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Narcolepsy

9
Pipeline Programs
13
Companies
50
Clinical Trials
6 recruiting
1
Approved Products

Pipeline by Development Stage

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

Drug Modality Breakdown

Vaccine
2100%
+ 29 programs with unclassified modality

On Market (1)

Approved therapies currently available

Axsome Therapeutics
SUNOSIApproved
solriamfetol
Axsome Therapeutics
Dopamine and Norepinephrine Reuptake Inhibitor [EPC]oral2019
17M Part D

Competitive Landscape

11 companies ranked by most advanced pipeline stage

Axsome Therapeutics
Axsome TherapeuticsNY - New York
2 programs
1
1
SUNOSI(solriamfetol)Phase 45 trials
reboxetinePhase 34 trials
Active Trials
NCT07398417Recruiting620Est. Mar 2028
NCT05113745Completed68Est. Nov 2024
NCT05059223Completed90Est. Mar 2024
+6 more trials
ViiV Healthcare
ViiV HealthcareNC - Durham
2 programs
1
GSK189254Phase 2
A/H1N1 vaccineN/AVaccine
Theranexus
TheranexusFrance - Lyon
1 program
1
Active comparator: Modafinil + placeboPhase 21 trial
Active Trials
NCT02821715Completed51Est. Feb 2019
NLS Pharmaceutics
NLS PharmaceuticsSwitzerland - Zurich
1 program
1
mazindol extended releasePhase 21 trial
Active Trials
NCT04923594Completed67Est. Jun 2022
MSD
MSDIreland - Ballydine
1 program
1
MK-6552Phase 11 trial
Active Trials
NCT06179407Terminated9Est. Oct 2024
Sharp Therapeutics
Sharp TherapeuticsPA - Pittsburgh
1 program
1
MK-6552Phase 1
Otsuka
OtsukaJapan - Tokushima
1 program
1
SEP363856Phase 11 trial
Active Trials
NCT05015673Completed18Est. May 2015
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
12 programs
Child and Adolescent Registry for Participants With NarcolepsyN/A1 trial
Transition from Xyrem to XywavN/A1 trial
JZP441PHASE_11 trial
ADX-N05PHASE_21 trial
ADX-N05PHASE_21 trial
+7 more programs
Active Trials
NCT04899947Recruiting500Est. Oct 2024
NCT04803786Completed110Est. Feb 2022
NCT06961266Terminated6Est. Jan 2026
+9 more trials
Teva
TevaIsrael - Petach Tikva
7 programs
Modafinil/armodafinilN/A1 trial
ArmodafinilPHASE_11 trial
ArmodafinilPHASE_35 trials
CEP-10953PHASE_31 trial
ModafinilPHASE_32 trials
+2 more programs
Active Trials
NCT01792583Terminated191Est. Nov 2023
NCT01624480Completed40Est. Dec 2015
NCT02552303Completed39Est. Jul 2015
+9 more trials
GSK
GSKLONDON, United Kingdom
2 programs
A/H1N1 vaccineN/AVaccine1 trial
GSK189254PHASE_21 trial
Active Trials
NCT01394614Completed24Est. Nov 2014
NCT00366080Terminated69Est. Jan 2008
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
1 program
HBS-201PHASE_11 trial
Active Trials
NCT07051252Completed46Est. Oct 2025

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Axsome Therapeuticssolriamfetol
Jazz PharmaceuticalsJZP258
Axsome Therapeuticssolriamfetol
Axsome Therapeuticssolriamfetol
Jazz PharmaceuticalsJZP-258
TevaArmodafinil
Axsome Therapeuticssolriamfetol
Axsome Therapeuticsreboxetine
Axsome Therapeuticssolriamfetol
Axsome Therapeuticssolriamfetol
Axsome Therapeuticssolriamfetol
Axsome Therapeuticssolriamfetol
Axsome Therapeuticssolriamfetol
Axsome Therapeuticsreboxetine
Axsome Therapeuticsreboxetine

Showing 15 of 50 trials with date data

Clinical Trials (50)

Total enrollment: 9,573 patients across 50 trials

Solriamfetol and CBT-I in Patients With Insomnia Disorder

Start: Jul 2023Est. completion: Apr 202660 patients
Phase 4Active Not Recruiting

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

Start: Jun 2023Est. completion: Mar 2025155 patients
Phase 4Completed

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

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

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

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

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

Start: Mar 2021Est. completion: Nov 202262 patients
Phase 4Completed
NCT00711516TevaArmodafinil

Study to Evaluate Armodafinil Treatment in Improving Prefrontal Cortical Activation and Working Memory Performance

Start: Sep 2008Est. completion: Oct 200940 patients
Phase 4Completed

Clinical Assessment of Response in the Treatment of Depression With Daytime Sleepiness Using Solriamfetol

