal pain, low platelets (thrombocytopenia), nausea/vomiting, an increase in triglycerides (a type of fat in the body) (hypertriglyceridemia), and fever.^[4]^[6]

Givinostat was approved for medical use in the United States in March 2024.^[4]^[7] Givinostat is the first nonsteroidal medication approved by the US Food and Drug Administration (FDA) to treat people with all genetic variants of Duchenne muscular dystrophy.^[4] The FDA considers it to be a first-in-class medication.^[8]

^ ^a ^b "Duvyzat- givinostat suspension". DailyMed. 29 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.
^ Cite error: The named reference Duvyzat EPAR was invoked but never defined (see the help page).
^ Cite error: The named reference Duvyzat PI was invoked but never defined (see the help page).
^ ^a ^b ^c ^d ^e "FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy". U.S. Food and Drug Administration (FDA). 21 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.
^ "NCI Drug Dictionary". National Cancer Institute. Archived from the original on 29 June 2023. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.
^ Cite error: The named reference Duvyzat FDA snapshot was invoked but never defined (see the help page).
^ "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.
^ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.

[Duvyzat_FDA_label-1] "Duvyzat- givinostat suspension". DailyMed. 29 March 2024. Archived from the original on 30 April 2024. Retrieved 25 April 2024.

[Duvyzat_EPAR-2] Cite error: The named reference Duvyzat EPAR was invoked but never defined (see the help page).

[Duvyzat_PI-3] Cite error: The named reference Duvyzat PI was invoked but never defined (see the help page).

[FDA_20240321-4] "FDA Approves Nonsteroidal Treatment for Duchenne Muscular Dystrophy". U.S. Food and Drug Administration (FDA). 21 March 2024. Archived from the original on 23 March 2024. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.

[5] "NCI Drug Dictionary". National Cancer Institute. Archived from the original on 29 June 2023. Retrieved 23 March 2024. This article incorporates text from this source, which is in the public domain.

[Duvyzat_FDA_snapshot-6] Cite error: The named reference Duvyzat FDA snapshot was invoked but never defined (see the help page).

[7] "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 29 April 2024. Archived from the original on 30 April 2024. Retrieved 30 April 2024.

[8] New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.

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