Narcolepsy Clinical Trial Landscape
Data updated: May 20, 2026
72 clinical trials tracked since 2008
Narcolepsy is being studied across 72 clinical trials registered since 2008, with 15 programs currently active. The competitive pipeline includes 9 active Phase 3 trials, 8 active Phase 2 trials, and 1 active Phase 1 trials. Top industry sponsors include Alkermes, Inc., Takeda, Centessa Pharmaceuticals (UK) Limited.
15 active
/
72 total (since 2008)
1
Phase 1 Active
17 total
8
Phase 2 Active
30 total
9
Phase 3 Active
26 total
0
Phase 4 Active
4 total
Top Industry Sponsors
Sorted by active Active Done Failed
Alkermes, Inc. 4 2 0
Takeda 3 5 2
Centessa Pharmaceuticals (UK) Limited 3 0 0
NLS Pharmaceutics 1 2 0
Suven Life Sciences Limited 1 1 0
+ 5 more sponsors — see full table below
Featured Phase 3 Trials
NCT07363720 RECRUITING
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Takeda n=88
NCT07455383 RECRUITING
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Alkermes, Inc. n=150
NCT07502443 RECRUITING
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
Alkermes, Inc. n=176
NCT07540897 RECRUITING
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
Alkermes, Inc. n=150
NCT05816382 RECRUITING
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Takeda n=500
+ 21 more Phase 3 trials — see full database below
Narcolepsy — Trials Started by Year (last 10 years)
2016 6
2017 2
2018 1
2019 5
2020 3
2021 7
2022 0
2023 6
2024 9
2025 6
2026 8
TheraRadar.com
Full Trial Database
Complete sponsor table, every trial across all phases, plus competitive analytics. Sortable, filterable, exportable for Pro users.
Top Sponsors (all-time)
Alkermes, Inc. 6
Takeda 10
Centessa Pharmaceuticals (UK) Limited 3
NLS Pharmaceutics 3
Suven Life Sciences Limited 2
Eisai Inc. 2
Vertex Pharmaceuticals Incorporated 1
Jazz Pharmaceuticals 11
Axsome Therapeutics, Inc. 4
Merck 3
Active Trials by Phase
Phase 1 1
Phase 2 8
Phase 3 9
Enrollment Size Distribution
1-50 23
51-200 39
201-500 9
501-1k 1
1k+ 0
All Industry Sponsors
Sorted by active Active Done Failed
Alkermes, Inc. 4 2 0
Takeda 3 5 2
Centessa Pharmaceuticals (UK) Limited 3 0 0
NLS Pharmaceutics 1 2 0
Suven Life Sciences Limited 1 1 0
Eisai Inc. 1 1 0
Vertex Pharmaceuticals Incorporated 1 0 0
Jazz Pharmaceuticals 0 10 1
Axsome Therapeutics, Inc. 0 4 0
Merck 0 2 1
NCT07363720 RECRUITING
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Takeda n=88
NCT07455383 RECRUITING
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1
Alkermes, Inc. n=150
NCT07502443 RECRUITING
A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 2
Alkermes, Inc. n=176
NCT07540897 RECRUITING
A Study to Evaluate the Efficacy, Safety and Tolerability of ALKS 2680 in Adults With Narcolepsy Type 1 (Brilliance NT1 - 304)
Alkermes, Inc. n=150
NCT07540364 NOT YET RECRUITING
A Phase 3 Study to Evaluate the Efficacy and Safety of Samelisant in Patients With Narcolepsy
Suven Life Sciences Limited n=240
NCT05816382 RECRUITING
A Study of TAK-861 for the Treatment of Selected Central Hypersomnia Conditions
Takeda n=500
NCT06767683 RECRUITING
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Alkermes, Inc. n=256
NCT05914194 NOT YET RECRUITING
A Eight-Week Study of NLS-2 (Mazindol Extended Release) in Participants With Narcolepsy Type 1
NLS Pharmaceutics n=48
NCT07598708 NOT YET RECRUITING
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Centessa Pharmaceuticals (UK) Limited n=222
NCT05113745 COMPLETED
A Study to Assess the Long-term Efficacy and Safety of AXS-12 (Reboxetine) in Subjects With Narcolepsy (ENCORE)
Axsome Therapeutics, Inc. n=68
NCT02611687 COMPLETED
Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label Period
Bioprojet n=110
NCT05059223 COMPLETED
A Study to Assess the Efficacy and Safety of AXS-12 (Reboxetine) in Patients With Narcolepsy
Axsome Therapeutics, Inc. n=90
NCT02720744 COMPLETED
Once-Nightly Sodium Oxybate for Treatment of Excessive Daytime Sleepiness and Cataplexy in Narcolepsy
Avadel n=212
NCT03030599 COMPLETED
A Study of the Efficacy and Safety of JZP-258 in Subjects With Narcolepsy With Cataplexy
Jazz Pharmaceuticals n=201
NCT02348593 COMPLETED
"Twelve-week Study of the Safety and Efficacy of JZP-110 in the Treatment of Excessive Sleepiness in Narcolepsy"
Jazz Pharmaceuticals n=239
NCT02348632 COMPLETED
"A Long-Term Safety Study of JZP-110 in the Treatment of Excessive Sleepiness in Subjects With Narcolepsy or OSA"
Jazz Pharmaceuticals n=645
NCT02221869 COMPLETED
A Multicenter Study of the Efficacy and Safety of Xyrem With an Open- Label Pharmacokinetic Evaluation and Safety Extension in Pediatric Subjects With Narcolepsy With Cataplexy
Jazz Pharmaceuticals n=106
NCT01638403 COMPLETED
Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.
Bioprojet n=180
NCT01399606 COMPLETED
Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)
Bioprojet n=102
NCT01800045 COMPLETED
Pitolisant to Assess Weekly Frequency of Cataplexy Attacks and EDS in Narcoleptic Patients (HARMONY CTP)
Bioprojet n=103
NCT01789398 COMPLETED
Patient Narcoleptic Treated With BF2.649 (Pitolisant) in add-on to Sodium Oxybate (HARMONY IV)
Bioprojet n=51
NCT01067235 COMPLETED
Efficacy and Safety Study of BF2.649 and BF2.649 Add on Modafinil on Cataplexy in Patients With Narcolespy
Bioprojet n=14
NCT01067222 COMPLETED
Efficacy and Safety Study of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy
Bioprojet n=110
Data: ClinicalTrials.gov · Trials registered 2008 onwards · Industry sponsors only