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Eszopiclone

Phase 3

Sleep Apnea | Small molecule | Other |ResMed Inc.|Last Updated: May 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment250
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07332442Continuous Positive Airway Pressure, Arousability and Links to Mechanisms in Obstructive Sleep ApneaPHASE3 RECRUITING 250May 1, 2026Jun 1, 2030May 6, 20261 United States
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Study Endpoints
Primary Endpoints
CPAP adherence
Daily over 3 months

Mean daily average of CPAP use over 3 months

Flanker inhibitory control and attention test
Baseline, 1-, 2- and 3-months

Executive function is assessed using the validated NIH Toolbox Cognition Battery's Flanker inhibitory control and attention test. In a Flanker task, participants are required to indicate the left-right orientation of a centrally presented stimulus while inhibiting attention to the potentially incongruent stimuli that surround it (i.e., the flankers, typically two on either side). Primary outcome is the overall percent of correct responses in incongruent trials.

Secondary Endpoints
Mean Epworth Sleepiness Scale score Scores
Baseline, 1-, 2-and 3-months
Mean Functional Outcomes of Sleep Questionnaire (FOSQ) short form score
Baseline, 1-, 2-and 3-months
Mean Insomnia Severity Index score (ISI) Scores
Baseline, 1-, 2-and 3-months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
EszopicloneEXPERIMENTALParticipants will receive eszopiclone the night of the laboratory split-night polysomnography (PSG, sleep monitoring with and without CPAP therapy). Following polysomnography, participants continue with eszopiclone and CPAP therapy
PlaceboPLACEBO_COMPARATORParticipants will receive placebo the night of the laboratory split-night polysomnography (PSG, sleep monitoring with and without CPAP therapy). Following polysomnography, participants continue with placebo and CPAP therapy
Interventions
NameTypeDescription
EszopicloneDRUG3mg for \< 65 and 2mg for ≥ 65 years
PlaceboDRUGMatched placebo
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Able to provide informed consent. * Clinically confirmed new diagnosis of OSA: 1. Polysomnography AHI ≥ 10 per hour of sleep and/or 2. Home sleep apnea testing, respiratory even index, REI ≥ 10 per hour of recording Exclusion Criteria: * Known non-OSA related conditions...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07332442studyFirstPostDate: changed