pitolisant
pitolisant: sourced relationships with 1 company · 5 clinical trials tracked.
pitolisant evidence translation
What we can confirm
5 tracked trials
What it means
What to watch
Prepared research question
How could pitolisant → HRMY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence4 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Harmony Biosciences Holdings, Inc. (HRMY) Idiopathic Hypersomnia; Prader-Willi Syndrome; Pregnancy Rel… | Phase 3 |
Clinical Trial Registry Records (5)
An Open-Label Study to Evaluate Safety of Pitolisant in Participants With Prader-Willi Syndrome
Primary endpoint: Percentage of participants reporting Treatment-Emergent Adverse Events (TEAEs)
A Phase 3, Randomized, Double-Blind, Placebo-controlled, Efficacy and Safety Study of Pitolisant Followed by an Open-Label Extension in Patients With Prader-Willi Syndrome
Primary endpoint: Change in severity of EDS as measured by Patient-Reported Outcomes Measurement Information System Bank v1.0 - Sleep-Related Impairment (PROMIS-SRI) T-score
An Open-Label Study to Evaluate the Long-Term Safety and Effectiveness of Pitolisant in Adult Patients With Idiopathic Hypersomnia Who Completed Study HBS-101-CL-010
Primary endpoint: Safety and tolerability of pitolisant
WAKIX® (Pitolisant) Pregnancy Registry: An Observational Study of the Safety of Pitolisant Exposure in Pregnant Women and Their Offspring
Primary endpoint: Major congenital malformation
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label Extension
Primary endpoint: Excessive Daytime Sleepiness
Frequently asked questions
Which companies have sourced relationships with pitolisant?
pitolisant has dated SEC/FDA relationship records for Harmony Biosciences Holdings, Inc..
How many clinical trials involve pitolisant?
BioSniper tracks 5 clinical trials involving pitolisant.