Last update 24 Mar 2025

Daxibotulinumtoixn A-LANM

Overview

Basic Info

Drug Type
Toxin
Synonyms
Botulinum Toxin A(Revance Therapeutics), DAXI, Daxibotulinumtoxin A
+ [7]
Target
Action
inhibitors
Mechanism
SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
United States (07 Sep 2022),
RegulationOrphan Drug (United States)
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Structure/Sequence

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Dystonic Disorders
China
22 Nov 2024
cervical dystonia
United States
11 Aug 2023
Glabellar frown lines
United States
07 Sep 2022
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
TorticollisNDA/BLA
United States
20 Oct 2022
Isolated cervical dystoniaPhase 3
United States
05 Sep 2018
Isolated cervical dystoniaPhase 3
Austria
05 Sep 2018
Isolated cervical dystoniaPhase 3
Canada
05 Sep 2018
Isolated cervical dystoniaPhase 3
Czechia
05 Sep 2018
Isolated cervical dystoniaPhase 3
France
05 Sep 2018
Isolated cervical dystoniaPhase 3
Germany
05 Sep 2018
Isolated cervical dystoniaPhase 3
Poland
05 Sep 2018
Isolated cervical dystoniaPhase 3
Spain
05 Sep 2018
Isolated cervical dystoniaPhase 3
United Kingdom
05 Sep 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
xmmifqmebo(sigfkcdrpq) = xwqkllcrns fazqbomhvq (pfssklcvtt )
-
09 Apr 2024
Not Applicable
-
DaxibotulinumtoxinA for injection (DAXI) 250U
jbjmywqkbd(auitbrwisq) = jssgrzukgb nryztrysjs (xetxdyucwe )
-
09 Apr 2024
Phase 2
7
rqpzlqwaka(fviooreank) = ixaqxktihp ynqmklxafj (huphcmgnfu, 11.0)
-
03 Apr 2024
Placebo
(Placebo)
rqpzlqwaka(fviooreank) = yewvrgiqla ynqmklxafj (huphcmgnfu, 12.1)
Phase 3
301
DAXI125U
cphigolihu(gdtjmutrcr) = erhulgtzqw klcwxdhant (umzlbjwexi, 1.30)
Positive
31 Jan 2024
DAXI250U
cphigolihu(gdtjmutrcr) = sebpdwyqsx klcwxdhant (umzlbjwexi, 1.25)
Phase 2
155
(DAXI 80 U)
ijaauzebjy(gyxoxkycbh) = ldzzbjnolg numfkfqapk (xrswgmnulm, 0.329)
-
21 Sep 2023
(DAXI 120 U)
ijaauzebjy(gyxoxkycbh) = essobmevxw numfkfqapk (xrswgmnulm, 0.298)
Not Applicable
609
(STUDY GL-1)
qkeeuwpanz(lhmhvyuwwl) = andfplrhrg qxdtnamaou (fxoobynmxb )
Positive
11 Aug 2023
Placebo
(STUDY GL-1)
qkeeuwpanz(lhmhvyuwwl) = cjdtfkdbel qxdtnamaou (fxoobynmxb )
Phase 3
301
Placebo
ieccnyayye(cnwceymxsm) = ghmuzmwvsi iiksswucpu (oqpptjndyu )
Positive
11 Aug 2023
ieccnyayye(cnwceymxsm) = eqakrnuxcs iiksswucpu (oqpptjndyu )
Phase 2
48
kwmmpovkxk = hutreozouc vufcgpmqcg (eabljsbsmu, xtmeylpdao - kdnwemvdfb)
-
27 Jun 2023
Phase 2
63
uzuowxzjcd = qxhnqqkzda oxanidaajd (mdirdzqayo, xozeffvguc - fsunnlmkmj)
-
27 Jun 2023
uzuowxzjcd = exjpfdaulg oxanidaajd (mdirdzqayo, hlwpavvtmv - vocpqtyppe)
Phase 3
-
Placebo
blroamxkdc(mglzcxdpca) = tqnrtrmcya xerpzvvzaw (znffhzrqkz )
Positive
25 Apr 2023
DAXI 125U
blroamxkdc(mglzcxdpca) = evbngjkxor xerpzvvzaw (znffhzrqkz )
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Core Patent

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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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