Drugs / Pitolisant
Pitolisant
also known as
BF 2.649 · Wakix · BF-2649 HYDROCHLORIDE · Ciproxidine · HBS-101 · Ozawade · PITOLISANT HYDROCHLORIDE · Tiprolisant · +1 more
Small molecule targets HRH3
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | WAKIX | — | 2024-06-21 – 2026-02-13 | fda.gov ↗ |
| Approved | US (FDA) | WAKIX | — | 2019-08-14 | fda.gov ↗ |
| Approved | EU (EMA) | Wakix | — | 2016-03-31 | europa.eu ↗ |
Trials 31 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 15 trials | ||||||
| Phase 1 | NCT04596267 | Sep 2021 → Feb 2023 | alcohol-related disorders | Boston Medical Center | Terminated | No outcome recorded |
| Phase 1 | NCT04026750 | Sep 2019 → Feb 2020 | hypoglycemia, type 1 diabetes mellitus | High Point Clinical Trials Center | Terminated | No outcome recorded |
| Phase 1 | NCT03152123 | Mar → Oct 2017 | substance abuse | Bioprojet | Completed | No outcome recorded |
| Phase 1 | NCT02929342 | Jul → Aug 2016 | — | Bioprojet | Completed | No outcome recorded |
| Phase 1 | NCT01619033 | Jul 2011 → Nov 2012 | impaired renal function disease | Bioprojet | Completed | No outcome recorded |
| Phase 25 trials | ||||||
| Phase 2 | NCT05953389 | Dec 2023 → Oct 2025 overdue | autism spectrum disorder | Bioprojet | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04257929 | Dec 2020 → Aug 2022 | Prader-Willi syndrome | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02800083 | Oct 2016 → Dec 2019 | alcohol abuse | Bioprojet | Withdrawn | No outcome recorded |
| Phase 2 | NCT01620554 | Oct 2010 → Dec 2011 | hypersomnia, obstructive sleep apnea syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 2 | NCT00642928 | Oct 2007 → Mar 2009 | Parkinson disease, hypersomnia | Bioprojet | Completed | No outcome recorded |
| Phase 318 trials | ||||||
| Phase 3 | NCT07219485 | Aug 2025 → Aug 2030 expected | Prader-Willi syndrome | Harmony Biosciences Management, Inc. | Enrolling by invitation | No outcome recorded |
| Phase 3 | NCT06366464 | May 2024 → Jul 2026 overdue | Prader-Willi syndrome | Harmony Biosciences Management, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05458128 | Aug 2022 → Oct 2025 | idiopathic hypersomnia | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05156047 | May 2022 → Sep 2023 | idiopathic hypersomnia | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT05223166 | Apr 2022 → Jul 2023 | sleep-wake disorder | Citrine Medicine Limited | Completed | No outcome recorded |
| Phase 3 | NCT02611687 | Jun 2016 → Apr 2021 | narcolepsy without cataplexy, narcolepsy-cataplexy syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT02739568 | Apr 2016 → Apr 2020 | hypersomnia, obstructive sleep apnea syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01800045 | Apr 2013 → Jan 2015 | narcolepsy-cataplexy syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01789398 | Sep 2012 → Aug 2014 | narcolepsy | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01072968 | Oct 2011 → May 2014 | obstructive sleep apnea syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01071876 | Aug 2011 → Mar 2014 | hypersomnia, obstructive sleep apnea syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01399606 | May 2011 → Oct 2013 | narcolepsy-cataplexy syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01638403 | Nov 2010 → Apr 2012 | narcolepsy | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01066442 | Mar 2010 → Aug 2012 | Parkinson disease | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01036139 | Dec 2009 → Aug 2012 | Parkinson disease | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01067235 | Oct 2009 → Jul 2010 | narcolepsy-cataplexy syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT01067222 | May 2009 → Jul 2010 | hypersomnia, narcolepsy-cataplexy syndrome | Bioprojet | Completed | No outcome recorded |
| Phase 3 | NCT02978651 | ? → Jan 2017 | hypersomnia, obstructive sleep apnea syndrome | Bioprojet | Withdrawn | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT05581576 | Sep 2022 → May 2023 | restless legs syndrome | William Ondo, MD | Unknown | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT05849675 | Apr 2023 → Feb 2024 | atypical depressive disorder, cognitive disorder | University of Oxford | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03433131 | — | narcolepsy without cataplexy | Harmony Biosciences Management, Inc. | No longer available | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT04886518 Comparator | Jun 2021 → Oct 2023 | hypersomnia, myotonic dystrophy type 1 | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00690274 Comparator | Jun 2008 → Oct 2011 | schizophrenia | University of Texas Southwestern Medical Center | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2025-10-15 | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | Viatris Completes Acquisition of Aculys Pharma Including Exclusive Rights to Pitolisant in Japan and to Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region viatris.com ↗ |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 34 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Pitolisant | “Long Term Open Label Study in Narcolepsy With BF2.649 (Pitolisant)” NCT01399606 ↗ |
| Known as | BF 2.649 | “BF 2.649, a new molecule, reduces significantly the diurnal sleepiness and demonstrated its anti-cataplexy effect in pre-clinical and clinical studies.” NCT01067235 ↗16“A Trial Evaluating Pitolisant (BF2.649) in Alcohol Use Disorder Treatment” NCT02800083 ↗ “Pitolisant (BF2.649)” NCT02739568 ↗ “Pitolisant (BF2.649)” NCT02978651 ↗ |
| Known as | BF-2649 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | Ciproxidine | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | HBS-101 | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | Ozawade | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | PITOLISANT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | Tiprolisant | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Known as | Wakix | “Pitolisant 17.8 MG [Wakix]” NCT05849675 ↗1“Pitolisant (Wakix)” NCT05581576 ↗ |
| Known as | Wakix, europe | ChEMBL registry synonym — accepted as the source's own label CHEMBL462605 ↗ |
| Action | Inhibit | “inverse agonist at the histamine H3 receptor” NCT00642928 ↗ |
| Modality | Small molecule | — CHEMBL462605 ↗ |
| Route | Oral | “orally active” NCT00642928 ↗ |
| Target | HRH3 | “Histamine H3 receptor inverse agonist” CHEMBL462605 ↗ |