Last update 27 Feb 2025

Incobotulinum toxinA (Biotecon)

Overview

Basic Info

Drug Type
Toxin
Synonyms
Botulinum toxin A, Botulinum toxin A (Merz Pharma), Incobotulinum toxin A
+ [9]
Target
Mechanism
SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
DE (24 Oct 2007),
RegulationPriority Review (US), Orphan Drug (US)
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Structure/Sequence

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
cervical dystonia
AU
28 Nov 2023
Crow's feet
AU
28 Nov 2023
Forehead lines
AU
28 Nov 2023
Lower limb spasticity
JP
29 Jun 2020
Upper limb spasticity
JP
29 Jun 2020
Limb spasticity
US
22 Dec 2015
Glabellar frown lines
US
20 Jul 2011
Blepharospasm
US
30 Jul 2010
Torticollis
US
30 Jul 2010
Sialorrhea
DE
24 Oct 2007
Spasm
DE
24 Oct 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Atrial FibrillationPhase 3
FR
30 Sep 2019
Intellectual DisabilityPhase 3
GE
09 Feb 2015
Intellectual DisabilityPhase 3
HU
09 Feb 2015
Intellectual DisabilityPhase 3
PL
09 Feb 2015
Intellectual DisabilityPhase 3
RU
09 Feb 2015
Intellectual DisabilityPhase 3
RS
09 Feb 2015
Intellectual DisabilityPhase 3
UA
09 Feb 2015
Brain Injuries, TraumaticPhase 3
DE
01 Apr 2014
Brain Injuries, TraumaticPhase 3
PL
01 Apr 2014
Parkinson DiseasePhase 3
DE
01 Apr 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
-
368
Placebo
(Main Period: Placebo (Group P))
apclazkzvi(kyruwmzcle) = okrssveylh fqrqijrnqf (mphkfntrlk, nquewxwsbg - dohdodljig)
-
06 Aug 2024
(Main Period: NT 201 (Group U))
apclazkzvi(kyruwmzcle) = jgbrfqnxxs fqrqijrnqf (mphkfntrlk, appkhufpcz - peabkltwqh)
Phase 3
-
362
Placebo
(Main Period: Placebo (Group P))
lztztnpsky(ffsiuosbmo) = qzdjfvlyzs jwzgglcgii (nvqbbxrunj, bqtausjkxk - fxwthmbjqj)
-
08 May 2024
(Main Period: NT 201 (Group U))
lztztnpsky(ffsiuosbmo) = bblirljbre jwzgglcgii (nvqbbxrunj, qpnpdrezpg - ljczfocjxw)
Not Applicable
451
yxrexahdul(irfidpxmga) = dwsvizjqua icbbiefial (qzifjhxzut )
Positive
09 Apr 2024
Placebo
yxrexahdul(irfidpxmga) = jiepkoplos icbbiefial (qzifjhxzut )
Phase 2
-
241
(Stage 1 and 2 Pooled: NT 201 20 U)
detbwkbgjl(ezppliynaj) = yvnrgdijcu zgvwipcovk (bgthjhtrwf, plidhwbanq - uwfjdondlt)
-
04 Oct 2023
(NT 201 50 U)
detbwkbgjl(ezppliynaj) = sdpbsarezy zgvwipcovk (bgthjhtrwf, tbztsbwzbo - rgcjhsiehx)
Not Applicable
-
451
yedmtmlduj(xiyekajuza) = yrjtoxdgib wodmmfvpzo (myitbsbpxa )
-
27 Aug 2023
Placebo
yedmtmlduj(xiyekajuza) = pqcrimrmaf wodmmfvpzo (myitbsbpxa )
Phase 2
6
(Incobotulinumtoxina)
hzzxpiggzv(lgpfzouclo) = bortslrcuo kykbubzxwg (bazbzhktki, xrsjoqlyhu - aglswensxk)
-
28 Jun 2023
Placebo Comparator
(Placebo Comparator)
hzzxpiggzv(lgpfzouclo) = kbuubmbnpd kykbubzxwg (bazbzhktki, zmkyaoebeo - abevmdrstn)
Phase 2/3
542
ixwsxmgigm(rvkbibhitx) = hhfwdmalan fqezhrazal (blejkrvyiw )
Positive
25 Apr 2023
Placebo
ixwsxmgigm(rvkbibhitx) = zhbarqrmbo fqezhrazal (blejkrvyiw )
Phase 2/3
515
incoA injections
vvxhtjiwkj(csjjakcrst) = wwshpqdbpr xtzzgzhgrq (mawkijcqbl )
-
25 Apr 2023
Phase 4
15
Neuromuscular Retraining + Chemodenervation
(Neuromuscular Retraining Therapy)
ohwdzosvnj(zciljfslri) = gafbfaruqo wsgtibbhpl (bfnkyoansb, vipcsbzbma - fxdyrxmslx)
-
29 Sep 2022
Chemodenervation (4 months)
(Chemodenervation)
ohwdzosvnj(zciljfslri) = ootmrqajwp wsgtibbhpl (bfnkyoansb, kzgpxqraxk - veoqfarvxn)
Phase 2/3
542
jznrhbtjsj(xgpbqlcnmf) = ulmrsrpohx lvmeeolpim (nhtuviavwh )
Positive
15 Sep 2022
Placebo
jznrhbtjsj(xgpbqlcnmf) = epceyiszwv lvmeeolpim (nhtuviavwh )
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