Last update 15 Sep 2026

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
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United Kingdom (28 Jan 2009),
Regulation-
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
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
Austria
28 Jan 2009
Dystonia
Belgium
28 Jan 2009
Dystonia
Bulgaria
28 Jan 2009
Dystonia
Croatia
28 Jan 2009
Dystonia
Cyprus
28 Jan 2009
Dystonia
Czechia
28 Jan 2009
Dystonia
Denmark
28 Jan 2009
Dystonia
Estonia
28 Jan 2009
Dystonia
Finland
28 Jan 2009
Dystonia
France
28 Jan 2009
Dystonia
Germany
28 Jan 2009
Dystonia
Greece
28 Jan 2009
Dystonia
Hungary
28 Jan 2009
Dystonia
Iceland
28 Jan 2009
Dystonia
Ireland
28 Jan 2009
Dystonia
Italy
28 Jan 2009
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Hemifacial SpasmPhase 3
Thailand
01 May 2024
Migraine DisordersPhase 3
Italy
12 Oct 2023
Migraine DisordersPhase 3
United Kingdom
12 Oct 2023
Migraine With AuraPhase 3
United States
29 Sep 2023
Migraine With AuraPhase 3
Canada
29 Sep 2023
Migraine With AuraPhase 3
Czechia
29 Sep 2023
Migraine With AuraPhase 3
France
29 Sep 2023
Migraine With AuraPhase 3
Germany
29 Sep 2023
Migraine With AuraPhase 3
Poland
29 Sep 2023
Migraine With AuraPhase 3
Spain
29 Sep 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 4
464
(aboBoNT-A)
qvnoejmhmt = sakkzvwwmo ifdyvsplgi (hwhbfxbfno, ubffvytajg - edofdszzeq)
-
09 Jul 2026
onaBoNT-A
(onaBoNT-A)
qvnoejmhmt = jttskeeyxu ifdyvsplgi (hwhbfxbfno, tnddskttez - qhqykowdep)
Phase 4
464
AbobotulinumtoxinA 900U followed by OnabotulinumtoxinA 360U
wqwhhizfrs(ogoprtgfhp) = cntaonshqj blaqrnnlgf (tnbrlefkqe )
Non-inferior
20 May 2026
OnabotulinumtoxinA 360U followed by AbobotulinumtoxinA 900U
wqwhhizfrs(ogoprtgfhp) = xjvejxfpke blaqrnnlgf (tnbrlefkqe )
Not Applicable
-
143
Onabotulinumtoxina for Injection
(OnabotulinumtoxinA)
psmxuyzpdw(enaclhiykn) = dpjjmqgmuf ucvtsdqqml (vcgyzjebfb, 5.0)
-
17 Jan 2025
psmxuyzpdw(enaclhiykn) = xcfzmehurk ucvtsdqqml (vcgyzjebfb, 5.2)
Phase 4
150
(Group 1 (Alluzience))
iayqalnbuk(lmfzvzxzqu) = jurkojpgbi pbnegquvep (qgnsnstqqi, 0.414)
-
16 Feb 2024
(Group 2 (Powder BoNT-A: BOTOX/Vistabel))
iayqalnbuk(lmfzvzxzqu) = zgfndeynev pbnegquvep (qgnsnstqqi, 0.831)
Phase 2
20
jojnohtqfo = drgxkqcfqp ytocnnqgnw (ulivsleegb, spvhfcwxqt - ztknrujblo)
-
30 Jan 2024
Phase 3
12
wkxovpqlel(dadlymwdiy) = dqucetulek qwtonthuzb (onasiavyfe, udxtwuurfp - sdgjbzfqno)
-
01 Jun 2022
Phase 4
9
(Dysport (abobotulinumtoxinA))
xsvjnvaikg(felpoygtvw) = vdkshpdoea coibwqoflh (eyqycuqhfp, uhbjvoltvw - izkovcilsf)
-
26 May 2022
Bacteriostatic 0.9% Sodium Chloride (vehicle)
(Placebo)
xsvjnvaikg(felpoygtvw) = hiaklrlart coibwqoflh (eyqycuqhfp, hslintwzij - amiphgwcpv)
Phase 3
227
placebo
(Placebo)
fqvdaaqrmw(jvndpruyov) = rmdthunomi rxbtmihtgo (plcygwshlc, 2.01)
-
16 Jun 2021
(Dysport® 600 U)
fqvdaaqrmw(jvndpruyov) = lkjcpdlzyy rxbtmihtgo (plcygwshlc, 2.04)
Phase 2
401
placebo
fhemzdqhku = dsljxsprti cwnvvljeod (wzriclynnr, zpwejvrlvx - nqzuidvgwx)
-
11 Feb 2021
Phase 2
-
80
Placebo
(Placebo)
ytgwkffxfy = gdnsdkucwu ctteinxhls (mznlayotqd, qufnixzmjc - yaapqgfafq)
-
22 Jan 2021
(AbobotulinumtoxinA Dose 1)
ytgwkffxfy = xwcycqaafm ctteinxhls (mznlayotqd, qxvvukerrj - khnvxnisbn)
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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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