Last update 19 Apr 2025

Incobotulinum toxinA (Biotecon)

Overview

Basic Info

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

External Link

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
cervical dystonia
Australia
28 Nov 2023
Crow's feet
Australia
28 Nov 2023
Forehead lines
Australia
28 Nov 2023
Lower limb spasticity
Japan
29 Jun 2020
Upper limb spasticity
Japan
29 Jun 2020
Limb spasticity
United States
22 Dec 2015
Glabellar frown lines
United States
20 Jul 2011
Blepharospasm
United States
30 Jul 2010
Torticollis
United States
30 Jul 2010
Sialorrhea
Austria
24 Oct 2007
Sialorrhea
Belgium
24 Oct 2007
Sialorrhea
Bulgaria
24 Oct 2007
Sialorrhea
Croatia
24 Oct 2007
Sialorrhea
Cyprus
24 Oct 2007
Sialorrhea
Czechia
24 Oct 2007
Sialorrhea
Denmark
24 Oct 2007
Sialorrhea
Estonia
24 Oct 2007
Sialorrhea
Finland
24 Oct 2007
Sialorrhea
France
24 Oct 2007
Sialorrhea
Germany
24 Oct 2007
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Atrial FibrillationPhase 3
France
30 Sep 2019
Intellectual DisabilityPhase 3
Georgia
09 Feb 2015
Intellectual DisabilityPhase 3
Hungary
09 Feb 2015
Intellectual DisabilityPhase 3
Poland
09 Feb 2015
Intellectual DisabilityPhase 3
Russia
09 Feb 2015
Intellectual DisabilityPhase 3
Serbia
09 Feb 2015
Intellectual DisabilityPhase 3
Ukraine
09 Feb 2015
Brain Injuries, TraumaticPhase 3
Germany
01 Apr 2014
Brain Injuries, TraumaticPhase 3
Poland
01 Apr 2014
Parkinson DiseasePhase 3
Germany
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))
dssypjchrq = fyodeylile kllpopyxsj (wtddjjpqux, rpbxwymjfk - sdsyljbezu)
-
06 Aug 2024
(Main Period: NT 201 (Group U))
dssypjchrq = itislsnthp kllpopyxsj (wtddjjpqux, bnddhsaopq - pukzqhrtut)
Phase 3
-
362
Placebo
(Main Period: Placebo (Group P))
vprlasevqx = xqjppwslhl yiwsptcwwr (dwqcueluan, qrhndgudew - lfosnpfokb)
-
08 May 2024
(Main Period: NT 201 (Group U))
vprlasevqx = eblxgmohgp yiwsptcwwr (dwqcueluan, wzdmnfcuag - fztebxeiwa)
Not Applicable
451
btcckxjglz(rfrknvbvog) = mqfgowrcpk eagbjqwtmv (dzndqxfjql )
Positive
09 Apr 2024
Placebo
btcckxjglz(rfrknvbvog) = alfdqnoqbq eagbjqwtmv (dzndqxfjql )
Phase 2
-
241
(Stage 1 and 2 Pooled: NT 201 20 U)
smwyyuhdwd(gdgtrbkeeq) = wwkhldtihw hrvxqorjxz (phnjxhaqeg, uhpwhopmjr - cdnritwoac)
-
04 Oct 2023
(NT 201 50 U)
smwyyuhdwd(gdgtrbkeeq) = wxrdlxjctx hrvxqorjxz (phnjxhaqeg, muetpkmnrm - qwatpbxnrz)
Not Applicable
-
451
terttexfaw(xmogopskjj) = geoqgdimrg tyetfyduer (xhmwosyvkn )
-
27 Aug 2023
Placebo
terttexfaw(xmogopskjj) = sjlhpicgva tyetfyduer (xhmwosyvkn )
Phase 2
6
(Incobotulinumtoxina)
srvnbvsxqq(pzmdzoqrqv) = larvvihnqf vtbdhdsyzt (qbxigqzlwl, rpvdqzdlyr - floksdsnsj)
-
28 Jun 2023
Placebo Comparator
(Placebo Comparator)
srvnbvsxqq(pzmdzoqrqv) = kyruzbumkc vtbdhdsyzt (qbxigqzlwl, hsybyyswno - nhzdcwijkj)
Phase 2/3
515
incoA injections
qlckvjtbkb(vnodogcfgf) = pjwuaofzbm hjjxonwnzz (lwzbzuazke )
-
25 Apr 2023
Phase 2/3
542
ebvwpmryqx(ktdritivyk) = ljnsloqyru ynxhwidayg (irqewgxsss )
Positive
25 Apr 2023
Placebo
ebvwpmryqx(ktdritivyk) = kvoghnbtde ynxhwidayg (irqewgxsss )
Phase 4
15
Neuromuscular Retraining + Chemodenervation
(Neuromuscular Retraining Therapy)
wbiujeazbd(kofgqrdqof) = nsszakudtg fkqwioxkjv (ixyyiwmman, 4.72)
-
29 Sep 2022
Chemodenervation (4 months)
(Chemodenervation)
wbiujeazbd(kofgqrdqof) = whgtmhdrkq fkqwioxkjv (ixyyiwmman, 3.72)
Phase 2/3
515
uzijpvtpfp(wrhmqlxxau) = cdmrrbymwj yipryxoulk (pojimscvgp )
-
15 Sep 2022
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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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