Recent Updates
Recently added Catalysts

DR-3001

Phase 3

Overactive Bladder | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Trials Updated: Mar 16, 2023

DR-3001 development status

Highest phase Phase 3
Registered trials 1 across 1 sponsor since May 2001

DR-3001 target and mechanism

ModalitySmall molecule

Also known as Oxybutinyn Vaginal Ring

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment1,344

FDA Designations

No designations recorded

DR-3001 clinical trials

DR-3001 · 2 trials · 1 indication

Phase 3 2
NCT00685113A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive BladderOveractive Bladder
COMPLETED1,104 Analytics
NCT00782769A Safety Extension Study of DR-OXY-301Overactive Bladder
COMPLETED240 Analytics
PHASE3COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
Overactive BladderUnlock trial analytics
PHASE3COMPLETED
A Safety Extension Study of DR-OXY-301
Overactive BladderUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in total weekly number of incontinence (urge and stress)episodes
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
Duration of Study

Secondary Endpoints

Change in average daily urinary frequency and average void volume
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Proportion of subjects with no incontinence episodes recorded in the final 3-day diary
Final 3-day diary
3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question
Baseline to end-of-treatment (Week 12/Early Withdrawal)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Oxybutinyn Vaginal Ring 4mgEXPERIMENTALinserted daily and replaced every 4 weeks
Oxybutinyn Vaginal Ring 6mgEXPERIMENTALinserted daily and replaced every 4 weeks

Interventions

NameTypeDescription
DR-3001DRUG4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
PlaceboDRUGPlacebo vaginal ring inserted vaginally and replaced every 4 weeks
Oxybutinyn Vaginal Ring 4mgDRUG -
Oxybutinyn Vaginal Ring 6mgDRUG -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexFEMALE
Healthy VolunteersYes
Study Sites84

Inclusion Criteria: * Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months * Able to distinguish between stress and urge incontinence * During the Screening Period able to demonstrate the presence of overactive bladder with urge in...

Countries:United StatesCanada
Unlock Eligibility Criteria

Frequently asked questions about DR-3001

What is DR-3001 used for?

DR-3001 is an investigational small molecule being developed for the treatment of overactive bladder. It is intended for use in women with this condition. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes DR-3001?

DR-3001 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 3 clinical trials for overactive bladder.

What phase is DR-3001 in?

DR-3001 is in Phase 3 clinical development. It is an investigational drug for overactive bladder and has not been approved by regulatory agencies. One Phase 3 trial has been completed, involving 1,104 female participants.

What clinical trials is DR-3001 in?

DR-3001 has one completed Phase 3 clinical trial, identified as NCT00685113. This trial evaluated the efficacy and safety of DR-3001 in women with overactive bladder. The study was randomized, double-blind, and placebo-controlled, enrolling 1,104 participants in the United States and Canada.

Is DR-3001 FDA approved?

DR-3001 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for overactive bladder. A Phase 3 trial has been completed, but the drug has not yet received regulatory approval.