Excessive Sleepiness

7
Pipeline Programs
3
Companies
5
Clinical Trials
1 recruiting
2
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
0
0
1
0
2
4
Early DiscoveryClinical DevelopmentMarket

On Market (2)

Approved therapies currently available

Teva
ARMODAFINILApproved
armodafinil
Teva
oral2012
U
NUVIGILApproved
armodafinil
Unknown Company
oral2007

Competitive Landscape

3 companies ranked by most advanced pipeline stage

Axsome Therapeutics
Axsome TherapeuticsNY - New York
2 programs
1
1
Solriamfetol Oral TabletPhase 41 trial
Solriamfetol 150 mgPhase 31 trial
Active Trials
NCT06568367Recruiting520Est. Dec 2026
NCT04788953Terminated84Est. Apr 2024
Teva
TevaIsrael - Petach Tikva
2 programs
1
1
ArmodafinilPhase 41 trial
armodafinilPhase 31 trial
Active Trials
NCT00758498Completed427Est. Feb 2009
NCT01080807Completed385Est. Oct 2010
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
1 program
1
JZP-110Phase 21 trial
Active Trials
NCT03037203Completed66Est. Aug 2018

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Axsome TherapeuticsSolriamfetol Oral Tablet
TevaArmodafinil
Axsome TherapeuticsSolriamfetol 150 mg
Tevaarmodafinil
Jazz PharmaceuticalsJZP-110

Clinical Trials (5)

Total enrollment: 1,482 patients across 5 trials

NCT04788953Axsome TherapeuticsSolriamfetol Oral Tablet

Clinical Trial of Solriamfetol for Excessive Sleepiness Related to Shift Work Disorder

Start: Jul 2021Est. completion: Apr 202484 patients
Phase 4Terminated
NCT01080807TevaArmodafinil

Efficacy and Tolerability of Armodafinil in Adults With Excessive Sleepiness Associated With Shift Work Disorder

Start: Mar 2010Est. completion: Oct 2010385 patients
Phase 4Completed

Studying Solriamfetol Modulation of TAAR-1, Dopamine, and Norepinephrine in Shift Work Disorder (SUSTAIN)

Start: Aug 2024Est. completion: Dec 2026520 patients
Phase 3Recruiting
NCT00758498Tevaarmodafinil

Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder

Start: Sep 2008Est. completion: Feb 2009427 patients
Phase 3Completed

A 4-Week Study of the Safety, Efficacy, and Pharmacokinetics of JZP-110 [(R)-2-amino-3-phenylpropylcarbamate Hydrochloride] in Subjects With Parkinson's Disease and Excessive Sleepiness

Start: Jan 2017Est. completion: Aug 201866 patients
Phase 2Completed

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 1,482 patients
3 companies competing in this space