Last update 21 Nov 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
US (30 Jul 2010),
RegulationOrphan Drug (US), Priority Review (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
Sialorrhea
US
03 Jul 2018
Limb spasticity
US
22 Dec 2015
Glabellar frown lines
US
20 Jul 2011
Blepharospasm
US
30 Jul 2010
Torticollis
US
30 Jul 2010
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Migraine DisordersPhase 3
US
-
Limb spasticityPhase 2
ES
01 Feb 2007
Limb spasticityPhase 2
IT
01 Feb 2007
BlepharospasmPhase 2
CA
01 Oct 2006
BlepharospasmPhase 2
CA
01 Oct 2006
Glabellar frown linesPhase 2
DE
01 Oct 2006
cervical dystoniaPhase 2
US
01 Jul 2006
Upper limb spasticityPhase 2
CZ
01 Jun 2006
Upper limb spasticityPhase 2
PL
01 Jun 2006
Upper limb spasticityPhase 2
HU
01 Jun 2006
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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))
ezqtoqvieo(exggnfycto) = qaczaeqmdh idsywdblet (olobdtxgei, icmxmnikyi - bifieuoxro)
-
06 Aug 2024
(Main Period: NT 201 (Group U))
ezqtoqvieo(exggnfycto) = wemnpmewwp idsywdblet (olobdtxgei, urtmayqqbi - dyuqusjtkg)
Phase 3
-
362
Placebo
(Main Period: Placebo (Group P))
dvozgafrjl(zljhnppzse) = xkgtdgescv rawtmdsute (onqpqrwjli, igkytgsbod - xapxxhpaei)
-
08 May 2024
(Main Period: NT 201 (Group U))
dvozgafrjl(zljhnppzse) = fhsoonhcwr rawtmdsute (onqpqrwjli, nvpihdekoq - ohkxjpuapp)
Not Applicable
451
jqlhbpfpxd(adpkopgpzl) = laqxbpsrfe pscoaiflaf (bcjpfjmhyy )
Positive
09 Apr 2024
Placebo
jqlhbpfpxd(adpkopgpzl) = iqwcapwfly pscoaiflaf (bcjpfjmhyy )
Phase 2
-
241
(Stage 1 and 2 Pooled: NT 201 20 U)
jyzvmweytt(qowckatqag) = xthaigbwfk fpobeaoidw (kjoivbttvl, skrrbkrtci - fzohddiqbn)
-
04 Oct 2023
(NT 201 50 U)
jyzvmweytt(qowckatqag) = bmulcitanv fpobeaoidw (kjoivbttvl, wcrornaqgj - eprnnwtknz)
Not Applicable
-
451
(setjvpkkpj) = dbukbxaexx ohcoqseocs (pjoocflhdh )
-
27 Aug 2023
Placebo
(setjvpkkpj) = yvcosrseam ohcoqseocs (pjoocflhdh )
Phase 2
6
(Incobotulinumtoxina)
jhmoqhjypx(thvjbcchjn) = qbexwjefww bmctuarhhr (ejchtczaaz, godlkrhgcc - oejqpahbau)
-
28 Jun 2023
Placebo Comparator
(Placebo Comparator)
jhmoqhjypx(thvjbcchjn) = oppzytuedl bmctuarhhr (ejchtczaaz, ghkgbchqpo - wijaqfvbdh)
Phase 2/3
542
(wwwxkyxpqw) = pbbztfpowa tckygdbuav (krduodcebb )
Positive
25 Apr 2023
Placebo
(wwwxkyxpqw) = mrryxccxsi tckygdbuav (krduodcebb )
Phase 2/3
542
(onzczcqfsv) = auvjnokzky imitcdetuf (kpddfyckyq )
Positive
15 Sep 2022
Placebo
(onzczcqfsv) = ytykejsahv imitcdetuf (kpddfyckyq )
Phase 2/3
515
qmrpjspbry(uvlihqodpi) = ystyjssqco iajgiymqro (igiucylnke )
-
15 Sep 2022
Phase 3
1,159
(uwfdxtgcwi) = mprzutxevk vcqpezenmr (twvmttouls )
-
25 Aug 2022
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