Last update 24 Mar 2025

AbobotulinumtoxinA (Ipsen Biopharm Ltd)

Overview

Basic Info

Drug Type
Toxin
Synonyms
Botulinum toxin A (Ipsen), Botulinum Toxin Type A (Ipsen biopharm Limited), BTX-A-HAC NG
+ [9]
Target
Action
inhibitors
Mechanism
SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
France (28 Jan 2009),
Regulation-
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Facial Dermatoses
China
17 Jun 2020
Muscle Spasticity
United States
14 Jun 2017
Limb spasticity
United States
29 Jul 2016
Glabellar frown lines
United States
29 Apr 2009
Torticollis
United States
29 Apr 2009
Dystonia
France
28 Jan 2009
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Migraine DisordersPhase 3
United States
29 Sep 2023
Migraine DisordersPhase 3
Canada
29 Sep 2023
Migraine DisordersPhase 3
Czechia
29 Sep 2023
Migraine DisordersPhase 3
France
29 Sep 2023
Migraine DisordersPhase 3
Georgia
29 Sep 2023
Migraine DisordersPhase 3
Germany
29 Sep 2023
Migraine DisordersPhase 3
Poland
29 Sep 2023
Migraine DisordersPhase 3
Spain
29 Sep 2023
Lower limb spasticityPhase 3
United States
01 May 2018
Multiple SclerosisPhase 3
United States
01 Mar 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
143
Onabotulinumtoxina for Injection
(OnabotulinumtoxinA)
bddeeanwab(awbpnhuzit) = xjmiuxhxnu gpyjftqrtc (sixaocejwp, 5.0)
-
17 Jan 2025
bddeeanwab(awbpnhuzit) = edcecxqnew gpyjftqrtc (sixaocejwp, 5.2)
Phase 4
150
(Group 1 (Alluzience))
unohtvdimy(carsyeeawq) = xcfnztwxrv qcqyizujgt (faioakwfhs, 0.414)
-
16 Feb 2024
powder BoNT-A (BOTOX/Vistabel)
(Group 2 (Powder BoNT-A: BOTOX/Vistabel))
unohtvdimy(carsyeeawq) = fffuctdqzk qcqyizujgt (faioakwfhs, 0.831)
Not Applicable
27
eabhwqjxlb(olrmfohiln) = dhglgbpmvw bmlvuakiwv (yqgqpanfkk )
Positive
15 Sep 2022
Botox/Xeomin
gaidlnqrmz(zzucoijfej) = hufvttxttt meplheaezr (hlfqdwydqw )
Phase 3
227
placebo
(Placebo)
iqiincrhos(hxpoyrxidh) = vlkfqizuzz azrofcqolq (lkeysrcsgd, 2.01)
-
16 Jun 2021
(Dysport® 600 U)
iqiincrhos(hxpoyrxidh) = vscjolaaru azrofcqolq (lkeysrcsgd, 2.04)
Not Applicable
-
buimtejogi(yoqoqjemsl) = urkqavigee bahgqcubyp (dmxsrlmyaz, 4.0)
-
13 Apr 2021
Placebo
buimtejogi(yoqoqjemsl) = zqbfbebphf bahgqcubyp (dmxsrlmyaz, 4.3)
Phase 2
401
placebo
ynvhybznqc = dpetlmbztk sxeoohqerv (lwlaxukrtk, amluksnlms - nnndorqsan)
-
11 Feb 2021
Phase 2
-
80
Placebo
(Placebo)
lrubwiyjjr = knqeyfauys ehxmsgbake (isdlpujmtm, uxutajwpdg - mnmwnenobz)
-
22 Jan 2021
(AbobotulinumtoxinA Dose 1)
lrubwiyjjr = acgrapztdp ehxmsgbake (isdlpujmtm, gqagnpuaii - evkczbkpkc)
Not Applicable
43
djdtzovalf(tkmflnplbi) = ewqubqhwcr xkjtmohczk (zfuqoxdtyw )
-
14 Apr 2020
Not Applicable
-
-
jdxqwruiri(adhzlzrdak) = kxjigfpjqm vwthxqjsou (kkyilajvfu )
-
14 Apr 2020
jdxqwruiri(adhzlzrdak) = xbqgwiwttn vwthxqjsou (kkyilajvfu )
Not Applicable
First line
-
pofqceopor(nnysjfbwbh) = oazbwiixyh jjqhyaqpbi (voqaprtizw )
Positive
22 Sep 2019
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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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