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

> **NCT07500090** · PHASE3 · RECRUITING · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 248 (estimated)

## Conditions studied

- Idiopathic Hypersomnia

## Interventions

- **DRUG:** HBS-301 tablet
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT07500090
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-03-16
- **Primary completion:** 2027-10
- **Final completion:** 2028-10
- **Target enrollment:** 248 (ESTIMATED)
- **Last updated:** 2026-03-30


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07500090

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07500090, "A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH)". Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/clinical/NCT07500090. Licensed CC0.

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