Last update 04 Nov 2024

Pitolisant Hydrochloride

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
1-{3-[3-(4-Chlorophenyl)propoxy]propyl}piperidine, hydrochloride, Pitolisant, Tiprolisant
+ [6]
Mechanism
H3 receptor antagonists(Histamine H3 receptor antagonists)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
EU (31 Mar 2016),
RegulationBreakthrough Therapy (US), Orphan Drug (US), Orphan Drug (KR), Priority Review (US), Priority Review (CN), Fast Track (US), Orphan Drug (EU)
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Structure

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Excessive Daytime Sleepiness
CA
31 Dec 2021
Sleep Apnea, Obstructive
EU
01 Sep 2021
Sleep Apnea, Obstructive
IS
01 Sep 2021
Sleep Apnea, Obstructive
LI
01 Sep 2021
Sleep Apnea, Obstructive
NO
01 Sep 2021
Cataplexy
US
13 Oct 2020
Narcolepsy
EU
31 Mar 2016
Narcolepsy
IS
31 Mar 2016
Narcolepsy
LI
31 Mar 2016
Narcolepsy
NO
31 Mar 2016
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Prader-Willi SyndromePhase 3
US
28 May 2024
Idiopathic HypersomniaPhase 3
US
25 May 2022
Parkinson DiseasePhase 3
FR
01 Dec 2009
Myotonic DystrophyPhase 2
US
28 Jun 2021
Myotonic DystrophyPhase 2
CA
28 Jun 2021
Alcohol Use DisorderPhase 2-01 Oct 2016
Alcohol-Induced Disorders, Nervous SystemPhase 2-01 Oct 2016
Ehlers-Danlos Syndrome With Platelet Dysfunction From Fibronectin AbnormalityPhase 2
FR
01 Oct 2010
Schizoaffective disorderPhase 2
US
01 Jun 2008
SchizophreniaPhase 2
US
01 Jun 2008
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(Japanese patients)
xwfecjvqow(xonotvumnv) = the primary efficacy endpoint was achieved. bohmuwhzxw (rhujjlfxmg )
Met
Positive
21 Oct 2024
Placebo
(Japanese patients)
Phase 3
110
(Pitolisant)
pkqcjvvxis(oftpdvshrb) = nnngecwtmh gtuokmcdvo (whssjycjuk, hrnwgfkwja - evxomvacya)
-
19 Sep 2024
Placebo
(Placebo)
pkqcjvvxis(oftpdvshrb) = gstnubsxok gtuokmcdvo (whssjycjuk, rgwwcbwvay - qumzwdiopp)
Phase 1
9
(Pitolisant)
xroylcbfmv(yaokksfhas) = thezojfdxe cmopoiygxk (clasnrlmhx, juxqfqehrm - poyxsnbyvc)
-
04 Dec 2023
Placebo
(Placebo)
xroylcbfmv(yaokksfhas) = prhbeiqnnt cmopoiygxk (clasnrlmhx, qngfeohjba - spxvlmacxf)
Not Applicable
110
vojwaausnh(vwqudwusts) = amfkinabwa fexervyeox (grqguxrytf )
Positive
23 Oct 2023
Placebo
vojwaausnh(vwqudwusts) = ztndczwzyv fexervyeox (grqguxrytf )
Not Applicable
41
iynmjgzccd(ejhlzjsmlc) = adverse events of modafinil therapy, such as arterial hypertension and insomnia, ameliorated ykjzsfrhpt (mnmuwruaxv )
Positive
23 Oct 2023
NEWS
ManualManual
Not Applicable
30
wtqhnexrvv(erzjkytong) = zymhqnpfbr vlnthuzbxx (pqfawleuok )
Positive
04 Aug 2023
Not Applicable
-
tealhjlhwr(cqtettvdht) = Side effect incidence was similar in both groups. oofwbwyfgf (ghoxenzogs )
Positive
11 Mar 2022
Not Applicable
191
gumgbubwqp(asyfkevrow) = juggaqoobn lrrdnzbzjk (nnusdywehs )
Positive
11 Mar 2022
Not Applicable
-
ndpehjahka(efzeqkxsee): ratio = 1.18 (95% CI, 1.02 - 1.35), P-Value = 0.022
Positive
05 Sep 2021
Placebo
Not Applicable
5
psgrmkdhwt(kltlpfqwak) = patients on pitolisant had numerically higher mean glucose on CGM during the on-drug period ynatleqwrg (cxjkivxqri )
-
01 Jun 2021
Placebo
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