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oxybutynin

Generic: OXYBUTYNIN·Brand: DITROPAN, DITROPAN XL, Ditropan, GELNIQUE, GELNIQUE 3%, Gelnique, OXYBUTYNIN, OXYBUTYNIN CHLORIDE, OXYTROL, OXYTROL FOR WOMEN, Oxytrol

oxybutynin: developed by 1 company · 1 clinical trial tracked · 2 FDA decisions.

oxybutynin evidence translation

What we can confirm

2 FDA records · 1 tracked trial

What it means

Source-backed records connect oxybutynin to ABBV; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could oxybutynin → ABBV affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Hot Flashes

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
AbbVie Inc. (ABBV)Approved
Clinical Trials (1)

A Phase IV, Longitudinal, Observational Study Examining Real-World Outcomes of Non-Hormonal Pharmacotherapies Among Individuals Treated for Bothersome Vasomotor Symptoms

NCT06049797
Completed

Primary endpoint: Mean change from baseline to week 12 in symptom bother measured by the Menopause-Specific Quality of Life Domain (MENQoL) 1-week recall VMS domain score

Observational999 enrolledStarted 2023-11Completion 2026-0548 sites · United StatesAstellas Pharma Global Development, Inc.
FDA Decisions2 records
ApprovalUse treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the pa(ABBV)FDA ↗
NDA202211Type 8 - Partial Rx to OTC SwitchStandardOtherFilm, Extended Release
Approval(ABBV)FDA ↗
NDA022204Type 3 - New Dosage FormStandardOtherGel

Frequently asked questions

Who is developing oxybutynin?

oxybutynin is being developed by AbbVie Inc..

How many clinical trials involve oxybutynin?

BioSniper tracks 1 clinical trial involving oxybutynin.

What is oxybutynin's latest FDA decision?

The most recent tracked FDA decision for oxybutynin is Approval for Use treats overactive bladder in women you may be suffering from overactive bladder if you have had 2 or more of the following symptoms for at least 3 months: ○ urinary frequency (the need to urinate more often than usual; typically more than 8 times in 24 hours) ○ urinary urgency (a strong need to urinate right away) ○ urge incontinence (leaking or wetting yourself if you cannot control the urge to urinate) non-drug therapies may also help you (see the consumer information leaflet inside the pa, dated January 25, 2013.