# A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy

> **NCT07675135** · PHASE3 · RECRUITING · sponsor: **Harmony Biosciences Management, Inc.** · enrollment: 258 (estimated)

## Conditions studied

- EDS
- Cataplexy
- Fatigue
- Narcolepsy

## Interventions

- **DRUG:** HBS-301
- **OTHER:** Placebo

## Key facts

- **NCT ID:** NCT07675135
- **Lead sponsor:** Harmony Biosciences Management, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-06-04
- **Primary completion:** 2027-10
- **Final completion:** 2027-11
- **Target enrollment:** 258 (ESTIMATED)
- **Last updated:** 2026-08-27


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07675135

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07675135, "A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy". Retrieved via MORVS 2026-10-21 from https://api.morvs.ai/clinical/NCT07675135. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*