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Idiopathic Hypersomnia

1
Pipeline Programs
4
Companies
8
Clinical Trials
3 recruiting
0
Approved Products

Pipeline by Development Stage

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

Competitive Landscape

4 companies ranked by most advanced pipeline stage

Harmony Biosciences
Harmony BiosciencesPLYMOUTH MEETING, PA
3 programs
1
HBS-301 tabletPhase 31 trial
Open-label pitolisantPHASE_31 trial
PitolisantPHASE_31 trial
Active Trials
NCT05156047Completed214Est. Sep 2023
NCT05458128Completed119Est. Oct 2025
NCT07500090Recruiting248Est. Oct 2028
Jazz Pharmaceuticals
Jazz PharmaceuticalsCA - Palo Alto
2 programs
JZP-258PHASE_31 trial
JZP258PHASE_41 trial
Active Trials
NCT03533114Completed154Est. Dec 2020
NCT05875974Completed207Est. Mar 2025
Zevra Therapeutics
Zevra TherapeuticsDenmark - Frederiksberg
1 program
SerdexmethylphenidatePHASE_21 trial
Active Trials
NCT05668754Completed50Est. Mar 2024
Takeda
TakedaTOKYO, Japan
1 program
TAK-360PHASE_22 trials
Active Trials
NCT06952699Recruiting88Est. Aug 2026
NCT06812078Recruiting96Est. Jul 2026

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
Jazz PharmaceuticalsJZP258
Harmony BiosciencesHBS-301 tablet
Harmony BiosciencesPitolisant
Harmony BiosciencesOpen-label pitolisant
Jazz PharmaceuticalsJZP-258
TakedaTAK-360
TakedaTAK-360
Zevra TherapeuticsSerdexmethylphenidate

Clinical Trials (8)

Total enrollment: 1,176 patients across 8 trials

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

A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)

Start: Mar 2026Est. completion: Oct 2028248 patients
Phase 3Recruiting

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

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

A Study of TAK-360 in Adults With Narcolepsy Without Cataplexy (NT2)

Start: May 2025Est. completion: Aug 202688 patients
Phase 2Recruiting

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

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
3 actively recruiting trials targeting 1,176 patients
4 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.