Viloxazine
Qelbree (viloxazine) is a small molecule pharmaceutical. Viloxazine was first approved as Qelbree on 2021-04-02. It is used to treat depression in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| behavior and behavior mechanisms | D001520 |
Trade Name
FDA
EMA
Qelbree
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Viloxazine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| QELBREE | Supernus Pharmaceuticals | N-211964 RX | 2021-04-02 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| qelbree | New Drug Application | 2025-08-15 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| depression | — | D003863 | F33.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
VILOXAZINE HYDROCHLORIDE, QELBREE, SUPERNUS PHARMS | |||
| 2026-04-02 | NCE | ||
| 2025-04-29 | NPP | ||
HCPCS
No data
Clinical
Clinical Trials
15 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | 1 | 2 | 3 | 3 | — | 8 |
| Hyperkinesis | D006948 | — | — | 1 | 1 | 3 | 2 | — | 6 |
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obstructive sleep apnea | D020181 | EFO_0003918 | G47.33 | — | 1 | — | — | — | 1 |
| Sleep apnea syndromes | D012891 | EFO_0003877 | G47.3 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Viloxazine |
| INN | viloxazine |
| Description | 2-[(2-ethoxyphenoxy)methyl]morpholine is an aromatic ether. |
| Classification | Small molecule |
| Drug class | - |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCOc1ccccc1OCC1CNCCO1 |
Identifiers
| PDB | — |
| CAS-ID | 46817-91-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL306700 |
| ChEBI ID | — |
| PubChem CID | 5666 |
| DrugBank | DB09185 |
| UNII ID | 5I5Y2789ZF (ChemIDplus, GSRS) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
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£
â‚£
Qelbree – Supernus Pharmaceuticals
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 466 documents
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Safety
Black-box Warning
Black-box warning for: Qelbree
Adverse Events
Top Adverse Reactions
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831 adverse events reported
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