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ZTlido

Phase 1

Healthy | Small molecule | Other |Scilex Holding Company|Last Updated: Nov 3, 2021

Target and mechanism

ModalitySmall molecule

Also known as ZTlido (Lidocaine Topical System) 1.8%, ZTlido 1.8%

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

ZTlido · 1 trial · 1 indication

Phase 1 1
NCT05106400Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing PatchesHealthy
COMPLETED24 Analytics
PHASE1COMPLETED
Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in Percent adhesion
0, 3, 6, 8, 10, and 12 hours

The adhesion performance (i.e., degree of lifting or detachment) is assessed by clinicians at each time point. The adhesion of Test Products 1, 2, and 3 (each over-the-counter external analgesic lidocaine-containing patch) are compared to the adhesion performance observed for the Reference Product.

Secondary Endpoints

Adverse events
12 hours
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
ZTlido (Lidocaine Topical System) 1.8%OTHER -
Salonpas (Lidocaine Patch 4%)OTHER -
Aspercreme (Lidocaine Patch 4%)OTHER -
IcyHot (Lidocaine 4% + Menthol 1% Patch)OTHER -

Interventions

NameTypeDescription
ZTlido (Lidocaine Topical System) 1.8%DRUG1 ZTlido (Lidocaine Topical System) 1.8% is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
Salonpas (Lidocaine Patch 4%)DRUG1 Salonpas (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
Aspercreme (Lidocaine Patch 4%)DRUG1 Aspercreme (Lidocaine Patch 4%) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
IcyHot (Lidocaine 4% + Menthol 1% Patch)DRUG1 IcyHot (Lidocaine 4% + Menthol 1% Patch) is applied predetermined area on the right or left side of the mid to upper back and worn for 12 hours
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Eligibility Criteria

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

Inclusion Criteria: * Healthy, male and female subjects aged 18 years and older with a Body Mass Index (BMI) range 18.0-32.49 kg/m2 inclusive (according to the formula of BMI = weight (kg) / \[height (m)2\]). * Subjects who have no evidence of underlying disease during screening and check-in and wh...

Countries:United States
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Frequently asked questions about ZTlido

What is ZTlido 1.8% used for?

ZTlido 1.8% is a small molecule drug being developed by Scilex Holding Company (SCLX). It is currently in Phase 1 clinical development for use in healthy volunteers. The drug is being studied for its adhesive properties compared to other lidocaine-containing patches.

What does ZTlido 1.8% target?

ZTlido 1.8% is a lidocaine-containing patch. Lidocaine is a local anesthetic that works by blocking nerve signals in the body. The drug is being studied for its adhesion characteristics in a clinical trial involving healthy volunteers.

Who makes ZTlido 1.8%?

ZTlido 1.8% is being developed by Scilex Holding Company, which trades under the ticker symbol SCLX. The company is conducting clinical research on this drug for use in healthy volunteers.

What phase is ZTlido 1.8% in?

ZTlido 1.8% is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is ZTlido 1.8% in?

ZTlido 1.8% has one completed clinical trial, NCT05106400, titled 'Clinical Adhesion Study Between ZTlido 1.8% and Three Over-the-counter External Analgesic Lidocaine-containing Patches'. This Phase 1 study enrolled 24 healthy volunteers in the United States.

Is ZTlido 1.8% the same as other lidocaine patches?

ZTlido 1.8% is being studied in comparison to three over-the-counter external analgesic lidocaine-containing patches. The clinical trial NCT05106400 was designed to assess the adhesion properties of ZTlido 1.8% relative to these other products.