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BAY2253651

Phase 2

Sleep Apnea, Obstructive | Small molecule | Respiratory |Bayer AG|Last Updated: Dec 11, 2020

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

BAY2253651 · 1 trial · 1 indication

Phase 2 1
NCT03603678Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel InhibitorSleep Apnea, Obstructive
COMPLETED34 Analytics
PHASE2COMPLETED
Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor
Sleep Apnea, ObstructiveUnlock trial analytics

Study Endpoints

Primary Endpoints

Rate of responders, defined by reduction of apnoea-hypopnoea-index (AHI) from baseline by ≥ 50%
2 days

Secondary Endpoints

Incidence of treatment emergent adverse events (TEAEs)
Up to 7 days
Severity of treatment emergent adverse events (TEAEs)
Up to 7 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A single dose BAY2253651EXPERIMENTALSingle dose BAY2253651
Part A single dose PlaceboPLACEBO_COMPARATORSingle dose matching placebo
Part B multiple dose BAY2253651EXPERIMENTALMultiple dose BAY2253651 on 5 consecutive nights

Interventions

NameTypeDescription
BAY2253651DRUG100 µg (500 µg/ml \* 200 µl) BAY2253651 intranasally
PlaceboDRUGMatching Placebo dosing
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Subjects need to be diagnosed with OSA (obstructive sleep apnea) but should be otherwise healthy at the discretion of the investigator. * Patients must be pretreated with CPAP (continuous positive airway pressure) for OSA for at least 3 months before randomization. * AHI of 15...

Countries:SwitzerlandUnited Kingdom
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Frequently asked questions about BAY2253651

What is BAY2253651 used for?

BAY2253651 is an investigational small molecule being studied for the treatment of Obstructive Sleep Apnea (OSA). It is a potassium channel inhibitor that was evaluated in a Phase 2 clinical trial. The drug is being developed by Bayer AG and is not yet approved for any use.

What does BAY2253651 target?

BAY2253651 targets potassium channels, acting as a potassium channel inhibitor. This mechanism was studied in the context of treating Obstructive Sleep Apnea. The drug is a small molecule developed by Bayer AG and is currently in clinical development.

Who makes BAY2253651?

BAY2253651 is being developed by Bayer AG, a multinational pharmaceutical company. The company's stock is traded under the ticker BAYRY. The drug is an investigational small molecule being studied for Obstructive Sleep Apnea and is currently in Phase 2 clinical development.

What phase is BAY2253651 in?

BAY2253651 is in Phase 2 clinical development. It has completed one Phase 2 trial for Obstructive Sleep Apnea. The drug is investigational and has not been approved by regulatory authorities. It is being developed by Bayer AG.

What clinical trials is BAY2253651 in?

BAY2253651 has been studied in one completed Phase 2 clinical trial, identified as NCT03603678. The trial was titled "Obstructive Sleep Apnea (OSA) Treated With a Potassium Channel Inhibitor" and enrolled 34 participants in Switzerland and the United Kingdom. The study was randomized, double-blind, and placebo-controlled.

Is BAY2253651 the same as BAY 2253651?

BAY2253651 is the same drug as BAY 2253651, with the name typically written without spaces. It is an investigational small molecule being developed by Bayer AG for Obstructive Sleep Apnea. The drug has completed a Phase 2 clinical trial and is not yet approved.