Data updated: Jun 28, 2026
Narcolepsy Clinical Trial Landscape
Narcolepsy is being studied across 76 clinical trials registered since 2008, with 19 programs currently active. The competitive pipeline includes 11 active Phase 3 trials, 6 active Phase 2 trials, and 2 active Phase 1 trials.
Top industry sponsors include Takeda, Alkermes, Inc., Centessa Pharmaceuticals (UK) Limited.
Trial activity
19 active / 76 total since 2008
Active by phase 11 Ph3 / 28 6 Ph2 / 28 2 Ph1 / 16 0 Ph4 / 4
Sponsor activity
Who is running trials now — green active, blue completed, red failed/terminated.
Sorted by active Active Done Failed
Takeda 5 5 2
Alkermes, Inc. 4 2 0
Centessa Pharmaceuticals (UK) Limited 3 0 0
Jazz Pharmaceuticals 1 10 1
NLS Pharmaceutics 1 2 0
Suven Life Sciences Limited 1 1 0
Eisai Inc. 1 1 0
Vertex Pharmaceuticals Incorporated 1 0 0
H. Lundbeck A/S 1 0 0
Axsome Therapeutics, Inc. 0 4 0
Merck 0 2 1
How the field has grown
New-trial starts peaked in 2026 (11 registered); 2025 saw 7. The right-hand chart shows median Phase 3 enrollment by start year — the number in parentheses is that year's Phase 3 trial count (19 in total), so single-trial years (and years with no Phase 3 starts) are obvious. Both are by trial start date; the current year is partial.
New trials started by year
2016 6
2017 2
2018 1
2019 5
2020 3
2021 7
2022 0
2023 6
2024 9
2025 7
2026 11
TheraRadar.com
Median Phase 3 enrollment by start year
2016 (2) 161
2017 (1) 201
2018 (0) 0
2019 (0) 0
2020 (1) 184
2021 (2) 79
2022 (0) 0
2023 (1) 500
2024 (3) 105
2025 (1) 256
2026 (8) 163
TheraRadar.com
Full trial pipeline
Every active and completed trial across Phase 1–4, with enrollment analytics. Sortable, filterable, exportable with Pro.
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 (AWAKE)
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 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
NCT07625280 NOT YET RECRUITING
A Study Evaluating the Efficacy and Safety of Xywav Expanded Dosing vs Placebo in Participants With Narcolepsy or IH
Jazz Pharmaceuticals n=108
NCT07646678 NOT YET RECRUITING
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Takeda n=500
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