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HBS-301 clinical trials

studies test it
3
open now
2
in phase 3
2
first study started
2026

How each study uses HBS-301 is sorted by a rule, right about nine times in ten. Readers can ask us to read every study one by one.Ask us to read each study

Get an email when these change. Save the HBS-301 studies recruiting or about to start — once a week, free: studies that open, close, add sites or post results.

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Example · made-up studies

Breast cancer · Recruiting: 2 came in, 3 changed

What changed in your saved searches, Oct 31 – Nov 6:

A study of drug A after surgery for early breast cancer

Came in · now Recruiting

Drug B with hormone therapy in advanced breast cancer

Changed

· Sites: 4 added, including Seoul and Busan

· Enrollment: 300 → 450 participants

Exercise during chemotherapy

Now Active, not recruiting

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Approvals

The first approval found in each region, with its record

United States
Not in FDA's approval records
European Union
Not in EMA's list of EU-wide authorisations

From FDA's Drugs@FDA and Purple Book (through openFDA) and the European Medicines Agency, files of Sept 2026 and 27 Oct 2026. National approvals in Europe and other countries are not included. How this is worked out

How studies write it

Studies that test it under each name

Name

pitolisant delayed-release
3

Development codes

HBS-201
1
HBS-301
1

By phase

A phase 1/2 study counts in both.

Phase 1
1
Phase 3
2

What it is tested for

Each study’s main condition, where its own words name it, so a study counts once.

Idiopathic Hypersomnia
1
Cataplexy
1

Who runs them

Industry 3 · Other 0

Harmony Biosciences Management, Inc. (3)

Coming up

From the study records. Dates are the sponsors’ own estimates and often move.

Reaching primary completion within a year · 2, 2 in phase 3

Studies that test HBS-301, phase 3 first.

Studies

Open first, then newest update. How each study uses HBS-301 is read from its arms, and is right about nine times in ten. Ask us to read each study. These are the studies that list it as an intervention; a search of ClinicalTrials.gov also finds studies that mention it only in a description, such as earlier treatment.

Testing it · 3