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

Stem definition	Drug id	CAS RN
	5227	1025504-45-3

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: valbenazine valbenazine tosylate ingrezza NBI-98854 NBI 98854 valbenazine ditosylate dysval	The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release. Molecular weight: 418.58 Formula: C24H38N2O4 CLOGP: 3.77 LIPINSKI: 0 HAC: 6 HDO: 1 TPSA: 74.02 ALOGS: -4.04 ROTB: 8 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

valbenazine
valbenazine tosylate
ingrezza
NBI-98854
NBI 98854
valbenazine ditosylate
dysval

The mechanism of action of valbenazine in the treatment of tardive dyskinesia is unknown, but is thought to be mediated through the reversible inhibition of vesicular monoamine transporter 2 (VMAT2), a transporter that regulates monoamine uptake from the cytoplasm to the synaptic vesicle for storage and release.

Molecular weight: 418.58
Formula: C24H38N2O4
CLOGP: 3.77
LIPINSKI: 0
HAC: 6
HDO: 1
TPSA: 74.02
ALOGS: -4.04
ROTB: 8

Status: ONP

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

Drug dosage:

None

ADMET properties:

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Property	Value	Reference
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ
t_half (Half-life)	18 hours	Lombardo F, Berellini G, Obach RS
CL (Clearance)	1.71 mL/min/kg	Lombardo F, Berellini G, Obach RS
Vd (Volume of distribution)	1.31 L/kg	Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma)	0.01 %	Lombardo F, Berellini G, Obach RS

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Approvals:

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Date	Agency	Company	Orphan
April 11, 2017	FDA	NEUROCRINE BIOSCIENCES INC
March 28, 2022	PMDA	Mitsubishi Tanabe Pharma Corporation

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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
Somnolence	479.52	35.01	250	4951	178435	63305386
Drooling	391.32	35.01	85	5116	3783	63480038
Tremor	292.00	35.01	163	5038	132076	63351745
Parkinsonism	275.46	35.01	78	5123	10361	63473460
Sedation	224.92	35.01	93	5108	38716	63445105
Dyskinesia	183.03	35.01	76	5125	31926	63451895
Hospitalisation	140.21	35.01	87	5114	84994	63398827
Death	115.36	35.01	147	5054	374234	63109587
Balance disorder	97.01	35.01	69	5132	84353	63399468
Therapeutic product effect decreased	93.51	35.01	96	5105	193091	63290730

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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
Drooling	414.64	45.50	86	2599	3296	34950950
Somnolence	274.92	45.50	144	2541	110972	34843274
Parkinsonism	170.18	45.50	50	2635	8088	34946158
Tremor	164.48	45.50	93	2592	82494	34871752
Sedation	151.97	45.50	58	2627	20948	34933298
Hospitalisation	99.49	45.50	59	2626	56843	34897403
Therapeutic product effect decreased	79.50	45.50	43	2642	34700	34919546
Drug ineffective	78.43	45.50	131	2554	456620	34497626
Fall	67.23	45.50	80	2605	202805	34751441
Anxiety	65.67	45.50	57	2628	99371	34854875

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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
Somnolence	447.82	36.45	247	5143	238734	79500264
Drooling	442.15	36.45	98	5292	5836	79733162
Tremor	301.80	36.45	170	5220	169913	79569085
Parkinsonism	233.47	36.45	73	5317	16511	79722487
Sedation	190.08	36.45	85	5305	51810	79687188
Death	149.94	36.45	187	5203	566327	79172671
Hospitalisation	147.43	36.45	87	5303	94149	79644849
Dyskinesia	143.93	36.45	67	5323	44706	79694292
Anxiety	103.12	36.45	104	5286	248408	79490590
Restlessness	97.29	36.45	52	5338	46440	79692558

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FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

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Source	Code	Description
ATC	N07XX13	NERVOUS SYSTEM OTHER NERVOUS SYSTEM DRUGS OTHER NERVOUS SYSTEM DRUGS Other nervous system drugs
FDA EPC	N0000190856	Vesicular Monoamine Transporter 2 Inhibitor
FDA MoA	N0000190855	Vesicular Monoamine Transporter 2 Inhibitors

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

Disease	Relation	SNOMED_ID	DOID
Tardive dyskinesia	indication	102449007

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	8.25	Basic
pKa2	7.56	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 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	8357697	Nov. 8, 2027	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10065952	Oct. 28, 2036	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10844058	Oct. 28, 2036	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10851103	Oct. 28, 2036	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10851104	Oct. 28, 2036	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10857137	Oct. 10, 2037	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10857148	Oct. 10, 2037	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10874648	Oct. 10, 2037	METHOD OF ADMINISTERING VALBENAZINE WHILE AVOIDING CONCOMITANT USE OF A STRONG CYP3A4 INDUCER
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10874648	Oct. 10, 2037	TREATMENT OF TARDIVE DYSKINESIA
EQ 40MG BASE	INGREZZA	NEUROCRINE	N209241	April 11, 2017	RX	CAPSULE	ORAL	10912771	Oct. 10, 2037	METHOD OF TREATING TARDIVE DYSKINESIA WHILE AVOIDING CONCOMITANT USE OF A STRONG CYP3A4 INDUCER

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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
Synaptic vesicular amine transporter	Transporter	Q05940	VMAT2_HUMAN	INHIBITOR	Ki	8.52	DRUG LABEL	DRUG LABEL
Potassium voltage-gated channel subfamily H member 2	Ion channel	Q12809	KCNH2_HUMAN		IC50	5.77	CHEMBL
Synaptic vesicular amine transporter	Transporter		VMAT2_RAT	INHIBITOR	Ki	6.73	IUPHAR

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External reference:

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ID	Source
017167	NDDF
017168	NDDF
14580381	PUBCHEM_CID
1639208-54-0	SECONDARY_CAS_RN
1918219	RXNORM
24795069	PUBCHEM_CID
255701	MMSL
32624	MMSL
4036639	VANDF
54K37P50KH	UNII

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Pharmaceutical products:

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Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-1060	CAPSULE	60 mg	ORAL	NDA	29 sections
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-1060	CAPSULE	60 mg	ORAL	NDA	29 sections
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-1080	CAPSULE	80 mg	ORAL	NDA	29 sections
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-1080	CAPSULE	80 mg	ORAL	NDA	29 sections
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-2040	CAPSULE	40 mg	ORAL	NDA	29 sections
INGREZZA	HUMAN PRESCRIPTION DRUG LABEL	1	70370-2040	CAPSULE	40 mg	ORAL	NDA	29 sections

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