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viloxazine 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| alkaloids and organic bases | 2820 | 46817-91-8 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
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.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.20 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| 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 |
| S (Water solubility) | 78 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| azlogd74 | LogD at pH 7.4 | 0.663 | High | 1 | |
| caco2-efflux | Caco-2 efflux ratio (BA/AB) | 0.759 | High | 1 | |
| caco2-intrinsic-papp | Caco-2 intrinsic apparent permeability | 30.269 | 10^-6 cm/s | High | 1 |
| dh-clint | Dog hepatocyte intrinsic clearance | 11.143 | uL/min/10^6 cells | High | 1 |
| dppb | Dog plasma protein binding (% unbound) | 59.440 | % | High | 1 |
| fcs-ppb | Fetal calf serum protein binding (% unbound) | 60.490 | % | High | 1 |
| herg | hERG pIC50 | 4.484 | pIC50 | High | 1 |
| hh-clint | Human hepatocyte intrinsic clearance | 1.416 | uL/min/10^6 cells | High | 1 |
| hlm-clint | Human liver microsomal intrinsic clearance | 3.334 | uL/min/mg protein | High | 1 |
| hppb | Human plasma protein binding (% unbound) | 68.230 | % | High | 1 |
| kinase-safety-class | ACVR2A,ACVR2B,AKT2,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,EIF2AK3,EPHB4,ERBB2,GRK2,ITK,JAK2,JAK3,MAP3K7,MAPK12,MAPK7,MET,NTRK2,PDK2,PDK4,PIM2,PRKDC,SIK2,SIK3,TEK,TGFBR1 | 31 | |||
| kinase-selectivity-class | AXL,ERBB2,GRK2,JAK1,PDK4,SIK2 | 6 | |||
| mdck-mdr1-efflux | MDCK-MDR1 efflux ratio | 1.282 | High | 1 | |
| mh-clint | Mouse hepatocyte intrinsic clearance | 39.446 | High | 1 | |
| mppb | Mouse plasma protein binding (% unbound) | 58.490 | High | 1 | |
| nih-mdck-mdr1-efflux | NIH MDCK-MDR1 efflux ratio | 2.153 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| pppb | Pig plasma protein binding (% unbound) | 74.170 | % | High | 1 |
| rh-clint | Rat hepatocyte intrinsic clearance | 89.950 | uL/min/10^6 cells | High | 1 |
| rh-fuinc | Rat hepatocyte fraction unbound in incubation | 85.450 | % | High | 1 |
| rppb | Rat plasma protein binding (% unbound) | 64.170 | % | High | 1 |
| solubility-dd | Solubility at pH 7.4 in DMSO | 935.406 | uM | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| April 2, 2021 | FDA | SUPERNUS PHARMS |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
| 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 |
|---|---|---|---|---|---|---|
| Suicidal ideation | 60.42 | 47.10 | 20 | 420 | 93917 | 110494942 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | N06AX09 | NERVOUS SYSTEM PSYCHOANALEPTICS ANTIDEPRESSANTS Other antidepressants |
| FDA MoA | N0000000102 | Norepinephrine Uptake Inhibitors |
| MeSH PA | D000928 | Antidepressive Agents |
| MeSH PA | D011619 | Psychotropic Drugs |
| MeSH PA | D014179 | Neurotransmitter Uptake Inhibitors |
| MeSH PA | D018377 | Neurotransmitter Agents |
| MeSH PA | D018663 | Adrenergic Agents |
| MeSH PA | D018687 | Antidepressive Agents, Second-Generation |
| MeSH PA | D018759 | Adrenergic Uptake Inhibitors |
| MeSH PA | D049990 | Membrane Transport Modulators |
| FDA EPC | N0000175695 | Norepinephrine Reuptake Inhibitor |
| 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 |
| CHEBI has role | CHEBI:35469 | antidepressant |
Related Drugs by ATC class:
N06AX Other antidepressants 28 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Cataplexy and narcolepsy | indication | 193042000 | |
| Attention deficit hyperactivity disorder | indication | 406506008 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 8.55 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 12121523 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 12121523 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11324753 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 11458143 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 12121523 | Sept. 4, 2029 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 100MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 150MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
| EQ 200MG BASE | QELBREE | SUPERNUS PHARMS | N211964 | April 2, 2021 | RX | CAPSULE, EXTENDED RELEASE | ORAL | 9603853 | Feb. 7, 2033 | FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 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:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Sodium-dependent noradrenaline transporter | Transporter | ANTAGONIST | IC50 | 6.70 | DRUG LABEL | DRUG LABEL | |||
| Sodium-dependent serotonin transporter | Transporter | Kd | 4.76 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Kd | 6.81 | CHEMBL | |||||
| Sodium-dependent serotonin transporter | Transporter | Ki | 4.78 | CHEMBL | |||||
| Sodium-dependent dopamine transporter | Transporter | Ki | 4.32 | CHEMBL | |||||
| Transporter | Transporter | Ki | 6.77 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| D08673 | KEGG_DRUG |
| 35604-67-2 | SECONDARY_CAS_RN |
| 4025281 | VANDF |
| 4040491 | VANDF |
| C0042665 | UMLSCUI |
| CHEBI:748327 | CHEBI |
| CHEMBL306700 | ChEMBL_ID |
| DB09185 | DRUGBANK_ID |
| CHEMBL2106483 | ChEMBL_ID |
| D014745 | MESH_DESCRIPTOR_UI |
| 5666 | PUBCHEM_CID |
| 11502 | IUPHAR_LIGAND_ID |
| 3489 | INN_ID |
| 5I5Y2789ZF | UNII |
| 11196 | RXNORM |
| 39447 | MMSL |
| d09726 | MMSL |
| 004063 | NDDF |
| 004064 | NDDF |
| 1179159000 | SNOMEDCT_US |
| 349857003 | SNOMEDCT_US |
| 420070007 | SNOMEDCT_US |
| 5I5Y2789ZF | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-131 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | NDA | 31 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-131 | CAPSULE, EXTENDED RELEASE | 100 mg | ORAL | NDA | 31 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-132 | CAPSULE, EXTENDED RELEASE | 150 mg | ORAL | NDA | 31 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-132 | CAPSULE, EXTENDED RELEASE | 150 mg | ORAL | NDA | 31 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-133 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | NDA | 31 sections |
| QELBREE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 17772-133 | CAPSULE, EXTENDED RELEASE | 200 mg | ORAL | NDA | 31 sections |