Drug
Pitolisant clinical trials
Also written BF2.649 and wakix.
- studies test it
- 31
- open now
- 2
- in phase 3
- 17
- first study started
- 2007
Keep track of what changes. Save the pitolisant studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Brand
Studies by the year they started
30 studies that test it; most in 2011 (4)
| Year | Studies |
|---|---|
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 4 |
| 2012 | 1 |
| 2013 | 1 |
| 2016 | 4 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 2 |
| 2022 | 3 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
By phase
A phase 1/2 study counts in both.
- Phase 1
- 5
- Phase 2
- 7
- Phase 3
- 17
- Phase 4
- 1
- No phase
- 1
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 7 · Other 24
Bioprojet (20) · Harmony Biosciences Management, Inc. (5) · University of Oxford (1) · Citrine Medicine Limited (1) · University of Texas Southwestern Medical Center (1) · Boston Medical Center (1) · High Point Clinical Trials Center (1) · William Ondo, MD (1)
Studies
Open first, then newest update. How each study uses pitolisant is read from its arms, and is right about nine times in ten.
Testing it · 31
- A Study of Pitolisant in Patients With Prader-Willi SyndromeRecruitingPhase 3Harmony Biosciences Management, Inc.NCT06366464Written as Pitolisant tablet
- A Study of Pitolisant in Participants With Prader-Willi SyndromeEnrolling by invitationPhase 3Harmony Biosciences Management, Inc.NCT07219485Written as Pitolisant
- Safety and Efficacy of Pitolisant on Excessive Daytime Sleepiness and Other Non-Muscular Symptoms in Patients With Myotonic Dystrophy Type 1CompletedPhase 2Harmony Biosciences Management, Inc.NCT04886518Written as Pitolisant Oral Tablet
- A Phase 2 Study to Evaluate the Safety and Efficacy of Pitolisant in Patients With Prader-Willi Syndrome, Followed by an Open Label ExtensionCompletedPhase 2Harmony Biosciences Management, Inc.NCT04257929Written as Pitolisant oral tablets
- A Long-Term Safety and Effectiveness Study to Evaluate Pitolisant in Adult Patients With Idiopathic HypersomniaCompletedPhase 3Harmony Biosciences Management, Inc.NCT05458128Written as Pitolisant
- Proof of Concept Study on Pitolisant Effect on Autism Spectrum Disorders in Children and AdolescentsActive, not recruitingPhase 2BioprojetNCT05953389Written as Pitolisant
- Efficacy and Safety of Pitolisant in Pediatric Narcoleptic Patients With or Without Cataplexy, Double-blind Study Followed by a Prolonged Open-label PeriodCompletedPhase 3BioprojetNCT02611687Written as pitolisant
- Pitolisant Effects on Affect and Cognition Exploratory Study (PEACE Study)CompletedNot applicableUniversity of OxfordNCT05849675Written as Pitolisant 17.8 MG [Wakix]
- Pitolisant Effects on Alcohol Self-Administration in Heavy DrinkersTerminatedPhase 1Boston Medical CenterNCT04596267Written as Pitolisant
- A Clinical Study to Evaluate the Efficacy and Safety of Pitolisant in the Treatment of EDS in Patients With OSACompletedPhase 3Citrine Medicine LimitedNCT05223166Written as Pitolisant
- Pitolisant in Refractory Restless Legs SyndromeStatus unknownPhase 4William Ondo, MDNCT05581576Written as Pitolisant
- Insulin Tolerance Test Study in Patients With Type 1 DiabetesTerminatedPhase 1High Point Clinical Trials CenterNCT04026750Written as Pitolisant
- Pitolisant (BF2.649) in the Treatment of EDS in Patients With OSACompletedPhase 3BioprojetNCT02739568Written as Pitolisant (BF2.649)
- Study to Demonstrate Cognitive Enhancing Effects of BF2.649CompletedPhase 2University of Texas Southwestern Medical CenterNCT00690274Written as BF2.649
- Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime SleepinessWithdrawnPhase 3BioprojetNCT02978651Written as Pitolisant (BF2.649)
- Determination the Abuse Potential of Pitolisant in Healthy, Non-Dependent Recreational Stimulant UsersCompletedPhase 1BioprojetNCT03152123Written as Pitolisant
- Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)CompletedPhase 3BioprojetNCT01399606Written as BF2.649
- Effects of BF2.649 in the Treatment of Excessive Daytime Sleepiness in Narcolepsy.CompletedPhase 3BioprojetNCT01638403Written as BF2.649
- A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder TreatmentWithdrawnPhase 2BioprojetNCT02800083Written as Pitolisant (BF2.649)
- Study to Assess the Absorption, Distribution, Metabolism and Excretion (ADME) of [14C]-Pitolisant in Healthy Male VolunteersCompletedPhase 1BioprojetNCT02929342Written as Pitolisant
Codes
What other systems call pitolisant · ClinicalTrials.gg INT005032
- MeSH (NLM) C516975pitolisantConfirmed ClinicalTrials.gov, NLM
- UNII (FDA) 4BC83L4PIYPITOLISANTConfirmed FDA, NLM, Wikidata
- RxNorm 2197878Confirmed FDA, Wikidata
- Wikidata Q426044pitolisantConfirmed FDA, NLM, Wikidata
- NCI Thesaurus C166747PitolisantOne source FDA
- DrugBank DB11642One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C516975 | pitolisant | Confirmed ClinicalTrials.gov, NLM |
| UNII (FDA) | 4BC83L4PIY | PITOLISANT | Confirmed FDA, NLM, Wikidata |
| RxNorm | 2197878 | — | Confirmed FDA, Wikidata |
| Wikidata | Q426044 | pitolisant | Confirmed FDA, NLM, Wikidata |
| NCI Thesaurus | C166747 | Pitolisant | One source FDA |
| DrugBank | DB11642 | — | One source Wikidata |
Also registered as pitolisant hydrochloride (UNII YV33CH63HI · RxNorm 2197879).
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.