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Botulinum purified neurotoxin, Type A

Phase 2

Glabellar Frown Lines | Biologics | Dermatology |Evolus, Inc.|Trials Updated: Apr 24, 2019

Botulinum purified neurotoxin, Type A target and mechanism

Molecular targetSNAP25
Target classHydrolytic Enzyme
ModalityBiologics

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment352

FDA Designations

No designations recorded

Botulinum purified neurotoxin, Type A clinical trials

Botulinum purified neurotoxin, Type A · 1 trial · 1 indication

Phase 2 1
NCT02184988Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar LinesGlabellar Frown Lines
COMPLETED352 Analytics
PHASE2COMPLETED
Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines
Glabellar Frown LinesUnlock trial analytics

Study Endpoints

Primary Endpoints

The Safety of Repeat DWP-450 Treatments - Proportion of Subjects With at Least One Adverse Event Over 1 Year
365 Days

The primary safety analysis was the calculation of the proportion of subjects with at least one adverse event that occurred from Day 0 through Day 365.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Botulinum neurotoxin, Type AEXPERIMENTALDWP-450 (Botulinum purified neurotoxin, Type A) Injection

Interventions

NameTypeDescription
Botulinum purified neurotoxin, Type ABIOLOGICALThe subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria (A subject must meet all of the following inclusion criteria in order to be eligible for enrollment in the study): * Subjects must be an adult 18 years of age or over * Subject is able to provide informed consent and comply with study instructions * Subject has moderate to severe...

Countries:United States
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Frequently asked questions about Botulinum purified neurotoxin, Type A

What is botulinum purified neurotoxin, Type A used for?

Botulinum purified neurotoxin, Type A is being studied by Evolus, Inc. for the treatment of glabellar frown lines, the vertical lines between the eyebrows. The development program in this indication has reached Phase 2, and the clinical work to date has focused on evaluating injection of the neurotoxin in adults with glabellar lines.

What does botulinum purified neurotoxin, Type A target?

Botulinum purified neurotoxin, Type A targets SNAP25, a hydrolytic enzyme. By acting on SNAP25, the neurotoxin interferes with the protein machinery involved in neurotransmitter release. This target class, a hydrolytic enzyme, is the basis for the molecule's pharmacological activity in the glabellar frown line program.

Who is developing botulinum purified neurotoxin, Type A?

Botulinum purified neurotoxin, Type A is being developed by Evolus, Inc., which trades under the ticker EOLS. The company is advancing the neurotoxin as a treatment for glabellar frown lines, and the program has reached Phase 2 clinical development.

What phase is botulinum purified neurotoxin, Type A in?

Botulinum purified neurotoxin, Type A is in Phase 2 development for glabellar frown lines. It is an investigational product and is not approved for this use. The Phase 2 program consists of one completed trial, and no trials in this program are currently active.

What clinical trials is botulinum purified neurotoxin, Type A in?

Botulinum purified neurotoxin, Type A has been evaluated in one Phase 2 trial, NCT02184988, titled Safety Study of DWP-450 (Botulinum Purified Neurotoxin, Type A) Injection to Treat Glabellar Lines. The trial was completed in the United States and enrolled 352 participants aged 18 years and older, including healthy volunteers.

Is botulinum purified neurotoxin, Type A the same as DWP-450?

Yes. DWP-450 is another name for botulinum purified neurotoxin, Type A. The Phase 2 trial NCT02184988, which studied injection of the neurotoxin to treat glabellar lines, refers to the product as DWP-450, so searches for either name point to the same Evolus, Inc. development program.