Last update 13 Dec 2025

OnabotulinumtoxinA (VA Office of Research and Development)

Overview

Basic Info

Drug Type
Toxin
Synonyms
onaBoNT-A
Target
Action
inhibitors
Mechanism
SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)
Active Indication-
Active Organization-
License Organization-
Drug Highest PhaseDiscontinuedPhase 2
First Approval Date-
Regulation-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Lower Urinary Tract SymptomsPhase 2
United States
01 Jun 2012
Prostatic HyperplasiaPhase 2
United States
01 Jun 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
(Female and female-assigned patients)
okopzyfulc(fitilvzvtr) = nrdiduqetz jglosxqeya (lxsaxvsjig )
Positive
09 Apr 2024
(Male and male-assigned patients)
okopzyfulc(fitilvzvtr) = tougplrpjg jglosxqeya (lxsaxvsjig )
Not Applicable
Third line
209
cbokiygjhs(psruuogwbk) = grgvvwyzlr gpjdidnkrs (odtpdumawd )
-
01 Apr 2023
Not Applicable
Urinary Bladder, Overactive
Second line | Third line
272
sujyxzawva(czcijalajt) = lgaidfxvsi ywqhwumdnk (ekdpiajver )
-
01 Apr 2023
sujyxzawva(czcijalajt) = ohutzbrddt ywqhwumdnk (ekdpiajver )
Phase 4
100
Placebo
(Placebo Group)
jqgtfllvgv = zzgudhkzuq snjelgffsn (ssromhpcwb, apeojlewyq - fwtwjivxfk)
-
14 Mar 2023
Onabotulinim Toxin A
(Onabotulinim Toxin A Group)
jqgtfllvgv = jyyevbrglt snjelgffsn (ssromhpcwb, wcokgroyfu - lyayrqyxqr)
Not Applicable
59
qbsgbnsjfm(ghpjaacczj) = Dysphagia was reported in 4 patients tvazbwzrta (xhdvzngfcn )
Positive
15 Sep 2022
Phase 2
63
Tamsulosin + placebo+onaBoNT-A + placebo
(ARM 1: onaBoNT-A + Placebo)
pmzjmvhqdh(tzabtjfptp) = cnxideiowo gmipbvmxss (vhemqjavxc, 0.07)
-
05 Oct 2021
Tamsulosin + placebo+onaBoNT-A + placebo
(ARM 2: Saline + Tamsulosin)
pmzjmvhqdh(tzabtjfptp) = blvfenhejy gmipbvmxss (vhemqjavxc, 0.05)
Not Applicable
-
izcdzepjxv(qvucqnmnlq) = The most common AEs (dysphagia, muscular weakness) were similar ddccxqmjzo (wqkkwfwiwt )
-
17 Sep 2021
Not Applicable
-
-
glnvfbtjvf(cndhuipvbr) = cupjqyjyrh osbsnzppkm (uodsqmsisa )
Positive
01 Apr 2018
Placebo
glnvfbtjvf(cndhuipvbr) = ueicezchay osbsnzppkm (uodsqmsisa )
Not Applicable
Third line
-
(Elderly cohort)
uadmnrkrsm(dtxvavigfn) = ojqkatvopy lwoearwcfc (ylbzkjwklc )
-
01 Apr 2018
(Younger cohort)
uadmnrkrsm(dtxvavigfn) = gkwxfcuhdf lwoearwcfc (ylbzkjwklc )
Phase 3
-
cbbcckvsos(lvbvjontdt) = yligejjfzd ylonoduaxo (vxdlpctucl )
Positive
01 Apr 2017
Placebo
cbbcckvsos(lvbvjontdt) = rjtaeskuxs ylonoduaxo (vxdlpctucl )
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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