[{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Successfully Completes Phase 1 Study in Lead Program for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Morningside Ventures","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"Apnimed Closes Series B Financing to Advance Once-Daily Oral Medication for Obstructive Sleep Apnea (OSA)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2021","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in Phase 2 Clinical Trial with AD109, Lead Candidate for Treatment of Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"November 2020","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Alpha Wave Ventures","pharmaFlowCategory":"D","amount":"$79.7 million","upfrontCash":"Undisclosed","newsHeadline":"Apnimed Completes Oversubscribed $79.75 Million Series C Extension Financing to Fund Two Planned Phase 3 Trials of AD109, an Oral Medication with the Potential to Be the First Therapy for Direct Treatment of Obstructive Sleep Apnea (OSA)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase 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2022","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"March 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data Show Clinically Meaningful Improvements for Investigational Oral Pharmacologic Treatment AD504 in People With Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Granted FDA Fast Track Designation for AD109, a Novel First-in-Class Oral Pharmacologic Combination for the Treatment of Obstructive Sleep Apnea (OSA)","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2022","url1":"","url2":"","graph1":"Sleep","graph2":"Phase II"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in LunAIRo, the First Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase III"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces First Patient Dosed in SynAIRgy, the Second Phase 3 Clinical Study of AD109, a Potential Nighttime Oral Treatment for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2023","url1":"","url2":"","graph1":"Sleep","graph2":"Phase III"},{"orgOrder":0,"company":"Apnimed","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Apnimed Announces Completion of Enrollment in Phase 3 LunAIRo Study of AD109, the Potential First Nighttime Oral Treatment for Obstructive Sleep Apnea","therapeuticArea":"Sleep","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2024","url1":"","url2":"","graph1":"Sleep","graph2":"Phase III"}]
Find Clinical Drug Pipeline Developments & Deals for Atomoxetine Hydrochloride
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of obstructive sleep apnea.
AD109 (aroxybutynin + atomoxetine) combines a novel NCE selective antimuscarinic, aroxybutynin, with a selective norepinephrine reuptake inhibitor (NRI), atomoxetine. It is being evaluated in phase 3 clinial trials for the treatment of Obstructive Sleep Apnea.
AD109 (atomoxetine) has the potential to be the first nighttime oral pharmacologic treatment for people with OSA who are either intolerant of or refuse to use positive airway pressure (PAP) therapy.
AD109 (atomoxetine) has the potential to be the first oral pharmacologic that both treats the underlying cause of OSA, airway obstruction at night, and improves daytime consequences of OSA such as fatigue.
AD109 (atomoxetine) is first oral pharmacologic that treats OSA airway obstruction at night. It is a first-in-class, novel, investigational combination dosed once daily at bedtime and is designed to treat OSA patients across a broad spectrum of disease severity.
AD504 (Atomoxetine) showed a significant reduction of the Apnea Hypopnea Index (AHI) (from 18.2 [11.8 to 31.3] on placebo to 7.4 [5.4 to 16.1] events/h on AD504, p=0.024 and Hypoxic Burden (HB) from 46.3 [25.1 to 88.3] on placebo to 18.7 [14.9 to 43.5], p=0.003 on AD504.
Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.
AD504 (atomoxetine plus trazodone) showed a strong trend in the reduction in apnea hypopnea index (AHI) from placebo, which was the study’s primary endpoint.
The proceeds will support Apnimed’s ongoing development and commercialization plans. The company is advancing its lead program, AD109, an oral disease-modifying therapeutic for the treatment of Obstructive Sleep Apnea, which is currently in late-stage Phase 2 clinical trials.
First patient has been dosed in first Phase 2 clinical trial evaluating AD109, the company’s first-in-class, oral pharmaceutical under development for the treatment of OSA.