Recent Updates
Recently added Catalysts

Xanax

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Jan 28, 2021

Xanax development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Mar 2009

Xanax target and mechanism

ModalitySmall molecule

Also known as alprazolam oral tablet, alprazolam commercial immediate release oral tablet

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment16

FDA Designations

No designations recorded

Xanax clinical trials

Xanax · 1 trial · 1 indication

Phase 1 1
NCT01330472An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing SitesHealthy Subjects
COMPLETED16 Analytics
PHASE1COMPLETED
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites
Healthy SubjectsUnlock trial analytics

Study Endpoints

Primary Endpoints

Area under the curve from time zero to infinity (AUCinf) of alprazolam
Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Peak plasma conc (Cmax) of alprazolam
Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose

Secondary Endpoints

Area under the curve from zero to the last time point (AUClast) of alprazolam
Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Area under the curve extrapolated (AUC%extrap) of alprazolam
Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Terminal half life of alprazolam
Predose, and at 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours postdose
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Xanax XR tablets 3 mg (sourced from Caugus)ACTIVE_COMPARATORXanax XR tablets 3 mg (sourced from Caugus), 1 x 3 mg (REFERENCE)
Xanax XR tablets 3 mg (sourced from Barceloneta),EXPERIMENTALXanax XR tablets 3 mg (sourced from Barceloneta), 1 x 3 mg (TEST)

Interventions

NameTypeDescription
Xanax XR tablets 3 mg (sourced from Caugus)DRUGTablets, 3 mg, single dose
Xanax XR tablets 3 mg (sourced from Barceloneta)DRUGTablets, 3 mg, single dose
Unlock Study Design Details

Eligibility Criteria

Age Range20 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive. * An informed consent document signed and dated by the subject. Exclusion Criteria: * Evidence or history of clinically significant abnormality. * A positive urine drug screen. * Subjects who...

Countries:Singapore
Unlock Eligibility Criteria

Frequently asked questions about Xanax

What is Xanax used for?

Xanax is used for the treatment of anxiety and panic disorders. It is a small molecule drug developed by Viatris Inc. (VTRS). The drug is currently in Phase 1 clinical development, with ongoing studies evaluating its safety and pharmacokinetics in healthy volunteers.

Who makes Xanax?

Xanax is developed by Viatris Inc., a global healthcare company traded on the NASDAQ under the ticker VTRS. The company is conducting Phase 1 clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is Xanax in?

Xanax is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities. The Phase 1 trials are designed to assess the drug's safety, tolerability, and pharmacokinetic profile in healthy volunteers.

What clinical trials is Xanax in?

Xanax has completed three Phase 1 clinical trials, all conducted in the United States. These include NCT00647634, NCT00647894, and NCT00650299, which evaluated the fasting and fed pharmacokinetics of alprazolam extended-release tablets compared to Xanax XR tablets in healthy volunteers.

Is Xanax the same as alprazolam?

Xanax is a brand name for alprazolam. The clinical trials for Xanax are studies of alprazolam extended-release tablets, comparing them to the reference product Xanax XR. These studies are conducted in healthy volunteers to assess bioequivalence.