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Find Clinical Drug Pipeline Developments & Deals for Viloxazine

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                          01

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : Qelbree (viloxazine HCl) is a selective norepinephrine reuptake inhibitor indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in pediatric patients 6 to 17 years of age.

                          Product Name : Qelbree

                          Product Type : Other Small Molecule

                          Upfront Cash : Inapplicable

                          January 27, 2025

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved FDF

                          Sponsor : Inapplicable

                          Deal Size : Inapplicable

                          Deal Type : Inapplicable

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                          02

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : An agreement aims to seek regulatory approval for Qelbree, an extended-release formulation of viloxazine for ADHD in children and adults.

                          Product Name : Qelbree

                          Product Type : Small molecule

                          Upfront Cash : Undisclosed

                          May 07, 2024

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved

                          Sponsor : Moksha8 Pharmaceuticals

                          Deal Size : Undisclosed

                          Deal Type : Licensing Agreement

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                          03

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : At daily flexible-dose 200 to 600mg, Phase III trial met primary endpoint showing reduction change from baseline of Adult ADHD Investigator Symptom Rating Scale total score at end of study was statistically significantly greater in adults treated with Qe...

                          Product Name : Qelbree

                          Product Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 29, 2022

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          04

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : The approval of Qelbree is supported by data from an extensive development program consisting of four Phase III clinical trials that studied more than 1000 pediatric patients from the age of 6 to 17 years.

                          Product Name : Qelbree

                          Product Type : Small molecule

                          Upfront Cash : Not Applicable

                          April 02, 2021

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Approved

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          05

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : If approved by the FDA, the Company is preparing for the commercial launch of SPN-812 for the treatment of ADHD in pediatric patients in the second quarter of 2021.

                          Product Name : SPN-812

                          Product Type : Small molecule

                          Upfront Cash : Not Applicable

                          February 22, 2021

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          06

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : At a daily dose of SPN-812 up to 600mg, the trial met the primary endpoint with robust statistical significance (p=0.0040) compared to placebo in improving the symptoms of ADHD from baseline to end of study as measured by ADHD Investigator Symptom Rating...

                          Product Name : SPN-812

                          Product Type : Small molecule

                          Upfront Cash : Not Applicable

                          December 22, 2020

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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                          07

                          Clinical Trial Supply
                          Not Confirmed
                          Clinical Trial Supply
                          Not Confirmed

                          Details : SPN-812, if approved by the FDA, will be the first truly new therapy to treat ADHD in a decade

                          Product Name : Undisclosed

                          Product Type : Small molecule

                          Upfront Cash : Not Applicable

                          January 22, 2020

                          Lead Product(s) : Viloxazine Hydrochloride

                          Therapeutic Area : Psychiatry/Psychology

                          Highest Development Status : Phase III

                          Sponsor : Not Applicable

                          Deal Size : Not Applicable

                          Deal Type : Not Applicable

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