Narcolepsy

24
Pipeline Programs
6
Companies
25
Clinical Trials
3 recruiting
3
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
4
0
4
0
11
5
Early DiscoveryClinical DevelopmentMarket

On Market (3)

Approved therapies currently available

Teva
ARMODAFINILApproved
armodafinil
Teva
oral2012
U
NUVIGILApproved
armodafinil
Unknown Company
oral2007
U
PROVIGILApproved
modafinil
Unknown Company
Sympathomimetic-like Agent [EPC]oral1998

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
12 programs
1
3
4
2
JZP-258Phase 41 trial
JZP258Phase 41 trial
JZP-110Phase 31 trial
JZP-110Phase 31 trial
XyremPhase 31 trial
+7 more programs
Active Trials
NCT04899947Recruiting500Est. Oct 2024
NCT04803786Completed110Est. Feb 2022
NCT06961266Recruiting8Est. Apr 2026
+9 more trials
Teva
TevaIsrael - Petach Tikva
7 programs
1
5
1
ArmodafinilPhase 31 trial
CEP-10953Phase 31 trial
ModafinilPhase 31 trial
ModafinilPhase 31 trial
ModafinilPhase 31 trial
+2 more programs
Active Trials
NCT01792583Terminated191Est. Nov 2023
NCT01624480Completed40Est. Dec 2015
NCT00078377Completed196Est. Jan 2005
+4 more trials
Axsome Therapeutics
Axsome TherapeuticsNY - New York
5 programs
1
1
2
AXS-12Phase 31 trial
AXS-12Phase 31 trial
AXS-12Phase 21 trial
Solriamfetol 150 mg Oral TabletPhase 11 trial
SunosiN/A1 trial
Active Trials
NCT06413420Recruiting1,731Est. Sep 2029
NCT05008341Completed6Est. Apr 2022
NCT03881852Completed21Est. Nov 2019
+2 more trials
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
1 program
1
HBS-201Phase 11 trial
Active Trials
NCT07051252Completed46Est. Oct 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
Jazz PharmaceuticalsJZP258
Jazz PharmaceuticalsJZP-258
Axsome TherapeuticsAXS-12
Axsome TherapeuticsAXS-12
Jazz PharmaceuticalsJZP-110
Jazz PharmaceuticalsJZP-110
TevaModafinil
TevaModafinil
Jazz PharmaceuticalsXyrem
TevaModafinil
TevaArmodafinil
TevaCEP-10953
Jazz PharmaceuticalsXyrem
Axsome TherapeuticsAXS-12
Jazz PharmaceuticalsJZP-110

Showing 15 of 25 trials with date data

Clinical Trials (25)

Total enrollment: 5,393 patients across 25 trials

A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

Start: Jun 2023Est. completion: Mar 2025160 patients
Phase 4Completed

An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy

Start: Mar 2021Est. completion: Nov 202262 patients
Phase 4Completed

A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)

Start: Oct 2021Est. completion: Nov 202468 patients
Phase 3Completed

A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy

Start: Sep 2021Est. completion: Mar 202490 patients
Phase 3Completed

"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"

Start: May 2015Est. completion: Dec 2017645 patients
Phase 3Completed

"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"

Start: May 2015Est. completion: Feb 2017239 patients
Phase 3Completed

Assess the Safety and Effectiveness of PROVIGIL Treatment in Children and Adolescents With Excessive Sleepiness

Start: Jan 2005Est. completion: Oct 200592 patients
Phase 3Completed

Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

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

Trial of Xyrem® (Sodium Oxybate) for the Treatment of Narcolepsy

Start: Oct 2004Est. completion: Dec 200759 patients
Phase 3Completed

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

Start: Oct 2004Est. completion: Sep 2005280 patients
Phase 3Completed
NCT00078377TevaArmodafinil

Safety and Efficacy Study of Armodafinil (CEP-10953) in the Treatment of Excessive Sleepiness Associated With Narcolepsy

Start: Mar 2004Est. completion: Jan 2005196 patients
Phase 3Completed

Armodafinil (CEP-10953) for Treatment of Narcolepsy, Obstructive Sleep Apnea/Hypopnea Syndrome, or Chronic Shift Work Sleep Disorder

Start: Jan 2004Est. completion: Jul 2006328 patients
Phase 3Completed

Trial Comparing Effects of Xyrem Taken Orally and Modafinil With Placebo in Treating Daytime Sleepiness in Narcolepsy

Start: Apr 2003Est. completion: Nov 2004231 patients
Phase 3Completed

Clinical Outcomes in Narcolepsy and Cataplexy: An Evaluation of Reboxetine Treatment (CONCERT)

Start: Jan 2019Est. completion: Nov 201921 patients
Phase 2Completed

Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy

Start: Jun 2016Est. completion: May 201924 patients
Phase 2Completed

A Study of the Safety and Effectiveness of ADX-N05 for Excessive Daytime Sleepiness in Subjects With Narcolepsy

Start: Sep 2012Est. completion: Aug 201393 patients
Phase 2Completed

A Study of the Safety and Effectiveness of ADX-N05 in the Treatment of Excessive Daytime Sleepiness

Start: Dec 2011Est. completion: May 201233 patients
Phase 2Completed

A Study of HBS-201 (Pitolisant Delayed-release)

Start: May 2025Est. completion: Oct 202546 patients
Phase 1Completed

A Study to Investigate Efficacy, Safety, Tolerability, and Pharmacokinetics of JZP441 Compared With Placebo in Participants With Narcolepsy Type 1

Start: May 2025Est. completion: Apr 20268 patients
Phase 1Recruiting
NCT05008341Axsome TherapeuticsSolriamfetol 150 mg Oral Tablet

Evaluate Sunosi® PK in Breast Milk and Plasma of Healthy Postpartum Women Following Single Dose Oral Administration

Start: Aug 2021Est. completion: Apr 20226 patients
Phase 1Completed
NCT01624480TevaArmodafinil

Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Armodafinil in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy

Start: Jul 2012Est. completion: Dec 201540 patients
Phase 1Completed
NCT04803786Jazz PharmaceuticalsTransition from Xyrem to Xywav

A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy

Start: Apr 2021Est. completion: Feb 2022110 patients
N/ACompleted
NCT04899947Jazz PharmaceuticalsChild and Adolescent Registry for Participants With Narcolepsy

Child and Adolescent Registry for Participants With Narcolepsy

Start: Oct 2020Est. completion: Oct 2024500 patients
N/ARecruiting

SUNOSI® (Solriamfetol) Pregnancy Registry

Start: Jul 2019Est. completion: Sep 20291,731 patients
N/ARecruiting
NCT01792583TevaModafinil/armodafinil

The Nuvigil and Provigil Pregnancy Registry

Start: Jun 2009Est. completion: Nov 2023191 patients
N/ATerminated

Phase Legend

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

Key Insights

11 late-stage (Phase 3) programs — potential near-term approvals
3 actively recruiting trials targeting 5,393 patients
6 companies competing in this space