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belinostat 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
histone deacetylase inhibitors	4876	414864-00-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: belinostat beleodaq PXD101	a hydroxamate-type inhibitor of histone deacetylase Molecular weight: 318.35 Formula: C15H14N2O4S CLOGP: 0.96 LIPINSKI: 0 HAC: 6 HDO: 3 TPSA: 95.50 ALOGS: -4.05 ROTB: 4 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

belinostat
beleodaq
PXD101

a hydroxamate-type inhibitor of histone deacetylase

Molecular weight: 318.35
Formula: C15H14N2O4S
CLOGP: 0.96
LIPINSKI: 0
HAC: 6
HDO: 3
TPSA: 95.50
ALOGS: -4.05
ROTB: 4

Status: OFP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
CL (Clearance)	23.60 mL/min/kg	Lombardo F, Berellini G, Obach RS
t_half (Half-life)	1.60 hours	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	0.80 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.06 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
July 3, 2014	FDA	SPECTRUM PHARMS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

FDA Adverse Event Reporting System (Geriatric)

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MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Disease progression	73.82	39.15	29	358	184333	79559668

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01XH04	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Histone deacetylase (HDAC) inhibitors
CHEBI has role	CHEBI:35610	antineoplastic agents
CHEBI has role	CHEBI:61115	histone deacetylase inhibitors
FDA EPC	N0000175588	Histone Deacetylase Inhibitor
FDA MoA	N0000175071	Histone Deacetylase Inhibitors
MeSH PA	D000970	Antineoplastic Agents
MeSH PA	D004791	Enzyme Inhibitors
MeSH PA	D056572	Histone Deacetylase Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Peripheral T-cell lymphoma	indication	109977009

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	7.83	acidic
pKa2	9.83	acidic

Orange Book patent data (new drug applications)

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Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
500MG/VIAL	BELEODAQ	ACROTECH BIOPHARMA	N206256	July 3, 2014	RX	POWDER	INTRAVENOUS	6888027	Aug. 10, 2026	TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA (PTCL).

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Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

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Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Histone deacetylase 4	Enzyme	P56524	HDAC4_HUMAN	INHIBITOR	IC50	7.57	SCIENTIFIC LITERATURE	SCIENTIFIC LITERATURE
Histone deacetylase 5	Enzyme	Q9UQL6	HDAC5_HUMAN	INHIBITOR	Ki	7.60	CHEMBL	CHEMBL
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN	INHIBITOR	Ki	9.07	CHEMBL	CHEMBL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN	INHIBITOR	Ki	9.07	CHEMBL	CHEMBL
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN	INHIBITOR	Ki	8.82	CHEMBL	CHEMBL
Histone deacetylase 6	Enzyme	Q9UBN7	HDAC6_HUMAN	INHIBITOR	Ki	8.80	CHEMBL	CHEMBL
Histone deacetylase 7	Enzyme	Q8WUI4	HDAC7_HUMAN	INHIBITOR	Ki	7.29	CHEMBL	CHEMBL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN	INHIBITOR	Ki	7.66	CHEMBL	CHEMBL
Histone deacetylase 9	Enzyme	Q9UKV0	HDAC9_HUMAN	INHIBITOR	Ki	7.62	CHEMBL	CHEMBL
Histone deacetylase 10	Enzyme	Q969S8	HDA10_HUMAN	INHIBITOR	Ki	7.23	CHEMBL	CHEMBL

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External reference:

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ID	Source
5OG	PDB_CHEM_ID
015607	NDDF
1543543	RXNORM
222033	MMSL
30383	MMSL
4033540	VUID
4033540	VANDF
6918638	PUBCHEM_CID
704194004	SNOMEDCT_US
704195003	SNOMEDCT_US

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Beleodaq	Human Prescription Drug Label	1	68152-108	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	26 sections
Beleodaq	Human Prescription Drug Label	1	72893-002	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections
Beleodaq	Human Prescription Drug Label	1	72893-002	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections
Beleodaq	Human Prescription Drug Label	1	72893-002	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections
Beleodaq	Human Prescription Drug Label	1	72893-002	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 mg	INTRAVENOUS	NDA	27 sections

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