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Oxybutynin Chloride

Phase 2FDA approved

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Oxybutynin Chloride development status

FDA approval on record Dec 16, 1998
Approval holderJanssen Pharms
ApplicationNDA020897
Highest phase Phase 2 run by Ortho-McNeil Janssen Scientific Affairs, LLC (NCT00990886)
Phase scored for VTRSPhase 1
Registered trials 1 across 1 sponsor since Oct 2009

Oxybutynin Chloride target and mechanism

Molecular targetCHRM2, CHRM3
Target classAntagonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials3
Total Enrollment168

FDA Designations

No designations recorded

Oxybutynin Chloride clinical trials

Oxybutynin Chloride · 3 trials · 1 indication

Phase 1 3
NCT00649272Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mgHealthy
COMPLETED80 Analytics
NCT00648843Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mgHealthy
COMPLETED28 Analytics
NCT00650481Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mgHealthy
COMPLETED60 Analytics
PHASE1COMPLETED
Fasting Study of Oxybutynin Chloride Extended-Release Tablets 15 mg and Ditropan XL® Tablets 15 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Food Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
HealthyUnlock trial analytics
PHASE1COMPLETED
Fasting Study of Oxybutynin Chloride Extended-release Tablets 5 mg and Ditropan XL® Tablets 5 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALOxybutynin Chloride Extended-Release Tablets, 15 mg
2ACTIVE_COMPARATORDitropan XL® Extended-release tablets, 15 mg

Interventions

NameTypeDescription
Oxybutynin Chloride Extended-Release Tablets, 15 mgDRUG15mg, single dose fasting
Ditropan XL® Extended-release tablets, 15 mgDRUG15mg, single dose fasting
Oxybutynin Chloride Extended-release Tablets 5 mgDRUG4x5mg, single dose fed
Ditropan XL® Tablets 5 mgDRUG4x5mg, single dose fed
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Eligibility Criteria

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

Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have a negative serum beta human chorionic gonadotropin (β-HCG) pregnancy test performed within 28 days prior to the start of the study and on the even...

Countries:United States
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Frequently asked questions about Oxybutynin Chloride

What is Oxybutynin Chloride?

Oxybutynin Chloride is a small molecule drug developed by Viatris Inc. (ticker VTRS). It is an antagonist that targets the CHRM2 and CHRM3 receptors. The drug is in Phase 1 clinical development, and its specific indications are currently undisclosed.

What does Oxybutynin Chloride target?

Oxybutynin Chloride targets the CHRM2 and CHRM3 receptors. It acts as an antagonist at these targets. This mechanism of action is characteristic of small molecule drugs in its class.

Who makes Oxybutynin Chloride?

Oxybutynin Chloride is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of this drug candidate.

What phase is Oxybutynin Chloride in?

Oxybutynin Chloride is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The Phase 1 trials have been completed, and no active trials are currently ongoing.

What clinical trials is Oxybutynin Chloride in?

Oxybutynin Chloride has been studied in three completed Phase 1 trials: NCT00650481, NCT00649272, and NCT00648843. These trials enrolled a total of 168 healthy volunteers in the United States. All trials were randomized and active-controlled, comparing the drug to Ditropan XL tablets.

Is Oxybutynin Chloride the same as Oxybutynin Chloride Extended-release Tablets?

Yes, Oxybutynin Chloride is also known as Oxybutynin Chloride Extended-release Tablets 5 mg and Oxybutynin Chloride Extended-Release Tablets, 15 mg. These alternative names refer to the same drug candidate developed by Viatris Inc.