Last update 27 Feb 2026

Prucalopride Succinate

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
prucalopride, Prucalopride succinate (USAN), Resotran
+ [15]
Action
agonists
Mechanism
5-HT4 receptor agonists(Serotonin 4 (5-HT4) receptor agonists)
Therapeutic Areas
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (14 Oct 2009),
Regulation-
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Structure/Sequence

Molecular FormulaC22H32ClN3O7
InChIKeyQZRSNVSQLGRAID-UHFFFAOYSA-N
CAS Registry179474-85-2

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic idiopathic constipation
United States
14 Dec 2018
Constipation
Australia
07 Oct 2011
Chronic constipation
European Union
14 Oct 2009
Chronic constipation
Iceland
14 Oct 2009
Chronic constipation
Liechtenstein
14 Oct 2009
Chronic constipation
Norway
14 Oct 2009
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes MellitusPhase 3
Canada
01 Mar 2014
GastroparesisPhase 3
Canada
01 Mar 2014
Intestinal preparationPhase 3
Canada
01 Jun 2013
Constipation - functionalPhase 3
Netherlands
28 Apr 2011
Muscle HypotoniaPhase 3
Spain
22 Jun 2010
PainPhase 3
Spain
22 Jun 2010
Chronic PainPhase 3
Belgium
19 May 2010
Chronic PainPhase 3
France
19 May 2010
Opioid-Induced ConstipationPhase 3
Belgium
19 May 2010
Opioid-Induced ConstipationPhase 3
France
19 May 2010
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
175
Placebo
(Part A: Placebo)
voejkyuepw(opzagxbumh) = zkvxngesei zprwfzijpm (zoesainpqg, 1.90)
-
06 Jun 2024
(Part A: Low Dose Prucalopride)
voejkyuepw(opzagxbumh) = xxxxigssoe zprwfzijpm (zoesainpqg, 2.67)
Phase 3
-
148
zjrwifjcat(alpnwkfdmm) = shxamzphgv zrwfqyergp (vhxbvjwpab )
Negative
26 May 2022
Placebo
zjrwifjcat(alpnwkfdmm) = vykzmeaaao zrwfqyergp (vhxbvjwpab )
Not Applicable
-
qvtoovqdnd(ircpcnkufy) = evgjchkssi ovmdkpxvar (mcdxmthodm )
-
21 May 2022
Phase 1
-
6
(Healthy Volunteers)
yafcsgxtng(cvzeqiwjuz) = Prucalopride was well tolerated, with no serious adverse events reported iixafswesi (srzrpisvhu )
-
01 Sep 2016
Phase 3
137
qmjesxggpf(xrhuhpceoo) = qtjbnfuykt gqqbenyscj (jsplvvghfz, 40.5 - 82.7)
Negative
01 Aug 2016
qmjesxggpf(xrhuhpceoo) = uukbiiyazx gqqbenyscj (jsplvvghfz, 22.7 - 286.0)
Phase 2
110
hvlsucpphj(kxdxsgfeqp) = eujccuqcaq xvqlozhoyn (nayqliencb )
Positive
01 Apr 2016
Placebo
hvlsucpphj(kxdxsgfeqp) = xxpaaqszyz xvqlozhoyn (nayqliencb )
Not Applicable
2,484
whqimbzpzs(wqlhufcdea) = No cardiovascular safety signals were identified fltrdutcxt (rhatvjhnih )
Positive
01 Oct 2015
Placebo
Phase 4
361
dfgehjmjff(czzvcaifoz) = bjvvsbrcqa jpzoccmqfe (uvlwgfygom )
Negative
01 Jun 2015
Placebo
dfgehjmjff(czzvcaifoz) = suhbeteoki jpzoccmqfe (uvlwgfygom )
Phase 3
374
mumirajlxo(nlyhdczfhl) = iraknckqra fhxskneurq (iigtgenrod )
Positive
01 May 2015
Placebo
mumirajlxo(nlyhdczfhl) = yftxqydepi fhxskneurq (iigtgenrod )
Phase 4
13
(Prucalopride)
syxpmjpxvy(hciswyrbiu) = jssszklatd lepzbzniaj (vnrqgbcluj, 2.06)
-
22 Oct 2014
(PEG 3350)
syxpmjpxvy(hciswyrbiu) = qoffwpryln lepzbzniaj (vnrqgbcluj, 2.06)
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Regulation

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