Viloxazine
Small molecule targets SLC6A2 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed attention deficit-hyperactivity disorder 1 milestone | |||||
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder | 2019-11-11 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration ( FDA ) for SPN-812” supernus.com ↗ |
| Filed attention deficit-hyperactivity disorder 8 2 milestones | |||||
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder 8 | 2021-02-08 | “resubmitted its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients.” supernus.com ↗ |
| Filed | US (FDA) | — | attention deficit-hyperactivity disorder 8 | 2020-01-21 | “New Drug Application (NDA) for SPN-812 for the treatment of children and adolescents with attention deficit hyperactivity disorder (ADHD) acceptable for review.” supernus.com ↗ “FDA accepted for review a New Drug Application (NDA) for SPN-812 for the treatment of ADHD” supernus.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | QELBREE | — | 2022-04-29 | fda.gov ↗ |
| Approved | US (FDA) | QELBREE | — | 2021-04-02 | fda.gov ↗ |
Trials 15
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-05-28 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Paragraph IV ANDA Filings for Qelbree® supernus.com ↗
Supernus is currently reviewing the details of these Notice Letters and intends to vigorously enforce its intellectual property rights relating to Qelbree. |
| 2025-01-27 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Label Update for Non-Stimulant ADHD Treatment, Qelbree®, Including New Pharmacodynamic Data and Information for Breastfeeding Women supernus.com ↗ |
| 2023-09-09 | Supernus Pharmaceuticals, Inc. | Results Supernus Announces New Qelbree® Data Showing Improvement in ADHD Symptoms supernus.com ↗
Topline results from Phase IV study demonstrate Qelbree is safe and well-tolerated, and significantly improved efficacy outcomes when added to a stimulant medication in pediatric patients with ADHD |
| 2022-04-29 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces FDA Approval of Qelbree® for the Treatment of ADHD in Adults supernus.com ↗
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced today that the U.S. Food and Drug Administration (FDA) approved an expanded indication for Qelbree (viloxazine extended-release capsules) for the treatment of attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. |
| 2021-09-02 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Qelbree™ sNDA for Adult Indication Accepted for Review by FDA supernus.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has acknowledged it has received the supplemental new drug application (sNDA) for Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in adult patients. |
| 2021-04-02 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces FDA Approval of Qelbree™ (SPN-812) for the Treatment of ADHD supernus.com ↗
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that the U.S. Food and Drug Administration (FDA) approved Qelbree (viloxazine extended-release capsules) for the treatment of attention-deficit hyperactivity disorder (ADHD) in pediatric patients 6 to 17 years of age. |
| 2021-02-22 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Receives FDA Notice Assigning Early April 2021 PDUFA Date for SPN-812 NDA supernus.com ↗
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced that it received notice from the U.S. Food and Drug Administration (FDA) that the company’s New Drug Application (NDA) resubmission for SPN-812 for the treatment of ADHD in pediatric patients is considered a Class I resubmission thereby assigning a timeline of two months for review by the FDA and establishing a new Prescription Drug User Fee Act (PDUFA) target action date in early April 2021. |
| 2021-02-08 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Resubmits New Drug Application for SPN-812 for the Treatment of ADHD in Pediatric Patients supernus.com ↗
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients. |
| 2020-12-22 | Supernus Pharmaceuticals, Inc. | Results Supernus Announces Positive Results from Phase III Study for SPN-812 in Adults with ADHD supernus.com ↗
Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system diseases, today announced positive topline results from a Phase III study of SPN-812 in adults (P306) for the treatment of attention deficit hyperactivity disorder (ADHD). |
| 2020-11-09 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Provides Regulatory Updates for SPN-812 and SPN-830 supernus.com ↗
The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for SPN-812 for the treatment of ADHD in pediatric patients 6 to 17 years of age. |
| 2020-02-25 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces Fourth Quarter and Full Year 2019 Financial Results supernus.com ↗
FDA assigned PDUFA target action date of November 8, 2020 for review of SPN-812 New Drug Application. |
