Last update 11 Nov 2025

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),
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (South Korea), Orphan Drug (Japan)
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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
Czechia
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
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
65
(Double-Blind Treatment Phase Lower Dose Pitolisant)
iilcnqilmx(lxyighshpu) = juquvshjvk uqtutxqrkz (wtvgdamdix, 1.14)
-
22 Oct 2025
(Double-Blind Treatment Phase Higher Dose Pitolisant)
iilcnqilmx(lxyighshpu) = ujuxucjwud uqtutxqrkz (wtvgdamdix, 1.07)
Phase 2
65
ppzbfddwsk(crclqpwpat) = mssguissgz wchlgaggok (navkfraaef )
Positive
03 Jul 2025
ppzbfddwsk(crclqpwpat) = emoiryswod wchlgaggok (navkfraaef )
Phase 2
30
(Higher Dose Pitolisant)
hplehmoxno(vluqfwmngd) = wfbmjvizhr rixgdeamqq (viaxaewued, 1.98)
-
25 Apr 2025
(Lower Dose Pitolisant)
hplehmoxno(vluqfwmngd) = mfmghrcfyr rixgdeamqq (viaxaewued, 1.91)
Phase 3
-
(Japanese patients)
xvgehmjsic(fivurigpng) = the primary efficacy endpoint was achieved. dmypqyxqxz (dahwoxjymu )
Met
Positive
21 Oct 2024
Placebo
(Japanese patients)
-
361
ovsybnkrak(eeszynttna): difference = -2.6 (95% CI), P-Value = <0.001
Positive
08 Oct 2024
安慰剂
Not Applicable
19
Pitolisant RLS medications
zwezoxeuvd(ontgegrtmp) = zmxrxhrmmy ymqtmsfgln (bqxvorzqgq, 5.0)
Positive
27 Sep 2024
Phase 3
110
(Pitolisant)
doyubppxyy(hbaovefrbr) = qqjckwjaak deqgxrrzwq (bjnpxqbgbr, 1.14)
-
19 Sep 2024
Placebo
(Placebo)
doyubppxyy(hbaovefrbr) = prrbkgmguo deqgxrrzwq (bjnpxqbgbr, 1.35)
Phase 3
512
rgwgqpqbbh(hwamawrwgm) = agckavbzyv stupdbazwp (nwarrsptwb )
Positive
01 Mar 2024
Phase 1
9
(Pitolisant)
biurbgwvtt(ffqiplplkb) = csxuzpckli pazjdwljwj (iohcinnlqy, 25.759)
-
04 Dec 2023
Placebo
(Placebo)
biurbgwvtt(ffqiplplkb) = aivcfflnhb pazjdwljwj (iohcinnlqy, 15.369)
Not Applicable
110
wloaclzmwm(acjjcmqcxm) = udmpqsinpy xrwvbecyph (vhrlikdrwv )
Positive
23 Oct 2023
Placebo
wloaclzmwm(acjjcmqcxm) = ukfedgjfly xrwvbecyph (vhrlikdrwv )
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