Excessive Daytime Sleepiness

8
Pipeline Programs
3
Companies
4
Clinical Trials
1 recruiting
4
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
0
0
0
2
5
Early DiscoveryClinical DevelopmentMarket

On Market (4)

Approved therapies currently available

U
ARMODAFINILApproved
armodafinil
Unknown Company
oral2016
U
NUVIGILApproved
armodafinil
Unknown Company
oral2007
U
SOLRIAMFETOLApproved
solriamfetol
Unknown Company
Axsome Therapeutics
SUNOSIApproved
solriamfetol
Axsome Therapeutics
Dopamine and Norepinephrine Reuptake Inhibitor [EPC]oral2019

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Axsome Therapeutics
Axsome TherapeuticsNY - New York
1 program
1
SolriamfetolPhase 41 trial
Active Trials
NCT04789174Completed59Est. Sep 2022
Teva
TevaIsrael - Petach Tikva
2 programs
2
ArmodafinilPhase 31 trial
Armodafinil 100 to 250 mg/dayPhase 31 trial
Active Trials
NCT00228566Completed247Est. Jul 2006
NCT00228553Completed743Est. Jul 2006
Centessa Pharmaceuticals
1 program
1
ORX142 TabletsPhase 11 trial
Active Trials
NCT07082829Recruiting208Est. Jun 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Axsome TherapeuticsSolriamfetol
TevaArmodafinil
TevaArmodafinil 100 to 250 mg/day
Centessa PharmaceuticalsORX142 Tablets

Clinical Trials (4)

Total enrollment: 1,257 patients across 4 trials

Solriamfetol's Effect on Cognitive Health in Apnea Participants During a Randomized Placebo-controlled Study

Start: May 2021Est. completion: Sep 202259 patients
Phase 4Completed
NCT00228566TevaArmodafinil

Study to Assess Patient Reported Outcomes With Armodafinil Treatment for Excessive Sleepiness in Adults With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome

Start: Oct 2005Est. completion: Jul 2006247 patients
Phase 3Completed
NCT00228553TevaArmodafinil 100 to 250 mg/day

Extension Study of the Safety and Efficacy of Armodafinil in the Treatment of Patients With Excessive Sleepiness

Start: May 2004Est. completion: Jul 2006743 patients
Phase 3Completed

A Study of ORX142 in Healthy Adult Subjects, Including Subjects 18 to 80 Years of Age

Start: Jun 2025Est. completion: Jun 2026208 patients
Phase 1Recruiting

Phase Legend

PreclinicalLab & animal studies
Phase 1Safety & dosing
Phase 2Efficacy testing
Phase 3Large-scale trials
On MarketApproved & available

Key Insights

2 late-stage (Phase 3) programs — potential near-term approvals
1 actively recruiting trials targeting 1,257 patients
3 companies competing in this space