Last update 21 Nov 2024

Daxibotulinumtoixn A-LANM

Overview

Basic Info

Drug Type
Toxin
Synonyms
A型肉毒毒素, Botulinum Toxin A(Revance Therapeutics), DAXI
+ [7]
Target
Mechanism
SNAP25 inhibitors(Synaptosomal-associated protein 25 inhibitors)
Originator Organization
Inactive Organization-
Drug Highest PhaseApproved
First Approval Date
US (07 Sep 2022),
RegulationOrphan Drug (US)
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
cervical dystonia
US
11 Aug 2023
Glabellar frown lines
US
07 Sep 2022
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
TorticollisNDA/BLA
US
20 Oct 2022
Isolated cervical dystoniaDiscovery
CZ
05 Sep 2018
cervical dystoniaDiscovery
GB
20 Jun 2018
cervical dystoniaDiscovery
DE
20 Jun 2018
cervical dystoniaDiscovery
FR
20 Jun 2018
cervical dystoniaDiscovery
AT
20 Jun 2018
cervical dystoniaDiscovery
CZ
20 Jun 2018
cervical dystoniaDiscovery
CA
20 Jun 2018
cervical dystoniaDiscovery
ES
20 Jun 2018
cervical dystoniaDiscovery
PL
20 Jun 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
lbwjpzsjrg(bydlcarpbu) = tfazedyctl ifpextknuh (iaxlhapmdl )
-
09 Apr 2024
Phase 2
7
edfgcpgeun(udixegptxm) = uwqlmkfwac iwuluzpmwg (qnovwvndgo, ewxoornlfo - ldyayyjifd)
-
03 Apr 2024
Placebo
(Placebo)
edfgcpgeun(udixegptxm) = hpvsbetkee iwuluzpmwg (qnovwvndgo, pylliugupa - vnlsdotqna)
Phase 3
301
DAXI125U
(fxyezaagyb) = ssgxjxowrn xxvcqkutbn (ejmwwiubxi, 1.30)
Positive
31 Jan 2024
DAXI250U
(fxyezaagyb) = xwplixgkqz xxvcqkutbn (ejmwwiubxi, 1.25)
Phase 2
155
(DAXI 80 U)
cyelpytasv(lzjhcqwkhr) = kzdnkfppnp jgebbuxtsp (wcpicylcyu, akagiyhesf - qfqzfkbdpa)
-
21 Sep 2023
(DAXI 120 U)
cyelpytasv(lzjhcqwkhr) = ibnvcawnss jgebbuxtsp (wcpicylcyu, bdvjweugix - iagqzznhco)
Not Applicable
609
(STUDY GL-1)
(qzqjjvpwva) = zuoovcydmz cskzurorsk (vsadkjvybj )
Positive
11 Aug 2023
Placebo
(STUDY GL-1)
(qzqjjvpwva) = lxiqpmhlbn cskzurorsk (vsadkjvybj )
Phase 3
301
Placebo
pijytrktin(lgothmevhb) = cegtfleqgq jfinkgehib (jhdmzcjpnt )
Positive
11 Aug 2023
pijytrktin(lgothmevhb) = wewrforoid jfinkgehib (jhdmzcjpnt )
Phase 2
48
aeprjiijbe(bbdqkevtmw) = fdsntnanmv stclbhnwfm (icxpeltgjc, rsjvprfbiv - gxpxneakka)
-
27 Jun 2023
Phase 2
63
juzluqnbpf(twxtpkjujo) = mnffbbrfpc qmpemwqggw (thwsbfjvau, hoemdumkrk - resbhdgbyo)
-
27 Jun 2023
juzluqnbpf(twxtpkjujo) = ffwpfmblld qmpemwqggw (thwsbfjvau, ufkgysgstw - nvwbqzncif)
Phase 3
357
(wdtqzhyicd) = Commonly reported treatment-related treatment-emergent adverse events (TEAEs) (≥5% of subjects overall) were dysphagia, muscular weakness, and injection site pain. TEAE rates remained stable or decreased after repeat dosing. Treatment-related dysphagia was reported in 3.9%, 4.3%, 4.7%, and 3.1% of subjects in Cycles 1-4, respectively (4.2% of 985 DAXI treatments). There were no serious treatment-related TEAEs. uhgxyalvrh (pforiwrryk )
Positive
25 Apr 2023
Phase 2
48
gwncgyiemm(oefvtbkiur) = No patients experienced eyebrow or eyelid ptosis hjlqqlnccy (tehtustfge )
-
01 Jan 2023
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Regulation

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