givinostat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definitionDrug idCAS RN
histone deacetylase inhibitors 5813 None

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • givinostat
  • duvyzat
  • ITF2357
  • givinostat hydrochloride
Givinostat is an inhibitor of histone deacetylases (HDACs). HDACs are enzymes that regulate gene expression by removing acetyl groups from histone proteins. The precise mechanism by which DUVYZAT exerts its effect in patients with DMD is unknown.
  • Molecular weight: 421.50
  • Formula: C24H27N3O4
  • CLOGP: 4.55
  • LIPINSKI: 0
  • HAC: 7
  • HDO: 3
  • TPSA: 90.90
  • ALOGS:
  • ROTB: 9
  • Status: ONP
    • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

None

Approvals:

DateAgencyCompanyOrphan
March 21, 2024 FDA Italfarmaco S.A.
June 6, 2025 EMA Italfarmaco S.P.A.

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Platelet count decreased 166.73 84.73 52 216 138529 42482538
Blood triglycerides increased 131.39 84.73 28 240 15868 42605199

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Platelet count decreased 145.89 68.75 40 166 230403 110358690
Blood triglycerides increased 134.86 68.75 25 181 23901 110565192

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC M09AX14 MUSCULO-SKELETAL SYSTEM
OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL SYSTEM
Other drugs for disorders of the musculo-skeletal system
FDA MoA N0000175071 Histone Deacetylase Inhibitors
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D056572 Histone Deacetylase Inhibitors
FDA EPC N0000175588 Histone Deacetylase Inhibitor
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors
FDA MoA N0000187061 Organic Cation Transporter 2 Inhibitors
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:48422 angiogenesis inhibitor
CHEBI has role CHEBI:61115 EC 3.5.1.98 (histone deacetylase) inhibitor
CHEBI has role CHEBI:67079 anti-inflammatory agent
CHEBI has role CHEBI:68495 apoptosis inducer

Related Drugs by ATC class:

M09AX Other drugs for disorders of the musculo-skeletal system 11 drugs
aceneuramic acidatalurencasimerseneteplirsengolodirsenhyaluronic acidnusinersenonasemnogene abeparvovecpalovarotenerisdiplamviltolarsen

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Duchenne muscular dystrophy indication 76670001 DOID:11723




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 8.86MG BASE/ML DUVYZAT ITALFARMACO SPA N217865 March 21, 2024 RX SUSPENSION ORAL 9421184 Feb. 3, 2032 A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT
EQ 8.86MG BASE/ML DUVYZAT ITALFARMACO SPA N217865 March 21, 2024 RX SUSPENSION ORAL 9867799 Feb. 3, 2032 A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT
EQ 8.86MG BASE/ML DUVYZAT ITALFARMACO SPA N217865 March 21, 2024 RX SUSPENSION ORAL 10688047 Oct. 28, 2036 A METHOD FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) USING GIVINOSTAT

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 8.86MG BASE/ML DUVYZAT ITALFARMACO SPA N217865 March 21, 2024 RX SUSPENSION ORAL March 21, 2029 NEW CHEMICAL ENTITY
EQ 8.86MG BASE/ML DUVYZAT ITALFARMACO SPA N217865 March 21, 2024 RX SUSPENSION ORAL March 21, 2031 TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY (DMD) IN PATIENTS 6 YEARS OF AGE AND OLDER

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])		Mechanism
action		Bioact sourceMoA source
Histone deacetylase 2 Enzyme INHIBITOR Ki 8.50 IUPHAR DRUG LABEL
Histone deacetylase 1 Enzyme INHIBITOR Ki 8.70 IUPHAR DRUG LABEL
Histone deacetylase 3 Enzyme INHIBITOR Ki 8.50 IUPHAR DRUG LABEL
Histone deacetylase 6 Enzyme INHIBITOR Ki 8.40 IUPHAR DRUG LABEL
Histone deacetylase 8 Enzyme INHIBITOR Ki 7.40 IUPHAR DRUG LABEL
Histone deacetylase 5 Enzyme INHIBITOR Ki 6.22 IUPHAR
Histone deacetylase 11 Enzyme IC50 6.54 CHEMBL
Histone deacetylase 7 Enzyme INHIBITOR EC50 6.79 IUPHAR
Histone deacetylase 4 Enzyme INHIBITOR EC50 7.28 IUPHAR
Histone deacetylase 9 Enzyme INHIBITOR Ki 6.41 IUPHAR
Histone deacetylase 10 Enzyme IC50 6.48 CHEMBL
Histone deacetylase Enzyme IC50 8.12 CHEMBL

External reference:

IDSource
497833-27-9 SECONDARY_CAS_RN
QCM PDB_CHEM_ID
CHEMBL1213492 ChEMBL_ID
C575255 MESH_SUPPLEMENTAL_RECORD_UI
DB12645 DRUGBANK_ID
4043216 VANDF
C2987670 UMLSCUI
CHEBI:94187 CHEBI
CHEMBL6068400 ChEMBL_ID
9132 INN_ID
732302-99-7 SECONDARY_CAS_RN
9804992 PUBCHEM_CID
384243 MMSL
42747 MMSL
d10180 MMSL
019777 NDDF
019778 NDDF
7490 IUPHAR_LIGAND_ID
5P60F84FBH UNII
2678889 RXNORM
1381702000 SNOMEDCT_US
44930611000001101 SNOMEDCT_US
C502418 MESH_SUPPLEMENTAL_RECORD_UI
D12742 KEGG_DRUG
5P60F84FBH INXIGHT DRUGS

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
DUVYZAT HUMAN PRESCRIPTION DRUG LABEL 1 11797-110 SUSPENSION 8.86 mg ORAL NDA 30 sections