BAY2586116 / Bayer - LARVOL DELTA

A novel TASK channel antagonist nasal spray reduces sleep apnea severity in physiological responders: A randomized, blinded, trial. (PubMed, Am J Physiol Heart Circ Physiol) - P2 | "In conclusion, BAY2586116 reduces OSA severity during sleep in people who demonstrate physiological improvement in upper airway collapsibility. These findings highlight the therapeutic potential for this novel pharmacotherapy target in selected individuals."

Journal • Anesthesia • CNS Disorders • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

BAY2586116 Nasal Spray and OSA Severity (clinicaltrials.gov) - P1 | N=10 | Completed | Sponsor: Flinders University | Recruiting ➔ Completed | Trial completion date: Jul 2023 ➔ Dec 2022

Trial completion • Trial completion date • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

Topical K channel blockage improves pharyngeal collapsibility: A translational, placebo-controlled trial. (PubMed, Chest) - P2 | "Acute topical application of BAY2586116 improves upper-airway collapsibility in anesthetized pigs and sleeping humans with OSA. These novel physiology findings highlight the therapeutic potential to target K channel mechanisms to treat OSA."

Journal • Anesthesia • CNS Disorders • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

BAY2586116 Nasal Spray and OSA Severity (clinicaltrials.gov) - P1 | N=8 | Recruiting | Sponsor: Flinders University

New P1 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

SPRAY-SMART: A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=93; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Clinical • Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose (clinicaltrials.gov) - P1; N=36; Completed; Sponsor: Bayer; Recruiting ➔ Completed

Clinical • Trial completion • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

SPRAY-SMART: A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=93; Active, not recruiting; Sponsor: Bayer; Recruiting ➔ Active, not recruiting; N=160 ➔ 93

Clinical • Enrollment change • Enrollment closed • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

KOALA: Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration (clinicaltrials.gov) - P2; N=14; Completed; Sponsor: Bayer; Active, not recruiting ➔ Completed

Clinical • Trial completion • CNS Disorders • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Bayer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Bayer

Clinical • New P1 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Disorder

SPRAY-SMART: A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=160; Recruiting; Sponsor: Bayer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

SPRAY-SMART: A Trial to Learn More About How Well BAY2586116 Works and How Safe it is in Participants With Moderate to Severe Obstructive Sleep Apnea (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: Bayer

Clinical • New P2 trial • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

KOALA: Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration (clinicaltrials.gov) - P2; N=14; Active, not recruiting; Sponsor: Bayer; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2021 ➔ May 2021; Trial primary completion date: Nov 2020 ➔ Mar 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Obstructive Sleep Apnea • Respiratory Diseases • Sleep Apnea • Sleep Disorder

KOALA: Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration (clinicaltrials.gov) - P2; N=12; Recruiting; Sponsor: Bayer; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

KOALA: Study on the Safety of Drug BAY2586116 and How it Works in Patients With Obstructive Sleep Apnea (a Sleep Disorder Caused by the Narrowing and Collapse of the Airway During Sleep) Including the Blood Level of the Drug and Effect of Its Doses and Routes of Administration (clinicaltrials.gov) - P2; N=12; Not yet recruiting; Sponsor: Bayer

Clinical • New P2 trial