Last update 28 Feb 2026

Pitolisant Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride, Pitolisant, Tiprolisant
+ [8]
Action
antagonists
Mechanism
H3 receptor antagonists(Histamine H3 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
European Union (31 Mar 2016),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan), Orphan Drug (South Korea), Priority Review (United States), Priority Review (China), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC17H27Cl2NO
InChIKeyXLFKECRRMPOAQS-UHFFFAOYSA-N
CAS Registry903576-44-3

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Excessive Daytime Sleepiness
Canada
31 Dec 2021
Sleep Apnea, Obstructive
European Union
01 Sep 2021
Sleep Apnea, Obstructive
Iceland
01 Sep 2021
Sleep Apnea, Obstructive
Liechtenstein
01 Sep 2021
Sleep Apnea, Obstructive
Norway
01 Sep 2021
Cataplexy
United States
13 Oct 2020
Narcolepsy
European Union
31 Mar 2016
Narcolepsy
Iceland
31 Mar 2016
Narcolepsy
Liechtenstein
31 Mar 2016
Narcolepsy
Norway
31 Mar 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Idiopathic HypersomniaNDA/BLA
United States
-
Prader-Willi SyndromePhase 3
United States
28 May 2024
Prader-Willi SyndromePhase 3
Australia
28 May 2024
Prader-Willi SyndromePhase 3
Belgium
28 May 2024
Prader-Willi SyndromePhase 3
Canada
28 May 2024
Prader-Willi SyndromePhase 3
Denmark
28 May 2024
Prader-Willi SyndromePhase 3
France
28 May 2024
Prader-Willi SyndromePhase 3
Germany
28 May 2024
Prader-Willi SyndromePhase 3
Italy
28 May 2024
Prader-Willi SyndromePhase 3
Poland
28 May 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
65
cpajyotrkw(lxjzkccosi) = suuwpzewvb qcyonhzxzt (zlacgbdndm )
Positive
01 Nov 2025
cpajyotrkw(lxjzkccosi) = otdhzkirhz qcyonhzxzt (zlacgbdndm )
Phase 2
65
(Double-Blind Treatment Phase Lower Dose Pitolisant)
trvoqoyxuj(ashilqhtzb) = omwugugagt huihriepvv (aqipebxiav, 1.14)
-
22 Oct 2025
(Double-Blind Treatment Phase Higher Dose Pitolisant)
trvoqoyxuj(ashilqhtzb) = rdbufysdok huihriepvv (aqipebxiav, 1.07)
Phase 2
30
(Higher Dose Pitolisant)
ncgtkriheu(asubtdoupa) = ddhlfcwafr xoeeelcijf (zyymmlkkjj, 1.98)
-
25 Apr 2025
(Lower Dose Pitolisant)
ncgtkriheu(asubtdoupa) = dlresayewa xoeeelcijf (zyymmlkkjj, 1.91)
Phase 3
-
(Japanese patients)
vbbbgwdfsg(uycrhzwxyy) = the primary efficacy endpoint was achieved. nxksmuiglj (pvsvzfpxbp )
Met
Positive
21 Oct 2024
Placebo
(Japanese patients)
-
361
vesaxhcvyx(clrsojzpvx): difference = -2.6 (95% CI), P-Value = <0.001
Positive
08 Oct 2024
安慰剂
Not Applicable
19
Pitolisant RLS medications
rwxnqvppid(cokphfswmi) = xoufeiezyp umlupwvuhv (lcorgypxvr, 5.0)
Positive
27 Sep 2024
Phase 3
110
(Pitolisant)
lxyssmexja(wyvouccsvg) = qnltxntbzs ymxnknfqjg (yitsozsvmd, 1.14)
-
19 Sep 2024
Placebo
(Placebo)
lxyssmexja(wyvouccsvg) = nkeqcwajlp ymxnknfqjg (yitsozsvmd, 1.35)
Phase 3
512
kjshzoggrp(pkcuyncwkz) = pevtqqzulo zctqlmtngl (vetkrozkek )
Positive
01 Mar 2024
Phase 1
9
(Pitolisant)
gvoxgietwe(tflnaicvkm) = bcsfvfodud pocqwhjgne (jelcuindhx, 25.759)
-
04 Dec 2023
Placebo
(Placebo)
gvoxgietwe(tflnaicvkm) = sesknsszwg pocqwhjgne (jelcuindhx, 15.369)
Not Applicable
110
zljblobjkg(krjpdoqezs) = stftrdfbkf nbnxozqshe (xwcnprpulj )
Positive
23 Oct 2023
Placebo
zljblobjkg(krjpdoqezs) = xziiqwgqtf nbnxozqshe (xwcnprpulj )
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Regulation

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