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

Stem definition	Drug id	CAS RN
histone deacetylase inhibitors	4682	404950-80-7

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: farydak panobinostat lactate panobinostat lactate anhydrous panobinostat LBH-589 LBH589	An indole and hydroxamic acid derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used as an antineoplastic agent in combination with BORTEZOMIB and DEXAMETHASONE for the treatment of MULTIPLE MYELOMA. Molecular weight: 349.43 Formula: C21H23N3O2 CLOGP: 2.42 LIPINSKI: 0 HAC: 5 HDO: 4 TPSA: 77.15 ALOGS: -5.25 ROTB: 7 Status: OFM Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

farydak
panobinostat lactate
panobinostat lactate anhydrous
panobinostat
LBH-589
LBH589

An indole and hydroxamic acid derivative that acts as a HISTONE DEACETYLASE inhibitor. It is used as an antineoplastic agent in combination with BORTEZOMIB and DEXAMETHASONE for the treatment of MULTIPLE MYELOMA.

Molecular weight: 349.43
Formula: C21H23N3O2
CLOGP: 2.42
LIPINSKI: 0
HAC: 5
HDO: 4
TPSA: 77.15
ALOGS: -5.25
ROTB: 7

Status: OFM

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
t_half (Half-life)	13.10 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	10.20 mL/min/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.10 %	Lombardo F, Berellini G, Obach RS

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Approvals:

Date	Agency	Company	Orphan
Aug. 28, 2015	EMA
Feb. 23, 2015	FDA	NOVARTIS PHARMS CORP

FDA Adverse Event Reporting System (Female)

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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
Malignant neoplasm progression	90.03	34.67	42	1443	82079	63405458
Diarrhoea	88.83	34.67	95	1390	715271	62772266
Platelet count decreased	81.84	34.67	44	1441	116078	63371459
Death	61.24	34.67	58	1427	374323	63113214
Thrombocytopenia	61.03	34.67	40	1445	151117	63336420
Plasma cell myeloma	47.58	34.67	21	1464	35884	63451653
Plasmacytoma	46.37	34.67	11	1474	2568	63484969

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FDA Adverse Event Reporting System (Male)

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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
Diarrhoea	102.38	34.11	118	1899	389794	34565120
Platelet count decreased	93.04	34.11	67	1950	119650	34835264
Malignant neoplasm progression	84.13	34.11	56	1961	87990	34866924
Morganella infection	48.11	34.11	10	2007	512	34954402
Bronchial haemorrhage	45.06	34.11	10	2007	699	34954215
Thrombocytopenia	39.98	34.11	47	1970	156200	34798714

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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
Platelet count decreased	158.61	32.97	97	3027	194567	79546697
Malignant neoplasm progression	137.52	32.97	78	3046	135912	79605352
Diarrhoea	124.16	32.97	161	2963	880328	78860936
Thrombocytopenia	74.49	32.97	70	3054	265189	79476075
Plasma cell myeloma	63.14	32.97	34	3090	53225	79688039
Death	51.98	32.97	85	3039	566429	79174835
Plasmacytoma	47.75	32.97	14	3110	4389	79736875
Morganella infection	44.29	32.97	10	3114	1117	79740147
Bronchial haemorrhage	42.71	32.97	10	3114	1310	79739954
White blood cell count decreased	40.39	32.97	43	3081	188245	79553019

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	L01XH03	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
FDA MoA	N0000182137	Cytochrome P450 2D6 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|

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Disease	Relation	SNOMED_ID	DOID
Multiple myeloma	indication	109989006	DOID:9538
Primary cutaneous T-cell lymphoma	indication	400122007

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🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.83	acidic
pKa2	13.3	acidic
pKa3	9.33	Basic

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
EQ 10MG BASE	FARYDAK	SECURA	N205353	Feb. 23, 2015	DISCN	CAPSULE	ORAL	8883842	June 13, 2028	TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
EQ 15MG BASE	FARYDAK	SECURA	N205353	Feb. 23, 2015	DISCN	CAPSULE	ORAL	8883842	June 13, 2028	TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE
EQ 20MG BASE	FARYDAK	SECURA	N205353	Feb. 23, 2015	DISCN	CAPSULE	ORAL	8883842	June 13, 2028	TREATMENT OF MULTIPLE MYELOMA, IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE

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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 11	Enzyme	Q96DB2	HDA11_HUMAN	INHIBITOR	Ki	8.46	CHEMBL	DRUG LABEL
Histone deacetylase 7	Enzyme	Q8WUI4	HDAC7_HUMAN	INHIBITOR	Ki	8.64	CHEMBL	DRUG LABEL
Histone deacetylase 8	Enzyme	Q9BY41	HDAC8_HUMAN	INHIBITOR	Ki	7.66	CHEMBL	DRUG LABEL
Histone deacetylase 4	Enzyme	P56524	HDAC4_HUMAN	INHIBITOR	Ki	9.22	CHEMBL	DRUG LABEL
Histone deacetylase 9	Enzyme	Q9UKV0	HDAC9_HUMAN	INHIBITOR	Ki	8.92	CHEMBL	DRUG LABEL
Histone deacetylase 10	Enzyme	Q969S8	HDA10_HUMAN	INHIBITOR	Ki	7.51	CHEMBL	DRUG LABEL
Histone deacetylase 5	Enzyme	Q9UQL6	HDAC5_HUMAN	INHIBITOR	Ki	9.15	CHEMBL	DRUG LABEL
Histone deacetylase 2	Enzyme	Q92769	HDAC2_HUMAN	INHIBITOR	Ki	9.19	CHEMBL	DRUG LABEL
Histone deacetylase 1	Enzyme	Q13547	HDAC1_HUMAN	INHIBITOR	Ki	9	CHEMBL	DRUG LABEL
Histone deacetylase 3	Enzyme	O15379	HDAC3_HUMAN	INHIBITOR	Ki	8.96	CHEMBL	DRUG LABEL

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External reference:

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ID	Source
LBH	PDB_CHEM_ID
015928	NDDF
015929	NDDF
1603349	RXNORM
232927	MMSL
30903	MMSL
4034263	VANDF
429068009	SNOMEDCT_US
429398005	SNOMEDCT_US
6918837	PUBCHEM_CID

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0650	CAPSULE	10 mg	ORAL	NDA	30 sections
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0651	CAPSULE	15 mg	ORAL	NDA	30 sections
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	0078-0652	CAPSULE	20 mg	ORAL	NDA	30 sections
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	73116-100	CAPSULE	10 mg	ORAL	NDA	34 sections
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	73116-101	CAPSULE	15 mg	ORAL	NDA	34 sections
FARYDAK	HUMAN PRESCRIPTION DRUG LABEL	1	73116-102	CAPSULE	20 mg	ORAL	NDA	34 sections

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