Start: Feb 2026Est. completion: Dec 2028508 patients
Phase 3Recruiting

Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design

Start: Jan 2026Est. completion: Mar 2028620 patients
Phase 3Recruiting

Open-Label Safety Study of Solriamfetol in Subjects With Binge Eating Disorder

Start: Feb 2025Est. completion: Dec 2026300 patients
Phase 3Enrolling By Invitation

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

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

Elucidating TAAR-1, Dopamine, and Norepinephrine in Binge Eating Disorder Using Solriamfetol

Start: Apr 2024Est. completion: Dec 2025450 patients
Phase 3Recruiting

Progressing TAAR-1, Dopamine, and Norepinephrine in Depression Using Solriamfetol

Start: Mar 2024Est. completion: Mar 2025346 patients
Phase 3Completed

A Study to Assess the Efficacy and Safety of Solriamfetol in Subjects With ADHD (FOCUS)

Start: Jul 2023Est. completion: Mar 2025516 patients
Phase 3Completed

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

"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

"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
NCT01305408TevaArmodafinil

Study to Evaluate the Efficacy and Safety of Armodafinil Treatment (150 mg/Day) as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Start: Mar 2011Est. completion: Jul 2013399 patients
Phase 3Completed
NCT01121536TevaArmodafinil

Extension Study of the Safety and Efficacy of Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Start: Apr 2010Est. completion: Oct 2013867 patients
Phase 3Terminated
NCT00893789TevaArmodafinil

Study to Evaluate the Efficacy and Safety of Armodafinil as Treatment for Patients With Excessive Sleepiness Associated With Mild or Moderate Closed Traumatic Brain Injury

Start: Apr 2009Est. completion: Jan 2011117 patients
Phase 3Terminated
NCT00236080TevaArmodafinil

Study of the Efficacy and Multiple-Dose Plasma Concentration-Time Profiles of Armodafinil and PROVIGIL

Start: Aug 2005Est. completion: Dec 2005136 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

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

Start: Oct 2004Est. completion: Dec 200759 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

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
NCT00080288TevaArmodafinil

Safety/Efficacy Study With Armodafinil (CEP-10953) in Treatment of Excessive Sleepiness Associated With Chronic SWSD

Start: Mar 2004Est. completion: Dec 2004254 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

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

Start: Sep 2003Est. completion: Sep 2006
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

Solriamfetol for the Treatment of Multiple Sclerosis Fatigue

Start: Jun 2024Est. completion: Mar 202746 patients
Phase 2Recruiting
NCT04923594NLS Pharmaceuticsmazindol extended release

Four-week Study of the Safety and Efficacy of NLS-2 (Mazindol Extended Release) in the Treatment of Narcolepsy

Start: Sep 2021Est. completion: Jun 202267 patients
Phase 2Completed

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

Start: Jan 2019Est. completion: Nov 201921 patients
Phase 2Completed
NCT02821715TheranexusActive comparator: Modafinil + placebo

Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients

Start: Sep 2016Est. completion: Feb 201951 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
NCT00825227TevaArmodafinil

Safety and Efficacy of Armodafinil for Fatigue Associated With Taxanes Alone or in Combination With Other Agents

Start: Dec 2008Est. completion: Feb 201010 patients
Phase 2Terminated
NCT00772005TevaArmodafinil

Study to Evaluate the Efficacy and Safety of Armodafinil as Adjunctive Therapy in Adults With Schizophrenia

Start: Sep 2008Est. completion: May 2010287 patients
Phase 2Completed
NCT01896128TevaArmodafinil

Combining Armodafinil With Neuro-rehabilitation to Improve Neurological Recovery and Reduce Disability Post-Stroke

Start: Jan 2008Est. completion: Jul 201519 patients
Phase 2Completed
NCT00481195TevaArmodafinil

Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

Start: Jun 2007Est. completion: Dec 2008257 patients
Phase 2Completed

Effectiveness Of The Drug GSK189254 In Treating Patients With Narcolepsy

Start: Nov 2006Est. completion: Jan 200869 patients
Phase 2Terminated

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: Jan 20266 patients
Phase 1Terminated

Study of MK-6552 in Participants With Narcolepsy Type 1 (MK-6552-004)

Start: Jan 2024Est. completion: Oct 20249 patients
Phase 1Terminated

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

This is a Study to Determine the Effect of Multiple Doses of an Investigational Drug, Taken by Mouth, in People With Narcolepsy-cataplexy. Accepting Both Males and Females Ages of 18 Years to 55 Years. This Study Will be Conducted in the US and Will Require Approximately 13 Weeks Participation.

Start: Jun 2014Est. completion: May 201518 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

Related Jobs

Phase Legend

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

Key Insights

1 late-stage (Phase 3) programs, potential near-term approvals
6 actively recruiting trials targeting 9,573 patients
13 companies competing in this space

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.