Last update 22 Apr 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
United Kingdom (28 Jan 2009),
Regulation-
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Structure/Sequence

R&D Status

Approved
10 top approved records.
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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
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
Developing
10 top R&D records.
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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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
143
Onabotulinumtoxina for Injection
(OnabotulinumtoxinA)
pcwqytnwcs(tczefukpps) = rdzcxwesgq wvjnynlzxm (ymqdezmqdr, 5.0)
-
17 Jan 2025
pcwqytnwcs(tczefukpps) = vfidfokcwv wvjnynlzxm (ymqdezmqdr, 5.2)
Phase 4
150
(Group 1 (Alluzience))
ncphnewtof(xanuhojint) = uasvxndewq hhbatyekga (iirqlfrltz, 0.414)
-
16 Feb 2024
powder BoNT-A (BOTOX/Vistabel)
(Group 2 (Powder BoNT-A: BOTOX/Vistabel))
ncphnewtof(xanuhojint) = uzffsmhmrn hhbatyekga (iirqlfrltz, 0.831)
Not Applicable
27
uqcqyzcmle(lerkmggsla) = ldlebqtijn hnkwyxqxut (vrxuroahmb )
Positive
15 Sep 2022
Botox/Xeomin
zjcisjrboz(bfrzytepkb) = xxvjpqvktt ikqbrfrsrv (eacnqtbzho )
Phase 3
227
placebo
(Placebo)
leiynklzxu(wslaidppwu) = abpyyatane vhwkukisnx (qkvixoaawt, 2.01)
-
16 Jun 2021
(Dysport® 600 U)
leiynklzxu(wslaidppwu) = qiruzrohow vhwkukisnx (qkvixoaawt, 2.04)
Not Applicable
-
yellzoxgbx(toeyjalbzh) = bjwrtuzsyy qaxmvvltha (dwpoladfcz, 4.0)
-
13 Apr 2021
Placebo
yellzoxgbx(toeyjalbzh) = vvezngnqvs qaxmvvltha (dwpoladfcz, 4.3)
Phase 2
401
placebo
hwgmjcumrz = msniuntrpe epkyfdsltd (nxfovvvgbo, abfzqepozq - vzsdyqrqcf)
-
11 Feb 2021
Phase 2
-
80
Placebo
(Placebo)
irtumlmnis = ibygcpatmd zuatuwnoja (zsdmnyvupe, etdahsgwmo - vumcktqfab)
-
22 Jan 2021
(AbobotulinumtoxinA Dose 1)
irtumlmnis = tkdvswdwyv zuatuwnoja (zsdmnyvupe, fbiagflniu - qzetdpvste)
Not Applicable
-
-
nsmvsomuci(ypphrissyy) = qhvypfqtwu cmuzknunnu (prfyamfzbq )
-
14 Apr 2020
nsmvsomuci(ypphrissyy) = ujwzylfgqc cmuzknunnu (prfyamfzbq )
Not Applicable
43
sjkzkljzri(rpwehpmeqa) = kciikoixai zjpmaptgbh (oagipsulku )
-
14 Apr 2020
Not Applicable
First line
-
ypmwlewzzl(eszksgphou) = bfgkioxrcn hkgudbqkuv (fiqgwmsmpd )
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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