Idiopathic Hypersomnia

8
Pipeline Programs
5
Companies
7
Clinical Trials
2 recruiting
1
Approved Products

Pipeline by Development Stage

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

On Market (1)

Approved therapies currently available

U
PITOLISANTApproved
pitolisant
Unknown Company
film coated

Competitive Landscape

5 companies ranked by most advanced pipeline stage

Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
1
1
JZP258Phase 41 trial
JZP-258Phase 31 trial
Active Trials
NCT03533114Completed154Est. Dec 2020
NCT05875974Completed207Est. Mar 2025
Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
2 programs
2
Open-label pitolisantPhase 31 trial
PitolisantPhase 31 trial
Active Trials
NCT05156047Completed214Est. Sep 2023
NCT05458128Completed119Est. Oct 2025
Alkermes
AlkermesDUBLIN 4, Ireland
1 program
1
ALKS 2680Phase 21 trial
Active Trials
NCT06843590RecruitingEst. Jun 2026
Zevra Therapeutics
Zevra TherapeuticsDenmark - Frederiksberg
1 program
1
SerdexmethylphenidatePhase 21 trial
Active Trials
NCT05668754Completed50Est. Mar 2024
Takeda
TakedaTOKYO, Japan
1 program
1
TAK-360Phase 21 trial
Active Trials
NCT06812078Recruiting96Est. Jul 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
Jazz PharmaceuticalsJZP258
Harmony BiosciencesPitolisant
Harmony BiosciencesOpen-label pitolisant
Jazz PharmaceuticalsJZP-258
AlkermesALKS 2680
TakedaTAK-360
Zevra TherapeuticsSerdexmethylphenidate

Clinical Trials (7)

Total enrollment: 840 patients across 7 trials

NCT05875974Jazz PharmaceuticalsJZP258

A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy

Start: Jul 2023Est. completion: Mar 2025207 patients
Phase 4Completed
NCT05458128Harmony BiosciencesPitolisant

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start: Aug 2022Est. completion: Oct 2025119 patients
Phase 3Completed
NCT05156047Harmony BiosciencesOpen-label pitolisant

A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia

Start: May 2022Est. completion: Sep 2023214 patients
Phase 3Completed
NCT03533114Jazz PharmaceuticalsJZP-258

A Multicenter Study of the Efficacy and Safety of JZP-258 in the Treatment of Idiopathic Hypersomnia (IH) With an Open-label Safety Extension

Start: Nov 2018Est. completion: Dec 2020154 patients
Phase 3Completed
NCT06843590AlkermesALKS 2680

A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia

Start: May 2025Est. completion: Jun 2026
Phase 2Recruiting
NCT06812078TakedaTAK-360

A Study of TAK-360 in Adults With Idiopathic Hypersomnia

Start: Feb 2025Est. completion: Jul 202696 patients
Phase 2Recruiting
NCT05668754Zevra TherapeuticsSerdexmethylphenidate

Placebo-Controlled, Double-Blind, Study to Determine the Safety and Efficacy of SDX in Patients With IH

Start: Dec 2022Est. completion: Mar 202450 patients
Phase 2Completed

Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

3 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 840 patients
5 companies competing in this space