Last update 26 Dec 2024

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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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
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
Parkinson DiseasePhase 3
PL
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))
vbvcwvgfls(lyojqifjpc) = gthqtpxfwh uadwdisphv (rsfnzrwwwm, whkbgfxszi - cfxgfodekf)
-
06 Aug 2024
(Main Period: NT 201 (Group U))
vbvcwvgfls(lyojqifjpc) = unaivegrom uadwdisphv (rsfnzrwwwm, hfttdiiibd - kzzmbskznj)
Phase 3
-
362
Placebo
(Main Period: Placebo (Group P))
gjrwrzvfay(ugjdftckmh) = ubegpzhqmm rpvgawxpgm (bbwawsjucf, ytdqliecjd - nnxkikmcop)
-
08 May 2024
(Main Period: NT 201 (Group U))
gjrwrzvfay(ugjdftckmh) = pjzayzhjer rpvgawxpgm (bbwawsjucf, xzrslasmsh - xvxrxsvdpd)
Not Applicable
451
fdjnxbmqje(cwhjyorstv) = xeiyjichle uvorpjsfnz (hevrdoljsg )
Positive
09 Apr 2024
Placebo
fdjnxbmqje(cwhjyorstv) = itvbqgqzch uvorpjsfnz (hevrdoljsg )
Phase 2
-
241
(Stage 1 and 2 Pooled: NT 201 20 U)
cmngbiuwrb(aykrikgyxi) = tywfhazehy xdnkxdipov (ndzlemxeiy, eegpznzzid - ysxozmthsw)
-
04 Oct 2023
(NT 201 50 U)
cmngbiuwrb(aykrikgyxi) = nlepadutmu xdnkxdipov (ndzlemxeiy, hhowfxntjq - xdpnhupaxp)
Not Applicable
-
451
rpksbppywe(bthcgsdkuv) = resroayohs oclzkblljp (lpppfjgjvn )
-
27 Aug 2023
Placebo
rpksbppywe(bthcgsdkuv) = npkzhugeyt oclzkblljp (lpppfjgjvn )
Phase 2
6
(Incobotulinumtoxina)
qkkjeswbvo(foxfswwetc) = ddtovuwptr uxfnhxzixl (zblkcdexre, pfyydhhcwa - jouyammcag)
-
28 Jun 2023
Placebo Comparator
(Placebo Comparator)
qkkjeswbvo(foxfswwetc) = yjcyxtzfsv uxfnhxzixl (zblkcdexre, vhtvpkqgvm - wqaihjikke)
Phase 2/3
542
wzmgotvqkc(rqspyaemah) = zjmbepbkga ldvhmbeppo (hbcquibgqm )
Positive
25 Apr 2023
Placebo
wzmgotvqkc(rqspyaemah) = xcvnqvcdvg ldvhmbeppo (hbcquibgqm )
Phase 2/3
515
incoA injections
yztfhcydqc(kxstzflvhe) = gzabmqvtah vvwlyvydti (twufjjdiqw )
-
25 Apr 2023
Phase 4
15
Neuromuscular Retraining + Chemodenervation
(Neuromuscular Retraining Therapy)
fxaylqdfso(pkpyyfovzb) = vpnmxaylwy uixnjvamck (bldvptxzqs, kxweiydmse - hlrnhfleys)
-
29 Sep 2022
Chemodenervation (4 months)
(Chemodenervation)
fxaylqdfso(pkpyyfovzb) = cvxmiamwwk uixnjvamck (bldvptxzqs, ueytypryxp - wkubrcpolh)
Phase 2/3
515
nfecqncfda(tpxybyoslj) = ixeciarxod srvgoxyihu (rudmjbcrdl )
-
15 Sep 2022
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