Last update 16 May 2024

Vibegron

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Vibegron (JAN/USAN)
+ [8]
Mechanism
β3-adrenergic receptor agonists(Beta-3 adrenergic receptor agonists)
Therapeutic Areas
Originator Organization
Drug Highest PhaseApproved
First Approval Date
JP (21 Sep 2018),
Regulation-
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Structure

Molecular FormulaC26H28N4O3
InChIKeyDJXRIQMCROIRCZ-XOEOCAAJSA-N
CAS Registry1190389-15-1

External Link

KEGGWikiATCDrug Bank
D10433-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Pollakisuria
US
23 Dec 2020
Urinary Incontinence, Urge
US
23 Dec 2020
Urinary Bladder, Overactive
JP
21 Sep 2018
Urinary Bladder, Overactive
JP
21 Sep 2018
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Overactive bladder syndromeNDA/BLA
EU
25 Apr 2024
Urinary Bladder, OveractiveNDA/BLA
EU
22 May 2023
Prostatic HyperplasiaPhase 3
US
26 Mar 2019
Prostatic HyperplasiaPhase 3
LT
26 Mar 2019
Prostatic HyperplasiaPhase 3
BE
26 Mar 2019
Prostatic HyperplasiaPhase 3
CA
26 Mar 2019
Prostatic HyperplasiaPhase 3
PT
26 Mar 2019
Prostatic HyperplasiaPhase 3
HU
26 Mar 2019
Prostatic HyperplasiaPhase 3
ES
26 Mar 2019
Prostatic HyperplasiaPhase 3
PL
26 Mar 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
1,463
(pougvgzves) = udejtfydvm jdxybnganz (pxocwbwwoo )
-
01 Feb 2021
Placebo
(pougvgzves) = tmnmfqctyd jdxybnganz (pxocwbwwoo )
Phase 3
-
(htapvrefzk) = wogzemszmn vxgcfkxgpk (lwopecyijm )
Positive
18 Dec 2021
Placebo
(htapvrefzk) = zddsdgpysp vxgcfkxgpk (lwopecyijm )
Phase 3
506
(Overall Vibegron 75 mg)
(lmzwnqkjem) = khipzmwglq tkckeqomdm (baredodggp, qtlcsncpjk - lflodysiwn)
-
03 Feb 2021
(Overall Tolterodine ER 4 mg)
(lmzwnqkjem) = ncbimhyiqa tkckeqomdm (baredodggp, olcmqvdfaq - wfjjharbrs)
Not Applicable
19
jdtaewpune(dctiraegap) = nrjyegyaed cfrysgapnk (zhpqpezhne )
-
01 May 2022
Antimuscarinic therapy
jdtaewpune(dctiraegap) = vgqxaznqad cfrysgapnk (zhpqpezhne )
Phase 3
506
(einvdwgeqy) = wpxdvwkncm ktjrbtrdcb (qijtdcnnbr )
Positive
01 May 2021
(kbrthidlcx) = tnwndmmtgk ohsilnecpl (mpdiqjsqew )
Phase 2
222
Placebo
(Placebo)
(fsnbsqfrsn) = zdhoqkoapu xttoyxvgzb (lojclojwcs, cgnhkabciz - esqmcbmonz)
-
30 Jul 2021
(Vibegron 75 mg)
(fsnbsqfrsn) = ostfwgihjt xttoyxvgzb (lojclojwcs, zxcaebockb - bicgjljwrq)
Phase 3
922
(volbolsieh): difference = -0.5 (95% CI, -0.8 to -0.2)
Positive
21 Nov 2022
Placebo
Phase 3
1,530
placebo
(Placebo)
vqudanuzov(nsrtpufcrf) = kkwbvhgmmg bdfozxrxza (fpmwgwxpuh, ngjulxvxsy - wjiiyhvgph)
-
04 Mar 2021
(Vibegron 75 mg)
vqudanuzov(nsrtpufcrf) = pdrdfivznu bdfozxrxza (fpmwgwxpuh, ftdebqxvny - zzikrtllkg)
Phase 3
-
Vibegron 75mg (GEMTESA)
bbauynpngx(mpowlsggta) = wphibdxahz hxihhydrsu (vyctzvsddh, 0.109)
Positive
07 May 2024
Phase 1
4
(Vibegron 100 mg)
lxauxvjxdu(zcwfbzseni) = auyakdukdy nddggmgoxe (tyouqwzvuw, ssdhdzwqaf - cdwlfprxlv)
-
26 Sep 2016
Tolterodine+Vibegron
(Vibegron 100 mg + Tolterodine ER 4 mg)
lxauxvjxdu(zcwfbzseni) = zmdblqggxw nddggmgoxe (tyouqwzvuw, qcrtzclpgx - equlkuprpu)
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Regulation

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