NarcolepsyPhase 1NCT07051252
A Study of HBS-201 (Pitolisant Delayed-release)
A Phase 1 study testing HBS-201 in people with Narcolepsy, run by Harmony Biosciences Management, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Narcolepsy
- What is being tested?
- HBS-201
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 May 2025to 13 Oct 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Has hypersomnolence due to another medical disorder.
- Is currently taking or has taken WAKIX (pitolisant).
- Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening.
- Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Harmony Site 8
Atlanta, Georgia, 30328
Harmony Site 3
Austin, Texas, 78731
Harmony Site 14
Brandon, Florida, 33511
Harmony Site 6
Canton, Ohio, 44718
Harmony Site 1
Cincinnati, Ohio, 45245
Harmony Site 5
Columbia, South Carolina, 29201
Harmony Site 10
Denver, North Carolina, 28037
Harmony Site 2
Huntersville, North Carolina, 28078
Harmony Site 4
Miami, Florida, 33176
Harmony Site 7
Morgantown, West Virginia, 26506
Harmony Site 13
Newton, Massachusetts, 02459
Harmony Site 12
North Charleston, South Carolina, 29406
Harmony Site 9
San Ramon, California, 94583
Harmony Site 11
Troy, Michigan, 48085
Harmony Site 15
Wyomissing, Pennsylvania, 19610
About this study
Official title: A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
Read the detailed description
This is a Phase 1b, open-label, multicenter study to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. Therapeutic dose range is defined as 17.8 milligram (mg) to 35.6 mg based on the FDA-approved prescribing information for WAKIX.
The study will consist of an up to 30-day Screening/Baseline Period, a 2-week Open-Label Period, and a 30-day Safety Follow-up Period.
- Conditions
- Narcolepsy
- Being tested
- HBS-201
- Keywords
- Narcolepsy, Pitolisant hydrochloride, Pitolisant delayed-release
- Medical subject headings
- Narcolepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HBS-201Drug
Also called pitolisant delayed-release (DR), pitolisant hydrochloride
On 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).
| Study group | Role | What they receive |
|---|---|---|
| HBS-201 | Experimental | Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14. Receives: Drug: HBS-201 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug
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.
Measured: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days
Frequency, severity, and seriousness of TEAEs
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.
Measured: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2025
- Study start21 May 2025
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NarcolepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harmony Biosciences Management, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07051252
- Sponsor's protocol ID
- HBS-101DR-CL-101
- Status last verified
- Dec 2025
- First submitted
- 30 Jun 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-Label Study of HBS-201 (Pitolisant Delayed-release) in Adult Participants With Narcolepsy
- ClinicalTrials.gov ID
- NCT07051252
- Acronym / sponsor ID
- HBS-101DR-CL-101
- Conditions
- Narcolepsy
- Keywords
- Narcolepsy, Pitolisant hydrochloride, Pitolisant delayed-release
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Harmony Biosciences Management, Inc.Industry (pharma, biotech, devices)
- Study start
- 21 May 2025 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 4 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy.
Detailed description
This is a Phase 1b, open-label, multicenter study to assess the tolerability of HBS-201 when starting at a therapeutic dose in adult participants with narcolepsy. Therapeutic dose range is defined as 17.8 milligram (mg) to 35.6 mg based on the FDA-approved prescribing information for WAKIX.
The study will consist of an up to 30-day Screening/Baseline Period, a 2-week Open-Label Period, and a 30-day Safety Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HBS-201 | Experimental | Drug: HBS-201Participants will take HBS-201 orally once daily in the morning upon wakening, beginning the morning of Day 1 and continuing through Day 14. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Has hypersomnolence due to another medical disorder.
- Is currently taking or has taken WAKIX (pitolisant).
- Has participated in an interventional research study involving another investigational medication, device, or behavioral treatment within 30 days or within 5 half-lives of the investigational medication prior to Screening.
- Based on the judgment of the Investigator, is unsuitable for the study for any reason, including but not limited to unstable or uncontrolled medical conditions (including psychiatric and neurological conditions) or a medical condition that might interfere with the conduct of the study, confound interpretation of study results, pose a health risk to the participant, or compromise the integrity of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HBS-201Also: pitolisant delayed-release (DR), pitolisant hydrochlorideOn 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). | Drug | HBS-201 |
Primary outcome
Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug
Time frame: 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
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HBS-201 in people with Narcolepsy, run by Harmony Biosciences Management, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants who discontinue treatment due to a treatment-emergent adverse event (TEAE) related to study drug (time frame: From administration of the first dose of study drug (Day 1) through 30 days after the final dose of study drug, approximately 44 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.