Sleep Apnea, Obstructive

7
Pipeline Programs
6
Companies
8
Clinical Trials
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
1
1
1
1
2
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

U
MODAFINILApproved
modafinil
Unknown Company
Sympathomimetic-like Agent [EPC]oral2012
U
PROVIGILApproved
modafinil
Unknown Company
Sympathomimetic-like Agent [EPC]oral1998

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Teva
TevaIsrael - Petach Tikva
1 program
1
ModafinilPhase 32 trials
Active Trials
NCT00107809Completed140Est. Sep 2005
NCT00214981CompletedEst. Sep 2006
Apnimed
ApnimedMA - Cambridge
1 program
1
AD128Phase 2/31 trial
Active Trials
NCT04394143CompletedEst. Jul 2021
Bayer
BayerLEVERKUSEN, Germany
2 programs
1
1
BAY2586116Phase 21 trial
BAY2586116Phase 11 trial
Active Trials
NCT05527457Completed10Est. Dec 2022
NCT04236440Completed14Est. Jun 2021
Ventus Therapeutics
2 programs
1
Treatment sleep studyPhase 1/21 trial
ProventN/A1 trial
Active Trials
NCT00901771Completed50Est. Dec 2009
NCT01061476Completed12Est. Jan 2011
Rhythm Pharmaceuticals
1 program
Transvenous hypoglossal nerve stimulationN/A1 trial
Active Trials
NCT03210142Completed23Est. Jul 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
TevaModafinil
TevaModafinil
ApnimedAD128
BayerBAY2586116
Ventus TherapeuticsTreatment sleep study
BayerBAY2586116
Rhythm PharmaceuticalsTransvenous hypoglossal nerve stimulation
Ventus TherapeuticsProvent

Clinical Trials (8)

Total enrollment: 249 patients across 8 trials

NCT00107809TevaModafinil

Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome

Start: Oct 2004Est. completion: Sep 2005140 patients
Phase 3Completed
NCT00214981TevaModafinil

Evaluate the Safety and Efficacy of Modafinil in Children and Adolescents With ADHD

Start: Sep 2003Est. completion: Sep 2006
Phase 3Completed
NCT04394143ApnimedAD128

Effect of AD128 to Treat Obstructive Sleep Apnea

Start: Oct 2020Est. completion: Jul 2021
Phase 2/3Completed
NCT04236440BayerBAY2586116

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

Start: Feb 2020Est. completion: Jun 202114 patients
Phase 2Completed
NCT01061476Ventus TherapeuticsTreatment sleep study

Sleep Apnea Treatment With Expiratory Resistance(Provent™)

Start: Jan 2010Est. completion: Jan 201112 patients
Phase 1/2Completed
NCT05527457BayerBAY2586116

BAY2586116 Nasal Spray and OSA Severity

Start: Aug 2022Est. completion: Dec 202210 patients
Phase 1Completed
NCT03210142Rhythm PharmaceuticalsTransvenous hypoglossal nerve stimulation

Minimally Invasive Hypoglossal Nerve Stimulation Study (Lingual Study)

Start: Jun 2017Est. completion: Jul 201823 patients
N/ACompleted
NCT00901771Ventus TherapeuticsProvent

Study of Provent Treatment of Obstructive Sleep Apnea in Patients Who Are Non-compliant With CPAP

Start: May 2009Est. completion: Dec 200950 patients
N/ACompleted

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

1 late-stage (Phase 3) programs — potential near-term approvals
6 companies competing in this space