MedPath

Harmony Biosciences Management, Inc.

🇺🇸United States
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

7

Active:2
Completed:1

Trial Phases

4 Phases

Phase 1:1
Phase 2:1
Phase 3:2
+1 more phases

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (5 trials with phase data)• Click on a phase to view related trials

Phase 3
2 (40.0%)
Not Applicable
1 (20.0%)
Phase 1
1 (20.0%)
Phase 2
1 (20.0%)

A Study of HBS-201 (Pitolisant Delayed-release)

Not Applicable
Recruiting
Conditions
Narcolepsy
Interventions
Drug: HBS-201
First Posted Date
2025-07-04
Last Posted Date
2025-07-16
Lead Sponsor
Harmony Biosciences Management, Inc.
Target Recruit Count
40
Registration Number
NCT07051252
Locations
🇺🇸

Harmony Site 9, San Ramon, California, United States

🇺🇸

Harmony Site 14, Brandon, Florida, United States

🇺🇸

Harmony Site 4, Miami, Florida, United States

and more 12 locations

Drug Interaction Study of ZYN002 Transdermal Gel and Probe Substrates

Phase 1
Recruiting
Conditions
Drug Interaction
Interventions
Drug: Part 1
Drug: Part 2
First Posted Date
2025-04-16
Last Posted Date
2025-08-05
Lead Sponsor
Harmony Biosciences Management, Inc.
Target Recruit Count
28
Registration Number
NCT06930872
Locations
🇦🇺

CMAX Clinical Research, Adelaide, South Australia, Australia

A Study of Pitolisant in Patients With Prader-Willi Syndrome

Phase 3
Recruiting
Conditions
Prader-Willi Syndrome
Interventions
Other: Placebo tablet
First Posted Date
2024-04-16
Last Posted Date
2025-09-02
Lead Sponsor
Harmony Biosciences Management, Inc.
Target Recruit Count
134
Registration Number
NCT06366464
Locations
🇺🇸

Santa Monica Clinical Trials, Los Angeles, California, United States

🇺🇸

Center of Excellence in Diabetes and Endocrinology, Sacramento, California, United States

🇺🇸

Rady Children's Hospital - Scan Diego, San Diego, California, United States

and more 54 locations

WAKIX® (Pitolisant) Pregnancy Registry

Recruiting
Conditions
Pregnancy Related
Narcolepsy
Interventions
Drug: Comparator Products
First Posted Date
2022-09-10
Last Posted Date
2025-08-05
Lead Sponsor
Harmony Biosciences Management, Inc.
Target Recruit Count
1329
Registration Number
NCT05536011
Locations
🇺🇸

Evidera (PPD), Morrisville, North Carolina, United States

A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic Hypersomnia

Phase 3
Active, not recruiting
Conditions
Idiopathic Hypersomnia
Excessive Daytime Sleepiness
Interventions
First Posted Date
2022-07-14
Last Posted Date
2025-08-15
Lead Sponsor
Harmony Biosciences Management, Inc.
Target Recruit Count
128
Registration Number
NCT05458128
Locations
🇺🇸

Western Michigan University Homer Stryker MD School of Medicine, Kalamazoo, Michigan, United States

🇺🇸

Sleep Dynamics, Neptune City, New Jersey, United States

🇺🇸

Cedars-Sinai Medical Towers, Los Angeles, California, United States

and more 29 locations
  • Prev
  • 1
  • 2
  • Next

News

Cannabinoid Drug Development Accelerates with 50+ Companies Advancing Clinical Trials

DelveInsight reports over 50 pharmaceutical companies are actively developing 55+ cannabinoid therapies across various clinical stages, representing significant momentum in the therapeutic cannabis space.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.