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HBS-201

Phase 1

Narcolepsy | Small molecule | Neurology |Harmony Biosciences Holdings, Inc.|Last Updated: Dec 12, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

HBS-201 · 1 trial · 1 indication

Phase 1 1
NCT07051252A Study of HBS-201 (Pitolisant Delayed-release)Narcolepsy
COMPLETED46 Analytics
PHASE1COMPLETED
A Study of HBS-201 (Pitolisant Delayed-release)
Narcolepsy
NCT0705125246
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Study Endpoints

Primary Endpoints

Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug
From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days

A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.

Frequency, severity, and seriousness of TEAEs
From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days

A TEAE is any adverse event (AE) reported after the first dose of study drug, or any worsening of a pre-existing condition reported after first dose of study drug.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HBS-201EXPERIMENTALParticipants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14.

Interventions

NameTypeDescription
HBS-201DRUGOn Days 1-7, participants will take HBS-201 17.8 mg per day (one 17.8 mg tablet) and on Days 8-14, participants will take HBS-201 35.6 mg per day (two 17.8 mg tablets).
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1\. Has a current documented diagnosis of narcolepsy type 1 or narcolepsy type 2 per International Classification of Sleep Disorders, 3rd Edition (ICSD-3) criteria. Exclusion Criteria: 1. Has hypersomnolence due to another medical disorder. 2. Is currently taking or has taken ...

Countries:United States
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Frequently asked questions about HBS-201

What is HBS-201 used for?

HBS-201 is an investigational small molecule being developed for the treatment of narcolepsy. It is currently in Phase 1 clinical development. The drug is being studied in patients with narcolepsy, a neurological condition characterized by excessive daytime sleepiness and sudden sleep attacks.

Who makes HBS-201?

HBS-201 is being developed by Harmony Biosciences Holdings, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol HRMY. The company is conducting clinical research on this investigational drug for the treatment of narcolepsy.

What phase is HBS-201 in?

HBS-201 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study of HBS-201 has been completed in the United States, involving 46 participants with narcolepsy.

What clinical trials is HBS-201 in?

HBS-201 has one completed clinical trial registered as NCT07051252, titled "A Study of HBS-201 (Pitolisant Delayed-release)". This Phase 1 study enrolled 46 participants with narcolepsy in the United States. The trial was uncontrolled and did not use randomization or blinding.

Is HBS-201 the same as pitolisant?

HBS-201 is described as pitolisant delayed-release in the clinical trial title. Pitolisant is an existing medication, and HBS-201 appears to be a delayed-release formulation of it. The Phase 1 study NCT07051252 specifically evaluates HBS-201 as pitolisant delayed-release for narcolepsy.