| 2020-01-21 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Announces FDA Acceptance for Review of New Drug Application for SPN-812 for the Treatment of ADHD supernus.com ↗ |
| 2019-11-11 | Supernus Pharmaceuticals, Inc. | Regulatory Supernus Submits New Drug Application for SPN-812 for the Treatment of ADHD supernus.com ↗ |
| 2019-03-28 | Supernus Pharmaceuticals, Inc. | Results Supernus Announces P304 Phase III Data Confirming Positive Results from Previous Three Phase III Studies on SPN-812 in ADHD supernus.com ↗ |
| 2018-12-20 | Supernus Pharmaceuticals, Inc. | Results Supernus Announces Positive Results from Phase III Study For SPN-812 in Adolescents with ADHD supernus.com ↗
At daily doses of 200 mg and 400 mg, the trial met the primary endpoint with robust statistical significance in improvement in the symptoms of ADHD from baseline to end of study as measured by the ADHD Rating Scale-5. |
| 2018-12-06 | Supernus Pharmaceuticals, Inc. | Results Supernus Announces Positive Results from Two Phase III Studies For SPN-812 in Children with ADHD supernus.com ↗
today announced positive topline results from each of two pivotal Phase III studies of SPN-812 in children for the treatment of attention deficit hyperactivity disorder (ADHD). |
All press releases naming this drug 26 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Viloxazine | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 202310“This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.” NCT04016792 ↗ “The purpose of this study was to evaluate whether treatment with SPN-812 (viloxazine extended-release) significantly reduces symptoms of ADHD in children.” PMID 32723670 ↗ Jul 2020 “We investigated the effect of a potentially more manageable noradrenergic, viloxazine, with and without trazodone, on OSA severity.” PMID 40360261 ↗ Aug 2025 “Evaluation of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk in Healthy Lactating Women” NCT06259331 ↗ “Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD” NCT04781140 ↗ “viloxazine extended-release capsules (AK-D101) compared with placebo” NCT07678827 ↗ “SPN-812 (viloxazine extended-release) is under investigation” PMID 33750646 ↗ Mar 2021 “SPN-812 (Viloxazine Extended-release Capsule)” NCT02633527 ↗ “Viloxazine extended-release capsule” NCT04786990 ↗ |
| Known as | AK-D101 | “viloxazine extended-release capsules (AK-D101) compared with placebo” NCT07678827 ↗ |
| Known as | ICI 58,834 | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Known as | Qelbree | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 20231“viloxazine extended-release capsules (viloxazine ER; Qelbree™)” PMID 34523063 ↗ Sep 2021 |
| Known as | SPN 812 | “Evaluation of the Excretion of Viloxazine and Its Metabolite 5-Hydroxy-viloxazine Glucuronide Into Breast Milk Following Multiple Doses of SPN-812 (600mg, QD) in Healthy Lactating Women” NCT06259331 ↗8“This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, compared to placebo in children in an analog classroom setting.” NCT04016792 ↗ “Evaluation of SPN 812 (Viloxazine Extended-release Capsule) 200 and 400 mg Efficacy and Safety in Adolescents With ADHD - A Double-Blind, Placebo-Controlled, Pivotal Trial” NCT03247517 ↗ “SPN-812 (viloxazine extended-release) is under investigation” PMID 33750646 ↗ Mar 2021 |
| Known as | Viloxazin | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Known as | Viloxazina | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Known as | viloxazine ER | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 2023 |
| Known as | viloxazine extended-release | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 20232“The purpose of this study was to evaluate whether treatment with SPN-812 (viloxazine extended-release) significantly reduces symptoms of ADHD in children.” PMID 32723670 ↗ Jul 2020 “SPN-812 (viloxazine extended-release) is under investigation” PMID 33750646 ↗ Mar 2021 |
| Known as | Viloxazine Extended-release Capsule | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 2023 |
| Known as | viloxazine extended-release capsules | “The objective of this post hoc analysis was to assess the degree to which viloxazine extended-release (viloxazine ER; viloxazine extended-release capsules; Qelbree® ) improves...” PMID 36847750 ↗ Feb 20231“viloxazine extended-release capsules (viloxazine ER; Qelbree™)” PMID 34523063 ↗ Sep 2021 |
| Known as | Viloxazine hcl | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Known as | VILOXAZINE HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Known as | Vivalan | ChEMBL registry synonym — accepted as the source's own label CHEMBL306700 ↗ |
| Action | Inhibit | “Norepinephrine transporter inhibitor” CHEMBL306700 ↗ |
| Modality | Small molecule | — CHEMBL306700 ↗ |
| Route | Oral | “immediate-release (IR) viloxazine capsules administered orally 3 times a day” NCT01107496 ↗ |
| Target | SLC6A2 | “Norepinephrine transporter inhibitor” CHEMBL306700 ↗ |