viloxazine Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
alkaloids and organic bases 2820 46817-91-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • viloxazine hydrochloride
  • viloxazine
  • emovit
  • viloxazin
  • viloxazine HCl
  • ICI 58,834
  • ICI 58834
A morpholine derivative used as an antidepressant. It is similar in action to IMIPRAMINE. The mechanism of action of viloxazine in the treatment of ADHD is unclear; however, it is thought to be through inhibiting the reuptake of norepinephrine.
  • Molecular weight: 237.30
  • Formula: C13H19NO3
  • CLOGP: 1.76
  • LIPINSKI: 0
  • HAC: 4
  • HDO: 1
  • TPSA: 39.72
  • ALOGS: -2.28
  • ROTB: 5

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
0.20 g O

ADMET properties:

PropertyValueReference
BA (Bioavailability) 85 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.73 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 2.10 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 4.10 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
April 2, 2021 FDA SUPERNUS PHARMS

FDA Adverse Event Reporting System (Female)

None

FDA Adverse Event Reporting System (Male)

None

Pharmacologic Action:

SourceCodeDescription
ATC N06AX09 NERVOUS SYSTEM
PSYCHOANALEPTICS
ANTIDEPRESSANTS
Other antidepressants
FDA MoA N0000000102 Norepinephrine Uptake Inhibitors
FDA EPC N0000175695 Norepinephrine Reuptake Inhibitor
MeSH PA D018663 Adrenergic Agents
MeSH PA D018759 Adrenergic Uptake Inhibitors
MeSH PA D000928 Antidepressive Agents
MeSH PA D018687 Antidepressive Agents, Second-Generation
MeSH PA D002491 Central Nervous System Agents
MeSH PA D049990 Membrane Transport Modulators
MeSH PA D018377 Neurotransmitter Agents
MeSH PA D014179 Neurotransmitter Uptake Inhibitors
MeSH PA D011619 Psychotropic Drugs
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000182138 Cytochrome P450 1A2 Inhibitors
FDA MoA N0000182139 Cytochrome P450 2B6 Inhibitors
FDA MoA N0000182141 Cytochrome P450 3A4 Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Cataplexy and narcolepsy indication 193042000
Attention deficit hyperactivity disorder indication 406506008

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 8.55 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 100MG BASE QELBREE SUPERNUS PHARMS N211964 April 2, 2021 RX CAPSULE, EXTENDED RELEASE ORAL April 2, 2026 NEW CHEMICAL ENTITY
EQ 150MG BASE QELBREE SUPERNUS PHARMS N211964 April 2, 2021 RX CAPSULE, EXTENDED RELEASE ORAL April 2, 2026 NEW CHEMICAL ENTITY
EQ 200MG BASE QELBREE SUPERNUS PHARMS N211964 April 2, 2021 RX CAPSULE, EXTENDED RELEASE ORAL April 2, 2026 NEW CHEMICAL ENTITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Sodium-dependent dopamine transporter Transporter Kd 6.81 CHEMBL
Sodium-dependent serotonin transporter Transporter Kd 4.76 CHEMBL
Sodium-dependent dopamine transporter Transporter Ki 4.32 CHEMBL
Sodium-dependent serotonin transporter Transporter Ki 4.78 CHEMBL
Transporter Transporter Ki 6.77 CHEMBL

External reference:

IDSource
D08673 KEGG_DRUG
35604-67-2 SECONDARY_CAS_RN
4025281 VANDF
C0877942 UMLSCUI
CHEBI:94405 CHEBI
CHEMBL2106483 ChEMBL_ID
CHEMBL306700 ChEMBL_ID
CHEMBL250052 ChEMBL_ID
CHEMBL251072 ChEMBL_ID
D014745 MESH_DESCRIPTOR_UI
71424 PUBCHEM_CID
3489 INN_ID
5I5Y2789ZF UNII
11502 IUPHAR_LIGAND_ID
DB09185 DRUGBANK_ID
11196 RXNORM
39447 MMSL
d09726 MMSL
004063 NDDF
004064 NDDF
349857003 SNOMEDCT_US
420070007 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
QELBREE HUMAN PRESCRIPTION DRUG LABEL 1 17772-131 CAPSULE, EXTENDED RELEASE 100 mg ORAL NDA 32 sections
QELBREE HUMAN PRESCRIPTION DRUG LABEL 1 17772-132 CAPSULE, EXTENDED RELEASE 150 mg ORAL NDA 32 sections
QELBREE HUMAN PRESCRIPTION DRUG LABEL 1 17772-133 CAPSULE, EXTENDED RELEASE 200 mg ORAL NDA 32 sections