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Details:
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.
Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2023
Details:
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.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 21, 2023
Details:
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.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Alpha Wave Ventures
Deal Size: $79.7 million Upfront Cash: Undisclosed
Deal Type: Series C Financing January 03, 2023
Details:
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.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 28, 2022
Details:
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.
Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area: Sleep Product Name: AD504
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 02, 2022
Details:
Positive data on investigational oral pharmacologic treatment AD109 showed statistically significant and clinically meaningful benefits for patients with obstructive sleep apnea.
Lead Product(s): Atomoxetin Hydrochloride,Aroxybutynin
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 09, 2022
Details:
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.
Lead Product(s): Atomoxetin Hydrochloride,Trazodone Hydrochloride
Therapeutic Area: Sleep Product Name: AD504
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2021
Details:
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.
Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Morningside Ventures
Deal Size: $25.0 million Upfront Cash: Undisclosed
Deal Type: Series B Financing March 25, 2021
Details:
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.
Lead Product(s): Aroxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 24, 2020
Details:
In this healthy volunteer study, R-oxybutynin, a key component of AD109, demonstrated a favorable pharmacokinetic (PK) profile and was well tolerated with no adverse events related to the study drug.
Lead Product(s): Oxybutynin,Atomoxetin Hydrochloride
Therapeutic Area: Sleep Product Name: AD109
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 17, 2020
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